Spikevax XBB 1 5 PM en

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
SPIKEVAX® XBB.1.5
andusomeran mRNA vaccine
[COVID-19 mRNA vaccine, monovalent (XBB.1.5 Variant)]
Dispersion for intramuscular injection
Multidose Vial, 0.10 mg / mL
Active Immunizing Agent
SPIKEVAX XBB.1.5 (andusomeran mRNA vaccine) is indicated for:

 Active immunization against coronavirus disease 2019 (COVID-19) caused by the severe acute
respiratory syndrome coronavirus 2 (SARS-CoV-2) virus in individuals 6 months of age and
older.
SPIKEVAX XBB.1.5 has been issued marketing authorization with Terms and Conditions that need to
be met by the Market Authorization Holder to ascertain the continued quality, safety and
effectiveness of the vaccine.
Patients should be advised of the nature of the authorization. For further information for SPIKEVAX
XBB.1.5 (andusomeran mRNA vaccine) please refer to Health Canada’s COVID-19 vaccines and
treatments portal.
Moderna Biopharma Canada Corp. Date of Initial Authorization:

155 Wellington St. W, Suite 3130 September 12, 2023
Toronto, ON
M5V 3L3
Submission Control Number: 275936
SPIKEVAX XBB.1.5 (andusomeran mRNA vaccine) Page 1 of 71

RECENT MAJOR LABEL CHANGES
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TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES ........................................................................................... 2

TABLE OF CONTENTS ............................................................................................................. 2
PART I: HEALTH PROFESSIONAL INFORMATION ..................................................................... 4
1 INDICATIONS .............................................................................................................. 4
1.1 Pediatrics................................................................................................................... 4
1.2 Geriatrics ................................................................................................................... 4
2 CONTRAINDICATIONS................................................................................................. 4
3 SERIOUS WARNINGS AND PRECAUTIONS .................................................................... 4
4 DOSAGE AND ADMINISTRATION................................................................................. 5
4.1 Dosing Considerations .............................................................................................. 5
4.2 Recommended Dose and Dosage Adjustment ......................................................... 5
4.2.1 Vaccination for Individuals 12 Years of Age and Older....................................... 5
4.2.2 Vaccination for Individuals Aged 5 to 11 Years .................................................. 5
4.2.3 Vaccination Schedule for Individuals Aged 6 Months to 4 Years ....................... 6
4.3 Reconstitution ........................................................................................................... 6
4.4 Administration .......................................................................................................... 6
5 OVERDOSAGE............................................................................................................. 7
6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 7
7 WARNINGS AND PRECAUTIONS .................................................................................. 8
7.1 Special Populations ................................................................................................... 9
7.1.1 Pregnant Women ................................................................................................ 9
7.1.2 Breast-feeding ..................................................................................................... 9
7.1.3 Pediatrics........................................................................................................... 10
7.1.4 Geriatrics ........................................................................................................... 10
8 ADVERSE REACTIONS................................................................................................ 10
8.1 Adverse Reaction Overview .................................................................................... 10
8.2 Clinical Trial Adverse Reactions ............................................................................. 13

8.2.1 SPIKEVAX XBB.1.5.............................................................................................. 13
8.2.2 SPIKEVAX Bivalent Original / Omicron BA.4/5 .................................................. 15
8.2.3 SPIKEVAX Bivalent (Original/Omicron BA.1) ..................................................... 15
8.2.4 SPIKEVAX (Original) ........................................................................................... 23
8.3 Less Common Clinical Trial Adverse Reactions ....................................................... 42
8.4 Post-Market Adverse Reactions.............................................................................. 43
9 DRUG INTERACTIONS ............................................................................................... 43
10 CLINICAL PHARMACOLOGY ....................................................................................... 43
10.1 Mechanism of Action ........................................................................................ 43
11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 44
12 SPECIAL HANDLING INSTRUCTIONS........................................................................... 44
PART II: SCIENTIFIC INFORMATION ...................................................................................... 45
13 PHARMACEUTICAL INFORMATION ........................................................................... 45
14 CLINICAL TRIALS ....................................................................................................... 45
14.1 Trial Design and Study Demographics .............................................................. 45
14.1.1 SPIKEVAX XBB.1.5.............................................................................................. 47
14.1.2 SPIKEVAX Bivalent (Original / Omicron BA.1) ................................................... 47
14.2 Study Results ..................................................................................................... 52
14.2.1 SPIKEVAX XBB.1.5.............................................................................................. 52
14.2.2 SPIKEVAX Bivalent Original / Omicron BA.4/5 .................................................. 52
14.2.3 SPIKEVAX Bivalent (Original / Omicron BA.1) ................................................... 53
15 MICROBIOLOGY ....................................................................................................... 67
16 NON-CLINICAL TOXICOLOGY ..................................................................................... 67
PATIENT MEDICATION INFORMATION ................................................................................. 68

PART I: HEALTH PROFESSIONAL INFORMATION
1 INDICATIONS
SPIKEVAX® XBB.1.5 (andusomeran mRNA vaccine) is indicated for active immunization against
coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2
(SARS-CoV-2) virus in individuals 6 months of age and older.
The safety and effectiveness of SPIKEVAX XBB.1.5 for individuals 6 months of age and older is inferred
from several studies of a primary series and booster dose of SPIKEVAX Bivalent (Original/Omicron BA.1)
in individuals 6 months to 5 years of age, a booster dose study of SPIKEVAX Bivalent (Original/Omicron
BA.1) in individuals >18 years of age, a booster dose study of SPIKEVAX XBB.1.5 in individuals > 18 years
of age, as well as data from studies which evaluated the primary series and booster vaccination with
SPIKEVAX (Original).
The National Advisory Committee on Immunization (NACI) provides additional guidance on the use of
the COVID-19 vaccines in Canada. Please refer to the COVID-19 vaccine: Canadian Immunization Guide
and current vaccine statements.
1.1 Pediatrics
The safety and efficacy of SPIKEVAX XBB.1.5 in individuals under 6 months of age has not yet been
established (see ADVERSE REACTIONS, and CLINICAL TRIALS sections).
1.2 Geriatrics
Clinical studies of SPIKEVAX Bivalent (Original/Omicron BA.1) that included participants 65 years of age
and older and their data contribute to the overall assessment of safety and effectiveness of SPIKEVAX
XBB.1.5 (andusomeran) mRNA COVID-19 vaccine (see ADVERSE REACTIONS and CLINICAL TRIALS
sections).
2 CONTRAINDICATIONS
SPIKEVAX XBB.1.5 is contraindicated in individuals who are hypersensitive to the active ingredient or to
any ingredients in the formulation, including any non-medicinal ingredient, or component of the
container. For a complete listing, see
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
3 SERIOUS WARNINGS AND PRECAUTIONS
At the time of authorization, there are no known serious warnings or precautions associated with this
product.

4 DOSAGE AND ADMINISTRATION
4.1 Dosing Considerations
SPIKEVAX XBB.1.5 is a dispersion for intramuscular injection that should be administered by a trained
healthcare worker.
Individuals ≥ 12 Years of Age: One dose of 50 mcg.
Individuals 5 to 11 Years of Age: One dose of 25 mcg.
Individuals 6 Months to 4 Years of Age:

 Not previously vaccinated: Two (2) doses of 25 mcg each.
 Previously vaccinated with 1 or more doses: One dose of 25 mcg.
COVID-19 Vial Cap Label Dose

Age Range Presentation Dose(s)
Vaccination History Colour Colour Volume
Not previously
12 years
vaccinated Royal Coral 1 dose:
of age or 0.10 mg/mL 0.5 mL
OR Blue Blue 50 mcg
older
previously vaccinated
Not previously
5 to 11
vaccinated Royal Coral 1 dose:
years of 0.10 mg/mL 0.25 mL
OR Blue Blue 25 mcg
age
previously vaccinated
Not previously Royal Coral 2 doses:
6 months 0.10 mg/mL 0.25 mL
vaccinated Blue Blue 25 mcg
to 4
yearsof Previously
Royal Coral 1 dose:
age vaccinated; 1 or more 0.10 mg/mL 0.25 mL
Blue Blue 25 mcg
previous doses
4.2 Recommended Dose and Dosage Adjustment
4.2.1 Vaccination for Individuals 12 Years of Age and Older
A dose of 50 mcg SPIKEVAX XBB.1.5 may be administered intramuscularly. If the individual has been
previously vaccinated with a COVID-19 vaccine, SPIKEVAX XBB.1.5 may be administered at least 6
months after receipt of a previous COVID-19 vaccine dose in individuals 12 years of age or older.
4.2.2 Vaccination for Individuals Aged 5 to 11 Years
A dose of 25 mcg SPIKEVAX XBB.1.5 may be administered intramuscularly. If the individual has been
previously vaccinated with a COVID-19 vaccine, SPIKEVAX XBB.1.5 may be administered at least 6
months after receipt of a previous COVID-19 vaccine dose individuals 5 through 11 years of age.

4.2.3 Vaccination Schedule for Individuals Aged 6 Months to 4 Years
Children Not Previously Vaccinated

A two-dose series of 25 mcg SPIKEVAX XBB.1.5 may be administered intramuscularly 4 weeks apart in
children 6 months to 4 years of age.
Children Previously Vaccinated

In individuals who received 1 or more previous doses of COVID-19 vaccine, SPIKEVAX XBB.1.5 may be
administered intramuscularly as one dose of 25 mcg at least 6 months after receipt of the previous dose
in individuals 6 months to 4 years of age.
If the child has received only 1 (one) prior dose of a COVID-19 vaccine, SPIKEVAX XBB.1.5 should be
administered to complete the two-dose series.
4.3 Reconstitution
SPIKEVAX XBB.1.5 must not be reconstituted, mixed with other medicinal products, or diluted. No
dilution is required prior to administration.
4.4 Administration
Use aseptic technique for preparation and administration.
Preparation
SPIKEVAX XBB.1.5 multidose vials are supplied as a frozen dispersion that does not contain preservative.
Each vial must be thawed prior to administration.
Number of Number of
Vaccination Presentation Volume in vial
0.5 mL doses 0.25 mL doses
SPIKEVAX XBB.1.5 0.10 mg /mL 2.5 mL 5 10
Thaw each vial before use.
Vial Cap Thaw time under refrigeration Thaw time at room temperature
Presentation
Colour between 2° to 8°C (36° to 46°F) between 15° to 25°C (59° to 77°F)
 2 hours
Royal After thawing, let vial stand at  45 minutes
0.10 mg/mL
Blue room temperature for 15 minutes
before administering.
Do not re-freeze vials after thawing.
Swirl the vial gently after thawing and between each withdrawal. Do not shake.

Administration
SPIKEVAX XBB.1.5 is a white to off-white dispersion. It may contain white or translucent product-related
particulates. Visually inspect SPIKEVAX XBB.1.5 vials for foreign particulate matter and/or discoloration
prior to administration. If either of these conditions exists, the vaccine should not be administered.
Administer SPIKEVAX XBB.1.5 intramuscularly (IM) only. The preferred site is the deltoid muscle of the
upper arm, or in infants and young children, the anterolateral aspect of the thigh. A needle length of ≥1
inch should be used as needles <1 inch may be of insufficient length to penetrate muscle tissue in some
adults.
Do not inject the vaccine intravascularly, subcutaneously or intradermally.
Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab. Withdraw each dose
of vaccine from the vial using a new sterile needle and syringe (preferentially a low dead-volume syringe
and/or needle) for each injection. Pierce the stopper preferably at a different site each time.
After Vial Puncture: The dose in the syringe should be used as soon as feasible and no later than 24
hours after the vial was first entered (needle-punctured).
SPIKEVAX XBB.1.5 is preservative free. Once the vial has been entered, it should be discarded after 24
hours. Do not refreeze. Thawed vials and filled syringes can be handled in room light conditions. Any
unused vaccine or waste material should be disposed of in accordance with local requirements.
5 OVERDOSAGE
In the case of a suspected vaccine overdose, monitoring of vital functions and symptomatic treatment
are recommended. Contact your regional poison control centre.
6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
Table 1 – Dosage Forms, Strengths, Composition and Packaging

Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients
Intramuscular injection Dispersion, (0.10 mg /mL)  Acetic acid
 Cholesterol
Andusomeran (mRNA) encoding the  DSPC (1,2-distearoyl-sn-glycero-3-
pre-fusion stabilized conformation phosphocholine)
variant (K982P and V983P) of the  Lipid SM-102
SARS-CoV-2 Spike glycoprotein  PEG2000-DMG (1,2-dimyristoyl-rac-
(Omicron subvariant XBB.1.5) glycerol,methoxy-polyethyleneglycol)
 Sodium acetate trihydrate
Multidose vial (2.5 mL)  Sucrose
 Trometamol
 Trometamol hydrochloride
 Water for injection

SPIKEVAX XBB.1.5 is provided as a white to off-white, sterile, preservative-free, frozen dispersion for
intramuscular injection. SPIKEVAX XBB.1.5 contains lipid nanoparticle (LNP), comprised of a messenger
ribonucleic acid (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of SARS-CoV-2 virus
omicron subvariant XBB.1.5 (K982P and V983P), and four lipids, formulated with the non-medicinal
ingredients listed in
Table 1. SPIKEVAX XBB.1.5 does not contain any preservatives, antibiotics, adjuvants, or human- or
animal-derived materials.
SPIKEVAX XBB.1.5 is supplied in a multi-dose 10R type 1 glass vial and in a multi-dose 2R type 1 glass vial.
The vial stopper does not contain natural rubber latex. Vials are packaged in a secondary carton
containing a total of ten (10) SPIKEVAX XBB.1.5 vials per carton. The 0.10 mg/mL multi-dose vial is
supplied with a royal blue flip-off plastic cap and has a vial label with the strength printed in coral blue.
To help ensure the traceability of vaccines for patient immunization record-keeping as well as safety
monitoring, health professionals should record the time and date of administration, quantity of
administered dose (if applicable), anatomical site and route of administration, brand name and generic
name of the vaccine, the product lot number and expiry date.
7 WARNINGS AND PRECAUTIONS
As with any vaccine, vaccination with SPIKEVAX XBB.1.5 may not protect all recipients.
Hypersensitivity and Anaphylaxis

Anaphylaxis has been reported in individuals who have received SPIKEVAX (elasomeran). As with all
vaccines, appropriate medical treatment, training for immunizers and supervision after immunization
should always be readily available in case of a rare anaphylactic event following the administration of
this vaccine.
Vaccine recipients should be kept under observation for at least 15 minutes after immunization; 30
minutes is a preferred interval when there is a specific concern about a possible vaccine reaction.
Subsequent doses of the vaccine should not be given to those who have experienced anaphylaxis to an
earlier dose of SPIKEVAX.
Cardiovascular
Myocarditis and Pericarditis

Very rare cases of myocarditis and/or pericarditis following vaccination with SPIKEVAX have been
reported during post-authorization use. There is an increased risk for myocarditis and pericarditis
following vaccination with SPIKEVAX, particularly within the first week following receipt of the second
primary series dose or first booster dose in male young adults. Available short-term follow-up data
suggest that the symptoms resolve in most individuals following standard treatment and rest, but
information on long-term sequelae is lacking. The decision to administer SPIKEVAX to an individual with
a history of myocarditis or pericarditis should take into account the individual’s clinical circumstances.

Healthcare professionals are advised to consider the possibility of myocarditis and/or pericarditis in their
differential diagnosis if individuals present with chest pain, shortness of breath, palpitations or other
signs and symptoms of myocarditis and/or pericarditis following immunization with a COVID-19 vaccine.
This could allow for early diagnosis and treatment. Cardiology consultation for management and follow
up should be considered. Vaccinees should be instructed to seek immediate medical attention if they
develop the signs or symptoms indicative of myocarditis or pericarditis as described above.
Acute Illness
Consideration should be given to postponing immunization in persons with severe febrile illness or
severe acute infection. Persons with moderate or severe acute illness should be vaccinated as soon as
the acute illness has improved.
Hematologic-Bleeding
As with other intramuscular injections, SPIKEVAX XBB.1.5 should be given with caution in individuals
with bleeding disorders, such as haemophilia, or individuals currently on anticoagulant therapy, to avoid
the risk of haematoma following the injection, and when the potential benefit clearly outweighs the risk
of administration.
Immune
Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a
diminished immune response to the vaccine.
Syncope
Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the
needle injection. Procedures should be in place to prevent injury from fainting and manage syncopal
reactions.
7.1 Special Populations
7.1.1 Pregnant Women
The safety and efficacy of SPIKEVAX XBB.1.5 in pregnant women have not yet been established.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/fetal
development, parturition, or post-natal development (see NON-CLINICAL TOXICOLOGY).
Individuals who are vaccinated with SPIKEVAX XBB.1.5 during pregnancy are encouraged to report
experienced adverse events by calling 1-866-MODERNA (1-866-663-3762).
7.1.2 Breast-feeding
It is unknown if SPIKEVAX XBB.1.5 is excreted in human milk. A risk to the newborns/infants cannot be
excluded. The developmental and health benefits of breastfeeding should be considered along with
the mother’s clinical need for immunization against COVID-19.

7.1.3 Pediatrics
The safety and efficacy of SPIKEVAX XBB.1.5 in children under 6 months of age have not yet been
established.
7.1.4 Geriatrics
Clinical studies of SPIKEVAX Bivalent (Original/Omicron BA.1) that included participants 65 years of age
and older and their data contribute to the overall assessment of safety and effectiveness of SPIKEVAX
XBB.1.5 (andusomeran) mRNA COVID-19 vaccine (see ADVERSE REACTIONS and CLINICAL TRIALS
sections).
8 ADVERSE REACTIONS
8.1 Adverse Reaction Overview
The safety of SPIKEVAX XBB.1.5 (andusomeran) mRNA vaccine for individuals 6 months of age and older
is inferred from several studies of a primary series and booster dose of SPIKEVAX Bivalent
(Original/Omicron BA.1) in individuals 6 months to 5 years of age, a booster dose study of SPIKEVAX
Bivalent (Original/Omicron BA.1) in individuals >18 years of age, a booster dose study of SPIKEVAX
XBB.1.5 in individuals > 18 years of age, as well as data from studies which evaluated the primary series
and booster vaccination with SPIKEVAX (Original).
Participants 18 Years of Age and Older
The safety of a monovalent booster dose of SPIKEVAX XBB.1.5 are evaluated in a Phase 2/3 open-label
study in adult participants (mRNA-1273-P205, Part J). The vaccines were administered as a fifth dose to
adults (50 micrograms) who previously received a two-dose primary series and a booster dose of an
original COVID-19 vaccine and a booster dose of a bivalent vaccine.
SPIKEVAX XBB.1.5 had a reactogenicity profile similar to prior doses of SPIKEVAX (original) and SPIKEVAX
Bivalent Original / Omicron BA.4/5. The most frequently reported adverse reactions after the SPIKEVAX
XBB.1.5 50 mcg booster dose were pain (68.0%), fatigue (44.0%), myalgia (38.0%), headache (34.0%),
arthralgia (28.0%),axillary swelling or tenderness (16.0%) and chills (14.0%).
The safety profile of SPIKEVAX Bivalent (Original/Omicron BA.1) in participants ≥ 18 years of age
presented below is based on data generated from an ongoing Phase 2/3 open-label study in participants
18 years of age and older (mRNA-1273-P205). In this study, 437 participants received the SPIKEVAX
Bivalent (Original/Omicron BA.1) 50 mcg booster dose (mRNA-1273.214, as 25 mcg elasomeran and 25
mcg imelasomeran), and 377 participants received the SPIKEVAX original 50 mcg booster dose (mRNA-
1273).
Overall, the frequency of solicited adverse reactions after the SPIKEVAX Bivalent 50 mcg booster dose
was similar to that observed following the SPIKEVAX (elasomeran) original 50 mcg booster dose. The
most frequently reported adverse reactions after the SPIKEVAX Bivalent 50 mcg booster dose were pain
(77.3%), fatigue (54.9%), headache (43.9%), myalgia (39.6%), arthralgia (31.1%) and axillary swelling or

tenderness (17.4%). The median duration of local and systemic adverse reactions was 2 days. The most
common adverse reactions after the SPIKEVAX original 50 µg booster dose was fatigue (51.4%),
headache (41.1%), myalgia (38.6%), and arthralgia (31.7%). The median duration of local and systemic
adverse reactions was 2 days.
Overall, after both the SPIKEVAX Bivalent 50 mcg booster dose and the SPIKEVAX original 50 mcg
booster dose there was a higher reported rate of solicited adverse reactions in younger age groups. The
incidence of pain, erythema, swelling/induration, lymphadenopathy (axillary swelling/tenderness),
fatigue, headache, myalgia, arthralgia, and nausea/vomiting was higher in adults 18 to 64 years of age
than in those 65 years of age and above (see Table , Table , Table and Table respectively).
Children and Adolescents 6 to 17 Years of Age
The safety and effectiveness of SPIKEVAX XBB.1.5 (andusomeran) mRNA vaccine for individuals 6
through 17 years of age are inferred from studies of a primary series and booster dose of SPIKEVAX
Bivalent (Original/Omicron BA.1) in individuals 6 months to 5 years of age, a booster dose of SPIKEVAX
Bivalent (Original/Omicron BA.1) in individuals 18 years of age and older, as well as data from studies
which evaluated the primary series and booster vaccination with SPIKEVAX.
Adolescents 12 to 17 Years of Age

Safety data in adolescents (12 to 17 years of age) were collected in an ongoing Phase 2/3 randomised,
placebo-controlled, observer-blind clinical trial (Study P203, NCT04649151) conducted in the United
States involving 3,726 participants who received at least one dose of SPIKEVAX (elasomeran) (n=2,486)
or placebo (n=1,240). Overall, solicited adverse reactions at any dose were reported more frequently
among adolescents in the vaccine group than in the placebo group. The most frequently reported
adverse reactions in adolescent subjects were pain at the injection site (97.2%), headache (78.4%),
fatigue (75.2%), myalgia (54.3%), and chills (49.1%) (see Table 11 and Table 12).
This study transitioned to an open-label Phase 2/3 study in which 1,364 participants 12 years through 17
years of age received a booster dose of SPIKEVAX at least 5 months after the second dose of the primary
series. The most common solicited local adverse reactions were pain (91%) and axillary swelling or
tenderness (28%). The most common solicited systemic ARs were fatigue (59%), headache (57%),
myalgia (40%), chills (31%), and arthralgia (24%).
Children 6 to 11 Years of Age

Safety data in children (6 years to 11 years of age) were collected in an ongoing Phase 2/3 two-part
clinical trial (Study P204, NCT04796896) conducted in the United States and Canada. Part 1 is an open-
label phase of the trial for safety, dose selection, and immunogenicity involving 380 participants who
received at least one dose of SPIKEVAX (0.25 mL, 50 mcg). Part 2 is the placebo-controlled phase for
safety, immunogenicity and efficacy and it included 4,002 participants 6 years to 11 years of age who
received at least one dose (0.25 mL, 50 mcg) of SPIKEVAX (n=3,007) or placebo (n=995), and 2,988
SPIKEVAX participants and 973 placebo participants had received dose 2. No participants in Part 1
participated in Part 2.
Overall, solicited adverse reactions were reported more frequently among children in the vaccine group
than in the placebo group. The most frequently reported adverse reactions in children 6 years to 11
years of age in Part 2 following administration of the primary series were pain at the injection site

(94.8%), fatigue (64.5%), headache (54.3%), chills (30.3%) and myalgia (28.2%) (see Table 13 and Table
14).
The study protocol was amended to include an open label booster dose phase that included 1,294
participants 6 years through 11 years of age who received a booster dose of SPIKEVAX at least 6 months
after the second dose of the primary series. No additional adverse reactions were identified in the open-
label portion of the study.
Children 6 Months to 5 Years of Age

Safety data for SPIKEVAX XBB.1.5 (andusomeran) mRNA vaccine is inferred from Study P306 where
SPIKEVAX Bivalent (Original / Omicron BA.1) was evaluated for use in two-dose primary series
vaccination (25 mcg). Data were collected in an ongoing Phase 3 open-label clinical trial conducted in
the United States. Part 1 included data in 179 participants 6 months through 5 years of age who
received at least one dose of SPIKEVAX Bivalent (Original / Omicron BA.1) (Study P306 Part 1,
NCT05436834). As of the data cut-off date of December 5, 2022, the median duration of follow-up for
safety was 68 days after Dose 2.
Safety data in children (6 months to 5 years of age) were collected in an ongoing Phase 2/3 two-part
clinical trial (Study P204, NCT04796896) conducted in the United States and Canada. Part 1 is an open-
label phase of the trial for safety, dose selection, and immunogenicity involving 225 participants who
received at least one dose of SPIKEVAX (25 mcg). Part 2 is the placebo-controlled phase for safety,
immunogenicity and efficacy; at the time of data snapshot (February 21, 2022), this trial involved 6,388
participants 6 months to 5 years of age who received at least one dose (25 mcg) of SPIKEVAX (n=4,792)
or placebo (n=1,596) and 4,560 SPIKEVAX participants and 1,499 placebo participants had received dose
2.
In participants 6 months to less than 2 years of age in Part 2 the median follow-up duration was 98.0
days after dose 1 and 68.0 days after dose 2. A total of 1,470 (83.5%) subjects in the SPIKEVAX group
and 482 (81.8%) subjects in the placebo group have been followed for 28 days or more after dose 2. A
total of 1,138 subjects in the SPIKEVAX group (64.6%) and 368 subjects in the placebo group (62.5%)
have been followed for 56 days or more after dose 2. In participants 2 years to less than 6 years of age in
Part 2 the median follow-up duration was 103.0 days after dose 1 and 71.0 days after dose 2. A total of
2,713 (89.5%) subjects in the SPIKEVAX group and 892 (88.6%) subjects in the placebo group have been
followed for 28 days or more after dose 2. A total of 2,180 subjects in the SPIKEVAX group (71.9%) and
710 subjects in the placebo group (70.5%) have been followed for 56 days or more after dose 2.
Overall, solicited adverse reactions were reported more frequently among children in the vaccine group
than in the placebo group. The most frequently reported local and systemic adverse reactions in
children 6 months to < 24 months of age in Part 2 following administration of the primary series were
irritability/crying (64.3%), pain (46.2%), sleepiness (35.1%) and loss of appetite (32.1%). The most
frequently reported local adverse reaction in children 2 years to 5 years of age in Part 2 following
administration of the primary series was pain (71.4%). The most frequently reported systemic adverse
reactions in children 24 months to ≤ 36 months of age in Part 2 following administration of the primary
series were irritability/crying (54.3%), sleepiness (36.0%) and loss of appetite (30.5%) The most
frequently reported systemic adverse reactions in children 37 months to 5 years of age in Part 2
following administration of the primary series was fatigue (48.8%).

8.2 Clinical Trial Adverse Reactions
Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the
clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to
the rates in the clinical trials of another vaccine. Adverse reaction information from clinical trials may be
useful in identifying and approximating rates of adverse vaccine reactions in real-world use.
8.2.1 SPIKEVAX XBB.1.5
8.2.1.1 Participants 18 Years of Age and Older
8.2.1.1.1 Booster Dose
Solicited Adverse Reactions
The safety, reactogenicity, and immunogenicity of a monovalent booster dose of SPIKEVAX XBB.1.5 are
evaluated in a Phase 2/3 open-label study in adult participants (mRNA-1273-P205, Part J). In this study,
50 participants received a monovalent booster dose of SPIKEVAX XBB.1.5 (50 micrograms), and
51 participants received a dose of an investigational bivalent vaccine (XBB.1.5/Omicron BA.4/5). The
vaccines were administered as a fifth dose to adults who previously received a two-dose primary series
and a booster dose of an original COVID-19 vaccine and a booster dose of a bivalent vaccine.
Participants were followed for a median duration of 20 days.
SPIKEVAX XBB.1.5 had a reactogenicity profile similar to prior doses of SPIKEVAX (original) and SPIKEVAX
Bivalent Original / Omicron BA.4/5. There were no Grade 4 local or systemic reactions and no fatal
events or serious adverse events in this interim analysis. Reported solicited local and systemic adverse
reactions are presented in Table , and Table respectively.
Table 2 – Summary of Participants with Solicited Local Adverse Reactions within 7 Days After the
Injection by Grade – 3rd Booster Dose: mRNA-1273.815, Participants 18 to 64 (Solicited Safety Set*)
SPIKEVAX XBB.1.5 Group (mRNA-1273.815)
50 mcg
N=50
n (%)
Pain
Any grade 34 (68.0)
Grade 3a 0 (0)
Axillary swelling/ Tenderness
Any grade 8 (16.0)
Grade 3b 0 (0)
Swelling (Hardness)
Any grade 5 (10.0)
c
Grade 3 0 (0)
Erythema (Redness)
Any grade 2 (4.0)

50 mcg
N=50
n (%)
Grade 3c 0 (0)
*Solicited Safety Set: All participants who received a dose and contributed any solicited Adverse Reaction data.
n= # of participants with specified reaction, percentages are based on n/N
N= number of exposed subjects who submitted any data for the event.
a Pain - Grade 3: any use of Rx pain reliever/prevents daily activity
bAxillary Swelling/Tenderness collected as solicited local adverse reaction (i.e., lymphadenopathy: localized axillary swelling or
tenderness ipsilateral to the vaccination arm) - Grade 3: any use of Rx pain reliever/prevents daily activity
c Erythema and Swelling/Induration - Grade 3: >100mm/>10cm
Table 3 – Summary of Participants with Solicited Systemic Adverse Reactions within 7 Days After the
Injection by Grade – 3rd Booster Dose: mRNA-1273.815, Participants 18 to 64 (Solicited Safety Set*)
50 mcg
N=50
n (%)
Fatigue
Any grade 22 (44.0)
Grade 3a 0 (0)
Myalgia
Any grade 19 (38.0)
Grade 3a 0 (0)
Headache
Any grade 17 (34.0)
Grade 3b 0 (0)
Arthralgia
Any grade 14 (28.0)
Grade 3a 0 (0)
Chills
Any grade 7 (14.0)
Grade 3c 0 (0)
Nausea/vomiting
Any grade 4 (8.0)
Grade 3d 0 (0.0)
Fever
Any grade 3 (6.0)
Grade 3e 1 (2.0)
a Grade 3 fatigue, myalgia, arthralgia: Defined as significant; prevents daily activity.
b Grade 3 headache: Defined as significant; any use of prescription pain reliever or prevents daily activity.
c Grade 3 chills: Defined as prevents daily activity and requires medical intervention.
d Grade 3 nausea/vomiting: Defined as prevents daily activity, requires outpatient intravenous hydration.
e Grade 3 fever: Defined as ≥39.0 – ≤40.0°C / ≥102.1 – ≤104.0°F.
Unsolicited Adverse Events
There were no fatal or serious adverse events and no adverse events of special interest reported in

Study P205 Part J. All unsolicited adverse events were grade 1 or grade 2 in severity; no grade 3 or
higher events were reported.
8.2.2 SPIKEVAX Bivalent Original / Omicron BA.4/5
The safety, reactogenicity, and immunogenicity of a bivalent booster dose of SPIKEVAX Bivalent
Original/Omicron BA.4-5 are evaluated in an ongoing Phase 2/3 open-label study in participants 18 years
of age and older (mRNA-1273-P205). In this study, 511 participants received a second booster dose of
SPIKEVAX Bivalent Original/Omicron BA.4/5 (50 micrograms), and 376 participants received a second
booster dose of SPIKEVAX (original) (50 micrograms).
SPIKEVAX Bivalent Original/Omicron BA.4/5 had a reactogenicity profile similar to that of the SPIKEVAX
(original) booster given as a second booster dose. The frequency of adverse reactions after
immunisation with SPIKEVAX Bivalent Original/Omicron BA.4-5 was also similar or lower relative to that
of a first booster dose of SPIKEVAX (original) (50 micrograms) and relative to the second dose of the
SPIKEVAX (original) primary series (100 micrograms). No new safety signals were identified. The
incidence of solicited adverse reactions did not appear to be increased in participants with prior SARS-
CoV-2 infection when compared to participants without infection before receipt of the booster dose.
8.2.3 SPIKEVAX Bivalent (Original/Omicron BA.1)
The safety, reactogenicity, and immunogenicity of a booster dose of SPIKEVAX Bivalent

(Original/Omicron BA.1) are evaluated in an ongoing Phase 2/3 open-label study in participants 18 years
of age and older (mRNA-1273-P205). In this study, 437 participants received the SPIKEVAX Bivalent 50
mcg booster dose (mRNA-1273.214, as 25 mcg elasomeran and 25 mcg imelasomeran), and 377
participants received the SPIKEVAX original 50 mcg booster dose (mRNA-1273). Participants were
followed for a median duration of 43 days and 57 days for the SPIKEVAX Bivalent 50 mcg booster dose
and SPIKEVAX 50 mcg booster dose, respectively. The safety profile of SPIKEVAX Bivalent
(Original/Omicron BA.1) with a median follow-up period of 113 days was similar to the safety profile of
SPIKEVAX (original) with a median follow up period of 127 days.
Solicited adverse reaction data were collected from Day 1 to Day 7 and reported by participants in an
electronic diary (e-Diary) after each dose and on electronic case report forms. The reactogenicity
observed for both local and systemic adverse reactions was similar for both groups with 380 (87%) of
subjects in the mRNA-1273.214 group and 301 (85%) of subjects in the mRNA-1273 group experiencing

any solicited adverse reactions (AR)s. The frequency of grade 3 adverse reactions was 8.0% in both
groups. There were no grade 4 solicited ARs in either group. Reported solicited local and systemic
adverse reactions are presented in 4, 5, 6 and 7 respectively.
Injection by Grade – 2nd Booster Dose: mRNA-1273.214, mRNA-1273 Participants 18 to 64 (Solicited
Safety Set*)
2nd Booster Dose
SPIKEVAX Bivalent
SPIKEVAX Group
(Original/Omicron BA.1) Group
Solicited local AR (mRNA-1273)
(mRNA-1273.214)
50 mcg
50 mcg
N=211
N=263
n (%)
n (%)
Pain
Any grade 231 (87.8) 175 (82.9)
a
Grade 3 2 (0.8) 4 (1.9)
Erythema
Any grade 20 (7.6) 10 (4.7)
b
Grade 3 7 (2.7) 1 (0.5)
Swelling/Induration
Any grade 22 (8.4) 15 (7.1)
b
Grade 3 4 (1.5) 2 (0.9)
Any grade 56 (21.3) 39 (18.5)
Grade 3c 0 (0) 4 (1.9)
b Erythema and Swelling/Induration - Grade 3: >100mm/>10cm
c Axillary Swelling/Tenderness collected as solicited local adverse reaction (i.e., lymphadenopathy: localized axillary swelling or
Injection by Grade – 2nd Booster Dose: mRNA-1273.214, mRNA-1273 Participants 65 Years of Age and
Older (Solicited Safety Set*)
2nd Booster Dose
SPIKEVAX Bivalent
SPIKEVAX Group
(mRNA-1273.214)
50 mcg
50 mcg
N=140
N=174
n (%)
n (%)
Pain
Any grade 107 (61.5) 94 (67.1)
a
Grade 3 or 4 2 (1.1) 0 (0)

2nd Booster Dose
SPIKEVAX Bivalent
SPIKEVAX Group
(mRNA-1273.214)
50 mcg
50 mcg
N=140
N=174
n (%)
n (%)
Erythema
Any grade 10 (5.7) 3 (2.1)
Grade 3b 2 (1.1) 1 (0.7)
Swelling/Induration
Any grade 8 (4.6) 8 (5.7)
Grade 3b 1 (0.6) 3 (2.1)
Any grade 20 (11.5) 15 (10.7)
c
Grade 3 1 (0.6) 0 (0)
b Erythema and Swelling/Induration - Grade 3: >100mm/>10cm
Injection by Grade – 2nd Booster Dose: mRNA-1273.214, mRNA-1273 Participants 18 to 64 (Solicited
Safety Set*)
2nd Booster Dose
SPIKEVAX Bivalent
SPIKEVAX Group
(mRNA-1273)
Solicited Systemic AR (mRNA-1273.214)
50 mcg
50 mcg
N=263
N=263
n (%)
n (%)
Fatigue
Any grade 154 (58.6) 115 (54.5)
Grade 3a 10 (3.8) 7 (3.3)
Headache
Any grade 129 (49.0) 100 (47.4)
Grade 3b 4 (1.5) 1 (0.5)
Myalgia
Any grade 113 (43.0) 90 (42.7)
Grade 3a 9 (3.4) 8 (3.8)
Arthralgia
Any grade 87 (33.1) 69 (32.7)
Grade 3a 3 (1.1) 2 (0.9)
Chills
Any grade 64 (24.3) 54 (25.6)
Grade 3c 1 (0.4) 0 (0.0)

2nd Booster Dose
SPIKEVAX Bivalent
SPIKEVAX Group
(mRNA-1273)
50 mcg
50 mcg
N=263
N=263
n (%)
n (%)
Nausea/vomiting
Any grade 35 (13.3) 27 (12.8)
Grade 3d 0 (0.0) 0 (0.0)
Fever
Any grade 10 (3.8) 10 (4.7)
Grade 3e 1 (0.4) 0 (0)
Use of antipyretic or pain medication 104 67
(39.5) (31.8)
Injection by Grade – 2nd Booster Dose: mRNA-1273.214, mRNA-1273 Participants 65 Years of Age and
Older (Solicited Safety Set)
2nd Booster Dose
SPIKEVAX Bivalent
SPIKEVAX Group
(mRNA-1273)
50 mcg
50 mcg
N= 140
N=174
n (%)
n (%)
Fatigue
Any grade 86 (49.4) 65 (46.8)
Grade 3a 5 (2.9) 4 (2.9)
Headache
Any grade 63 (36.2) 44 (31.7)
Grade 3b 1 (0.6) 1 (0.7)
Myalgia
Any grade 60 (34.5) 45 (32.4)
Grade 3a 1 (0.6) 5 (3.6)
Arthralgia
Any grade 49 (28.2) 42 (30.2)
Grade 3a 1 (0.6) 1 (0.7)
Chills
Any grade 40 (23.0) 20 (14.4)
Grade 3c 0 (0.0) 1 (0.7)
Nausea/vomiting
Any grade 10 (5.7) 8 (5.8)

2nd Booster Dose
SPIKEVAX Bivalent
SPIKEVAX Group
(mRNA-1273)
50 mcg
50 mcg
N= 140
N=174
n (%)
n (%)
Grade 3d 1 (0.6) 0 (0.0)
Fever
Any grade 9 (5.2) 2 (1.4)
Grade 3e 0 (0.0) 0 (0.0)
Use of antipyretic or pain medication 46 40
(26.4) (28.6)
Table 8 – Summary of Participants with Solicited Adverse Reactions Within 7 Days After the Injection
by Grade and Pre-booster SARS-CoV-2 Status – 2nd Booster Dose: mRNA-1273.214; mRNA-1273
(Solicited Safety Set)
2nd Booster Dose
SPIKEVAX Bivalent
SPIKEVAX Group
mRNA-1273
mRNA-1273.214
50 µg
50 µg
Pre-booster SARS-CoV-2 Status Pre-booster SARS-CoV-2 Status
Solicited Adverse Reaction Negative Positive Negative Positive
Category (N=340) (N=96) (N=250) (N=92)
Grade* n (%) n (%) n (%) n (%)
Solicited adverse reactions - N1 340 96 250 92
Any grade solicited adverse 299 (87.9) 80 (83.3) 217 (86.8) 77 (83.7)
reactions
95% CI 84.0, 91.2 74.4, 90.2 82.0, 90.7 74.5, 90.6
Grade 3 29 (8.5) 6 (6.3) 24 (9.6) 4 (4.3)
Solicited local adverse reactions - N1 340 96 250 92
Any grade solicited local adverse 272 (80.0) 74 (77.1) 200 (80.0) 73 (79.3)
reactions
95% CI 75.3, 84.1 67.4, 85.0 74.5, 84.8 69.6, 87.1
Grade 3 14 (4.1) 1 (1.0) 9 (3.6) 3 (3.3)
Pain - N1 340 96 250 92
Any grade 265 (77.9) 72 (75.0) 193 (77.2) 71 (77.2)
Grade 3 4 (1.2) 0 3 (1.2) 1 (1.1)
Erythema (redness)a - N1 340 96 250 92
Any grade 27 (7.9) 3 (3.1) 10 (4.0) 3 (3.3)
Grade 3 8 (2.4) 1 (1.0) 1 (0.4) 1 (1.1)
Swelling (hardness)- N1 340 96 250 92

2nd Booster Dose
SPIKEVAX Bivalent
SPIKEVAX Group
mRNA-1273
mRNA-1273.214
50 µg
50 µg
Pre-booster SARS-CoV-2 Status Pre-booster SARS-CoV-2 Status
Solicited Adverse Reaction Negative Positive Negative Positive
Category (N=340) (N=96) (N=250) (N=92)
Grade* n (%) n (%) n (%) n (%)
Any grade 26 (7.6) 4 (4.2) 19 (7.6) 4 (4.3)
Grade 3 5 (1.5) 0 5 (2.0) 0
Axillary swelling or tenderness - N1 340 96 250 92
Any grade 58 (17.1) 18 (18.8) 35 (14.0) 18 (19.6)
Grade 3 1 (0.3) 0 3 (1.2) 1 (1.1)
Solicited systemic adverse reactions - 340 96 250 92
N1
Any grade solicited systemic 244 (71.8) 63 (65.6) 171 (68.4) 57 (62.0)
adverse reactions
95% CI 66.7, 76.5 55.2, 75.0 62.2, 74.1 51.2, 71.9
Grade 3 19 (5.6) 5 (5.2) 15 (6.0) 1 (1.1)
Feverb - N1 339 96 250 92
Any grade 16 (4.7) 3 (3.1) 10 (4.0) 2 (2.2)
Grade 3 1 (0.3) 0 0 0
Headache - N1 340 96 250 92
Any grade 154 (45.3) 38 (39.6) 106 (42.4) 37 (40.2)
Grade 3 5 (1.5) 0 2 (0.8) 0
Fatigue - N1 340 96 250 92
Any grade 194 (57.1) 46 (47.9) 134 (53.6) 42 (45.7)
Grade 3 11 (3.2) 4 (4.2) 10 (4.0) 1 (1.1)
Myalgia - N1 340 96 250 92
Any grade 137 (40.3) 36 (37.5) 93 (37.2) 40 (43.5)
Grade 3 10 (2.9) 0 13 (5.2) 0
Arthralgia - N1 340 96 250 92
Any grade 110 (32.4) 26 (27.1) 80 (32.0) 29 (31.5)
Grade 3 4 (1.2) 0 3 (1.2) 0
Nausea/vomiting - N1 340 96 250 92
Any grade 36 (10.6) 9 (9.4) 25 (10.0) 10 (10.9)
Grade 3 0 1 (1.0) 0 0
Chills - N1 340 96 250 92
Any grade 86 (25.3) 18 (18.8) 58 (23.2) 15 (16.3)
Grade 3 1 (0.3) 0 1 (0.4) 0
Abbreviations: CI = confidence interval; SARS-CoV-2 = severe acute respiratory infection coronavirus-2.
*No Grade 4 Solicited Adverse Reactions were observed.
N1 = number of exposed participants who submitted any data for the event. Any = Grade 1 or higher. Percentages are based on
the number of exposed participants who submitted any data for the event (N1). The 95% CI is calculated using the
Clopper-Pearson method.
a Toxicity grade for erythema (redness) is defined as: Grade 1 = 25 – 50 mm; Grade 2 = 51 – 100 mm; Grade 3 = greater than 100
mm.
b Toxicity grade for fever is defined as: Grade 1 = 38 – 38.4°C; Grade 2 = 38.5 – 38.9°C; Grade 3 = 39 – 40°C.

Overall, there were no safety concerns or differences identified in solicited adverse reactions based on
pre-booster SARS-CoV-2 status. The frequency of solicited local ARs was similar among participants with
a positive pre-booster SARS-CoV-2 status 74/96 [77.1%]) and participants with a negative pre-booster
SARS-CoV-2 status (272/340 [80.0%])
There were no important clinical differences between unsolicited events that occurred within 28 days
for participants who received the SPIKEVAX Bivalent (Original/Omicron BA.1, mRNA-1273.214) 50 mcg
booster dose when compared to participants who received the SPIKEVAX original (mRNA-1273) 50 mcg
booster dose. There were 81/437 participants (18.5%) in the SPIKEVAX Bivalent group that reported
unsolicited events, regardless of relationship to the vaccine, compared to 78/377 participants (20.7%) in
the SPIKEVAX original group.
In both groups the majority of unsolicited events were consistent with reactogenicity events. The most
commonly reported unsolicited events within 28 days after the SPIKEVAX Bivalent 50 mcg booster dose,
regardless of causality were fatigue (11/437 [2.5%]); headache and arthralgia (7/437 [1.6%] each). The
most commonly reported unsolicited events within 28 days after the SPIKEVAX original 50 mcg booster
dose, regardless of causality were fatigue (12/377 [3.2%]), upper respiratory tract infection (9/377
[2.4%]), and coronavirus infection (i.e., coronaviruses other than SARS-CoV-2) (8/377 [2.1%]). There
were no deaths reported in any of the two groups in the study.
Serious adverse events (SAE) were reported in 0.5% (2/437) of subjects who received the SPIKEVAX
Bivalent 50 mcg booster dose; and 0.3% (1/377) of subjects who received the SPIKEVAX original 50 mcg
booster dose, within 28 days after vaccination. Up to the data cut-off date (27 Apr 2022), one additional
SAE occurred in the SPIKEVAX Bivalent 50 mcg booster dose group.
8.2.3.2 Participants 6 Months to 5 Years of Age
8.2.3.2.1 Primary Series
The safety of a primary series of SPIKEVAX Bivalent (Original/Omicron BA.1) are evaluated in an ongoing
Phase 3 open-label clinical trial. In this study, 179 participants 6 months through 5 years of age who
received at least one dose of bivalent vaccine (mRNA-1273.214, as 12.5 mcg elasomeran and 12.5 mcg
imelasomeran). As of the data cutoff date of December 5, 2022, the median duration of follow-up for
safety was 68 days after Dose 2.
Local and systemic adverse reactions and use of antipyretic medication were solicited in an electronic
diary for 7 days following each injection (i.e., day of vaccination and the next 6 days) among participants
receiving bivalent vaccine (Original and Omicron BA.1) with at least 1 documented dose. Events that
persisted for more than 7 days were followed until resolution.
The solicited local and systemic adverse reactions in participants 6 months through 36 months of age
following administration of a primary series with SPIKEVAX Bivalent (Original / Omicron BA.1) included
irritability/crying (55.2%), pain at the injection site (50.6%), sleepiness (43.7%), loss of appetite (36.8%),

fever (20.7%), axillary (or groin) swelling/tenderness (6.9%), erythema at the injection site (6.9%), and
swelling at the injection site (5.7%). The solicited local and systemic adverse reactions in participants 37
months through 5 years of age following administration of a primary series with SPIKEVAX Bivalent
(Original / Omicron BA.1) included pain at the injection site (52.2%), fatigue (41.8%), myalgia (22.0%),
headache (17.6%), fever (17.4%), arthralgia (16.5%), chills (11.0%), nausea/vomiting (9.9%), axillary (or
groin) swelling/tenderness (9.8%), and erythema at the injection site (2.2%).
The reported number and percentage of the solicited local and systemic adverse reactions by dose in
participants 6 months through 36 months of age are presented in Table 9 and participants 37 months to
5 years are presented in Table 10.
Table 9 – Number and Percentage of Participants With Solicited Local and Systemic Adverse Reactions
Starting Within 7 Days After Each Dose of SPIKEVAX Bivalent (Original / Omicron BA.1) in Participants
6 Months Through 36 Months (Solicited Safety Set, Dose 1 and Dose 2)*
SPIKEVAX Bivalent (Original / Omicron BA.1)
Primary Series
Dose 1 Dose 2
(N=87) (N=70)
n (%) n (%)
Local Adverse Reactions
Pain 29 (33.3) 28 (40.0)
Axillary (or groin) swelling/tenderness 5 (5.7) 2 (2.9)
Erythema (redness) ≥5 mm 2 (2.3) 4 (5.7)
Erythema (redness), Grade 3: >50 mm 1 (1.1) 0 (0)
Swelling (hardness) ≥5 mm 2 (2.3) 3 (4.3)
Swelling (hardness), Grade 3: >50 mm 1 (1.1) 0 (0)
Systemic Adverse Reactions
Irritability/crying 35 (44.3) 29 (41.4)
Irritability/crying, Grade 3a 0 (0) 1 (1.4)
Sleepiness 24 (30.4) 22 (31.4)
Loss of appetite 20 (25.3) 19 (27.1)
Loss of appetite, Grade 3b 0 (0) 1 (1.4)
Fever >38.0°C / >100.4°F 8 (9.2) 10 (14.3)
Use of antipyretic or pain medication 22 (25.3) 15 (21.4)
* 7 days included day of vaccination and the subsequent 6 days. Events and use of antipyretic or pain medication were
collected in the electronic diary (e-diary). Absence of rows for Grade 3 or Grade 4 adverse reactions indicates no events were
reported.
a Grade 3 irritability/crying: Defined as lasting >3 hours or inconsolable.
b Grade 3 loss of appetite: Defined as missed >2 feeds/meals completely or refuses most feeds/meals.

Table 10 – Number and Percentage of Participants With Solicited Local and Systemic Adverse
Reactions Starting Within 7 Days After Each Dose of SPIKEVAX Bivalent (Original / Omicron BA.1) in
Participants 37 Months Through 5 Years (Solicited Safety Set, Dose 1 and Dose 2)*
SPIKEVAX Bivalent (Original / Omicron BA.1)
Primary Series
Dose 1 Dose 2
(N=92) (N=71)
n (%) n (%)
Local Adverse Reactions
Pain 32 (34.8) 34 (47.9)

Axillary (or groin) swelling/tenderness 6 (6.5) 3 (4.2)
Erythema (redness) ≥25 mm 1 (1.1) 1 (1.4)
Systemic Adverse Reactions
Fatigue 23 (25.6) 24 (33.8)
Fatigue, Grade 3a 1 (1.1) 0
Headache 10 (11.1) 8 (11.3)
Fever ≥38.0°C 8 (8.7) 9 (12.7)
Fever, Grade 3: 39.0° - 40.0°C 2 (2.2) 2 (2.8)
Myalgia 11 (12.2) 11 (15.5)
Chills 4 (4.4) 6 (8.5)
Nausea/vomiting 5 (5.6) 5 (7.0)
Arthralgia 7 (7.8) 9 (12.7)
Use of antipyretic or pain medication 13 (14.1) 22 (31.0)
* 7 days included day of vaccination and the subsequent 6 days. Events and use of antipyretic or pain medication were
collected in the electronic diary (e-diary). Absence of rows for Grade 3 or Grade 4 adverse reactions indicates no events were
reported.
a Grade 3 fatigue: Defined as prevents daily activity.
Solicited local and systemic adverse reactions reported following administration of bivalent vaccine
(Original and Omicron BA.1) had a median duration of 2 days for participants 6 months through 5 years
of age.
Participants were monitored for unsolicited adverse events for up to 28 days following each dose and
follow-up is ongoing. Serious adverse events and medically attended adverse events will be recorded for
the entire study duration. As of December 5, 2022, among participants 6 months through 5 years of age
who had received at least 1 dose of SPIKEVAX Bivalent (Original / Omicron BA.1) (n=179), unsolicited
adverse events that occurred within 28 days following each vaccination were reported by 30.7% of
participants (n=55). In these analyses, 60.3% of participants had at least 28 days of follow-up after Dose
2. No new safety concerns were identified.
8.2.4 SPIKEVAX (Original)

The safety profile presented below is based on data generated in an ongoing Phase 3, placebo-
controlled clinical study of SPIKEVAX (elasomeran) in subjects ≥ 18 years of age in which pre-specified
cohorts of subjects who were either ≥ 65 years of age or 18 to 64 years of age with comorbid medical
conditions were included. At the time of the analysis, the safety analysis set included a total of 30,351
subjects who received at least one dose of SPIKEVAX (n=15,181) or placebo (n=15,170). Subjects were
followed for a median of 92 days from first injection and 63 days from second injection.
Solicited adverse reaction data were collected from Day 1 to Day 7 and reported by participants in an
electronic diary (e-Diary) after each dose and on electronic case report forms. Reported solicited local
and systemic adverse reactions are presented in 11, Table , Table and Table respectively.
Table 11 – Solicited Local Adverse Reactions Within 7 Days After First and Second Injection by Grade-
Participants 18 to 64 Years of Age (Safety Analysis Set*)
Dose 1 Dose 2
SPIKEVAX Group SPIKEVAX Group
Solicited local AR Placebo Group Placebo Group
100 mcg 100 mcg
N=11,407 N=10,918
N=11,406 N=10,985
n (%) n (%)
n (%) n (%)
Pain
Any grade 9,908 (86.9) 2,177 (19.1) 9,873 (89.9) 2,040 (18.7)
a
Grade 3 or 4 366 (3.2) 23 (0.2) 506 (4.6) 22 (0.2)
Erythema
Any grade 344 (3.0) 47 (0.4) 982 (8.9) 43 (0.4)
b
Grade 3 or 4 34 (0.3) 11 (<0.1) 210 (1.9) 12 (0.1)
Swelling/Induration
Any grade 767 (6.7) 34 (0.3) 1,389 (12.6) 36 (0.3)
Grade 3 or 4b 62 (0.5) 3 (<0.1) 182 (1.7) 4 (<0.1)
Axillary swelling/
Tenderness
Any grade 1,322 (11.6) 567 (5.0) 1,775 (16.2) 470 (4.3)
Grade 3 or 4c 37 (0.3) 13 (0.1) 46 (0.4) 11 (0.1)
*Safety Analyses Set: all randomized participants who received ≥1 vaccine or control dose.
a Pain - Grade 3: any use of Rx pain reliever/prevents daily activity; Grade 4: requires E.R. visit or hospitalization
b Erythema and Swelling/Induration - Grade 3: >100mm/>10cm; Grade 4: necrosis/exfoliative dermatitis
tenderness ipsilateral to the vaccination arm) - Grade 3: any use of Rx pain reliever/prevents daily activity; Grade 4: requires
E.R. visit or hospitalization.

Table 12 – Solicited Local Adverse Reactions Within 7 Days After First and Second Injection by Grade -
Participants 65 Years of Age and Older (Safety Analysis Set*)
Solicited local AR Dose 1 Dose 2
Placebo Group Placebo Group
100 mcg 100 mcg
N=3,748 N=3,648
N=3,762 N=3,692
n (%) n (%)
n (%) n (%)
Pain
Any grade 2,782 481 3,070 437
(74.0) (12.8) (83.2) (12.0)
Grade 3 or 4a 50 32 98 18
(1.3) (0.9) (2.7) (0.5)
Erythema
Any grade 86 20 275 13
(2.3) (0.5) (7.5) (0.4)
Grade 3 or 4b 8 2 77 3
(0.2) (<0.1) (2.1) (<0.1)
Swelling/Induration
Any grade 165 18 400 13
(4.4) (0.5) (10.8) (0.4)
Grade 3 or 4b 20 3 72 7
(0.5) (<0.1) (2.0) (0.2)
Axillary swelling/
Tenderness
Any grade 231 155 315 97
(6.1) (4.1) (8.5) (2.7)
Grade 3 or 4 c 12 14 21 8
(0.3) (0.4) (0.6) (0.2)
a Pain - Grade 3: any use of Rx pain reliever/prevents daily activity; Grade 4: requires E.R. visit or hospitalization
b Erythema and Swelling/Induration - Grade 3: >100mm/>10cm; Grade 4: necrosis/exfoliative dermatitis
tenderness ipsilateral to the vaccination arm) - Grade 3: any use of Rx pain reliever/prevents daily activity; Grade 4: requires
E.R. visit or hospitalization.
Table 13 – Solicited Systemic Adverse Reactions Within 7 Days After First and Second Injection by
Grade - Participants 18 to 64 Years of Age (Safety Analysis Set*)
Solicited Systemic AR Dose 1 Dose 2
100 mcg 100 mcg
N=11,407 N=10,918
N=11,406 N=10,985
n (%) n (%)
n (%) n (%)
Fatigue
Any grade 4,384 3,282 7,430 2,687
(38.4) (28.8) (67.6) (24.6)
Grade 3a 120 83 1,174 86
(1.1) (0.7) (10.7) (0.8)
Grade 4b 1 0 0 0
(<0.1) (0) (0) (0)

100 mcg 100 mcg
N=11,407 N=10,918
N=11,406 N=10,985
n (%) n (%)
n (%) n (%)
Headache
Any grade 4,030 3,304 6,898 2,760
(35.3) (29.0) (62.8) (25.3)
Grade 3c 219 162 553 129
(1.9) (1.4) (5.0) (1.2)
Myalgia
Any grade 2,699 1,628 6,769 1,411
(23.7) (14.3) (61.6) (12.9)
Grade 3a 73 38 1,113 42
(0.6) (0.3) (10.1) (0.4)
Arthralgia
Any grade 1,893 1,327 4,993 1,172
(16.6) (11.6) (45.5) (10.7)
Grade 3a 47 29 647 37
(0.4) (0.3) (5.9) (0.3)
Grade 4b 1 0 0 0
(<0.1) (0) (0) (0)
Chills
Any grade 1,051 730 5,341 658
(9.2) (6.4) (48.6) (6.0)
Grade 3d 17 8 164 15
(0.1) (<0.1) (1.5) (0.1)
Nausea/vomiting
Any grade 1,068 908 2,348 801
(9.4) (8.0) (21.4) (7.3)
Grade 3e 6 8 10 8
(<0.1) (<0.1) (<0.1) (<0.1)
Fever
Any grade 105 37 1,908 39
(0.9) (0.3) (17.4) (0.4)
Grade 3f 10 1 184 2
(<0.1) (<0.1) (1.7) (<0.1)
Grade 4g 4 4 12 2
(<0.1) (<0.1) (0.1) (<0.1)
Use of antipyretic or 2,656 1,523 6,292 1,248
pain medication (23.3) (13.4) (57.3) (11.4)
b Grade 4 fatigue, arthralgia: Defined as requires emergency room visit or hospitalization.
c Grade 3 headache: Defined as significant; any use of prescription pain reliever or prevents daily activity.
d Grade 3 chills: Defined as prevents daily activity and requires medical intervention.
e Grade 3 nausea/vomiting: Defined as prevents daily activity, requires outpatient intravenous hydration.
f Grade 3 fever: Defined as ≥39.0 – ≤40.0°C / ≥102.1 – ≤104.0°F.
g Grade 4 fever: Defined as >40.0°C / >104.0°F.

Grade - Participants 65 Years of Age and Older (Safety Analysis Set*)
100 mcg 100 mcg
N=3,748 N=3,648
N=3,762 N=3,692
n (%) n (%)
n (%) n (%)
Fatigue
Any grade 1,251 851 2,152 716
(33.3) (22.7) (58.3) (19.6)
Grade 3a 30 22 254 20
(0.8) (0.6) (6.9) (0.5)
Headache
Any grade 921 723 1,704 650
(24.5) (19.3) (46.2) (17.8)
Grade 3b 52 34 106 33
(1.4) (0.9) (2.9) (0.9)
Myalgia
Any grade 742 443 1,739 398
(19.7) (11.8) (47.1) (10.9)
Grade 3a 17 9 205 10
(0.5) (0.2) (5.6) (0.3)
Arthralgia
Any grade 618 456 1,291 397
(16.4) (12.2) (35.0) (10.9)
Grade 3a 13 8 123 7
(0.3) (0.2) (3.3) (0.2)
Chills
Any grade 202 148 1,141 151
(5.4) (4.0) (30.9) (4.1)
Grade 3c 7 6 27 2
(0.2) (0.2) (0.7) (<0.1)
Nausea/vomiting
Any grade 194 166 437 133
(5.2) (4.4) (11.8) (3.6)
Grade 3d 4 4 10 3
(0.1) (0.1) (0.3) (<0.1)
Grade 4e 0 0 1 0
(0) (0) (<0.1) (0)
Fever
Any grade 10 7 370 4
(0.3) (0.2) (10.0) (0.1)
Grade 3f 1 1 18 0
(<0.1) (<0.1) (0.5) (0)
Grade 4g 0 2 1 1
(0) (<0.1) (<0.1) (<0.1)
Use of antipyretic or 673 477 1546 329
pain medication (17.9) (12.7) (41.9) (9.0)

d Grade 3 Nausea/vomiting: Defined as prevents daily activity, requires outpatient intravenous hydration.
e Grade 4 Nausea/vomiting: Defined as requires emergency room visit or hospitalization for hypotensive shock.
f Grade 3 fever: Defined as ≥39.0 – ≤40.0°C / ≥102.1 – ≤104.0°F.
g Grade 4 fever: Defined as >40.0°C / >104.0°F.
Serious Adverse Events

Serious adverse events were reported in 0.6% of participants who received SPIKEVAX and 0.6% of
participants who received a placebo, from the first dose until 28 days following the last vaccination.
Serious adverse events were reported in 1% of participants who received SPIKEVAX and 1% of
participants who received a placebo, from the first dose until the last observation (cut-off date
November 25, 2020). In these analyses, 87.9% of study participants had at least 28 days of follow-up
after dose 2, and the median follow-up time for all participants was 9 weeks after dose 2.
There were no other notable patterns or numerical imbalances between treatment groups for specific
categories of adverse events (including other neurologic, neuro-inflammatory, and thrombotic events)
that would suggest a causal relationship to SPIKEVAX.
Three serious adverse events were likely related to SPIKEVAX: two cases of facial swelling occurring
within 7 days of receiving Dose 2, in female patients aged 46 and 51; one case of nausea and vomiting
with headaches and fever occurring within 7 days after Dose 2 and requiring in-hospital treatment in a
61-year-old female, with past medical history of headaches with nausea and vomiting requiring
hospitalization. One case of Bell’s palsy, which occurred 32 days following receipt of vaccine, was
classified as a serious adverse event. Currently available information on Bell’s palsy is insufficient to
determine a causal relationship with the vaccine.
No deaths related to the vaccine were reported in the study.
Non-Serious Adverse Events

In the COVE Phase 3 study, unsolicited adverse events occurring within 28 days after each vaccination
were reported by 23.9% of subjects who received SPIKEVAX, and 21.6% of subjects who received the
placebo. These adverse events were predominantly solicited adverse reactions occurring outside of the
conventional 7-day monitoring period after the injection (injection site pain, fatigue, headaches,
myalgia, etc.).
Unsolicited adverse events that occurred in ≥ 1% of study participants who received SPIKEVAX and at a
rate at least 1.5-fold higher rate than placebo, were lymphadenopathy related events (1.1% of versus
0.6%) and delayed injection site reactions reported >7 days after vaccination (1.2% versus 0.4%). All of
the lymphadenopathy events are similar to the axillary swelling/tenderness in the injected arm reported
as solicited adverse reactions. Delayed injection site reactions included one or more of the following:
erythema, pain and swelling, and are likely related to vaccination. Hypersensitivity events were
reported in 1.5% of the SPIKEVAX group compared to 1.1% of the placebo group, but this imbalance was
mostly due to injection site rash and injection site erythema/swelling occurring more frequently in the
SPIKEVAX group.

There were three reports of Bell’s palsy in the SPIKEVAX group (one of which was a serious adverse
event), which occurred 22, 29, and 32 days after the second dose of vaccine, and one in the placebo
group which occurred 17 days after the first dose of saline. Currently available information on Bell’s
palsy is insufficient to determine a causal relationship with the vaccine. There were no other notable
patterns or numerical imbalances between treatment groups for specific categories of non-serious
adverse events (including neurologic, musculoskeletal or inflammatory events) that would suggest a
causal relationship to SPIKEVAX.
Study P201 Part B is an ongoing Phase 2, randomized, observer-blind, placebo-controlled, dose-

confirmation study to evaluate the safety, reactogenicity, and immunogenicity of SPIKEVAX
(elasomeran) in participants 18 years of age and older (NCT04405076). In an open-label phase of this
study, 171 participants received a single booster dose (50 mcg) at least 6 months after receiving the
second dose (100 mcg) of the SPIKEVAX primary series. At the time of analysis, participants were
followed-up for safety for one month after receiving the booster.
The solicited adverse reaction profile for the booster dose was similar to that after the second dose in
the primary series. The most common solicited local adverse reactions (ARs) were pain at injection site
(84%) and axillary swelling or tenderness (20%). The most common solicited systemic ARs were fatigue
(59%), headache (55%), myalgia (49%), arthralgia (41%), and chills (35%). The local and systemic ARs
were transient, and most resolved by Day 4. The frequency and severity of solicited ARs was
numerically comparable between age cohorts (18 to <55; ≥55 years of age). The most common
unsolicited AEs were headache (2.3%) and fatigue (2.3%); these were also solicited AEs that extended
beyond Day 7. All unsolicited AEs were mild or moderate in severity. Of the 171 participants who
received a booster dose of SPIKEVAX, there were no serious adverse events reported from the booster
dose through 29 days after the booster dose.
8.2.4.2 Adolescents 12 to 17 Years of Age
Data on solicited local and systemic adverse reactions and use of antipyretic medication were collected
on a daily basis in an electronic diary for 7 days following each injection (i.e., day of vaccination and the
next 6 days) among adolescent participants receiving SPIKEVAX (n=2,482) and participants receiving
placebo (n=1,238) with at least 1 documented dose. Events that persisted for more than 7 days were
followed until resolution.
The reported number and percentage of the solicited local and systemic adverse reactions in
participants 12 through 17 years of age by dose are presented in Table 15 and Table 16 respectively.
Solicited local and systemic adverse reactions reported following administration of SPIKEVAX had a
median duration of 1 to 3 days.

Table 15 – Solicited Local Adverse Reactions Within 7 Days After First and Second Injection by Grade –
Participants 12 to 17 Years of Age (Solicited Safety Analysis Set)
Dose 1 Dose 2
Vaccine Group Placebo Groupa Vaccine Group Placebo Groupa
n (%) n (%) n (%) n (%)
N=2,482 N=1,238 N=2,478 N=1,220
Pain
Any grade 2,310 431 2,290 370
(93.1) (34.8) (92.4) (30.3)
Grade 3b 133 1 126 3
(5.4) (<0.1) (5.1) (0.2)
Axillary swelling/ tenderness
Any grade 578 101 519 61
(23.3) (8.2) (21.0) (5.0)
Grade 3b 10 0 7 0
(0.4) (0) (0.3) (0)
Swelling (hardness)
≥25 mm 403 12 509 12
(16.2) (1.0) (20.5) (1.0)
Grade 3c 27 0 56 0
(1.1) (0) (2.3) (0)
Erythema (redness)
≥25 mm 334 8 484 11
(13.5) (0.6) (19.5) (0.9)
Grade 3c 21 0 72 0
(0.8) (0) (2.9) (0)
n= # of participants with specified reaction, percentages are based on n/N.
a
Placebo was a saline solution.
b
Grade 3 pain and axillary swelling/tenderness: Defined as any use of prescription pain reliever; prevents daily
activity.
c
Grade 3 swelling and erythema: Defined as >100 mm / >10 cm.
Grade – Participants 12 to 17 Years of Age (Solicited Safety Analysis Set)
Dose 1 Dose 2
n (%) n (%) n (%) n (%)
N=2,482 N=1,238 N=2,478 N=1,220
Fatigue
Any grade 1,188 453 1,679 353
(47.9) (36.6) (67.8) (28.9)
Grade 3b 33 18 188 10
(1.3) (1.5) (7.6) (0.8)
Headache
Any grade 1,106 477 1,739 370
(44.6) (38.5) (70.2) (30.3)
Grade 3c 56 17 112 14
(2.3) (1.4) (4.5) (1.1)
Grade 4d 0 0 1 0

Dose 1 Dose 2
n (%) n (%) n (%) n (%)
N=2,482 N=1,238 N=2,478 N=1,220
(0) (0) (<0.1) (0)
Myalgia
Any grade 668 205 1,154 153
(26.9) (16.6) (46.6) (12.5)
Grade 3d 24 10 129 3
(1.0) (0.8) (5.2) (0.2)
Chills
Any grade 456 138 1,066 97
(18.4) (11.1) (43.0) (8.0)
Grade 3e 4 1 11 0
(0.2) (<0.1) (0.4) (0)
Arthralgia
Any grade 371 143 716 113
(15.0) (11.6) (28.9) (9.3)
Grade 3d 15 5 57 2
(0.6) (0.4) (2.3) (0.2)
Nausea/vomiting
Any grade 281 110 591 106
(11.3) (8.9) (23.9) (8.7)
Grade 3f 2 0 2 0
(<0.1) (0) (<0.1) (0)
Grade 4g 0 0 1 0
(0) (0) (<0.1) (0)
Fever
Any grade 63 12 302 12
(2.5) (1.0) (12.2) (1.0)
Grade 3 9 1 46 1
(≥39.0° – ≤40.0°C) (0.4) (<0.1) (1.9) (<0.1)
Grade 4 0 0 1 1
(>40.0°C) (0) (0) (<0.1) (<0.1)
Use of antipyretic or 748 118 1,242 108
analgesic medications (30.1) (9.5) (50.1) (8.9)
a
b
Grade 3 fatigue, myalgia, arthralgia: Defined as significant; prevents daily activity.
c
Grade 3 headache: Defined as significant; any use of prescription pain reliever or prevents daily activity.
d
Grade 4 headache: Defined as requires emergency room visit or hospitalisation.
e
Grade 3 chills: Defined as prevents daily activity and requires medical intervention.
f
Grade 3 nausea/vomiting: Defined as prevents daily activity, requires outpatient intravenous hydration.
g
Grade 4 nausea/vomiting: Defined as requires emergency room visit or hospitalisation for hypotensive shock.
Participants (12 to 17 years of age) were monitored for unsolicited adverse events for up to 28 days
following each dose and follow-up is ongoing. Serious adverse events and medically attended adverse

events will be recorded for the entire study duration. As of May 8, 2021, 3,726 participants
(vaccine=2,486, placebo=1,240) had received at least 1 dose and 97.3% of the study participants had at
least 28 days of follow-up after Dose 2. The median follow-up time for all participants was 53 days after
Dose 2.
Unsolicited adverse events that occurred within 28 days following each vaccination were reported by
20.5% of participants (n=510) who received SPIKEVAX and 15.9% of participants (n=197) who received
placebo. Imbalances in unsolicited adverse events up to 28 days after any injection are primarily
attributable to events related to local reactogenicity such as lymphadenopathy.
Serious adverse events within 28 days of any injection were reported by < 0.1% (n=2) of participants
who received SPIKEVAX and < 0.1% (n=1) of participants who received placebo. As of May 8, 2021,
serious adverse events during the overall study period were reported by 0.2% (n=6) of participants who
received SPIKEVAX and 0.2% (n=2) of participants who received placebo. No SAEs during the study were
assessed by the investigator as related to study vaccine.
Safety data for a booster dose of SPIKEVAX in adolescents were collected in an ongoing Phase 2/3
clinical trial (Study P203, NCT04649151) with multiple parts. The open-label booster portion of the study
involved 1,364 participants 12 years through 17 years of age who received a booster dose (50 mcg) of
SPIKEVAX at least 5 months after the second dose of the primary series (100 mcg). As of the data cutoff
date of May 16, 2022, the median duration of follow-up for safety was 116 days after the booster dose.
Local and systemic adverse reactions (ARs) were solicited in an electronic diary for 7 days following the
injection among participants receiving SPIKEVAX as a booster dose. Solicited ARs were reported by most
(95.1%) participants after the booster dose (N=1,312); 11.0% reported a Grade 3 solicited AR. The
solicited local ARs were pain (91%), axillary swelling or tenderness (28%), swelling (hardness) (14%) and
erythema (redness) (9%). The solicited systemic ARs were fatigue (59%), headache (57%), myalgia (40%),
chills (31%), arthralgia (24%), nausea/vomiting (18%) and fever (6%). T he median duration of solicited
local and systemic adverse reactions was 3 days.
Participants were monitored for unsolicited adverse events for up to 28 days following the booster dose.
As of May 16, 2022, among the 1,364 participants who had received a booster dose, unsolicited adverse
events that occurred within 28 days following vaccination were reported by 14.2% of participants
(n=194). In these analyses, 97.4% of study participants had at least 28 days of follow-up after the
booster dose.
Through the cut-off date of May 16, 2022, with a median follow-up duration of 116 days after booster,
no serious adverse events following the booster dose were reported.

8.2.4.3 Children 6 to 11 Years of Age
Data on solicited local and systemic adverse reactions were collected on a daily basis in an electronic
diary for 7 days following each injection (i.e., day of vaccination and the next 6 days) among pediatric
participants aged 6 to 11 years receiving SPIKEVAX (n=3,007) and participants receiving placebo (n=995)
with at least 1 documented dose, and 2,988 participants receiving SPIKEVAX and 973 participants in the
placebo group had received dose 2 in Study P204 Part 2. For events that persisted for more than 7 days
the caregiver was prompted to continue to record until resolution.
participants 6 through 11 years of age by dose are presented in Table 17 and Table 18 respectively. The
majority of solicited local adverse reactions following administration of SPIKEVAX occurred within the
first 1 to 2 days after any dose and persisted for a median of 3 days.
Participants 6 to 11 of Age in Study P204 Part 2 (Solicited Safety Analysis Set )
Dose 1 Dose 2 Dose 3
Vaccine Group Vaccine Group Vaccine Group
Placebo Groupa Placebo Groupa
50 mcg 50 mcg 25 mcg
n (%) n (%)
n (%) n (%) n (%)
N=993 N=969
N=3,004 N=2,988 N=1,280
Pain
Any grade 2,796 465 2,832 480 1152
(93.1) (46.8) (94.8) (49.5) (90.1)
Grade 3b 28 0 81 2 24
(0.9) (2.7) (0.2) (1.9)
Erythema (redness)
Any grade 349 13 559 10 137
(11.9) (1.3) (18.7) (1.0) (10.7)
Grade 3c 16 1 33 1 4
(0.5) (0.1) (1.1) (0.1) (0.3)
Swelling (hardness)
Any grade 354 12 507 12 139
(11.8) (1.2) (17.0) (1.2) (10.9)
Grade 3c 19 1 20 0 4
(0.6) (0.1) (0.7) (0) (0.3)
Axillary swelling/
tenderness
Any grade 465 84 537 65 355
(15.5) (8.5) (18.0) (6.7) (27.8)
Grade 3b 3 1 3 2 4
(<0.1) (0.1) (0.1) (0.2) (0.3)
a

b
Grade 3 pain and axillary swelling/tenderness: Defined as prevents daily activity.
c
Grade 3 swelling and erythema: Defined as >100 mm / >10 cm
Grade – Participants 6 to 11 Years of Age in Study P204 Part 2 (Solicited Safety Analysis Set)
Dose 1 Dose 2 Dose 3
Vaccine Group Vaccine Group Vaccine Group
Placebo Groupa Placebo Groupa
50 mcg 50 mcg 25 mcg
n (%) n (%)
n (%) n (%) n (%)
N=993 N=969
N=3,004 N=2,988 N=1,280
Fever
Any grade 99 15 714 19 108
(3.3) (1.5) (23.9) (2.0) (8.5)
Grade 3 17 2 113 2 16
(≥39.0° – (0.6) (0.2) (3.8) (0.2) (1.3)
≤40.0°C)
Grade 4 0 0 0 0 1
(>40.0°C) (<0.1)
Headache
Any grade 938 306 1,622 275 489
(31.2) (30.8) (54.3) (28.4) (38.2)
Grade 3b 18 4 119 8 22
(0.6) (0.4) (4.0) (0.8) (1.7)
Fatigue
Any grade 1,298 334 1,925 335 625
(43.2) (33.6) (64.5) (34.6) (48.9)
Grade 3b 31 8 191 8 47
(1.0) (0.8) (6.4) (0.8) (3.7)
Myalgia
Any grade 438 96 843 105 269
(14.6) (9.7) (28.2) (10.8) (21.0)
Grade 3b 11 1 71 1 19
(0.4) (0.1) (2.4) (0.1) (1.5)
Arthralgia
Any grade 260 75 482 84 160
(8.7) (7.6) (16.1) (8.7) (12.5)
Grade 3b 3 1 25 0 12
(<0.1) (0.1) (0.8) (0) (0.9)
Nausea/vomiting
Any grade 325 107 716 97 168
(10.8) (10.8) (24.0) (10.0) (13.1)
Grade 3c 5 0 19 0 6
(0.2) (0) (0.6) (0) (0.5)
Chills
Any grade 309 67 904 74 179
(10.3) (6.7) (30.3) (7.6) (14.0)
Grade 3b 3 0 19 0 4
(<0.1) (0) (0.6) (0) (0.3)
a

b
Grade 3 headache, fatigue, myalgia, arthralgia and chills: Defined as prevents daily activity.
c
Grade 3 nausea/vomiting: Defined as prevents daily activity.
Participants (6 to 11 years of age) were monitored for unsolicited adverse events for up to 28 days
following each dose. Serious adverse events and medically attended adverse events will be recorded for
the entire study duration. As of November 10, 2021, overall safety data are available for the 4,382
participants enrolled in Study P204 Part 1 and Part 2 which includes data from 3,387 participants who
received at least one 50 mcg dose of SPIKEVAX (Part 1=380; Part 2=3,007) and 995 placebo participants
in Part 2.
Unsolicited adverse events that occurred within 28 days following each vaccination were reported by
29.6% of participants (n=3,007) who received SPIKEVAX and 25.1% of participants (n=995) who received
placebo. Unsolicited adverse events that occurred in ≥ 1% of study participants who received SPIKEVAX
and at a rate at least 1.5-fold higher rate than placebo, were injection site erythema (3.0% versus 0.1%)
and injection site lymphadenopathy (1.7% vs 0.4%). Hypersensitivity events were reported in 4.7% of
the SPIKEVAX group compared to 2.5% of the placebo group, but this imbalance was mostly due to
injection site rash and urticaria occurring more frequently in the SPIKEVAX group.
Serious adverse events (SAE) within 28 days of any injection were reported by <0.1% (n=4) of
participants who received SPIKEVAX. No SAEs during the study were assessed by the investigator as
related to study vaccine.
Safety data for a booster dose of SPIKEVAX (elasomeran) in individuals 6 years through 11 years of age
were collected in an ongoing Phase 2/3 clinical trial with multiple parts. The open-label booster portion
of the study involved 1,294 participants 6 years through 11 years of age who received a booster dose of
SPIKEVAX (elasomeran) at least 6 months after the second dose of the primary series (Study P204,
NCT04796896). As of the data cutoff date of May 23, 2022, the median duration of follow-up for safety
was 29 days after the booster dose. No additional adverse reactions were identified in the open-label
portion of the study.
The most common solicited local adverse reactions (ARs) were pain (90 %) and axillary swelling or
tenderness (28 %). The most common solicited systemic ARs were fatigue (49%), headache (38%),
myalgia (21%), and chills (14%). The median duration of solicited local and systemic adverse reactions
was 3 days.
Serious adverse events and medically attended adverse events will be recorded for the entire study
duration. As of May 23, 2022, among the 1,294 participants who had received a booster dose,
unsolicited adverse events that occurred within 28 days following vaccination were reported by 13.1%
of participants (n=169). In these analyses, 55.4% of study participants had at least 28 days of follow-up

after the booster dose. Serum sickness-like reaction with onset 10 days following administration of a
booster dose was reported in an 8-year-old participant. This event was assessed as related to
vaccination. After initiation of treatment with antihistamines and steroids, symptoms resolved within 15
days with the exception of intermittent urticaria that was ongoing 31 days after the onset of the
reaction.
As of May 23, 2022, with a median follow-up duration of 29 days after booster, there was one serious
adverse event of abdominal pain reported 16 days following booster dose by a 7-year-old participant.
Currently available information is insufficient to determine a causal relationship with the vaccine.
8.2.4.4 Children 6 Months to 5 Years of Age
The safety profile presented below is based on data generated in an ongoing Phase 2/3, placebo
controlled clinical study on subjects 6 months to 5 years of age in which pre-specified cohorts of subjects
who were either 6 months to < 2 years of age or 2 years to 5 years of age (Study P204). At the time of
the analysis, the safety analysis set included 375 subjects who were 6 months to < 1 year of age, 1,373
subjects who were 1 to < 2 years of age, and 3,007 subjects who were 2 to 5 years of age.
Data on solicited local and systemic adverse reactions and use of antipyretic medication were collected
on a daily basis in an electronic diary for 7 days following each injection (i.e., day of vaccination and the
next 6 days) among pediatric participants aged 6 months to 5 years of age receiving SPIKEVAX (n=4,792)
and participants receiving placebo (n=1,596) with at least 1 documented dose, and 4,561 participants
receiving SPIKEVAX and 1,498 participants in the placebo group had received dose 2 in Study P204 Part
2. For events that persisted for more than 7 days the caregiver was prompted to continue to record until
resolution.
participants 6 months to less than 2 years by dose are presented in Table 19 and Table 20 respectively.
The majority of solicited local and systemic adverse reactions following administration of SPIKEVAX
occurred within the first 2 days after any dose and persisted for a median of 2 to 3 days.
The reported number and percentage of the solicited local adverse reactions in participants 2 years to 5
years by dose are presented in Table 21. The reported number and percentage of the solicited systemic
adverse reactions in participants 24 months to less than or equal to 36 months and in participants 37
months to 5 years by dose are presented in Table 22 and Table 23, respectively. The majority of solicited
local and systemic adverse reactions following administration of SPIKEVAX occurred within the first 1 to
2 days after any dose and persisted for a median of 2 days.

Participants 6 Months to < 24 Months of Age in Study P204 Part 2 (Solicited Safety Analysis Set )
Dose 1 Dose 2
Vaccine Group Vaccine Group
25 µg Placeboa 25 µg Placeboa
N=1,746 N=582 N=1,596 N=526
n (%) n (%) n (%) n (%)
Pain
Any 652 175 738 135
(37.4) (30.1) (46.2) (25.7)
Grade 3b 0 0 0 0
(0) (0) (0) (0)
Erythema (redness)
Any 150 24 215 20
(8.6) (4.1) (13.5) (3.8)
Grade 3c 5 2 13 0
(0.3) (0.3) (0.8) (0)
Swelling (hardness)
Any 146 15 243 11
(8.4) (2.6) (15.2) (2.1)
Grade 3c 5 0 14 0
(0.3) (0) (0.9) (0)
Axillary (or groin) swelling
or tenderness
Any 102 26 148 28
(5.9) (4.5) (9.3) (5.3)
Grade 3b 0 0 0 0
(0) (0) (0) (0)
a
b
c
Grade – Participants 6 Months to < 24 Months of Age in Study P204 Part 2 (Solicited Safety Analysis
Set)
Dose 1 Dose 2
Placeboa Placeboa
25 µg 25 µg
N=582 N=526
N=1,746 N=1,596
n (%) n (%)
n (%) n (%)
Fever
Any 191 49 232 44
(11.0) (8.4) (14.6) (8.4)
Grade 3 11 3 7 6
(≥39.6°C to ≤40°C) (0.6) (0.5) (0.4) (1.1)
Grade 4 1 1 3 0
(>40.0°C) (<0.1) (0.2) (0.2) (0)

Dose 1 Dose 2
Placeboa Placeboa
25 µg 25 µg
N=582 N=526
N=1,746 N=1,596
n (%) n (%)
n (%) n (%)
analgesic (27.6) (24.2) (34.0) (21.1)
medicationsc
Irritability/crying
Any 1,175 361 1,021 307
(67.6) (62.1) (64.3) (58.5)
Grade 3b 24 6 25 5
(1.4) (1.0) (1.6) (1.0)
Sleepiness
Any 645 217 558 175
(37.1) (37.3) (35.1) (33.3)
Grade 3b 4 1 1 1
(0.2) (0.2) (< 0.1) (0.2)
Loss of appetite
Any 524 152 510 132
(30.2) (26.2) (32.1) (25.1)
Grade 3b 10 1 16 2
(0.6) (0.2) (1.0) (0.4)
a
b
Grade 3 irritability/crying, sleepiness and loss of appetite: Defined as prevents daily activity
Participants 2 to 5 Years of Age in Study P204 Part 2 (Solicited Safety Analysis Set )
Dose 1 Dose 2
Placeboa Placeboa
25 µg 25 µg
N = 970 N = 959
N = 2,957 N = 2,938
n (%) n (%)
n (%) n (%)
Pain
Any 1,813 382 2,099 395
(61.4) (39.4) (71.4) (41.2)
Grade 3 b 4 0 11 0
(0.1) (0) (0.4) (0)
Erythema (redness)
Any 164 14 259 15
(5.5) (1.4) (8.8) (1.6)
Grade 3c 12 3 12 0
(0.4) (0.3) (0.4) (0)
Swelling (hardness)
Any 134 17 240 11
(4.5) (1.8) (8.2) (1.1)
Grade 3c 10 2 13 0
(0.3) (0.2) (0.4) (0)

Dose 1 Dose 2
Placeboa Placeboa
25 µg 25 µg
N = 970 N = 959
N = 2,957 N = 2,938
n (%) n (%)
n (%) n (%)
Axillary (or groin)
swelling or
tenderness
Any 205 56 267 31
(6.9) (5.8) (9.1) (3.2)
Grade 3b 0 0 1 0
(0) (0) (< 0.1) (0)
analgesic (16.8) (12.5) (27.2) (10.9)
medicationsd
a
b
c
d
Events and use of antipyretic or pain medication were collected in the electronic diary (e-diary).
Grade – Participants 24 Months to ≤ 36 Months of Age in Study P204 Part 2 (Solicited Safety Analysis
Set)
Dose 1 Dose 2
Placeboa Placeboa
25 µg 25 µg
N = 320 N = 330
N = 944 N = 963
n (%) n (%)
n (%) n (%)
Fever
Any 106 25 182 35
(11.3) (7.8) (18.9) (10.6)
Grade 3 3 3 12 0
(≥39.6°C to ≤40°C) (0.3) (0.3) (1.2) (0)
Grade 4 3 1 3 0
(>40.0°C) (0.3) (0.3) (0.3) (0)
Irritability/crying
Any 513 163 523 148
(54.5) (51.1) (54.3) (44.8)
Grade 3b 12 6 10 2
(1.3) (1.9) (1.0) (0.6)
Sleepiness
Any 285 92 347 89
(30.3) (28.8) (36.0) (27.0)
Grade 3b 2 0 1 0
(0.2) (0) (0.1) (0)
Loss of appetite
Any 225 71 294 69
(23.9) (22.3) (30.5) (20.9)
Grade 3b 7 1 8 0

Dose 1 Dose 2
Placeboa Placeboa
25 µg 25 µg
N = 320 N = 330
N = 944 N = 963
n (%) n (%)
n (%) n (%)
(0.7) (0.3) (0.8) (0)
a
b
Grade 3 irritability/crying, sleepiness and loss of appetite: Defined as prevents daily activity.
Grade – Participants 37 Months to 5 Years of Age in Study P204 Part 2 (Solicited Safety Analysis Set)
Dose 1 Dose 2
mRNA-1273 mRNA-1273
Placeboa Placeboa
25 µg 25 µg
N = 650 N = 629
N = 2,013 (N = 1,975
n (%) n (%)
n (%) n (%)
Fever
Any 155 33 316 28
(7.7) (5.1) (16.0) (4.5)
Grade 3 23 4 58 2
(≥39°C to ≤40°C) (1.1) (0.6) (2.9) (0.3)
Grade 4 1 1 4 0
(>40.0°C) (<0.1) (0.2) (0.2) (0)
Headache
Any 232 78 310 51
(11.5) (12.0) (15.7) (8.1)
Grade 3b 5 2 8 1
(0.2) (0.3) (0.4) (0.2)
Fatigue
Any 807 236 956 185
(40.1) (36.3) (48.4) (29.4)
Grade 3b 21 11 45 8
(1.0) (1.7) (2.3) (1.3)
Myalgia
Any 200 60 310 47
(9.9) (9.2) (15.7) (7.5)
Grade 3b 5 2 9 3
(0.2) (0.3) (0.5) (0.5)
Arthralgia
Any 124 32 168 28
(6.2) (4.9) (8.5) (4.5)
Grade 3b 2 1 3 0
(< 0.1) (0.2) (0.2) (0)
Nausea/vomiting
Any 137 50 194 30
(6.8) (7.7) (9.8) (4.8)
Grade 3b 7 2 6 0
(0.3) (0.3) (0.3) (0)
Chills

Dose 1 Dose 2
mRNA-1273 mRNA-1273
Placeboa Placeboa
25 µg 25 µg
N = 650 N = 629
N = 2,013 (N = 1,975
n (%) n (%)
n (%) n (%)
Any 129 40 245 31
(6.4) (6.2) (12.4) (4.9)
Grade 3b 1 0 10 2
(< 0.1) (0) (1.0) (0.6)
a
b
Grade 3 headache, fatigue, myalgia, arthralgia, nausea/vomiting and chills: Defined as prevents daily activity.

Participants (6 months to 5 years of age) were monitored for unsolicited adverse events for up to 28
days following each dose. Serious adverse events and medically attended adverse events will be
recorded for the entire study duration. As of February 21, 2022, among participants 2 through 5 years of
age who had received at least 1 dose of SPIKEVAX (25 mcg) or placebo (SPIKEVAX=3,031,
placebo=1,007), unsolicited adverse events that occurred within 28 days following each vaccination
were reported by 40.0% of participants (n=1,212) who received SPIKEVAX and 37.5% of participants
(n=378) who received placebo. In these analyses, 89.3% of study participants 2 through 5 years of age
had at least 28 days of follow-up after Dose 2.
Among participants 6 through 23 months of age who had received at least 1 dose of SPIKEVAX (25 mcg)
or placebo (SPIKEVAX=1,761, placebo=589), unsolicited adverse events that occurred within 28 days
following each vaccination were reported by 49.3% of participants (n=869) who received SPIKEVAX and
48.2% of participants (n=284) who received placebo. In these analyses, 83.1% of study participants 6
through 23 months of age had at least 28 days of follow-up after Dose 2. Among participants 2 through
5 years of age, one unsolicited adverse event of injection site erythema (1.3% versus 0.2%) occurred in ≥
1% of study participants who received SPIKEVAX and at a rate at least 1.5-fold higher rate than placebo.
Among participants 6 months through 23 months of age, unsolicited adverse events that occurred in ≥
1% of study participants who received SPIKEVAX and at a rate at least 1.5-fold higher rate than placebo,
were otitis media acute (1.4% versus 0.7%), injection site lymphadenopathy (1.4% versus 0.2%) and
injection site erythema (1.1% versus 0.2%).
As of February 21, 2022, serious adverse events were reported by 0.3% (n=9) of participants who
received SPIKEVAX and 0.2% (n=2) participants who received placebo who were 2 through 5 years of
age, and by 0.9% (n=15) of participants who received SPIKEVAX and 0.2% (n=1) participants who
received placebo who were 6 through 23 months of age. In these analyses, 89.3% of study participants 2
through 5 years of age had at least 28 days of follow-up after Dose 2, and the median follow-up time for
all participants was 71 days after Dose 2. In these analyses, 83.1% of study participants 6 through 23
months of age had at least 28 days of follow-up after Dose 2, and the median follow-up time for all
participants was 68 days after Dose 2. In participants 2 through 5 years of age who received SPIKEVAX,
none of the events were considered related to vaccine. In participants 6 through 23 months of age who
received the vaccine, a 1-year-old female experienced serious adverse events of a Grade 3 fever 6 hours
after Dose 1 and a febrile convulsion 2 days after Dose 1. These events were considered related to
vaccination.

Safety data for a booster dose of SPIKEVAX (elasomeran) in individuals 6 months through 5 years of age
of the study involved 145 participants 6 months through 5 years of age who received a 10 mcg booster
dose of SPIKEVAX (elasomeran) at least 6 months after the second dose of the primary series (Study
P204). As of the data cut-off date of August 18, 2022, the median duration of follow-up for safety was 99
days after the booster dose.

The most common solicited local adverse reactions (ARs) reported in participants 17 to 36 months of
age were pain (42 %), erythema (11%) and swelling (11 %). The most common solicited local adverse
reactions (ARs) reported in participants 37 months to 5 years of age were pain (56 %), swelling (12%)
and erythema (4%). The most common solicited systemic ARs in participants 17 to 36 months of age
were irritability/crying (53%), sleepiness (27%), loss of appetite (23%) and fever (10%). The most
common solicited systemic ARs in participants 37 months to 5 years of age were fatigue (32%),
headache (20%), myalgia (12%), arthralgia (8%), chills (8%) and nausea (4%). The median duration of
solicited local and systemic adverse reactions was 3 days.

Serious adverse events and medically attended adverse events will be recorded for the entire study
duration. As of August 18, 2022, among the 145 participants who had received a booster dose,
unsolicited adverse events that occurred within 28 days following vaccination were reportered by 24.1%
of participants (n=35). In these analyses, 99.3% of study participants had at least 28 days of follow-up
after the booster dose. Through the cut-off date, there were no unsolicited adverse events not already
captured as solicited local and systemic reactions that were considered causally related to the vaccine.

As of August 18, 2022, with a median follow-up duration of 99 days after booster, there were no serious
adverse events reported following the booster dose.
8.3 Less Common Clinical Trial Adverse Reactions
The following events were reported in the ongoing Phase 3, placebo-controlled clinical study of
SPIKEVAX (elasomeran) in participants ≥ 18 years of age:
Nervous System Disorders: Acute peripheral facial paralysis †
Skin and Subcutaneous Tissue Disorders: Rash.
General Disorders and Administration Site Conditions: Injection site pruritus, injection site rash,
injection site swelling, injection site erythema, injection site urticaria, facial swelling. §
† Throughout the safety follow-up period, acute peripheral facial paralysis (or palsy) was reported by three participants in the
SPIKEVAX group and one participant in the placebo group. Onset in the vaccine group participants was 22 days, 28 days, and 32
days after Dose 2.

§ There were two serious adverse events of facial swelling in vaccine recipients with a history of injection of dermatological
fillers. The onset of swelling was reported on Day 1 and Day 3, respectively, relative to day of vaccination.
8.4 Post-Market Adverse Reactions
The following adverse reactions have been identified during post-authorization use of SPIKEVAX
(elasomeran).
Immune System Disorders: Anaphylaxis, hypersensitivity.
Cardiac Disorders: Myocarditis and/or pericarditis (see WARNINGS AND PRECAUTIONS).
Skin and Subcutaneous Tissue Disorders: Erythema multiforme, acute and delayed urticaria.
Nervous System Disorders: facial paralysis / Bell’s palsy, hypoaesthesia / paraesthesia, dizziness.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always
possible to reliably estimate their frequency or establish a causal relationship to product exposure.
9 DRUG INTERACTIONS
No interaction studies have been performed.
Other Vaccines
Do not mix SPIKEVAX XBB.1.5 with other vaccines/products in the same syringe.
10 CLINICAL PHARMACOLOGY
10.1 Mechanism of Action
SPIKEVAX XBB.1.5 encodes for the pre-fusion stabilized Spike (S) protein of SARS-CoV-2 Omicron
subvariant XBB.1.5. After intramuscular injection, cells take up the lipid nanoparticle, effectively
delivering the mRNA sequences into cells for expression of the SARS-CoV-2 S antigen. The delivered
mRNA does not enter the cellular nucleus or interact with the genome, is nonreplicating, and is
expressed transiently. The proteins undergo post-translational modification and trafficking resulting in
properly folded, fully functional Spike proteins that are inserted into the cellular membrane of the
expressing cell(s). The Spike proteins are membrane bound, mimicking the presentation of natural
infection. The vaccine induces both neutralizing antibody and cellular immune responses (T-cell and B-
cell) to the Spike (S) antigen, which may contribute to protection against COVID-19 disease.

11 STORAGE, STABILITY AND DISPOSAL
Storage Prior to Use
As Displayed on the Vial Labels and Cartons

The SPIKEVAX XBB.1.5 multidose vials are stored frozen between -50° to -15°C (-58° to 5°F). Store in the
original carton to protect from light.
Additional Storage Information Not Displayed on the Vial Labels and Cartons
 Vials can be stored refrigerated between 2° to 8°C (36° to 46°F) for up to 30 days prior to first use.
 Unpunctured vials may be stored between 8° to 25°C (46° to 77°F) for up to 24 hours.
 Do not refreeze once thawed.
Transportation of Thawed Vials in Liquid State at 2° to 8°C (36° to 46°F)

If transport at -50° to -15°C (-58° to 5°F) is not feasible, available data support transportation of one or
more thawed vials in liquid state for up to 12 hours at 2° to 8°C (36° to 46°F) when shipped using
shipping containers which have been qualified to maintain 2° to 8°C (36° to 46°F) and under routine road
and air transport conditions with shaking and vibration minimized. Precautions should be taken
(packaging/dunnage) to minimize vibration of vials when transporting at this temperature. Once thawed
and transported in liquid state at 2° to 8°C (36° to 46°F), vials should not be refrozen and should be
stored at 2° to 8°C (36° to 46°F) until use.
Thawing Vials Prior To Use

The SPIKEVAX XBB.1.5 multidose vial contains a frozen dispersion that does not contain a
preservative and must be thawed prior to administration. Remove the required number of vial(s) from
storage and thaw each vial before use.
Vial Cap Thaw time under refrigeration Thaw time at room temperature
Presentation
Colour between 2° to 8°C (36° to 46°F) between 15° to 25°C (59° to 77°F)
 2 hours
After thawing, let vial stand at  45 minutes
0.10 mg/mL Royal Blue
room temperature for 15 minutes
before administering.
After thawing, do not refreeze.
Storage After Use (Punctured Vials)
SPIKEVAX XBB.1.5 is preservative-free. Once the vial has been entered (needle-punctured), it can be
stored at room temperature or refrigerated, but must be discarded after 24 hours. Do not refreeze.
12 SPECIAL HANDLING INSTRUCTIONS
SPIKEVAX XBB.1.5 must not be mixed with other medicinal products or diluted. Any unused vaccine or
waste material should be disposed of in accordance with local requirements.

PART II: SCIENTIFIC INFORMATION
13 PHARMACEUTICAL INFORMATION
Drug Substance
Proper name: Andusomeran (mRNA vaccine)
Chemical name: mRNA-1273.815 LS (Large Scale) Lipid Nanoparticle (LNP)
Product Characteristics
SPIKEVAX XBB.1.5 is an mRNA-lipid complex [lipid nanoparticle (LNP)] dispersion that contains
andusomeran (mRNA CX-038839) that encodes for the pre-fusion stabilized Spike glycoprotein of the
SARS-CoV-2 Omicron subvariant XBB.1.5 (containing mutations K982P and V983P), and four lipids which
act as protectants and carriers of the mRNA.
SPIKEVAX XBB.1.5 is supplied as a multidose liquid ready-to-use dispersion for intramuscular

administration. The 0.10 mg/mL presentation of SPIKEVAX XBB.1.5 is supplied in a 10R clear Type 1 glass
vial.
14 CLINICAL TRIALS
14.1 Trial Design and Study Demographics
The safety and effectiveness of SPIKEVAX XBB.1.5 (andusomeran) mRNA vaccine for children 6 months
to 11 years of age are inferred from studies of a primary series of SPIKEVAX Bivalent (Original/Omicron
BA.1) in individuals 6 months to 5 years of age and older. Safety data from SPIKEVAX primary series
studies in individuals ≥18 years of age and studies from SPIKEVAX Bivalent as a booster dose in
individuals ≥18 years of age and individuals 6 months to 5 years of age are also considered supportive.
The safety and effectiveness of SPIKEVAX XBB.1.5 for children 6 to 11 years of age and adolescents 12
through 17 years of age are also inferred from studies of a booster dose of SPIKEVAX Bivalent
(Original/Omicron BA.1) in individuals 18 years of age and older, as well as data from studies which
evaluated the primary series and booster vaccination with SPIKEVAX. The safety of SPIKEVAX XBB.1.5 in
adolescents 12 through 17 years of age is inferred from safety data from studies of a booster dose of
SPIKEVAX in adolescents 12 through 17 years of age and from the safety profile of SPIKEVAX
administered as a booster dose in children 6 to 11 years of age. Safety data from studies in individuals
≥18 years of age using SPIKEVAX Bivalent (50 mcg) are also considered supportive.
The safety of SPIKEVAX XBB.1.5 is based on safety data from clinical trials which evaluated primary and
booster vaccination with SPIKEVAX (see CLINICAL TRIALS, Clinical Trial Adverse Reactions) and post
marketing safety data. Safety data accrued with SPIKEVAX and SPIKEVAX Bivalent in individuals ≥18
years of age are relevant to the SPIKEVAX XBB.1.5 vaccine in individuals 6 through 17 years of age
because these vaccines are manufactured using the same process.
Table 24 – Summary of SPIKEVAX, SPIKEVAX Bivalent and SPIKEVAX XBB.1.5 Clinical Trials

Dosage, route of
Study
Study # Study Drug Study Design administration and
subjectsa (n)
duration
P301 SPIKEVAX Randomized, placebo- 100 mg, IM, 2 doses 14,134
controlled study in adults 29 days apart
18 years of age and older
P201 SPIKEVAX Open-label study arm 50 mcg booster dose, 171
Part B assessing immunogenicity IM, at least 6 months
in participants 18 years of following primary
age and older series
P203 SPIKEVAX Open-label study arm 50 mcg booster dose, 1346
Part 1C-1 assessing immunogenicity IM, at least 5 months
and safety in participants following primary
12 to 17 years of age and series
older
P204 SPIKEVAX Open-label study assessing 10 mcg or 25 mcg 1439
immunogenicity and safety booster dose, IM
in participants 6 months to
11 years of age and older
P205 SPIKEVAX Open-label Phase 2/3 50 mcg second 437
Part G Bivalent assessing immunogenicity booster dose, IM
(Original/Omicron and safety in participants
BA.1) 18 years of age and older
P205 SPIKEVAX Open-label Phase 2/3 50 mcg second 511
Part H Bivalent assessing immunogenicity booster dose, IM
Original/Omicron and safety in participants
BA.4/5 18 years of age and older
P205 SPIKEVAX XBB.1.5 Open-label Phase 2/3 50 mcg administered 101
Part J assessing safety, as fifth dose in adults
reactogenicity and who previously
immunogenicity in received 2-dose
participants 18 years of primary series, a
age and older booster dose and a
bivalent booster
dose, IM
P306 SPIKEVAX Open-label Phase 25 mcg, IM, 2 doses 142
Part 1 Bivalent 3assessing safety and 28 days apart
(Original/Omicron immunogenicity of
BA.1) bivalent 2-dose primary
series in participants 6
months to 5 years of age
P306 SPIKEVAX Open-label Phase 3 10 mcg booster dose, 539
Part 2 Bivalent assessing safety and IM, at least 4 months
(Original/Omicron immunogenicity of a following primary
BA.1) booster dose in series
participants 6 months to 5
years of age

A Total vaccinated subjects; does not include placebo population.
The safety, reactogenicity, and immunogenicity of SPIKEVAX XBB.1.5 are evaluated in an ongoing Phase
2/3 open-label study in participants 18 years of age and older (Study P205, Part J). In this study 50
participants received a 50 mcg dose of SPIKEVAX XBB.1.5, and 51 participants received a dose of an
investigational bivalent vaccine (XBB.1.5/Omicron BA.4/5). Overall, of the SPIKEVAX XBB.1.5 group
60.0% were female and 40.0% were male. The mean age was 51.6 years (range: 21 to 84 years) and
22.0% of participants were ≥ 65 years of age. The interval between the fourth dose (SPIKEVAX Bivalent
Original/Omicron BA.4/5) and the fifth dose of SPIKEVAX XBB.1.5 was a median of 8.2 months.
14.1.2 SPIKEVAX Bivalent (Original / Omicron BA.1)
The safety, reactogenicity, and immunogenicity of the SPIKEVAX Bivalent (Original / Omicron BA.1)
booster dose are evaluated in an ongoing Phase 2/3 open-label study in participants 18 years of age and
older (Study P205). In this study 437 participants received the SPIKEVAX Bivalent 50 mcg booster dose
and 377 participants received the SPIKEVAX (Original) 50 mcg booster dose. Overall, of the SPIKEVAX
Bivalent group 59.0% were female, 41.0% were male, 89.2% were White, and 10.8% were Hispanic or
Latino. The median age was 60 years (range: 20 to 88 years) and 39.8% of participants were ≥ 65 years
of age. Demographic and baseline characteristics were similar between the SPIKEVAX Bivalent 50 mcg
and SPIKEVAX 50 mcg groups.
In Study P205 SPIKEVAX Bivalent was administered as a second booster dose. The median time between
a first booster dose and the second booster dose with SPIKEVAX Bivalent was 136 days (range: 88 to 408
days). At baseline, 22.0% of subjects receiving SPIKEVAX Bivalent as a second booster dose had
evidence of prior SARS-CoV-2 infection.
14.1.2.2 Participants 6 Months to 5 Years of Age
The safety, reactogenicity and effectiveness of SPIKEVAX Bivalent (Original / Omicron BA.1) for use as a
primary series (2 doses of 25 mcg) are evaluated in an ongoing, Phase 3, open-label study in participants
6 months to 5 years of age (Study P306 Part 1). SPIKEVAX Bivalent (Original / Omicron BA.1) was
administered to vaccine-naïve children compared with recipients of SPIKEVAX (original) in the same
group in Study P204. In this study as of the data cut-off (05 Dec 2022) 142 subjects received two doses
of SPIKEVAX Bivalent, and 179 subjects received at least 1 dose. The per-protocol immunogenicity set
was 71 participants that were compared to 632 subjects who received the SPIKEVAX (original) two-dose

primary series in Study P204. Overall, of the SPIKEVAX Bivalent group 54.7% were male, 45.3% were
female, 65.4% were White, 25.7% were Black and 11.7% were Hispanic or Latino. The median age was 3
years. At baseline, 63.4% of subjects receiving SPIKEVAX Bivalent had evidence of prior SARS-CoV-2
infection. Participants will be followed for occurrence of COVID-19 and safety until 1 year after the last
dose.
The safety and immunogenicity of the SPIKEVAX Bivalent (Original / Omicron BA.1) booster dose are
evaluated in an ongoing, Phase 3, open-label study in participants 6 months to 5 years of age (Study
P306 Part 2). SPIKEVAX Bivalent was administered as a single 10 mcg booster dose to participants who
had received a SPIKEVAX (original) two-dose primary series at least 4 months prior. As of the data cut-
off (05 Dec 2022), 539 subjects had received a booster dose. The median time between dose 2 of the
primary series and the SPIKEVAX Bivalent booster dose was 7.85 months.
The safety and efficacy of SPIKEVAX (elasomeran) were evaluated in Study P301, a Phase 3 randomized,
placebo-controlled, multicentre study in participants 18 years of age and older (COVE Study). A total of
30,351 (15,181 in the SPIKEVAX group and N=15,170 in the placebo group) participants were
randomized equally to receive 2 doses of SPIKEVAX or placebo separated by 28 days. Randomization was
stratified by age and risk of severe COVID-19 as follows: ≥ 65 years old, < 65 years old and at increased
risk for the complications of COVID-19, and < 65 years old and not at increased risk for the complications
of COVID-19.
Pregnant or breastfeeding women and individuals with known history of SARS-CoV-2 infection,
immunosuppressive or immunodeficient state, asplenia or recurrent severe infections were excluded
from the study. The primary efficacy was symptomatic* COVID-19 infection confirmed by Polymerase
Chain Reaction (PCR) and by a clinical adjudication committee. The population for the analysis of the
primary efficacy endpoint included participants who did not have evidence of prior infection with SARS-
CoV-2 through 14 days after the second dose. Participants are planned to be followed for up to 24
months for assessments of safety and efficacy against COVID-19 disease.
* Symptomatic COVID-19 case definition: At least two of the following systemic symptoms: fever (≥38ºC), chills, myalgia, headache, sore throat,
new olfactory and taste disorder(s); or the participant must have experienced at least one of the following respiratory signs/symptoms: cough,
shortness of breath or difficulty breathing, or clinical or radiographical evidence of pneumonia; and the participant must have at least one NP
swab, nasal swab, or saliva sample (or respiratory sample, if hospitalized) positive for SARS- CoV-2 by RT-PCR. COVID-19 cases were adjudicated
by a Clinical Adjudication Committee.

Table 25 – Demographic Characteristics – Subjects ≥ 18 Years of Age Without Evidence of Infection
Prior to 14 Days After Dose 2 – Evaluable Efficacy Population (Data Accrued Through November 21,
2020)
SPIKEVAX Group Placebo Group Total
(N=14,134) (N=14,073) (N=28,207)
n (%) n (%) n (%)
Sex
Female 6,768 (47.9) 6,611 (47.0) 13,379 (47.4)
Male 7,366 (52.1) 7,462 (53.0) 14,828 (52.6)
Age (years)
Mean (SD) 51.6 (15.44) 51.6 (15.54) 51.6 (15.49)
Median 53.0 52.0 53.0
Min, max 18, 95 18, 95 18, 95
Age – Subgroups (years)
18 to <65 10,551 (74.6) 10,521 (74.8) 21,072 (74.7)
65 and older 3,583 (25.4) 3,552 (25.2) 7,135 (25.3)
Race
American Indian or Alaska Native 108 (0.8) 111 (0.8) 219 (0.8)
Asian 620 (4.4) 689 (4.9) 1,309 (4.6)
Black or African American 1,385 (9.8) 1,349 (9.6) 2,734 (9.7)
Native Hawaiian or Other Pacific Islander 35 (0.2) 31 (0.2) 66 (0.2)
White 11,253 (79.6) 11,174 (79.4) 22,427 (79.5)
Other 299 (2.1) 295 (2.1) 594 (2.1)
Ethnicity
Hispanic or Latino 2,789 (19.7) 2,780 (19.8) 5,569 (19.7)
Not Hispanic or Latino 11,212 (79.3) 11,165 (79.3) 22,377 (79.3)
Race and Ethnicity
Non-Hispanic White
9,023 (63.8) 8,916 (63.4) 17,939 (63.6)
Communities of color 5,088 (36.0) 5,132 (36.5) 10,220 (36.2)
Occupational Risk* 11,586 (82.0) 11,590 (82.4) 23,176 (82.2)
Healthcare worker 3,593 (25.4) 3,581 (25.4) 7,174 (25.4)
High Risk Condition**
One high risk condition present 2,616 (18.5) 2,591 (18.4) 5,207 (18.5)
Two or more high risk conditions
590 (4.2) 576 (4.1) 1,166 (4.1)
present
No high risk condition 10,928 (77.3) 10,906 (77.5) 21,834 (77.4)
Age and Health Risk for Severe COVID-
19***
18 to <65 years and not at risk 8,189 (57.9) 8,200 (58.3) 16,389 (58.1)
18 to <65 years and at risk 2,367 (16.7) 2,324 (16.5) 4,691 (16.6)
≥ 65 years 3,578 (25.3) 3,549 (25.2) 7,127 (25.3)
* Occupational risk includes: Healthcare Workers; Emergency Response; Retail/Restaurant Operations; Manufacturing and
Production; Operations, Warehouse Shipping and Fulfillment centers, Transportation and Delivery Services, Border Protection
and Military Personnel Personal care and in-home services; Hospitality and Tourism Workers, Pastoral; Social or Public Health
Workers; and Educators and Students.
** High risk for severe COVID-19 is defined as patients who meet at least one of the following criteria (protocol-defined):
• Chronic lung disease (e.g., emphysema and chronic bronchitis, idiopathic pulmonary fibrosis, and cystic fibrosis) or
moderate to severe asthma
• Significant cardiac disease (e.g., heart failure, coronary artery disease, congenital heart disease, cardiomyopathies, and
• pulmonary hypertension)

• Severe obesity (body mass index ≥ 40 kg/m2)
• Diabetes (Type 1, Type 2 or gestational)
• Liver disease
• Human immunodeficiency virus (HIV) infection
*** Age and health risk for severe COVID-19 is used as stratification factor for randomization.
A booster dose of SPIKEVAX (elasomeran) was evaluated in Study P201 Part B, an open-label part
assessing immunogenicity following administration of a 50 ug booster dose in participants 18 years of
age and older (N=171) who had received a SPIKEVAX primary series in Study P201 Part A. Participants
were predominantly female (60.8%), had a mean age of approximately 52 years and were
predominantly white (95.9%).
Safety, efficacy, and immunogenicity data for SPIKEVAX in adolescents were collected in an ongoing
Phase 2/3 randomised, placebo-controlled, observer-blind clinical trial (Study P203) conducted in the
United States involving 3,726 participants 12 through 17 years of age who received at least one dose of
SPIKEVAX (n=2,486) or placebo (n=1,240). Overall, 51.4% were male, 48.6% were female, 11.6% were
Hispanic or Latino, 83.9% were White, 3.4% were African American, 5.9% were Asian, 0.5% were
American Indian or Alaska Native, <0.1% were Native Hawaiian or Pacific Islander, 1.0% were other
races, and 4.5% were multiracial. Demographic characteristics were similar among participants who
received SPIKEVAX and those who received placebo.
A booster dose of SPIKEVAX was evaluated in an ongoing Phase 2/3 clinical trial (Study P203,
NCT04649151) with multiple parts. The open-label booster portion of the study involved 1,364
participants 12 years through 17 years of age who received a 50 mcg booster dose of SPIKEVAX
(elasomeran) at least 5 months after the second dose of the primary series. The median time from the
second dose of the primary series to the booster dose was 316 days (range: 274 to 422 days). Overall,
51.2% were male, 48.8% were female, 13.1% were Hispanic or Latino, 84.9% were White, 3.2% were
African American, 4.8% were Asian, 0.5% were American Indian or Alaska Native, <0.1% were Native
Hawaiian or Pacific Islander, 0.7% were other races, and 5.2% were Multiracial.
Safety, efficacy and immunogenicity data for SPIKEVAX in children 6 through 11 years of age were
collected in an ongoing Phase 2/3 two-part clinical trial conducted in the United States and Canada.
Part 1 is an open-label phase of the trial for safety, dose selection, and immunogenicity and included
380 participants 6 through 11 years of age who received at least 1 dose (0.25 mL, 50 mcg) of SPIKEVAX.
Part 2 is the placebo-controlled phase for safety, immunogenicity and efficacy, and included 4,002
participants 6 through 11 years of age who received at least one dose of SPIKEVAX (n=3,007) or placebo

(n=995). No participants in Part 1 participated in Part 2. Overall, in Part 2 50.8% were female and
49.2% male, 18.5% were Hispanic or Latino, 65.6% were White, 10.0% were African American, 9.9%
were Asian, 0.4% were American Indian or Alaska Native, <0.1% were Native Hawaiian or Pacific
Islander, 2.1% were other races and 10.6% were multiracial. Demographic characteristics were similar
among participants who received Moderna COVID-19 Vaccine and those who received placebo.
A booster dose of SPIKEVAX was evaluated in participants 6 through 11 years of age in an ongoing Phase
2/3 clinical trial with multiple parts. The open-label booster portion of the study involved 1,294
participants 6 years through 11 years of age who received a 25 mcg booster dose of SPIKEVAX
(elasomeran) at least 6 months after the second dose of the primary series (Study P204, NCT04796896).
Overall, 51.9%% were male, 48.1% were female, 15.6% were Hispanic or Latino, 65.7% were White,
11.0% were African American, 7.8% were Asian, 0.5% were American Indian or Alaska Native, <0.1%
were Native Hawaiian or Pacific Islander, 1.9% were other races, and 11.8% were Multiracial.
14.1.3.4 Children 6 months to 5 Years of Age
Safety, efficacy and immunogenicity data for SPIKEVAX (original) in children 6 months through 5 years of
age were collected in an ongoing Phase 2/3 two-part clinical trial (Study P204). Part 1 is an open-label
phase of the trial for safety, dose selection, and immunogenicity and included 225 participants 6 months
through 5 years of age who received at least 1 dose (25 mcg) of SPIKEVAX. Part 2 is the placebo-
controlled phase for safety, immunogenicity and efficacy, and included 6,388 participants 6 months
through 5 years of age who received at least one dose of SPIKEVAX (n=4,792) or placebo (n=1,596). No
participants in Part 1 participated in Part 2. Overall, in Part 2 50.9% were male, 49.1% were female,
13.9% were Hispanic or Latino, 77.4% were White, 4.0% were African American, 5.6% were Asian, 0.3%
were American Indian or Alaska Native, 0.2% were Native Hawaiian or Pacific Islander, 1.5% were other
races, and 10.5% were multiracial. Demographic characteristics were similar among participants who
received SPIKEVAX and those who received placebo.
Safety data for a booster dose of SPIKEVAX (elasomeran) in individuals 6 months through 5 years of age
of the study involved 145 participants 6 months through 5 years of age who received a 10 mcg booster
dose of SPIKEVAX (elasomeran) at least 6 months after the second dose of the primary series (Study
P204). Overall, 55.2% were male, 44.8% were female, 10.3% were Hispanic or Latino, 80.0% were White,
2.8% were African American, 6.2% were Asian, 0.7% were American Indian or Alaska Native, 0.0% were
Native Hawaiian or Pacific Islander, 2.8% were other races, and 7.6% were Multiracial.

14.2 Study Results
The safety, reactogenicity, and immunogenicity of SPIKEVAX XBB.1.5 is evaluated in an ongoing Phase
2/3 open-label study in participants 18 years of age and older (Study P205 Part J). In this study, 50
participants received a 50 mcg dose of SPIKEVAX XBB.1.5 and 51 participants receive a dose of an
investigational bivalent vaccine (XBB.1.5/Omicron BA.4/5, 50 mcg).
Study P205 Part J evaluated the safety, reactogenicity and immunogenicity of SPIKEVAX XBB.1.5 when
administered as a fifth dose to adults to previously received 2 doses of SPIKEVAX (original) (100 mcg) as
a primary series, a first booster dose of SPIKEVAX (original) (50 mcg) and a second booster dose of
SPIKEVAX Bivalent Original/Omicron BA.4/5 (50 mcg). The evaluation of the safety and reactogenicity of
SPIKEVAX XBB.1.5 was a primary objective. In addition, the evaluation of the Day 15 immunogenicity
against variants contained in the vaccine was also a primary objective. All analysis were descriptive.
The median follow-up time in the interim analysis was 20 days (data cutoff date of 16 May 2023).
SPIKEVAX XBB.1.5 elicited neutralizing responses at Day 15 against the SARS-CoV-19 variants assessed,
including XBB.1.5, XBB.1.16, BA.4/5, BQ.1.1 and D614G. When assessed against XBB.1.5 the neutralising
antibody geometric mean titre (GMT) and corresponding 95% CI was 2579.0 (1809.1, 3676.7) 15 days
after the SPIKEVAX XBB.1.5 dose, and the and the GMR (95% CI) was 16.7 (12.8, 21.7). When SPIKEVAX
XBB.1.5 was assessed against BA.4/5, the GMT (95% CI) was 9673.4 (6965.6, 13433.8) and the GMR was
6.3 (4.8, 8.2). Reactogenicity was similar to prior doses of the original SPIKEVAX vaccine and SPIKEVAX
Bivalent Original/Omicron BA.4/5.
14.2.2 SPIKEVAX Bivalent Original / Omicron BA.4/5
14.2.2.1.1 Booster Dose – Immunogenicity
The safety, reactogenicity, and immunogenicity of a SPIKEVAX Bivalent Original/Omicron BA.4/5 booster
dose are evaluated in an ongoing Phase 2/3 open-label study in participants 18 years of age and older
(Study P205 Part H). In this study, 511 participants received the SPIKEVAX Bivalent Original/Omicron
BA.4-5 50 mcg booster dose, and 376 participants received the SPIKEVAX (original) 50 mcg booster dose.
Study P205 Part H evaluated the safety, reactogenicity and immunogenicity of SPIKEVAX Bivalent
Original/Omicron BA.4/5 when administered as a second booster dose to adults who previously received
2 doses of SPIKEVAX (original) (100 mcg) as a primary series and a first booster dose of SPIKEVAX
(original) (50 mcg). In Study P205 Part F, study participants received SPIKEVAX (original) (50 mcg) as a
second booster dose and the Part F group serves as a within-study, non-contemporaneous comparator
group to the SPIKEVAX Bivalent Original/Omicron BA.4/5 group.
The primary immunogenicity analysis was based on the primary immunogenicity set which includes
participants with no evidence of SARS-CoV-2 infection at baseline (pre-booster). In the primary analysis,
the original SARS-CoV-2 estimated neutralising antibody geometric mean titre (GMT) and corresponding

95% CI was 87.9 (72.2, 107.1) and 2324.6 (1921.2, 2812.7) 28 days after the SPIKEVAX Bivalent
Original/Omicron BA.4/5 and SPIKEVAX (original) booster doses, respectively. The Day 29 GMR for
SPIKEVAX Original/Omicron BA.4/5 50 mcg booster dose versus the SPIKEVAX (original) 50 mcg booster
dose was 6.29 (5.27, 7.51), meeting the pre-specified criterion for superiority (lower bound of CI >1).
The estimated neutralising antibody GMTs (95% CI) against Omicron BA.4/BA.5 adjusted for pre-booster
titre and age group were 2747.3 (2399.2, 3145.9) and 436.7 (389.1, 490.0) 28 days after SPIKEVAX
Bivalent Original/Omicron BA.4/5 and SPIKEVAX (original) booster doses, respectively, and the GMR
(95% CI) was 6.29 (5.27, 7.51), meeting the pre-specified criterion for non-inferiority (lower bound of CI
>0.667).
14.2.3 SPIKEVAX Bivalent (Original / Omicron BA.1)
The safety, reactogenicity, and immunogenicity of the SPIKEVAX Bivalent (Original/Omicron BA.1)
booster dose are evaluated in an ongoing Phase 2/3 open-label study in participants 18 years of age and
older (Study P205). For the purpose of this clinical indication, data from Part G and Part F of the study
are considered. Part G consisted of participants that were administered SPIKEVAX Bivalent vaccine as a
second booster dose (50 mcg, mRNA-1273.214 [25 mcg elasomeran and 25 mcg imelasomeran]). The
comparator group is from Part F, where study participants received SPIKEVAX original (50 mcg, mRNA-
1273) as a second booster dose.
Immunobridging analyses compared the neutralizing antibody titers (ID50) 29 days following the second
booster dose (P205 Part G; N=334) to the corresponding titers 29 days following the second booster
dose (P205 Part F; N=260) against the Omicron BA.1 subvariant.
In this study, the primary analysis was based on the immunogenicity set, which included participants
with no evidence of SARS-CoV-2 infection at baseline (pre-second booster dose).
The estimated Day 29 neutralising antibody GMTs against Omicron were 2479.9 (95%CI: 2264.5, 2715.8)
and 1421.2 (95%CI: 1283.0, 1574.4) in the SPIKEVAX Bivalent (Part G) and SPIKEVAX original (Part F)
second booster groups, respectively, and the GMR was 1.75 (97.5% CI: 1.49, 2.04). The Omicron SRRs
were 100% (95%CI: 98.9, 100) and 99.2% (95%CI: 97.2, 99.9), 29 days in the mRNA-1273.214 and mRNA-
1273 groups, respectively, and the SRR difference was 1.5% (97.5%CI: -1.1, 4.0). The findings are
summarized in 6.

Table 26 – Ancestral SARS-CoV-2 (D614G) and Omicron Neutralizing Antibody Titres (ID50) - SPIKEVAX
Bivalent (mRNA-1273.214) 50 µg and SPIKEVAX (mRNA-1273) 50 µg Administered as Second Booster
Doses
Omicron variant Ancestral SARS-CoV-2
P205 Part G P205 Part F P205 Part G P205 Part F
SPIKEVAX Bivalent SPIKEVAX Bivalent
(Original/Omicron (Original/Omicron
BA.1) SPIKEVAX mRNA- BA.1) SPIKEVAX
mRNA-1273.214 1273 mRNA-1273.214 mRNA-1273
50 µg 50 µg 50 µg 50 µg
Antibody: PsVNA nAb ID50 titres (N=334) (N=260) (N=334) (N=260)
Pre-booster, n 334 260 334 260
Observed GMT (95% CI)a 298.13 332.02 1266.74 1521.00
(258.75, 343.49) (282.05, 390.85) (1120.19, 1432.47) (1352.77, 1710.15)
Day 29, n 334 260 334 260
Observed GMT (95% CI)a 2372.42 1473.46 5977.26 5649.33
(2070.63, 2718.20) (1270.85, 1708.38) (5321.90, 6713.32) (5056.85, 6311.23)
Observed GMFR (95% CI)a 7.96 4.44 4.72 3.71
(7.18, 8.82) (3.97, 4.96) (4.36, 5.11) (3.42, 4.03)
GLSM [estimated GMT] 2479.89 1421.24 6422.32 5286.63
(95% CI)b (2264.47, 2715.80) (1282.98, 1574.41) (5990.12, 6885.71) (4887.07, 5718.86)
GMR (97.5% CI)b 1.75 1.22
(1.49, 2.04) (1.08, 1. 37)
Seroresponse, N1 333 258 334 260
Seroresponse rate, n (%)c 333 (100) 256 (99.2) 334 (100) 260 (100)
95% CId (98.9, 100.0) (97.2, 99.9) (98.9, 100.0) (98.6, 100.0)
Difference in seroresponse 1.5 0
rates (97.5%)e (-1.1, 4.0)
Abbreviations: CI = confidence interval; GLSM = geometric least squares mean; GMFR = geometric mean fold-rise; GMR =
geometric mean ratio; GMT = geometric mean titre; ID 50 = 50% inhibitory dilution; LLOQ = lower limit of quantification; nAb =
neutralising antibodies; PsVNA = pseudotyped virus neutralisation assay; SARS-CoV-2 = severe acute respiratory syndrome-2; n
= number of participants with non-missing data at the corresponding timepoint; N1 = number of participants with non-missing
data at pre-vaccination baseline and the corresponding timepoint.
a 95% CI is calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values
for GM value and GM fold-rise, respectively, then back transformed to the original scale for presentation.
b Based on ANCOVA modeling; the model includes adjustment for treatment group, pre-booster antibody titres, and age
groups.
C Seroresponse at a participant level is defined as a change from below the LLOQ to equal or above 4 x LLOQ if the participant’s
baseline is below the LLOQ, or at least a 4-fold rise if the baseline is equal to or above the LLOQ. For participants without pre-
Dose 1 antibody titer information, seroresponse is defined as >= 4*LLOQ for participants with negative SARS-CoV-2 status at
their pre-dose 1 of the primary series, and these titers are imputed as <LLOQ at pre-dose 1 of primary series. For participants
without SARS-CoV-2 status information at pre-dose 1 of primary series, their pre-booster SARS-CoV-2 status is used to impute
their SARS-CoV-2 status at their pre-dose 1 of primary series.
d 95% CI is calculated using the Clopper-Pearson method.
e 97.5% CI was calculated by stratified Miettinen-Nurminen method adjusted by age group. The SRR difference is a calculated
common risk difference using inverse-variance stratum weights and the middle point of Miettinen-Nurminen confidence limits
of each one of the stratum risk differences. The stratified Miettinen-Nurminen estimate of the CI cannot be calculated when the
seroresponse rate in both groups is 100%, absolute difference is reported.
14.2.3.2 Three-month Antibody Persistence of SPIKEVAX Bivalent (Original/Omicron BA.1) Booster
Participants in Study P205 Part G were sequentially enrolled to receive 50 micrograms of SPIKEVAX
(original) (n = 376) or SPIKEVAX Bivalent Original/Omicron BA.1 (n = 437) as second booster doses. In

participants with no pre-booster incidence of SARS-CoV-2, SPIKEVAX Bivalent Original/Omicron BA.1
elicited Omicron-BA.1-neutralising antibody titres (observed GMT) that were significantly higher (964.4
[834.4, 1114.7]) than those of SPIKEVAX (original) (624.2 [533.1, 730.9]) and similar between boosters
against ancestral SARS-CoV-2 at three months.
14.2.3.2.1 SPIKEVAX Bivalent (Original/Omicron BA.1) Observed Neutralising Antibody Titres for
Omicron Subvariant BA.4/5
In an exploratory analysis, additional analytical testing of SPIKEVAX Bivalent (Original/Omicron BA.1) was
conducted to assess neutralizing antibody response against the dominant circulating SARS-CoV-2
Omicron subvariants BA.4/5 in July 2022.
For all participants regardless of prior SARs-CoV-2 infection the estimated Day 29 neutralising antibody
GMTs against Omicron BA. 4/5 were 985.38 (95%CI: 914.77, 1061.434) and 588.36 (95%CI: 544.08,
636.24) in the SPIKEVAX Bivalent (Part G) and SPIKEVAX original (Part F) second booster groups,
respectively, and the GMR was 1.68 (95%CI: 1.52, 1.84).
For participants without prior SARs-CoV-2 infection, the estimated Day 29 neutralising antibody GMTs
against Omicron BA. 4/5 were 776.45 (95%CI: 719.49, 837.92) and 458.28 (95%CI: 420.62, 499.32) in the
SPIKEVAX Bivalent (Part G) and SPIKEVAX original (Part F) second booster groups, respectively, and the
GMR was 1.69 (95%CI: 1.51, 1.90).
For participants with prior SARs-CoV-2 infection, the estimated Day 29 neutralising antibody GMTs
against Omicron BA. 4/5 were 2246.25 (95%CI: 1975.52, 2554.09) and 1406.89 (95%CI: 1227.88,
1612.01) in the SPIKEVAX Bivalent (Part G) and SPIKEVAX original (Part F) second booster groups,
respectively, and the GMR was 1.60 (95%CI: 1.34, 1.91).
14.2.3.3.1 Primary Series – Efficacy (Based on Cut-off Date of December 5, 2022)
Study P306 Part 1 is an ongoing Phase 3 open-label clinical trial to evaluate the safety and
immunogencity of SPIKEVAX Bivalent (Original / Omicron BA.1) in individuals ages 6 months to 5 years of
age. Participants with a known history of SARS-CoV-2 infection within 90 days of study vaccination were
excluded from the study. A total of 179 participants were enrolled to receive 2 doses of SPIKEVAX
Bivalent (Original /Omicron BA.1) (25 mcg per dose, mRNA-1273.214 [12.5 mcg elasomeran and 12.5
mcg imelasomeran] 1 month apart. Of the 179 participants, 142 had received 2 doses at the time of the
data cut, of whom 108 had at least 28 days of follow-up after Dose 2.
Effectiveness in individuals 6 months through 5 years of age is based on a comparison of immune

responses in this age group in Study P306 Part 1 to individuals 6 months through 5 years of age who
received a primary series of SPIKEVAX (original) (25 mcg per dose) in Study P204.
In Study P306 Part 1, the neutralizing antibody concentrations against a pseudovirus expressing the
original SARS-CoV-2 Spike protein (D614G) and a pseudovirus expressing the Omicron BA.1 Spike protein
were evaluated. Primary immunogenicity analyses compared the GMC ratios 28 days after Dose 2 with
SPIKEVAX Bivalent (Original / Omicron BA.1) to those following Dose 2 with SPIKEVAX (original). Analyses

of GMC ratios met predefined success criteria for superiority against Omicron BA.1 and noninferiority
against the Original strain (Table 27).
Table 27 – Summary of Geometric Mean Concentration Ratio 28 Days After Dose 2 with SPIKEVAX
Bivalent (Original / Omicron BA.1) or SPIKEVAX (original) in Participants 6 Months Through 5 Years of
Age – Per-Protocol Immunogenicity Set*
Bivalent Vaccine
Moderna COVID- GMRa
(Original and
19 Vaccine (Bivalent Vaccine
Omicron BA.1)
Assay N=632 [Original and Omicron Met Success Criteria
N=71
GMCa BA.1]/Moderna COVID-
GMCa
(95% CI) 19 Vaccine) (97.5% CI)
(95% CI)
1889.7 74.3 25.4 Lower limit of 95% CI

Omicron BA.1
(1520.4, 2348.7) (68.5, 80.8) (20.1, 32.1) >1 Criterion: Yesb
Original SARS- 1432.9 1732.5 0.8 Lower limit of 95% CI

CoV-2 (D614G) (1173.4, 1749.7) (1620.9, 1851.8) (0.7, 1.0) >0.667 Criterion: Yesc
* Per-Protocol Immunogenicity Set included all subjects who received the planned doses of study vaccine per schedule, had Day
57 neutralizing antibody data available, and had no major protocol deviations that impact key or critical data.
a The log-transformed antibody levels are analyzed using an analysis of covariance (ANCOVA) model with the group variable
(children in Study P306 and in Study P204) as fixed variable, adjusted by age group (two age groups: 6 months through 23
months, 2 years through 5 years), and by the baseline SARS-CoV-2 infection status. Coefficients for Least Squares Means use
margins by level. The resulted LS means, difference of LS means, and 95% CI are back transformed to the original scale for
presentation.
b Superiority is declared if the lower limit of the 2-sided 95% CI for the GMC ratio is >1.
c Non-inferiority is declared if the lower limit of the 2-sided 95% CI for the GMC ratio is ≥0.667.
Note: Antibody values < the lower limit of quantitation (LLOQ) are replaced by 0.5 × LLOQ. Values > the upper limit of
quantitation (ULOQ) are replaced by the ULOQ if actual values are not available.
14.2.4.1.1 Primary Series - Efficacy (Based on Cut-off Date of November 21, 2020)
The analysis of the primary efficacy endpoint in the COVE Study (P301) included 28,207 participants 18
years of age and older (14,134 in the SPIKEVAX group and 14,073 in the placebo group). At the time of
the final primary efficacy analysis, participants had been followed for symptomatic COVID-19 disease for
a median of 2 months after the second dose, corresponding to 3304.9 person years for the SPIKEVAX
group and 3273.7 person years in the placebo group.
There were 11 confirmed COVID-19 cases identified in the SPIKEVAX group and 185 in placebo group,
respectively, for the primary efficacy analysis. Compared to placebo, efficacy of SPIKEVAX in participants
with first COVID-19 occurrence from 14 days after Dose 2 was 94.1% (two-sided 95% confidence interval
of 89.3% to 96.8%). In participants 65 years of age and older, efficacy of SPIKEVAX was 86.4% (two-sided
95% confidence interval of 61.4%% to 95.5%). At the time of primary efficacy analysis, there was a total
of 30 severe COVID-19 cases reported in the placebo group starting 14 days after Dose 2, per

adjudication committee assessment. No cases of severe COVID-19 were reported in the SPIKEVAX
group.
14.2.4.1.2 Booster Dose - Immunogenicity
Effectiveness of the single booster dose of 50 mcg of SPIKEVAX in adults 18 years of age and older who
received a 2-dose primary series with 100 mcg SPIKEVAX at least 6 months prior to booster was inferred
by comparing the antibody titers from Study P201 Part B to the pivotal adult Study P301.
Study P201 Part B was an open-label study assessing immunogenicity responses following
administration of a 50 mcg booster of SPIKEVAX to participants primed with 100 mcg doses of SPIKEVAX.
Participants with negative baseline SARS-CoV-2 status were randomly selected from Study P301
participants in the SPIKEVAX group to form an Immunogenicity Subset in Study P301, which was used as
the comparator arm for the Study P201 Part B immunobridging analysis.
Immunobridging analyses compared the neutralizing antibody titers (ID50) 28 days following the booster
dose (201 Part B; N=149) to the corresponding titers 28 days after completion of the primary series in a
random subset of participants 18 years of age and older from the Phase 3 efficacy study (P301; N=1055).
In participants who were primed with a 2-dose series of 100 mcg of SPIKEVAX, single booster dose of 50
mcg of SPIKEVAX demonstrated a geometric mean fold rise of 12.99 (95% CI: 11.04, 15.29) from pre-
booster values of neutralizing antibodies as compared to 28 days after the booster dose. The geometric
mean ratio (comparing the antibody levels on Day 29 in Study P201 Part B vs. the antibody levels on Day
57 after the priming series in Study P301) was 1.76 (95% CI: 1.50, 2.06), successfully meeting the pre-
specified non-inferiority criterion of 0.67 corresponding to non-inferiority margin of 1.5. The analysis is
summarized in Table .
Table 28 – Neutralizing Antibody Geometric Mean Titers (ID50) Against a Pseudovirus Expressing the
SARS-CoV-2 Spike Protein at 28 Days After a Booster Dose in Study P201 Part B vs 28 Days After
Completion of the Primary Series in Study P301, Participants ≥18 Years of Age, Per-Protocol
Immunogenicity Set
Study P201 Part B Study P301
GMT Ratio
Booster Dose Primary Series
(Study P201 Part B/ Met Success Criteriac
Na=149 Na=1053
Study P301)
GMTb (95% CI) GMTb (95% CI)
Lower limit of 95% CI ≥0.67 Criterion: Yes
1802 (1548, 2099) 1027 (968, 1089) 1.76 (1.50, 2.06)
Point Estimate ≥1.0 Criterion: Yes
* Per-Protocol Immunogenicity Set included all subjects who had both baseline (or Study P201 Part B Day 1) and post-
vaccination immunogenicity samples, did not have SARS-CoV-2 infection at baseline (or Study P201 Part B Day 1), did not have a
major protocol deviation that impacted immune response, and had post-injection immunogenicity assessment at timepoint of
primary interest (Day 29 for Study P201 Part B and Day 57 for Study P301).
a Number of subjects with non-missing data at the corresponding timepoint.
b The statistical analysis plan pre-specified an analysis of covariance model for estimating the geometric mean titer that adjusts
for differences in age groups (<65 years, ≥65 years).

c Immunobridging is declared if the lower limit of the 2-sided 95% CI for the GMR is >0.67 and the point estimate of the GLSM
ratio is ≥1.0.
Note: Antibody values < the lower limit of quantitation (LLOQ) are replaced by 0.5 × LLOQ. Values > the upper limit of
quantitation (ULOQ) are replaced by the ULOQ if actual values are not available.
GLSM = Geometric least squares mean
GMR = Geometric mean ratio

14.2.4.2.1 Primary Series - Efficacy and Immunogenicity (Based on Cut-off Date of May 8, 2021)
The vaccine safety, efficacy and immunogenicity in participants 12 to 17 years of age was evaluated in
Study P203, an ongoing Phase 2/3 randomised, placebo-controlled, observer-blind, clinical trial.
Participants with a known history of SARS-CoV-2 infection were excluded from the study. A total of
3,732 participants were randomised 2:1 to receive 2 doses of SPIKEVAX or 2 doses of saline placebo 28
days apart. Participants will be followed for efficacy and safety until 1 year after the second dose.
There were 0 confirmed COVID-19 cases identified in the mRNA-1273 COVID-19 Vaccine (N=2,162) and 4
in placebo groups (N=1,073), respectively, for the vaccine efficacy analysis. Compared to placebo, efficacy
of mRNA-1273 COVID-19 Vaccine in participants with first COVID-19 occurrence from 14 days after Dose
2 was 100% (two-sided 95% confidence interval of 28.9% to 100%).
An analysis of SARS-CoV-2 50% neutralising titers in randomly selected subsets of participants was
performed to demonstrate non-inferior immune responses (within 1.5-fold) comparing adolescents 12
to 17 years of age (from Study P203) to participants 18 to 25 years of age (from Study P301) who had no
serological or virological evidence of past SARS-CoV-2 infection. The immune response to SPIKEVAX in
adolescents 12 to 17 years of age (n=340) was non-inferior to the immune response in participants 18 to
25 years of age (n=305), based on results for SARS-CoV-2 neutralizing titers at 28 days after the second
dose. The geometric mean titers (GMT) ratio of the adolescents 12 to 17 years of age group to the
participants 18 to 25 years of age group was 1.08, with a 2-sided 95% CI of 0.93 to 1.24, meeting the 1.5-
fold non-inferiority criterion (the lower bound of the 2-sided 95% CI for the geometric mean ratio [GMR]
>0.67).
Effectiveness of a booster dose of 50 mcg of SPIKEVAX in participants 12 years through 17 years of age
was inferred by comparing the post-booster antibody titers from Study P203 to those following the
primary series in adults 18 through 25 years of age in the pivotal adult Study P301.
In an open-label phase of Study P203, participants 12 years through 17 years of age received a single
booster dose at least 5 months after completion of the primary series (two doses 28 days apart). The
primary immunogenicity analysis population included 257 booster dose participants from Study P203
and a random subset of 295 participants from Study P301 (ages ≥18 to ≤25 years) who previously
completed a primary vaccination series of two doses 28 days apart of SPIKEVAX. Study P301 and Study
P203 participants included in the analysis population had no serologic or virologic evidence of
SARS-CoV-2 infection prior to the first primary series dose and prior to the booster dose, respectively.
The median time from Dose 2 of the primary series to the booster dose in the primary immunogenicity
analysis set in Study P203 was 295 days (range: 274 to 357 days).
In the 257 participants from Study P203, pre-booster (booster dose-Day 1) nAb GMC was 400.4 (95% CI:
370.0, 433.4); on booster dose-Day 29, the GMC was 7172.0 (95% CI: 6610.4, 7781.4). Post-booster
booster dose-Day 29 GMC increased approximately 18-fold from pre-booster GMC.

The primary immunogenicity analyses of the GMC ratio and difference in seroresponse rates following
the booster dose in Study P203 compared to after the primary series in Study P301 met the pre-defined
immunobridging success criteria. Seroresponse for a participant was defined as achieving a ≥4-fold rise
of neutralizing antibody concentration from baseline (before the first dose of the primary series in Study
P301 and Study P203). These analyses are summarized in Table 29.
Table 29 – Comparison of Geometric Mean Concentration and Seroresponse Rate Against a

Pseudovirus Expressing the SARS-CoV-2 Spike Protein at 28 Days After a Booster Dose in Study P203
(Participants 12 Years Through 17 Years of Age) vs 28 Days After Completion of the Primary Series in
Study P301 (Participants 18 through 25 Years of Age) - Per-Protocol Immunogenicity Sets
Study P203* Study P301†
Booster Dose Primary Series Met Success Criteria
Na=257 Na=294
GMC Ratio
GMC (95% CI) GMC (95% CI)
(Study P203/Study P301)
7172 (6610, 7781) 1400 (1273, 1541) 5.1 (4.5, 5.8) Yes b
Difference in Seroresponse Rate
Seroresponsec Seroresponsec
(Study P203-Study P301)
n/N1 (%) n/N1 (%)
%
(95% CI)d (95% CI)d
(95% CI)e
257/257 (100) 292/294 (99.3) 0.7
Yesf
(98.6, 100) (97.6, 99.9) (-0.8, 2.4)
* Per-Protocol Immunogenicity Subset – Pre-Booster SARS-CoV-2 Negative for Study P203 included all subjects
who had both pre-booster and post-booster immunogenicity samples, did not have SARS-CoV-2 infection at pre-
booster, did not have a major protocol deviation that impacted immune response, and had post-booster
immunogenicity assessment at timepoint of primary interest (28 days post-Booster Dose).
† Per-Protocol Immunogenicity Subset for Study P301 included all subjects who had both baseline (pre-
vaccination) and post-vaccination immunogenicity samples, did not have SARS-CoV-2 infection at baseline, did
not have a major protocol deviation that impacted immune response, and had post-injection immunogenicity
assessment at timepoint of primary interest (28 days post-Dose 2).
a
Number of subjects with non-missing data at the corresponding timepoint.
b
Immunobridging success is declared if the lower limit of the 2-sided 95% CI for the GMC Ratio is ≥0.667 and the
point estimate of the GMC Ratio is ≥0.8.
c
Seroresponse is defined as ≥4-fold rise of pseudovirus neutralizing antibody concentration from baseline (pre-
Dose 1 of primary series in Study P203 and Study P301), where baseline concentration < LLOQ is set to LLOQ for
the analysis.
N1=number of participants with non-missing data at pre-vaccination baseline and 28 days post-Booster Dose for
Study P203 or 28 days post-Dose 2 for Study P301.
n=number of participants who achieved seroresponse at 28 days post-Booster Dose for Study P203 or 28 days
post-Dose 2 for Study P301.
d
95% CI is calculated using the Clopper-Pearson method.
e
95% CI is calculated using the Miettinen-Nurminen (score) confidence limits.
f
Immunobridging success is declared if the lower limit of the 2-sided 95% CI for the percentage difference is ≥ -
10%.
Note: Antibody values < the lower limit of quantitation (LLOQ) are replaced by 0.5 × LLOQ. Values > the upper limit
of quantitation (ULOQ) are replaced by the ULOQ if actual values are not available.
A descriptive analysis evaluated seroresponse rates using pre-booster neutralizing antibody

concentration in Study P203 participants. The booster dose seroresponse rate, with seroresponse

defined as at least a 4-fold rise relative to the pre-booster concentration, was 96.5%. In this post-hoc
analysis, the difference in seroresponse rates was -2.8% (96.5 % in Study P203 - 99.3% in Study P301)
with the 95% CI of (-5.9, -0.6).
14.2.4.3.1 Primary Series – Immunogenicity and Efficacy (Based on Cut-off Date of November 10, 2021
The vaccine safety, efficacy and immunogenicity in participants 6 to 11 years of age was evaluated in
Study P204 Part 2, an ongoing Phase 2/3 randomised, placebo-controlled, observer-blind, clinical trial.
Participants with a known history of SARS-CoV-2 infection within 2 weeks of study vaccination were
excluded from the study. A total of 4,016 participants were randomised 3:1 to receive 2 doses (0.25 mL,
50 mcg) of SPIKEVAX or saline placebo 28 days apart. Participants will be followed for efficacy and safety
until 1 year after the second dose. In Part 2, the median length of follow-up at the data cutoff date of
November 10, 2021 was 82 days after dose 1 and 51 days after dose 2.
Efficacy in children 6 to 11 years of age is primarily based upon a comparison of immune responses in
this age group to adults 18 to 25 years of age.
An immunobridging analysis evaluating SARS-CoV-2 50% neutralising titers and seroresponse rates 28
days after Dose 2 was conducted in subset of children aged 6 to 11 in the paediatric study (Study P204;
N=320) and in participants 18 through 25 years of age from the Phase 3 efficacy study (Study P301;
N=295). Subjects had no immunologic or virologic evidence of prior SARS-CoV-2 infection at baseline.
The GMR of the neutralising antibody titers in children 6 to 11 years of age compared to the 18- to 25-
year-olds was 1.239 (95% CI: 1.072, 1.432). The difference in seroresponse rate was 0.1% (95% CI: -1.9,
2.1). Non-inferiority criteria (lower bound of the 95% CI for GMR > 0.67 and lower bound of the 95% CI
of the seroresponse rate difference > -10%) were met (see Table 30).
Table 30 – Immunogenicity Analysis, Neutralizing Antibody Geometric Mean Titers (ID50), Study P204
and Study P301 – Comparison of Children 6 Years to < 12 Years of Age to Participants 18 Through 25
Years of Age
Study P204 Study P301
6 years to < 12 Years 18 to ≤ 25 Years
SPIKEVAX 50 mcg SPIKEVAX 100 mcg
N=320 N=295
Baseline GMT 9.250 9.285
GMT Observed at Day 57 1610.203 1299.855
GMR at Day 57 (Study P204 vs P301; model
1.239 (1.072, 1.432)
based)(95% CI)a
Participants achieving seroresponse, %b at Day 57 99.1 99.0
Difference in seroresponse rate (Study P204
0.1 (-1.9, 2.1)
vs P301), % (95% CI)c
Abbreviations: CI = confidence interval; GMR = geometric mean ratio; GMT = geometric mean titer (noted as observed or model
based, which is estimated by geometric least squares mean); ID50 = 50% inhibitory dose.
a The log-transformed antibody levels are analyzed using an ANCOVA model with the group variable (children in
P204 and young adults in P301) as fixed effect. The resulted LS means, difference of LS means, and 95% CI are
back transformed to the original scale for presentation.
b Seroresponse at a participant level is defined as a change from below the LLOQ to equal or above 4 × LLOQ, or at
least a 4-fold rise if baseline is equal to or above the LLOQ. Percentages are based on the number of participants

with non-missing data at baseline and the corresponding timepoint.
c 95% CI is calculated using the Miettinen-Nurminen (score) confidence limits.
An exploratory efficacy analysis evaluating confirmed COVID-19 cases that accrued up to the data cutoff
date of November 10, 2021 was performed in 3,497 participants who received two doses of either
SPIKEVAX (n=2,644) or placebo (n=853), and had a negative baseline SARS-CoV-2 status. There were 3
confirmed cases in each arm, with the incidence rate per 1000 person-years being smaller in the vaccine
arm (5.04) than in the placebo arm (16.26).
Effectiveness of a booster dose of 25 mcg of SPIKEVAX in participants 6 years through 11 years of age
was inferred by comparing the post-booster antibody titers from Study P204 to those following the
primary series in adults 18 through 25 years in the pivotal adult Study P301.
In an open-label phase of Study P204, participants 6 years through 11 years of age received a single
booster dose at least 6 months after completion of the primary series (two doses 1 month apart). The
primary immunogenicity analysis population included 95 booster dose participants in Study P204 and a
random subset of 295 participants 18 through 25 years from Study P301 who received two doses of
SPIKEVAX 1 month apart. Study P301 and P204 participants included in the analysis population had no
serologic or virologic evidence of SARS-CoV-2 infection prior to the first primary series dose and prior to
the booster dose, respectively.
In the 95 participants, on booster dose-Day 29, the GMC was 5847.5 (95% CI: 4999.6, 6839.1) and the
SRR was 100 (95% CI: 95.9, 100.0). Serum nAb levels for children 6 through 11 years in the Per-Protocol
immunogenicity subset with pre-booster SARS-CoV-2 negative status and the comparison with those
from young adults (18 to 25 years of age) were studied. The GMR of booster dose Day 29 GMC
compared to young adults Day 57 GMC was 4.2 (95% CI [3.5, 5.0]), meeting the noninferiority criteria
(i.e., lower bound of the 95% CI > 0.667); the SRR difference was 0.7% (95% CI: -3.5, 2.4), meeting the
noninferiority criteria (lower bound of the 95% of the SRR difference >-10%).
the booster dose in Study P204 compared to following the primary series in Study P301 met the pre-
defined immunobridging success criteria. Seroresponse for a participant was defined as achieving a ≥4-
fold rise of neutralizing antibody concentration from baseline (before the first dose of the primary series
in Study P204 and Study P301). These analyses are summarized in Table 31.
Table 31 – Comparison of Geometric Mean Concentration and Seroresponse Rate Against a

Pseudovirus Expressing the SARS-CoV-2 Spike Protein at 28 Days After a Booster Dose in Study P204
(Participants 6 Years Through 11 Years of Age) vs 28 Days After Completion of the Primary Series in
Study P301 (Participants 18 through 25 Years of Age) - Per-Protocol Immunogenicity Sets
Study P204* Study P301†
Met Success
Booster Dose Primary Series
Criteria
Na=95 Na=294
GMC Ratio
GMC (95% CI) GMC (95% CI)
(Study P204/ Study P301)
5848 (5000, 6839) 1400 (1273, 1541) 4.2 (3.5, 5.0) Yesb
Seroresponsec Seroresponsec Difference in Seroresponse Rate
n/N1 (%) n/N1 (%) (Study P204-Study P301)

(95% CI)d (95% CI)d %
(95% CI)e
88/88 (100) 292/294 (99.3) 0.7
Yesf
(95.9, 100) (97.6, 99.9) (-3.5, 2.4)
* Per-Protocol Immunogenicity Subset – Pre-Booster SARS-CoV-2 Negative for Study 4 included all subjects who
had both pre-booster and post-booster immunogenicity samples, did not have SARS-CoV-2 infection at pre-
immunogenicity assessment at timepoint of primary interest (28 days post-Booster Dose).
† Per-Protocol Immunogenicity Subset for Study 1 included all subjects who had both baseline (pre-vaccination)
and post-vaccination immunogenicity samples, did not have SARS-CoV-2 infection at baseline, did not have a
major protocol deviation that impacted immune response, and had post-injection immunogenicity assessment at
timepoint of primary interest (28 days post-Dose 2).
a
b
Immunobridging success is declared if the lower limit of the 2-sided 95% CI for the GMC Ratio is ≥0.667.
c
Seroresponse is defined as ≥4-fold rise of pseudovirus neutralizing antibody concentration from baseline (pre-
Dose 1 of primary series in Study 4 and Study 1), where baseline concentration < LLOQ is set to LLOQ for the
analysis.
N1=number of participants with non-missing data at pre-vaccination baseline and 28 days post-Booster Dose for
Study 4 or 28 days post-Dose 2 for Study 1.
n=number of participants who achieved seroresponse at 28 days post-Booster Dose for Study 4 or 28 days post-
Dose 2 for Study 1.
d
e
f
Immunobridging success is declared if the lower limit of the 2-sided 95% CI for the percentage difference is
≥ -10%.
A descriptive analysis evaluated seroresponse rates using pre-booster neutralizing antibody

concentration in study P204 participants. The booster dose seroresponse rate, with seroresponse
defined as at least a 4-fold rise relative to the pre-booster concentration, was 92.6%. In this post-hoc
analysis, the difference in seroresponse rates was -6.7% (95% CI -13.8, -2.7).
14.2.4.4.1 Primary Series – Immunogenicity and Efficacy (Based on Cut-off date of February 21, 2022)
The vaccine safety, efficacy and immunogenicity in participants 6 months to 5 years of age was
evaluated in Study P204 Part 2, an ongoing Phase 2/3 randomised, placebo-controlled, observer-blind,
clinical trial in healthy children 6 months to through 11 years of age. The study enrolled children in 3 age
groups: 6 years through 11 years; 2 years through 5 years; and 6 months through 23 months.
Participants with a known history of SARS-CoV-2 infection within 2 weeks of study vaccination were
excluded from the study.
A total of 6,403 participants 6 months through 5 years of age were randomised 3:1 to receive 2 doses
(25 mcg) of SPIKEVAX (n=4,802) or saline placebo (n=1,601) 28 days apart. Participants will be followed
for efficacy and safety until 1 year after the second dose. In Part 2, the median length of follow-up at the

data cut-off date of February 21, 2022, was 71 days for participants 2 through 5 years of age and 68 days
for participants 6 months through 23 months of age.
Immunogenicity
Efficacy in participants 6 months to 5 years of age is primarily based on a comparison of immune

responses in this age group to adults 18 to 25 years of age. An immunobridging analysis was conducted
of SARS-CoV-2 50% neutralizing titers and seroresponse rates 28 days after Dose 2 in a random subset of
children 6 months to 5 years of age in the paediatric Study P204 and participants 18 through 25 years of
age from the Phase 3 efficacy Study P301; subjects had no immunologic or virologic evidence of prior
SARS-CoV-2 at baseline (referred to as the Per-Protocol Immunogenicity Set). Noninferior immune
responses as assessed by geometric mean 50% neutralizing titers and seroresponse rates were
demonstrated in a comparison of children 2 to 5 years of age to participants 18 through 25 years of age
and children 6 months to < 2 years of age to participants 18 through 25 years of age (Table 32).
For children aged 2 years to 5 years of age, comparison of Day 57 nAb responses in the Per Protocol
Immunogenicity Subset to those of adults 18 through 25 years of age demonstrated a GMR of 1.014
(95% CI: 0.881, 1.167), meeting the prespecified noninferiority success criteria (i.e., lower bound of the
95% CI for GMR ≥ 0.67; point estimate ≥ 0.8). The difference in seroresponse rates (SRR) between the
children and adults was 0.4% (95% CI: 2.7, 1.5), also meeting the prespecified noninferiority success
criterion (lower bound of the 95% CI of the SRR difference ≥ -10%; point estimate of the SSR difference ≥
-5%).
For infants and toddlers from 6 months to < 2 years of age, comparison of Day 57 nAb responses in the
Per Protocol Immunogenicity Subset to those of adults 18 through 25 years of age demonstrated a GMR
of 1.280 (95% CI: 1.115, 1.470), meeting the prespecified noninferiority success criterion (i.e., lower
bound of the 95% CI for GMR ≥ 0.67; point estimate ≥ 0.8). The difference in SRR rates between the
infants/toddlers and young adults was 0.7% (95% CI: -1.0, 2.5), also meeting the prespecified
noninferiority success criteria (lower bound of the 95% CI of the seroresponse rate difference > 10%).
Table 32 – Immunogenicity Analysis, Neutralizing Antibody Geometric Mean Concentration, Study

P204 and Study P301 – Comparison of Children 6 months to 5 Years of Age to Participants 18 Through
25 Years of Age
Study P204 Study P204 Study P301
6 months to < 2 Years 2 years to 5 Years 18 to ≤ 25 Years
SPIKEVAX 25 mcg SPIKEVAX 25 mcg SPIKEVAX 100 mcg
N=230 N=264 N=291
Baseline GMC 7.9 7.7 11.1
GMC Observed at Day 57 1780.658 1410.015 1390.781
GMR at Day 57 (Study P204 vs 1.280 1.014
n/a
P301; model based)(95% CI)a (1.115, 1.470) (0.881, 1.167)
Participants achieving
100 98.9 99.3
seroresponse, %b at Day 57
Difference in seroresponse
rate (Study P204 vs P301), % 0.7 (-1.0, 2.5) -0.4 (-2.7, 1.5) n/a
(95% CI)c
Abbreviations: CI = confidence interval; GMR = geometric mean ratio; GMC = geometric mean concentration (noted as
observed or model based, which is estimated by geometric least squares mean).
a The log-transformed antibody levels are analyzed using an ANCOVA model with the group variable (children in

P204 and young adults in P301) as fixed effect. The resulted LS means, difference of LS means, and 95% CI are
back transformed to the original scale for presentation.
b Seroresponse at a participant level is defined as a change from below the LLOQ to equal or above 4 × LLOQ, or at
least a 4-fold rise if baseline is equal to or above the LLOQ. Percentages are based on the number of participants
with non-missing data at baseline and the corresponding timepoint.
c 95% CI is calculated using the Miettinen-Nurminen (score) confidence limits.
Efficacy
A descriptive efficacy analysis evaluating confirmed COVID-19 cases that accrued up to the data cutoff
date of February 21, 2022, was performed in 5,476 participants who received two doses of either
SPIKEVAX or placebo, and had a negative baseline SARS-CoV-2 status (referred to as the Per-Protocol Set
for Efficacy) (for participants 6 months through 23 months, 1,511 participants in the vaccine group, 513
in the placebo group; for participants 2 years through 5 years, 2,594 in the vaccine group, 858 in the
placebo group).
Vaccine efficacy was evaluated during the period when the B.1.1.529 (Omicron) variant was the
predominant variant in circulation.
The efficacy information in children 2 through 5 years of age and 6 through 23 months of age are
presented in Table 33 and Table 34, respectively. No cases of severe COVID-19 were reported in the
study.
Table 33 – Efficacy analysis: COVID-19 and SARS-CoV-2 infections in participants 2 through 5 years of
age starting 14 days after dose 2 – per-protocol set for efficacy
SPIKEVAX Placebo
N=2,594 N=858
Incidence rate Incidence rate % Vaccine
Cases of COVID-19 Cases of COVID-19 efficacy (95%
(n) per 1,000 (n) per 1,000 CI)*
person-years person-years
COVID-19 cases - 46.4
71 103.761 43 193.528
definition 1a (19.8, 63.8)
119 175.023 61 276.980
definition 2b (12.5, 54.0)
See end of Table 21 for footnotes.
Table 34 – Efficacy analysis: COVID-19 and SARS-CoV-2 infections in participants 6 through 23 months
of age starting 14 days after dose 2 – per protocol set for efficacy
SPIKEVAX Placebo
N=1,511 N=513
Incidence rate Incidence rate % Vaccine
Cases of COVID-19 Cases of COVID-19 efficacy (95%
(n) per 1,000 (n) per 1,000 CI)*
person-years person-years
definition 1a 37 99.981 18 146.042
(-27.7, 62.0)

51 138.239 34 279.822
definition 2b (21.4, 68.6)
N = Number of participants at risk at 14 days after Dose 1 for specific efficacy endpoint.
* Vaccine efficacy defined as 1 — ratio of incidence rate (SPIKEVAX vs. placebo). The 95% CI of the ratio is calculated using the
exact method conditional upon the total number of cases, adjusting for person-years.
a Participant must have experienced at least two of the following systemic symptoms: fever (≥38°C / ≥100.4°F), chills, myalgia,
headache, sore throat, new olfactory and taste disorder(s); or the participant must have experienced at least one of the
following respiratory signs/symptoms: cough, shortness of breath or difficulty breathing, or clinical or radiographical evidence
of pneumonia; and the participant must have at least one NP swab, nasal swab, or saliva sample (or respiratory sample, if
hospitalised) positive for SARS-CoV-2 by RT-PCR.
b Presence of at least one symptom from a list of COVID-19 symptoms and a positive NP swab or saliva sample for SARS-CoV-2
by RT-PCR. Listed symptoms were fever (temperature >38°C / ≥100.4°F), or chills, cough, shortness of breath or difficulty
breathing, fatigue, muscle aches, or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose,
nausea, or vomiting or diarrhea.
14.2.4.5 Booster Dose
Effectiveness of a booster dose of 10 mcg of SPIKEVAX in participants 6 months through 5 years of age
is based on a comparison of immune responses, as assessed by neutralizing antibody concentration
against a pseudovirus expressing the SARS-CoV-2 Spike protein from a USA_WA1/2020 isolate carrying
the D614G mutation, following the booster dose in participants 6 months through 5 years of age in
Study P204 to that following the primary series in adults 18 years through 25 years of age in the pivotal
adult Study P301.
In an open-label phase of Study P204, participants 6 months through 5 years of age received a single
booster dose of SPIKEVAX (original) (10 micrograms mRNA) at least 6 months after completion of a
SPIKEVAX (original) primary series (two doses 1 month apart). The primary immunogenicity analysis
population included 56 booster dose participants in Study P204 and a random subset of 295 participants
18 through 25 years from the adult study who had completed primary vaccination with two doses of
SPIKEVAX 1 month apart. Study P301 and P204 participants included in the analysis population had no
serologic or virologic evidence of SARS-CoV-2 infection prior to the first primary series dose and prior to
the booster dose, respectively. Among the 56 participants in the primary immunogenicity analysis
population, the median age for receipt of the booster dose was 2.3 years (range 1.4 to 5.6 years).
the booster dose in Study P204 compared to following the primary series in Study P301 met the pre-
defined immunobridging success criteria. Seroresponse for a participant was defined as achieving a ≥4-
fold rise of neutralising antibody concentration from baseline (before the first dose of the primary series
in this study and the adult Study). These analyses are summarised in Table 33.

Table 35- Comparison of GMC and seroresponse rate against a pseudovirus expressing the SARS-CoV-2
spike protein at 28 days after a booster dose (children 17 months - 5 years of age) vs 28 days after
completion of the primary series (participants 18 years – 25 years of age) – per-protocol
immunogenicity subsets
6 months – 5 years* Adult study† GMC ratio Met success criterion
booster dose primary series (6 months –
Na=56 Na=294 5 years/adult study)
GMC GMC
(95% CI) (95% CI)
5 713 1 400 4.1
Yesb
(4 604, 7 089) (1 275, 1 539) (3.2, 5.2)
6 months – 5 years Adult study primary Difference in Met Success Criterion
booster dose series seroresponse rate
seroresponsec seroresponsec (6 months –
N=56 N=294 5 years/adult
n/N1 (%) n/N1 (%) study)%
(95% CI)d (95% CI)d (95% CI)e
53/53 (100) 292/294 (99.3) 0.7
Yesf
(93.3, 100.0) (97.6, 99.9) (-6.1, 2.4)
* Per-protocol immunogenicity subset – pre-booster SARS-CoV-2 negative for this study included all subjects who
had both pre-booster and post-booster immunogenicity samples, did not have SARS-CoV-2 infection at pre-
immunogenicity assessment at timepoint of primary interest (28 days post-booster dose).
† Per-protocol immunogenicity subset for the adult study included all subjects who had both baseline (pre-
vaccination) and post-vaccination immunogenicity samples, did not have SARS-CoV-2 infection at baseline, did
not have a major protocol deviation that impacted immune response, and had post-injection immunogenicity
assessment at timepoint of primary interest (28 days post-dose 2).
a
b
Immunobridging success is declared if the lower limit of the 2-sided 95% CI for the GMC Ratio is ≥0.667.
c
Seroresponse is defined as ≥4-fold rise of pseudovirus neutralising antibody concentration from baseline
(pre-dose 1 of primary series in this study and the adult study), where baseline concentration < LLOQ is set to
LLOQ for the analysis.
N1 = number of participants with non-missing data at pre-vaccination baseline and 28 days post-booster dose for
this study or 28 days post-dose 2 for the adult study.
n = number of participants who achieved seroresponse at 28 days post-booster dose for this study or 28 days post-
dose 2 for the adult study.
d
e
f
Immunobridging success is declared if the lower limit of the 2-sided 95% CI for the percentage difference is
≥ -10%.
In a descriptive analysis, the booster dose seroresponse rate among participants 17 months through
5 years of age, with seroresponse defined as at least a 4-fold rise relative to the pre-booster

concentration, was 94.6%. The difference in seroresponse rates (this study participants minus adult
study participants) in this post-hoc analysis was -4.7% (95% CI -14.0, -0.9).
15 MICROBIOLOGY
No microbiological information is required for this vaccine product.
16 NON-CLINICAL TOXICOLOGY
General Toxicology: Intramuscular administration of SPIKEVAX (or other Moderna mRNA investigational
vaccines) at doses ranging from 9 to 150 mcg/dose administered once every 2 weeks for up to 6 weeks
resulted in transient injection site erythema and edema, body temperature increases, and a generalized
systemic inflammatory response. Transient hepatocyte vacuolation and/or Kupffer cell hypertrophy,
often observed without liver enzyme elevations, was observed and considered secondary to the
systemic inflammatory response. In general, all changes resolved within 2 weeks.
Carcinogenicity: SPIKEVAX has not been evaluated for carcinogenicity in animals, as carcinogenicity
studies were not considered relevant to this vaccine.
Genotoxicity: SM-102, a proprietary lipid component of SPIKEVAX, SPIKEVAX Bivalent, SPIKEVAX

Bivalent Original/Omicron BA.4/5 and SPIKEVAX XBB.1.5 is not genotoxic in the bacterial mutagenicity
and the human peripheral blood lymphocytes chromosome aberration assays. Two intravenous in vivo
micronucleus assays were conducted with mRNA therapies using the same lipid nanoparticle (LNP)
formulation as SPIKEVAX Bivalent (Original/Omicron BA.1). Equivocal results observed at high systemic
concentrations were likely driven by micronuclei formation secondary to elevated body temperature
induced by a LNP-driven systemic inflammatory response. The genotoxic risk to humans is considered to
be low due to minimal systemic exposure following intramuscular administration, limited duration of
exposure, and the negative in vitro results.
Reproductive and Developmental Toxicology: In a pre- and post-natal developmental toxicity study,
0.2 mL of a vaccine formulation containing the same quantity of mRNA (100 mcg) and other ingredients
included in a single human dose of SPIKEVAX was administered to female rats by the intramuscular
route on four occasions: 28 and 14 days prior to mating, and on gestation days 1 and 13. No vaccine-
related adverse effects on female fertility, fetal development or postnatal development were reported
in the study.

PATIENT MEDICATION INFORMATION
READ THIS FOR SAFE AND EFFECTIVE USE OF YOUR MEDICINE
SPIKEVAX® XBB.1.5
[COVID-19 mRNA vaccine, monovalent (Omicron subvariant XBB.1.5)]
Andusomeran mRNA vaccine, Dispersion for Intramuscular Injection
Read this carefully before you start taking SPIKEVAX XBB.1.5. This leaflet is a summary and will not tell
you everything about this vaccine. Talk to your healthcare professional about your medical condition
and treatment and ask if there is any new information about SPIKEVAX XBB.1.5.
What is SPIKEVAX XBB.1.5 used for?

SPIKEVAX XBB.1.5 is a vaccine used to prevent the coronavirus disease 2019 (COVID-19) caused by the
SARS-CoV-2 virus. It can be given to people aged 6 months and older.
The safety and effectiveness of SPIKEVAX XBB.1.5 mRNA vaccine for individuals 6 months of age and
older is inferred from several studies of a primary series and booster dose of SPIKEVAX Bivalent
(Original/Omicron BA.1) in individuals 6 months to 5 years of age, a booster dose of SPIKEVAX Bivalent
(Original/Omicron BA.1) in individuals >18 years of age, a booster dose study of SPIKEVAX XBB.1.5 in
individuals > 18 years of age as well as data from studies which evaluated the primary series and booster
vaccination with SPIKEVAX (Original).
How does SPIKEVAX XBB.1.5 work?

SPIKEVAX XBB.1.5 works by causing the body to produce its own protection (antibodies) against the
SARS-CoV-2 virus that causes the COVID-19 infection. SPIKEVAX XBB.1.5 uses a molecule called
messenger ribonucleic acid (mRNA, the genetic code for a piece of the virus) to deliver the set of
instructions that cells in your body can use to make antibodies to help fight the virus that causes COVID-
19. The vaccine is given by injection with a needle in the upper arm.
You cannot get COVID-19 from this vaccine.
As with any vaccine, SPIKEVAX XBB.1.5 may not fully protect all those who receive it. Even after you
have had the vaccine, continue to follow the recommendations of local public health officials to prevent
spread of COVID-19.
What are the ingredients in SPIKEVAX XBB.1.5?

Medicinal ingredients: Andusomeran (mRNA)
Non-medicinal ingredients:
 acetic acid
 cholesterol
 DSPC (1,2-distearoyl-sn-glycero-3-phosphocholine)
 PEG2000-DMG (1,2-dimyristoyl-rac-glycerol,methoxy-polyethyleneglycol)
 lipid SM-102
 sodium acetate trihydrate

 sucrose
 trometamol
 trometamol hydrochloride
 water for injection
SPIKEVAX XBB.1.5 comes in the following dosage forms:

White to off-white dispersion for injection provided in a multidose vial.
Do not receive SPIKEVAX XBB.1.5 if:

 you are allergic to the active substance or any of the other ingredients of this vaccine (see What are
the ingredients in SPIKEVAX XBB.1.5?)
 you have had an allergic reaction to a previous dose of SPIKEVAX
 you currently have symptoms that could be due to COVID-19. Talk with your healthcare professional
about your symptoms and getting a COVID-19 test. Your healthcare professional will advise you
when you are able to receive the vaccine.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take
SPIKEVAX XBB.1.5. Talk about any health conditions or problems you may have, including if you:
 have any allergies
 have had previous problems following administration of SPIKEVAX such as an allergic reaction or
breathing problems
 have a weakened immune system due to a medical condition or are on a medicine that affects your
immune system
 have a bleeding problem, bruise easily or use a blood thinning medication
 have a high fever or severe infection
 have any serious illness
 have previously had episodes of myocarditis (inflammation of the heart muscle) and/or pericarditis
(inflammation of the lining outside the heart)
 are pregnant, think you may be pregnant or plan to become pregnant
 are breastfeeding or plan to breastfeed
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins,
minerals, natural supplements or alternative medicines.
There is limited information on the use of SPIKEVAX XBB.1.5 with other vaccines. Tell your healthcare
professional if you have recently received any other vaccine.
How is SPIKEVAX XBB.1.5 given:

 Your doctor, pharmacist or nurse will inject the vaccine into a muscle (intramuscular injection) in
your upper arm.
 During and after each injection of the vaccine, your doctor, pharmacist or nurse will watch over you
for around 15 minutes to monitor for signs of an allergic reaction.
Usual dose:
 12 years of age and older: One (1) dose of SPIKEVAX XBB.1.5 is 50 micrograms.
 5 to 11 years of age: One (1) dose of SPIKEVAX XBB.1.5 is 25 micrograms.

 6 months to 4 years of age:
o If the child has not been previously vaccinated: Two (2) doses of SPIKEVAX XBB.1.5 of 25
micrograms each.
o If the child has had 1 or more COVID-19 vaccine doses previously: One (1) dose of SPIKEVAX
XBB.1.5 is 25 micrograms.
Overdose:
In the event of suspected overdose with SPIKEVAX XBB.1.5,
contact your regional poison control centre.
Missed Dose:
If you forget to go back to your healthcare professional at the scheduled time for your next dose, ask
your healthcare professional for advice.
What are possible side effects from using SPIKEVAX XBB.1.5?

Like all vaccines, SPIKEVAX XBB.1.5 can cause side effects.
The following are common or very common side effects of SPIKEVAX XBB.1.5. Most of these side effects
are mild and do not last long. Tell your doctor if you have side effects that bother you:
 pain at the injection site
 tiredness, sleepiness
 headache
 muscle ache and stiffness
 chills
 fever
 swelling or redness at the injection site
 decreased appetite
 nausea and/or vomiting
 enlarged lymph nodes
 hypoaesthesia (decreased sense of touch or sensation, numbness) or paraesthesia (tingling, itching
or pricking sensation)
 dizziness
Non-severe allergic reactions (such as rash, itching, hives or swelling of the face), severe allergic
reactions, erythema multiforme (red round patches on the skin) and facial paralysis / Bell’s palsy have
been reported with the administration of SPIKEVAX. Myocarditis (inflammation of the heart muscle) and
pericarditis (inflammation of the lining outside the heart) have been reported following SPIKEVAX
administration.
These are not all the possible side effects you may have when taking SPIKEVAX XBB.1.5. If you
experience any side effects not listed here, tell your healthcare professional.
Should you develop any serious symptoms or symptoms that could be an allergic reaction, seek medical
attention right away. Symptoms of an allergic reaction include:
 hives (bumps on the skin that are often very itchy)
 swelling of the face, tongue or throat

 difficulty breathing
If you experience a severe allergic reaction, call 9-1-1, or go to the nearest hospital.
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to
interfere with your daily activities, tell your healthcare professional.
Reporting Suspected Side Effects for Vaccines

For the general public: Should you experience a side effect following immunization, please report it
to your healthcare professional.
Should you require information related to the management of the side effect, please contact your
healthcare professional. The Public Health Agency of Canada, Health Canada and Moderna
Biopharma Canada Corp. cannot provide medical advice.
For healthcare professionals: If a patient experiences a side effect following immunization, please
complete the Adverse Events Following Immunization (AEFI) Form appropriate for your
province/territory (https://www.canada.ca/en/public-health/services/immunization/reporting-
adverse-events-following-immunization/form.html) and send it to your local Health Unit.
Storage:
Your doctor or pharmacist is responsible storing, supplying and administering SPIKEVAX XBB.1.5, as well
as disposing of any unused product correctly.
Keep out of reach and sight of children.
If you want more information about SPIKEVAX XBB.1.5:
 Talk to your healthcare professional.
 Find the full product monograph that is prepared for healthcare professionals and includes this
Patient Medication Information by visiting the Health Canada website:
(https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-
product-database.html; the manufacturer’s website https://www.modernacovid19global.com/ca/,
or by calling 1-866-MODERNA (1-866-663-3762).
This leaflet was prepared by Moderna Biopharma Canada Corp.
Last Revised: September 12, 2023

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PRODUCT MONOGRAPH

INCLUDING PATIENT MEDICATION INFORMATION

SPIKEVAX XBB.1.5 (andusomeran mRNA vaccine) is indicated for:

Moderna Biopharma Canada Corp. Date of Initial Authorization:

Submission Control Number: 275936

SPIKEVAX XBB.1.5 (andusomeran mRNA vaccine) Page 1 of 71

RECENT MAJOR LABEL CHANGES ........................................................................................... 2

SPIKEVAX XBB.1.5 (andusomeran mRNA vaccine) Page 2 of 71

SPIKEVAX XBB.1.5 (andusomeran mRNA vaccine) Page 3 of 71

3 SERIOUS WARNINGS AND PRECAUTIONS

SPIKEVAX XBB.1.5 (andusomeran mRNA vaccine) Page 4 of 71

4.1 Dosing Considerations

Individuals ≥ 12 Years of Age: One dose of 50 mcg.

Individuals 5 to 11 Years of Age: One dose of 25 mcg.

Individuals 6 Months to 4 Years of Age:

COVID-19 Vial Cap Label Dose

4.2 Recommended Dose and Dosage Adjustment

4.2.1 Vaccination for Individuals 12 Years of Age and Older

4.2.2 Vaccination for Individuals Aged 5 to 11 Years

SPIKEVAX XBB.1.5 (andusomeran mRNA vaccine) Page 5 of 71

Children Not Previously Vaccinated

Children Previously Vaccinated

Use aseptic technique for preparation and administration.

Thaw each vial before use.

Do not re-freeze vials after thawing.

SPIKEVAX XBB.1.5 (andusomeran mRNA vaccine) Page 6 of 71

Do not inject the vaccine intravascularly, subcutaneously or intradermally.

6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING

Table 1 – Dosage Forms, Strengths, Composition and Packaging

SPIKEVAX XBB.1.5 (andusomeran mRNA vaccine) Page 7 of 71

7 WARNINGS AND PRECAUTIONS

Hypersensitivity and Anaphylaxis

Myocarditis and Pericarditis

SPIKEVAX XBB.1.5 (andusomeran mRNA vaccine) Page 8 of 71

7.1 Special Populations

7.1.1 Pregnant Women

SPIKEVAX XBB.1.5 (andusomeran mRNA vaccine) Page 9 of 71

8.1 Adverse Reaction Overview

Participants 18 Years of Age and Older

SPIKEVAX XBB.1.5 (andusomeran mRNA vaccine) Page 10 of 71

Children and Adolescents 6 to 17 Years of Age

Adolescents 12 to 17 Years of Age

Children 6 to 11 Years of Age

SPIKEVAX XBB.1.5 (andusomeran mRNA vaccine) Page 11 of 71

Children 6 Months to 5 Years of Age

SPIKEVAX XBB.1.5 (andusomeran mRNA vaccine) Page 12 of 71

8.2.1 SPIKEVAX XBB.1.5

8.2.1.1 Participants 18 Years of Age and Older

8.2.1.1.1 Booster Dose

Solicited Adverse Reactions

SPIKEVAX XBB.1.5 (andusomeran mRNA vaccine) Page 13 of 71

Unsolicited Adverse Events

SPIKEVAX XBB.1.5 (andusomeran mRNA vaccine) Page 14 of 71

8.2.2 SPIKEVAX Bivalent Original / Omicron BA.4/5

8.2.2.1 Participants 18 Years of Age and Older

8.2.2.1.1 Booster Dose

Solicited Adverse Reactions

8.2.3 SPIKEVAX Bivalent (Original/Omicron BA.1)