CDC 118387 DS1

Evidence to Recommendation Framework:
Moderna COVID-19 vaccine in children

ages 6 months – 5 years
&
Pfizer-BioNTech COVID-19 vaccine in children
ages 6 months – 4 years
Sara Oliver, MD, MSPH

ACIP Meeting
June 17, 2022
cdc.gov/coronavirus
Evidence to Recommendations Framework
Evidence to Recommendations (EtR) Framework
 Structure to describe information considered in moving from evidence to

ACIP vaccine recommendations
 Provide transparency around the impact of additional factors on
deliberations when considering a recommendation
Policy Question
 Should vaccination with Moderna COVID-19 vaccine (2-doses, 25µg, IM)

be recommended for children 6 months–5 years of age, under an Emergency
Use Authorization?
 Should vaccination with Pfizer-BioNTech COVID-19 vaccine (3-doses, 3µg, IM)

be recommended for children 6 months–4 years of age, under an Emergency
Use Authorization?
Evidence to Recommendations (EtR) Framework:
PICO Question
Population Children ages 6 months – 4 years or 5 years
Moderna COVID-19 vaccine (mRNA-1273) 2-doses, 25µg, IM
Intervention –or–
Pfizer-BioNTech COVID-19 vaccine (BNT162b2) 3-doses, 3µg, IM
Comparison No vaccine
Symptomatic laboratory confirmed COVID-19

Hospitalization due to COVID-19
Multisystem inflammatory syndrome in children (MIS-C)
Outcomes Asymptomatic SARS-CoV-2 infection
Serious adverse events
Reactogenicity grade ≥3
5
EtR Domain Question(s)

Public Health Problem • Is the problem of public health importance?
• How substantial are the desirable anticipated effects?
Benefits and Harms • How substantial are the undesirable anticipated effects?
• Do the desirable effects outweigh the undesirable effects?
• Does the target population feel the desirable effects are large relative to
Values the undesirable effects?
• Is there important variability in how patients value the outcome?
Acceptability • Is the intervention acceptable to key stakeholders?
Feasibility • Is the intervention feasible to implement?
Resource Use • Is the intervention a reasonable and efficient allocation of resources?
Equity • What would be the impact of the intervention on health equity?
EtR Domain
Public Health Problem
Data for young children overall
will be presented
Benefits and Harms
Values
Acceptability
Feasibility
Resource Use
Equity
EtR Domain
Benefits and Harms
Values
Acceptability Use of mRNA COVID-19

Feasibility vaccines broadly
Resource Use will be presented
Equity
EtR Domain
Benefits and Harms
Values
Manufacturer-specific
data
Acceptability will be presented
Feasibility
Resource Use
Equity
EtR Domain: Public Health Problem
Trends in number of COVID-19 cases in the United States
among persons of all ages
January 23, 2020 – June 14, 2022

Cases: 85,681,615
7-day
average:
103,935
cases
Source: COVID Data Tracker, https://covid.cdc.gov/covid-data-tracker/#trends_dailytrendscases. Accessed 6/16/2022

COVID-19 weekly cases per 100,000 population among
children ages 0 – 17 years by age group – United States
March 1, 2020 – June 14, 2022
2000
1800 Total number of COVID-19 cases
Incident cases per 100,000 population
1600 <1 year 578,168

1400 1–4 years 1,945,389
1200
5–11 years 5,106,673
1000 <1 year
12–17 years 5,691,196
800 1–4 years
600 5–11 years
400 12–17 years
200
0
Case earliest date by end of week

Reporting may be incomplete for the most recent two weeks of data, denoted by the grey box.
Source: COVID Data Tracker, https://covid.cdc.gov/covid-data-tracker/#demographicsovertime. Accessed 6/14/2022
COVID-19-associated hospitalizations among children and
adolescents ages 6 months – 17 years, COVID-NET
March 21, 2020 – May 7, 2022
10
9
Hospitalization rate per 100,000 population
5 6 months-4 years
5-11 years
4
12-17 years
3
0
3/21/20 6/21/20 9/21/20 12/21/20 3/21/21 6/21/21 9/21/21 12/21/21 3/21/22
Week End Date
Source: COVID-NET, https://gis.cdc.gov/grasp/COVIDNet/COVID19_3.html. Accessed 5/21/2022

Cumulative COVID-19-associated hospitalizations among
children and adolescents ages 6 months – 17 years, COVID-NET
March 21, 2020 – May 7, 2022
140
Cumulative hospitalization rate per 100,000
120
100
80
population
6 months-4 years
60 5-11 years
12-17 years
40
20
0
3/21/20 6/21/20 9/21/20 12/21/20 3/21/21 6/21/21 9/21/21 12/21/21 3/21/22
Week Ending Date
Source: COVID-NET, https://gis.cdc.gov/grasp/COVIDNet/COVID19_3.html. Accessed 5/21/2022

COVID-19 deaths in children and adolescents by age based
on death certificate data, National Center for Health
Statistics, January 1, 2020 – May 11, 2022
250
200 Young children 6 months – 4 years:

202 COVID-19 deaths
COVID-19 deaths
150
1.7% of all deaths in this age group
100
50
0
0-5 months 6-11 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17
months
Age in years
The provisional counts for COVID-19 deaths are based on a current flow of mortality data in the National Vital Statistics System. National provisional counts include deaths
occurring within the 50 states and the District of Columbia that have been received and coded as of the date specified. It can take several weeks for death records to be
submitted to National Center for Health Statistics (NCHS), processed, coded, and tabulated. Therefore, the data may be incomplete, and will likely not include all deaths that
occurred during a given time period, especially for the more recent time periods.
Source: https://data.cdc.gov/NCHS/Provisional-COVID-19-Deaths-Counts-by-Age-in-Years/3apk-4u4f/data. Accessed 5/14/22
COVID-19 was a leading cause of death among children ages
0 – 4 years
March 1, 2020 – April 30, 2022
Age group Rank of COVID-19 among causes
of death
<1 year 4
1 – 4 years 5
5 – 9 years 5
10 – 14 years 4
15 – 19 years 4
Based on death certificate data from the National Center for Health Statistics. COVID-19 based on cumulative total incidence of COVID-19 deaths from March 1, 2020-April 30,
2022.
Source: Preprint: Flaxman S, Whittaker C, Semenova E et al. Covid-19 is a leading cause of death in children and young people ages 0-19 years in the United States. medRxiv
2022.05.23.22275458; doi: https://doi.org/10.1101/2022.05.23.22275458
COVID-19 is a leading cause of death among infants age
<1 year
March 1, 2020–April 30, 2022
Crude rate per
Causes of Death Death (n)
100,000
1. Certain conditions originating in the perinatal period 272.1 10294

2. Congenital malformations, deformations and
113.7 4301
chromosomal abnormalities
3. Accidents (unintentional injuries) 33.5 1266
4. Covid-19 (cumulative) 7.2 269
5. Diseases of heart 7.1 268
2022.
Source: Flaxman S, Whittaker C, Semenova E et al. Covid-19 is a leading cause of death in children and young people ages 0-19 years in the United States. medRxiv
2022.05.23.22275458; doi: https://doi.org/10.1101/2022.05.23.22275458
COVID-19 is a leading cause of death among children
ages 1–4 years
March 1, 2020–April 30, 2022
Crude rate
Causes of Death per Death (n)
100,000
1. Accidents (unintentional injuries) 7.3 1149
2. Congenital malformations, deformations and chromosomal
2.6 416
abnormalities
3. Malignant neoplasms 1.8 285
4. Assault (homicide) 1.8 284
5. Covid-19 (cumulative) 0.9 134
2022.
Source: Flaxman S, Whittaker C, Semenova E et al. Covid-19 is a leading cause of death in children and young people ages 0-19 years in the United States. medRxiv
2022.05.23.22275458; doi: https://doi.org/10.1101/2022.05.23.22275458
Pediatric vaccine preventable diseases: Deaths per year in
the United States prior to recommended vaccines
1Vogt TM , Wise ME, Bell BP, Finelli L. Declining hepatitis A mortality in the United States during the era of hepatitis A vaccination. J Infect Dis2008; 197:1282–8.
2National Notifiable Diseases Surveillance System with additional serogroup and outcome data from Enhanced Meningococcal Disease Surveillance for 2015-2019.
3Meyer PA, Seward JF, Jumaan AO, Wharton M. Varicella mortality: trends before vaccine licensure in the United States, 1970-1994. J Infect Dis. 2000;182(2):383-390.
doi:10.1086/315714
4Roush SW , Murphy TV; Historical comparisons of morbidity and mortality for vaccine-preventable diseases in the United States. JAMA 2007; 298:2155–63.
5 Glass RI, Kilgore PE, Holman RC, et al. The epidemiology of rotavirus diarrhea in the United States: surveillance and estimates of disease burden. J Infect Dis. 1996 Sep;174
Suppl 1:S5-11.
6 https://data.cdc.gov/NCHS/Provisional-COVID-19-Deaths-Counts-by-Age-in-Years/3apk-4u4f/data. Accessed 5/14/22
Seroprevalence of infection-induced SARS-CoV-2 antibodies
among children ages 6 months–17 years — National
Commercial Lab Seroprevalence Study
September 2021– April 2022
Shading indicates confidence intervals for each trend line.

Data updated for March/April 2022, based on Clarke K, Kim Y, Jones J et al. Pediatric Infection-Induced SARS-CoV-2 Seroprevalence Estimation Using Commercial Laboratory
Specimens: How Representative Is It of the General U.S. Pediatric Population? (April 26, 2022).
SSRN: https://ssrn.com/abstract=4092074 or http://dx.doi.org/10.2139/ssrn.4092074
Reinfection occurs more frequently in those previously infected
and not vaccinated compared to infected and vaccinated
Prior infection not vaccinated
Prior infection before one vaccine dose

Prior infection before two vaccine doses
Prior infection before three vaccine doses
Carazo S, Skowronski DM, Brisson M, et al. “Protection against Omicron re-infection conferred by prior heterologous SARS-CoV-2 infection, with and without mRNA vaccination” medRxiv, May
2022. Protection against Omicron re-infection conferred by prior heterologous SARS-CoV-2 infection, with and without mRNA vaccination | medRxiv
Data on hospitalizations: Plumb ID, Feldstein LR, Barkley E, et al. Effectiveness of COVID-19 mRNA Vaccination in Preventing COVID-19–Associated Hospitalization Among Adults with Previous
SARS-CoV-2 Infection — United States, June 2021–February 2022. MMWR Morb Mortal Wkly Rep 2022;71:549-555. DOI: http://dx.doi.org/10.15585/mmwr.mm7115e2
Improved antibody response after vaccination
 Among children, COVID-19 vaccine induces a broader neutralizing antibody
response compared with infection induced immunity:
– From a U.S. multicenter cohort, antibody profiles of unvaccinated pediatric patients
hospitalized for COVID-19 were compared to profiles of vaccinated children.
– In contrast to those with SARS-CoV-2 infection, children vaccinated with two doses
demonstrated higher titers against Alpha, Beta, Gamma, Delta and Omicron.
– The findings suggest that antibodies produced by prior SARS-CoV-2 infection (pre-
Omicron) may not neutralize the currently circulating Omicron variant.
– This builds on evidence among adults that previous infection provides poor protection
from infection with Omicron.
 Highlights the importance of vaccinating children with prior infection to prevent
both severe disease and future infections.
Tang J, Novak T, Hecker J, et al. “Cross-reactive immunity against the SARS-CoV-2 Omicron variant is low in pediatrics patients with prior COVID-19 or MIS-C.” Nature Communications. (2022)
13:2979. https://doi.org/10.1038/s41467-022-30649-1
Summary
U.S. COVID-19 epidemiology in children 6 months–4 years
 COVID-19 has caused >2 million cases among children ages 6 months – 4 years
 Children 6 months–4 years of age are at risk of severe illness from COVID-19
– More than half of hospitalized children ages 6 months–4 years had no underlying conditions
– COVID-19 associated hospitalizations among children ages 6 months–4 years have similar or
increased severity compared to older children and adolescents
– Burden of COVID-19 associated death is similar to or exceeds that of other pediatric vaccine
preventable diseases
 Prior infection may not provide broad protection against newer SARS-CoV-2
variants
 COVID-19 pandemic continues to have significant impact on families
Work Group Interpretation
Is COVID-19 disease among children ages 6 months – 5 years of public health

importance?
o No o Probably no o Probably yes o Yes o Varies o Don’t know

EtR Domain: Benefits and Harms
Benefits and Harms Summary
 Moderna COVID-19 vaccine

– GRADE summary
 Pfizer-BioNTech COVID-19 vaccine

– GRADE summary
 Other considerations
 Number needed to vaccinate assessment
GRADE
Moderna COVID-19 vaccine: Children ages 6 months–5 years
 Moderna phase 2/3 randomized controlled trial in United States
 Randomized 3:1 vaccine to saline placebo
 Analyses performed separately for 6–23 months and 2–5 years, results pooled for a combined
estimate for 6 months–5 years
 Data evaluated: all eligible randomized participants who received all vaccinations as randomized
within the predefined window and no other important protocol deviations
– Data cut off: Feb 21, 2022
 Per protocol, the two co-primary endpoints for immunobridging were geometric mean ratios
(GMR) & serologic response
– Efficacy data also provided for symptomatic infection. Relative risks (RR) were calculated
from cases in the study population. Vaccine efficacy estimates were defined as 100% x (1-RR)
• Sensitivity analyses of VE were performed to include COVID-19 cases that were
identified using home testing lacking RT-PCR confirmation
27
Outcome: Symptomatic Lab-confirmed COVID-19
Population Events/Vaccine Events/Placebo Vaccine efficacya
(n/N) (n/N) (95% confidence interval)
Per protocol population
CDC case definitionb, no evidence of 170/4105 95/1371 40.3% (23.9% , 53.3%)
prior infection, ≥14 d post dose 2
CDC case definitionb, seropositivec or 181/4791 97/1597 37.8% (20.9%, 51.1%)
seronegative, ≥14 d post dose 2
CDC case definitionb, sensitivity analysis 253/4105 133/1371 36.6% (22.4%, 48.1%)
including home tests, ≥14 d post dose 2
Adult trial case definitiond ,no evidence 108/4105 61/1371 40.9% (19.6%, 56.8%)
of prior infection, ≥14 d post dose 2
a Manufacturer vaccine efficacy estimates calculated using incidence rates. For GRADE, vaccine efficacy calculated from the relative risk
b Requires at least 1 prespecified clinical symptom and a positive RT-PCR
c Approximately 10% of participants were seropositive at baseline
d Requires at least 2 prespecified systemic symptoms or at least 1 respiratory symptom and a positive RT-PCR
28
Immunobridging: Summary of Geometric Mean Ratio (GMR)
GMR (model Met
GMT (model based) c GMT (model based) c
Outcome Nb Nb based) c Noninferiority
(95% CI) (95% CI)
(95% CI) Objectived
6-23 Months 18-25 Years
Pseudovirus neutralizing
1780.7 1390.8
antibody level by pseudovirus 230 291 1.28 (1.12, 1.47) Yes
(1606.4, 1973.8) (1269.1, 1524.2)
neutralizing assay (ID50)a
2-5 Years 18-25 Years
Pseudovirus neutralizing
1410.0 1390.8
antibody level by pseudovirus 264 291 1.01 (0.88, 1.17) Yes
(1273.8, 1560.8) (1262.5, 1532.1)
neutralizing assay (ID50)a
Abbreviations: ID50 = 50% inhibitory dose; GLSM = geometric least squares mean; GMR = geometric mean ratio; CI=confidence interval
aSampling time point was at 28 days after the second dose (day 57).
bSubjects with a negative serology test at baseline and completion of the 2-dose series on schedule.
cThe 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.
dNoninferiority is declared if the lower bound of the 2-sided 95% CI for the GMR is greater than 0.67. 29
GRADE: Symptomatic Laboratory-confirmed COVID-19
Assessed Using Direct Efficacy
 RR 0.62 (0.49, 0.79)

 No serious concerns in certainty assessment
 Evidence type: High certainty (type 1)
RR= relative risk

Assessed Using Immunobridging
 Ages 6–23 months
– GMR 1.28 (1.12, 1.47); non-inferiority criteria met
 Ages 2–5 years
 Serious concerns of indirectness because immunogenicity is a surrogate

measure of efficacy
 Evidence type: Moderate certainty (type 2)

Outcome: Asymptomatic SARS-CoV-2 infection
 Asymptomatic SAR-CoV-2 infection is identified by absence of symptoms

AND at least 1 of following:
– Binding antibody level against SARS-CoV-2 nucleocapsid protein
negative at Day 1 that becomes positive post-baseline. Antibody levels
taken only on the immunogenicity subset (n=494)
– Positive RT-PCR test post-baseline at scheduled or unscheduled visit
Outcome: Asymptomatic SARS-CoV-2 infection
Study/population Events/Vaccine Events/Placebo Vaccine Efficacya
bAb level against SARS-Cov 2 nucleocapsid 111/4105 44/1371 16.0% (-18.5%, 40.5%)
protein negative at Day 1 that becomes positive
post-baseline or positive RT-PCR test post-
baseline at scheduled or unscheduled/illness
visit without symptoms
bAb level against SARS-Cov 2 nucleocapsid 135/4105 52/1371 21.1% (4.5%, 34.8%)
protein negative at Day 1 that becomes positive
post-baseline or positive RT-PCR or home
antigen test post-baseline or where test
modality was not identified at scheduled or
unscheduled/illness visit without symptoms
aManufacturer vaccine efficacy estimates calculated using incidence rates. For GRADE, vaccine efficacy calculated from
the relative risk
GRADE: Asymptomatic SARS-CoV-2 infection
 RR 0.84 (0.60, 1.19)

 Serious concerns of indirectness because asymptomatic SARS-CoV-2 PCR
testing on the full cohort only occurred once and serology was not done
on all participants
 Serious concerns of imprecision due to the wide confidence interval
 Evidence type: Low certainty (type 3)
RR= relative risk

Outcome: Serious Adverse Eventsa,b,c
Events/Vaccine % SAE Events/Placebo % SAE Associated with

Study/populationd
(n/N)e Vaccine (n/N)e Placebo vaccination
Moderna, unpublished 15/1761 0.85% 1/589 0.17% 1f

RCT- 6-23 months
Moderna, unpublished 9/3031 0.30% 2/1007 0.20% 0

RCT- 2-5 years
Moderna, unpublished 24/4792 0.50% 3/1596 0.19% 1f

RCT- 6 months-5 years
a Serious adverse event (SAE) is defined as death, life-threatening event, inpatient hospitalization or prolongation of existing hospitalization, persistent or
significant incapacity or substantial disruption of the ability to conduct normal life functions, medically important event, or congenital anomaly/birth defect
b No deaths were reported in any trial participants
c Follow up through Feb 21, 2022
d Included all randomized participants who received at least 1 dose of vaccine
E Number of participants experiencing SAEs (participants may experience more than one SAE)
F One participant experienced two SAEs of fever and febrile seizure that were considered possibly related to the study intervention by FDA
RCT= randomized controlled trials
35
GRADE: Serious Adverse Events
 RR 2.67 (0.80, 8.84)

 Serious concerns of indirectness due to short duration of follow up of 2
months after dose 2
 Very serious concerns of imprecision due to the study size and width of
the confidence interval
 Evidence type: Very low certainty (type 4)
RR= relative risk

Outcome: Reactogenicity, Severe (Grade ≥3)
 Local reactions
– Grade 3:
• 6–23 months: pain at injection site preventing daily activity; injection site redness >5 cm or swelling >5 cm; axillary
(underarm or groin) swelling or tenderness ipsilateral to injection side
• 2–5 years: pain at injection site preventing daily activity; injection site redness >10 cm or swelling >10 cm; axillary
(underarm or groin) swelling or tenderness ipsilateral to injection side
– Grade 4: emergency room visit or hospitalization for axillary (underarm or groin) swelling or severe pain at
the injection site, necrosis (redness and swelling categories) or exfoliative dermatitis (redness category only)
 Systemic events
– Grade 3:
• ≤36 months: fever 39.6°C to 40.0°C, irritability/crying, sleepiness, or loss of appetite that prevents daily activity
• 37 months–5 years: fever 39°C to 40°C, nausea/vomiting, chills, fatigue, headache, muscle pain, or joint pain that
prevents daily activity
– Grade 4: fever >40.0°C, fatigue, headache, muscle pain, joint pain, or nausea/vomiting that require
emergency room visit or hospitalization
Outcome: Reactogenicity, Severe (Grade ≥3)a
Study/population Events/Vaccine % Vaccine Events/Placebo % Placebo
(n/N) (n/N)
Moderna, unpublished
366/4774 7.7% 65/1582 4.1%
(either dose)
Any local (either dose) 84/4774 1.8% 6/1582 0.4%

Any systemic (either dose)b 288/4774 6.0% 59/1582 3.7%
a Reactogenicity outcome includes local and systemic events, grade ≥3 after either dose. Grade 3: prevents daily routine
activity. Grade 4: requires emergency room visit or hospitalization.
B There were 15 fevers of > 40.0 °C in the vaccine group and 3 in the placebo group
GRADE: Reactogenicity, Severe (Grade ≥3)
 RR 1.87 (1.44 to 2.42)

 No serious concerns in certainty assessment
 Evidence type: High certainty (type 1)
RR= relative risk

Summary of GRADE
Outcome Importance Design Findings Evidence
(# studies) type
Benefits
1. Symptomatic lab-confirmed
Critical RCT (1) Moderna COVID-19 vaccine is effective in preventing symptomatic COVID-19 1
COVID-19
1b. Symptomatic lab-confirmed
Critical RCT (1) Moderna COVID-19 vaccine is effective in preventing symptomatic COVID-19 2
COVID-19 (immunobridging)
2. Hospitalization due to
Important No studies Data not available from any studies ND
COVID-19
3. Multisystem inflammatory
syndrome in children (MIS-C)
4. Asymptomatic SARS-CoV-2 The vaccine did not demonstrate efficacy in prevention of asymptomatic
Important RCT (1) 3
infection SARS-CoV-2 infection
Harms
0.5% of participants with SAEs among vaccinated and 0.2% among
unvaccinated; certainty in the estimate was very low. Two SAEs which
5. Serious adverse events Critical RCT (1) 4
occurred in one participant were judged by the investigator to be related to
vaccination.
Severe reactions were more common in vaccinated; any grade ≥3 reaction
6. Reactogenicity Important RCT (1) 1
was reported by 7.7% of vaccinated vs. 4.1% of placebo group
Evidence type: 1=high; 2=moderate; 3=low; 4=very low; ND, no data 40
Conclusions
 Efficacy seen after two doses of Moderna COVID-19 vaccine in children

ages 6 months–5 years of age consistent with real-world vaccine
effectiveness in all other ages during Omicron predominance
 Antibody levels after 2 doses in children ages 6 months–5 years

produces similar antibody levels after 2 doses in individuals ages 18–25
years
 Reactogenicity post-vaccine consistent with other recommended

vaccines in this age group
41
GRADE
Pfizer-BioNTech COVID-19 vaccine: Children ages 6 months–4 years
 Pfizer-BioNTech phase 2/3 RCT conducted in United States, Finland, Poland, and Spain
 Randomized 2:1 vaccine to saline placebo
 Analyses performed separately for 6-23 months and 2-4 years, results pooled for a combined estimate
for 6 months-4 years
 Interval between Dose 1 and Dose 2 of 21 days
 Interval between Dose 2 and Dose 3 varied
– Ages 6–23 months: Median interval of 16 weeks
– Ages 2–4 years: Median interval of 11 weeks
 Data evaluated: direct efficacy and immunobridging (per protocol co-primary endpoint) on all eligible
randomized participants who received all vaccinations as randomized and no other important protocol
deviations
– Data cut-off: April 29, 2022 median follow-up after dose 3: 1.3 months
– Relative risks (RR) were calculated from cases in the study population. Vaccine efficacy estimates
were defined as 100% x (1-RR)
42
RCT= randomized controlled trial
GRADE
Population Vaccine Placebo Total

6 months–4 years n (%) n (%) n (%)
Randomized population 3013 (100%) 1513 (100%) 4526 (100%)
Dose 1 3013 (100%) 1513 (100%) 4526 (100%)
Dose 2 2985 (99.1%) 1503 (99.3%) 4488 (99.2%)
Dose 3 992 (32.9%) 464 (30.7%) 1456 (32.2%)
43
Pfizer COVID-19 vaccine: Children ages 6 months–4 years
Evaluable efficacyb
With or withoutc evidence of prior 1/386 2/184 76.2 (-161.2, 97.8)
infection (≥7 d post Dose 3),
ages 6–23 months
With or withoutc evidence of prior 2/606 5/280 81.5 (5.3, 96.4)
ages 2–4 years
With or withoutcevidence of prior 3/992 7/464 80.0 (22.8, 94.8)
ages 6mo–4 years
aManufacturer vaccine efficacy estimates calculated using incidence rates. For GRADE, vaccine efficacy calculated from the relative risk
bAll eligible randomized participants who received all vaccinations as randomized and had no other important protocol deviations as
determined by the investigator

cApproximately 30% of participants were seropositive at baseline
44
Immunobridging: Summary of Geometric Mean Ratio (GMR)
Met
GMTd GMTd GMRe
nc nc Noninferiority
(95% CI) (95% CI) (95% CI)
Objectivef
6–23 months (3 doses, 3 µg) 16–25 years (2 doses, 30 µg)

SARS-CoV-2 neutralization 1406.5 1180.0 1.19
assay – NT50a,b 82 170 Yes
(1211.3, 1633.1) (1066.6, 1305.4) (1.00, 1.43)
2–4 years (3 doses, 3 µg) 16–25 years (2 doses,30 µg)

SARS-CoV-2 neutralization 1535.2 1180.0 1.30
assay – NT50a,b 143 170 Yes
(1388.2, 1697.8) (1066.6, 1305.4) (1.13, 1.50)
Abbreviations: NT50 = 50% neutralizing titer; GMT = geometric mean titer; GMR = geometric mean ratio; LLOQ = lower limit of quantitation
aAmong participants who had no serological or virological evidence (1-month post-Dose 2 [16-25 years] or 1-month post-Dose 3 [6 mo – 4 years]) of past SARS-CoV-2 infection and had negative NAAT at any unscheduled visit up to one
month after dose two.

bSampling time point was one month after dose two.
cNumber of subjects with valid and determinate assay results for the specified assay at the given dose and sampling time point.
dGMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5 LLOQ.
eGMRs and 2-sided 95% CIs were calculated by exponentiating the mean difference of the logarithms of the titers (Group 1a [6 to 23 months] or Group 1b [2 to 4 years] – Group 2 [16–25 years]) and the corresponding CI (based on the
Student t distribution).
fNoninferiority is declared if the lower bound of the 2-sided 95% CI for the GMR is greater than 0.67.
45
Outcome: Symptomatic Lab-confirmed COVID-19, dose 2 efficacy
6–23 months
With or without evidence of prior 80/1178 48/598 15.4 (-19.4, 40.0)
infection, ≥7 Days after Dose 2 to
before Dose 3, ages 6–23 monthsb
2–4 years
With or without evidence of prior 100/1835 74/915 32.6 (10.0, 49.6)
infection, ≥7 Days after Dose 2 to
before Dose 3, ages 2–4 yearsc
aManufacturer vaccine efficacy estimates calculated using incidence rates. For GRADE, vaccine efficacy calculated from the relative
risk
bMet non-inferiority criteria for immunobridging to 16–25-year-olds
cDid not meet non-inferiority criteria for immunobridging to 16–25-year-olds
46
Assessed Using Direct Efficacy
 RR 0.2 (0.05, 0.77)

 Serious concern for indirectness due to the short duration of follow-up
of 1.3 months
 Very serious concerns for imprecision due to study size
RR= relative risk

Assessed Using Immunobridging
 Ages 6–23 months
 Ages 2–4 years

 Serious concerns of indirectness because immunogenicity is a surrogate

measure of efficacy
 Evidence type: Moderate certainty (type 2)
Outcome: Serious Adverse Events
 Safety population, approximately 1700 ages 6–23 months

– Included all randomized participants who received at least 1 dose of vaccine*
– Data from Dose 1 to data cutoff date (April 29, 2022); Median follow-up after dose 3:
1.3 months
 Safety population, approximately 2700 ages 2–4 years
– Included all randomized participants who received at least 1 dose of vaccine*
– Data from Dose 1 to data cutoff date (April 29, 2022); Median follow-up after dose 3:
1.4 months
*Six participants in 6-23 months age group and 9 participants in 2 to 4 years age group excluded due to not receiving vaccine or placebo. 49
Outcome: Serious Adverse Eventsa,b
Events/Vaccine % SAE Events/Placebo % SAE Associated with
Study/populationc
(nd/N) Vaccine (nd/N) Placebo vaccination
Pfizer/BioNTech RCT 17/1178e 1.4 14/598f 2.3 0

Ages 6 – 23 months
Pfizer/BioNTech RCT 12/1835g 0.7 8/915h 0.9 1i
Ages 2 – 4 years
Pfizer/BioNTech RCT 29/3013 1.0 22/1504 1.5 1

Ages 6 months – 4 years
a Serious adverse event (SAE) is defined as any untoward medical occurrence that, results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization,
results in persistent disability/incapacity, or is a congenital anomaly/birth defect. SAEs after dose 1 or dose 2 or dose 3 are reported.
bNo deaths were reported in any trial participants
c Included all randomized participants who received at least 1 dose of vaccine.
d Number of participants experiencing SAEs (participants may experience more than one SAE), data cutoff 29 April 2022.
e Twenty-two SAEs were reported in 17 vaccine recipients ages 6 to 23 months.
f Eighteen SAEs occurred in 14 placebo recipients ages 6 to 23 months.
g Fifteen SAEs were reported in 12 vaccine recipients ages 2 to 4 years.
hEight SAEs occurred in 8 placebo recipients ages 2 to 4 years.
50
i One vaccine recipient had 2 SAEs (fever and pain in extremity requiring hospitalization) considered possibly related by the Investigator. FDA considered the events potentially consistent with
symptoms due to unspecified viral infection

GRADE: Serious Adverse Events
 RR 0.66 (0.38, 1.15)

 Very serious concern for indirectness due to the short duration of
follow-up of 1 month post dose 3 and because only 31% of trial
participants received dose 3, limiting the ability to detect serious
adverse events that occur at a higher rate after dose 3
 Serious concerns of imprecision due to the study size
RR= relative risk

Outcome: Reactogenicity, Severe (Grade ≥3)
 All ages: Local reactions (redness, swelling, pain/tenderness at injection site)
– Grade 3: pain at injection site that prevents daily activity; redness >7 cm; and swelling >7 cm
– Grade 4: emergency room visit or hospitalization for severe pain at the injection site, necrosis (redness and
swelling categories) or exfoliative dermatitis (redness category only)
 Ages 6–23 months: Systemic events (fever, decreased appetite, drowsiness, irritability)
– Grade 3: fever >38.9°C to 40.0°C or events that prevent daily activity
– Grade 4: fever >40.0°C or events that require emergency room visit or hospitalization
 Ages 2–4 years: Systemic events (fever, vomiting, diarrhea, headache, fatigue, chills, new or
worsened muscle pain, new or worsened joint pain)
– Grade 3: fever >38.9°C to 40.0°C , vomiting that requires IV hydration; diarrhea of ≥6 loose stools in 24 hours;
severe fatigue, severe headache, severe muscle pain, or severe joint pain that prevents daily activity
– Grade 4: fever >40.0°C, fatigue, headache, muscle pain, joint pain, diarrhea, or vomiting that require emergency
room visit or hospitalization
Outcome: Reactogenicity, Severe (Grade ≥3)a
Study/population Events/Vaccine % Vaccine Events/Placebo % Placebo

(n/N) (n/N)
Pfizer-BioNTech,
129/3010 4.3% 54/1510 3.6%
unpublished (any dose)
Any local (any dose) 4/3010 0.1% 3/1510 0.2%

Any systemic (any dose)b 125/3010 4.2% 52/1510 3.4%
Note: Grade 3: prevents daily routine activity. Grade 4: requires emergency room visit or hospitalization
a Reactogenicity outcome includes local and systemic events, grade ≥3 after either dose.
b Six fevers of > 40.0 °C were reported among vaccine recipients and one among placebo recipients
GRADE: Reactogenicity (Grade ≥3)
 RR 1.20 (0.88, 1.64)

 Serious concern for indirectness was noted because only 31% of trial
participants received dose 3 limiting the ability to detect severe
reactogenicity that occurs specifically after dose 3
 Evidence type: 2 (moderate certainty)
Summary of GRADE
Outcome Importance Design Findings Evidence
(# studies) type
Benefits
1a. Symptomatic lab-confirmed Pfizer-BioNTech COVID-19 vaccine is effective in preventing symptomatic
Critical RCT (1) 4
COVID-19 (efficacy) COVID-19; certainty in the estimate was very low
1b. Symptomatic lab-confirmed Pfizer-BioNTech COVID-19 vaccine is effective in preventing symptomatic
Critical RCT (1) 2
COVID-19 (immunobridging) COVID-19
2. Hospitalization due to
COVID-19
3. Multisystem inflammatory
syndrome in children (MIS-C)
4. Asymptomatic SARS-CoV-2
infection
Harms
1.0% of participants with SAEs among vaccinated and 1.5% among
5. Serious adverse events Critical RCT (1) unvaccinated; certainty in the estimate was very low. 2 SAEs in 1 participant 4
in the vaccine arm were judged to be related to vaccination.
Severe reactions were slightly more common in vaccinated; any grade ≥3
6. Reactogenicity Important RCT (1) 2
reaction was reported by 4.3% of vaccinated vs. 3.6% of placebo group
Evidence type: 1=high; 2=moderate; 3=low; 4=very low; ND, no data 55
Conclusions
 Antibody levels after 3 doses in children ages 6 months–4 years produces

similar antibody levels after 2 doses in individuals ages 16–24 years
 Reactogenicity post-vaccine similar after each of the 3 vaccine doses, and
similar to reactions seen in placebo recipients
 Efficacy estimates difficult to interpret given small numbers and limited
follow-up time
– Impact of longer interval in the trial between dose 2 and dose 3 on efficacy,
reactogenicity or safety are unknown
56
Other considerations for mRNA COVID-19 vaccines in young children
 COVID-19 vaccines and seropositivity

 Myocarditis in young children
 Cardiac complications after SARS-CoV-2 infections
 Vaccine-associated myocarditis in children and adolescents
 Numbers needed to vaccinate analysis
57
COVID-19 vaccines and seropositivity
 Omicron-wave surges of pediatric COVID-19 hospitalizations occurred even with high
seroprevalence, suggesting this alone is not sufficient to provide broad protection
 Many seropositive individuals vaccinated without concerns
 Vaccination remains the safest strategy for preventing complications from SARS-
CoV-2 infection and offers additional protection against re-infection
– Prior infection may not provide broad protection against newer SARS-CoV-2 variants
 Clinical Considerations states that people who recently had SARS-CoV-2 infection
may consider delaying their COVID-19 vaccine by 3 months after infection
– An increased time between infection and vaccination may result in an improved immune
response to vaccination
– Low risk of reinfection has been observed in the weeks to months following infection
Myocarditis in young children
Background rates
 Before the COVID-19 pandemic, peaks in

myocarditis hospitalizations seen in
infants and adolescents
– In adolescents, typically viral in etiology
– In infants, many cases can represent
cardiomyopathy with genetic component
LOS = Length of hospital stay

Vasudeva et al. Am J Cardiology 2021 https://www.sciencedirect.com/science/article/pii/S0002914921002617
Previously presented: https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-06/02-COVID-Oster-508.pdf 59
Cardiac complications due to SARS-CoV-2 in young children
 Cardiac complications in the setting of acute SARS-CoV-2 infection in young

children are uncommon
 Most cardiac complications post-SARS-CoV-2 infection in infants related to
MIS-C
– 1.8% of MIS-C cases are children ages 6-11 months1
– Infants <1 year of age with MIS-C have severe cardiovascular involvement in
~55-65% of cases1
1 MIS-C National Surveillance Data, provided by Multisystem Inflammatory Syndrome Unit, Epidemiology & Surveillance Task Force, CDC 60
VAERS reporting rates of myocarditis (per 1 million doses administered)
after mRNA COVID-19 vaccination, days 0–7 and 8–21 post-vaccination*,†
0–7 days 8–21 days 0–7 days 8–21 days
Males Males Females Females
Age (yrs) Dose 1 Dose 2 Booster Dose 1 Dose 2 Booster Dose 1 Dose 2 Booster Dose 1 Dose 2 Booster
Pfizer- 5–11 0.2 2.6 0.0 0.6 0.0 0.0 0.2 0.7 0.0 0.2 0.0 0.0
BioNTech
12–15 5.3 46.4 15.3 1.2 1.2 0.9 0.7 4.1 0.0 0.4 0.2 0.9
16–17 7.2 75.9 24.1 1.7 3.2 1.3 0.0 7.5 0.0 0.7 0.4 0.0
18–24 4.2 38.9 9.9 1.1 2.2 0.4 0.6 4.0 0.6 0.2 0.7 0.0
25–29 1.8 15.2 4.8 0.4 1.1 0.5 0.4 3.5 2.0 0.2 0.0 0.8
Pfizer-
BioNTech
and
30–39 1.9 7.5 1.8 0.4 0.8 0.2 0.6 0.9 0.6 0.3 0.2 0.0
Moderna
40–49 0.5 3.3 0.4 0.2 0.5 0.0 0.4 1.6 0.6 0.2 0.2 0.0
50–64 0.5 0.7 0.4 0.2 0.3 0.1 0.6 0.5 0.1 0.2 0.5 0.1
65+ 0.2 0.3 0.6 0.3 0.2 0.1 0.1 0.5 0.1 0.1 0.2 0.1
* As of May 26, 2022; reports verified to meet case definition by provider interview or medical record review; primary series and 1st booster doses only
†An estimated 1–10 cases of myocarditis per 100,000 person years occurs among people in the United States, regardless of vaccination status; adjusted for days 0–7 and 8–21 risk intervals, this
estimated background is 0.2 to 2.2 per 1 million person-day 0–7 risk interval and 0.4 to 3.8 per 1 million person-day 8–21 risk interval (peach shaded cells indicate that reporting rate exceeded 61
estimated background incidence for the period)
Vaccine-associated myocarditis in young children
 Risk of myocarditis after mRNA COVID-19 vaccination, if any, in young

children is unknown
– No cases occurred during clinical trials (n=7,804 with at least 7 days of follow-up)
 Based on the epidemiology of classic myocarditis and safety monitoring in

children ages 5-11 years, myocarditis after mRNA COVID-19 vaccination in
young children is anticipated to be rare
– Underlying epidemiology of myocarditis fundamentally different in infants
– Dose used in young children lower than dose used in older children
62
Post-authorization vaccine effectiveness
Overcoming COVID-19 platform
2 doses of Pfizer-BioNTech vaccine against hospitalization, Dec 19, 2021-Apr 27, 2022
No. vaccinated COVID-19
patients/Total COVID-19 Adjusted VE
patients (%) % (95% CI)
5–11 years* 25/325 (8) 68 (48-81)
12–18 years 109/286 (38) 51 (31-65)
2–22 weeks since vaccination 42/219 (19) 58 (34-74)
23–45 weeks since vaccination 67/244 (27) 42 (14-61)
*median time from vaccination to hospitalization is 37 days
-20 0 20 40 60 80 100
2 doses of Pfizer-BioNTech vaccine against MIS-C, Jul 1, 2021-Apr 7, 2022

No. vaccinated MIS-C Median (IQR)
patients/Total no. days from 2nd Adjusted VE
MIS-C patients (%) dose to MIS-C (95% CI)
5–11 years 10/144 (7) 44 (32-56) 78 (48-90)
12–18 years 14/160 (9) 120 (57-169) 90 (81-95)
28-120 days since vaccination 7/153 (5) 60 (42-89) 90 (75-96)
≥121 days since vaccination 7/131 (5) 172 (138-215) 92 (78-97)
0 20 40 60 80 100
Vaccine Effectiveness (%)
Methods for calculation of number needed to vaccinate
Benefits — Calculated per 1 million fully vaccinated with mRNA vaccine
 Age group: 6 months – 4 years
 Pandemic average age-specific incidence rates
– Hospitalization rates: COVID-NET1
– Case rates: Case based surveillance2
 Assumed VE against hospitalization: 42-84%3
 Assumed VE against symptomatic infection: 30%-60%4
 Time Horizon: 120-day period
VE: Vaccine Effectiveness

1https://gis.cdc.gov/grasp/COVIDNet/COVID19_3.html
2 Used rates in children ages 1-4 years because ages in months was not available: https://covid.cdc.gov/covid-data-tracker/#demographicsovertime
3Based on the ratio of infection to severe disease seen in 5–11-year-olds applied to the VE against infection seen in 6 months – 4 years
4Based on VE seen in pediatric clinical trials 64
Number of children ages 6 months – 4 years needed to
vaccinate to prevent 1 infection or 1 hospitalization over
120 days
Calculated using pandemic average rates
670 – 1,300 vaccinations needed to prevent 1 case
6,150 -12,300 vaccinations needed to prevent 1 hospitalization
Assumptions: Benefits accrue over 120 days; Data Sources: COVID-Net https://gis.cdc.gov/grasp/COVIDNet/COVID19_3.html.
Number of children ages 6 months – 4 years needed to
vaccinate to prevent 1 hospitalization: COVID-19 vs. influenza
over 6 months
COVID-19 Influenza
1,660 - 3,320 1,030 - 6,890

vaccinations needed to vaccinations needed to
prevent 1 hospitalization prevent 1 hospitalization
Assumptions: Benefits accrue over 6 months; Data Sources: Influenza number needed to vaccinate: Pediatrics. 2007 Sep;120(3):467-72. doi:
10.1542/peds.2007-0167; COVID-Net hospitalization rates from 10/1/2021-4/30/2022: https://gis.cdc.gov/grasp/COVIDNet/COVID19_3.html.
Summary
Known and potential benefits
 Clinical trials provide data for protection against symptomatic infection
 Clinical trials were not powered to detect efficacy against severe disease in
young children, but similar patterns expected to what is seen in everyone
ages 5 years and over, with higher protection against severe disease
 Emerging data in adults suggest that post-COVID conditions may be less
likely to occur in vaccinated individuals
 Vaccination in this age group may also provide parents with increased
confidence to return to pre-pandemic activities, improving social
interactions in young children
67
Summary
Known and potential harms
 Clinical trials provide safety data in nearly 8,000 vaccinated young children
 Post-authorization safety data after almost 600 million doses of COVID-19
vaccines given in the United States
 Post-authorization safety data for children ages 5-11 years very reassuring:
reporting rates of myocarditis in males only slightly elevated compared to
background incidence
– Likely related to both underlying epidemiology of myocarditis and dose de-escalation
68
Benefits and Harms: Summary of the Available Evidence
 First COVID-19 vaccine clinical trials conducted exclusively during Omicron
predominance
– Post-authorization vaccine effectiveness studies with lower VE in Omicron, compared
to previous SARS-CoV-2 variants
 Both mRNA COVID-19 vaccines for young children met non-inferiority

criteria for neutralizing antibody levels
– Differences in certainty of efficacy estimates for each mRNA vaccine; cannot directly
compare estimates
 Receipt of a primary COVID-19 vaccine series can provide protection

against COVID-19 disease and severe outcomes
 Benefits of COVID-19 vaccines in young children outweigh possible risks
69
Benefits and Harms
How substantial are the desirable anticipated effects?
• How substantial are the anticipated effect for each main outcome for which
there is a desirable effect?
o Minimal o Small o Moderate o Large o Varies o Don’t know

Benefits and Harms
How substantial are the undesirable anticipated effects?
• How substantial are the anticipated effect for each main outcome for which
there is an undesirable effect?

Benefits and Harms
Do the desirable effects outweigh the undesirable effects?
- What is the balance between the desirable effects relative to the
undesirable effects?
o Favors intervention (Moderna COVID-19 vaccine)

o Favors comparison (no vaccine)
o Favors both
o Favors neither
o Unclear
Benefits and Harms
Do the desirable effects outweigh the undesirable effects?
- What is the balance between the desirable effects relative to the
o Favors intervention (Pfizer-BioNTech COVID-19 vaccine)

o Favors comparison (no vaccine)
o Favors both
o Favors neither
o Unclear
EtR Domain: Values
Survey of parental attitudes and intentions toward pediatric
COVID-19 and recommended vaccinations
 Survey designed to assess parental beliefs and attitudes toward pediatric COVID-19
vaccinations among children ages 6 months – 4 years
 Data collection period: February 2 – February 10, 2022
 Final sample (N = 2,048)
CHILD AGE GROUP GENDER RARACE/ETHNICITY

Targeted percentages 49.9% Child Ages 6 – 23 months 51.1% Female 34.2% Non-Hispanic White
50.2% Child Ages 2 – 4 years 48.1% Male 32.8% Non-Hispanic Black
0.8% Transgender or Other 33.0% Hispanic
Gender Identity
CDC and University of Iowa/RAND survey, unpublished

Half of the parents of children ages 6 months – 4 years said
they ‘definitely’ or ‘probably’ would vaccinate their child,
once they become eligible
‘Definitely’ or
‘Probably’ will
vaccinate
Unsure
‘Definitely’ or
‘Probably’ will not
vaccinate

A third of parents of children ages 6 months – 4 years said
they ‘definitely’ or ‘probably’ would not vaccinate their
child, once eligible
‘Definitely’ or
‘Probably’ would
vaccinate
Unsure
‘Definitely’ or
‘Probably’ would not
vaccinate

Only a fifth of all respondents said they would get their child ages 6
months – 4 years vaccinated within 3 months after becoming eligible
% of respondents who selected the response option (n=2,048)
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%
Under 3 months 19.6%
3–6 months 21.0%
Over 6 months 25.5%
Don’t know 30.1%
Refuse to answer 3.8%

Preference for a 2-dose or 3-dose series
3-dose series sooner

20%
No preference
20%
2-dose series later

28%
Not vaccinating
32%

Impact of demographics on pediatric vaccination intentions
 Percentage of parents of children ages 6 months – 4 years who ‘definitely’

or ‘probably’ will vaccinate their child when eligible significantly varied by:
– Gender of parent
• 51% males vs. 44% females
– Race and Ethnicity

• 53% Hispanic/Latino vs. 46% NH Black and 43% NH White
– Education
• 60% ≥ Bachelor’s degree, 40% Some college/Trade school and 42% ≤ High school degree

Parental intent for vaccination of children 6 months – 4 years,
National Immunization Survey-Child COVID Module (NIS-CCM), December 2021 – May 2022
 The NIS-CCM is a random-digit- May 33.5 19.6 19.4 10.1 17.2

dial cellular telephone survey of April 33.6 17.1 19.6 9.2 20.2
households with children that March 36.5 16.3 18.8 9.2 19.0
began on July 22, 2021 February 37.2 16.1 18.9 9.0 18.6
 In May, one-third (33.5%) of January 39.6 18.5 17.7 9.1 14.9

parents report they definitely will December 41.3 18.0 16.1 7.3 17.1
get their child 6 months–4 years 0 20 40 60 80 100
vaccinated Definitely will get child vaccinated Probably will get child vaccinated
 17.2% of parents report they Unsure if will get child vaccinated Probably will NOT get child vaccinated
definitely will not get their child Definitely will NOT get child vaccinated
vaccinated
May: Interviews May 1-28, 2022, n=3465; April: Interviews March 27–April 30, 2022, n=4,063; March: Interviews February 27–March 26, 2022, n=3,626 ; February: Interviews January
30–February 26, 2022, n=3,231 ;January: Interviews January 2–29, 2022, n=3,221; December: Interviews November 28 – December 31, 2021, n=1,313
NIS-CCM estimates (5-17 years) available on COVIDVaxView at: https://www.cdc.gov/vaccines/imz-managers/coverage/covidvaxview/interactive.html

National Immunization Survey-Child COVID Module (NIS-CCM) , May 2022
 In May, a smaller percentage

(29.6%) of parents of children
6-23 months 29.6 42.9 27.5
6–23 months reported definite
intent to vaccinate their child
compared to parents of
children 2–4 years (35.4%) 2-4 years 35.4 37.1 27.2
 There was no difference in the

percentage reporting 0 20 40 60 80 100
definite/probably will not get Definitely will get child vaccinated

child vaccinated Probably/Unsure will get child vaccinated
Definitely/probably will NOT get child vaccinated
May: Interviews May 1-28, 2022, n=3465

One in five parents of children under five will vaccinate their
child right away once available, but most remain more cautious
 Survey respondents were asked, “Thinking about your child under the age of 5, once
there is a COVID-19 vaccine authorized and available for your child’s age group, do
you think you will…?”
Get them vaccinated right away Wait and see Only if required Definitely not
April '22 18% 38% 11% 27%
Feb '22 21% 26% 15% 35%
Jan '22 31% 29% 12% 26%
Sept '21 23% 33% 7% 35%
July '21 20% 40% 10% 30%
KFF COVID-19 Vaccine Monitor. https://www.kff.org/coronavirus-covid-19/dashboard/kff-covid-19-vaccine-monitor-dashboard/#parents Accessed May 25, 2022

Most parents say they don’t have enough information about
COVID-19 vaccine safety and effectiveness for children under 5
 Survey respondents were asked, “Do you feel you have enough information about
the safety and effectiveness of the COVID-19 vaccine for…?
*Survey conducted prior to safety and efficacy information available on COVID-19 vaccines in young children
KFF COVID-19 Vaccine Monitor: April 2022. https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccine-monitor-april-2022 Accessed May 25, 2022
Values: Summary of the Available Evidence
 Half of parents of children ages 6 months through 4 years definitely or
probably would vaccinate their child, once eligible
– However, nearly a third of parents of children ages 6 months through 4 years definitely or
probably would not vaccinate their child, once eligible
 One in five parents of children under 5 (18%) are eager to vaccinate their child
and plan to do so right away once a COVID-19 vaccine is authorized for their
child’s age group, but many others remain more cautious
 In a survey conducted prior to available data on COVID-19 vaccines in young
children, many parents of children under five say they don’t have
enough information about the safety and effectiveness of COVID-19 vaccines
for children in this age group (56%)
Values
Criteria 1:
Does the target population feel that the desirable effects are large relative to
• How does the target population view the balance of desirable versus undesirable
effects?
• Would parents/caregivers feel that the benefits outweigh the harms and burden?
• Does the population appreciate and value the Pfizer-BioNTech & Moderna COVID-19
vaccine?
Values
Criteria 2:
Is there important uncertainty about, or variability in, how much people value
the main outcomes?
• How much do individuals value each outcome in relation to the other outcomes?
• Is there evidence to support those value judgements?
• Is there evidence that the variability is large enough to lead to different decisions?
o Important uncertainty or variability

o Probably important uncertainty or variability
o Probably not important uncertainty or variability
o No important uncertainty or variability
o No known undesirable outcomes
EtR Domain: Acceptability
Pediatricians are top trusted source of child vaccine
information for parents across community types
 Percent of parents who say they trust each of the following a great deal or a fair
amount to provide reliable information about the COVID-19 vaccines for children:
KFF COVID-19 Vaccine Monitor: Winter Update on Parents’ Views (November 8-23, 2021). https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccine-
monitor-vaccine-attitudes-rural-suburban-urban/ Accessed March 7, 2022
Vaccines for Children (VFC) program and COVID-19
 As of early May 2022, more than two-thirds of Vaccines For Children

(VFC) program providers were enrolled as COVID-19 vaccine providers
 For young children, encouraging VFC providers to enroll as COVID-19
vaccine providers and encouraging enrolled providers to administer the
COVID-19 vaccine becomes even more critical to ensure access to
COVID-19 vaccine as well as all other routine childhood vaccines
CDC. Updated Pediatric COVID-19 Vaccination Operational Planning Guide – Information for the COVID-19 Vaccine for Children 6 Months through 4 years old and/or COVID-19
Vaccine for Children 6 Months through 5 Years Old. https://www.cdc.gov/vaccines/covid-19/downloads/Pediatric-Planning-Guide.pdf Accessed June 1, 2022
Additional jurisdiction coordination for COVID-19
vaccination among children
 Continued coordination through jurisdictions will be needed for the Indian

Health Service (IHS), Tribal and Urban Indian Health Programs, and Health
Resources and Services Administration (HRSA) programs
 Similar to the COVID-19 vaccine rollout for 5–11-year-olds, jurisdictions should
plan their ordering strategy and identify priority locations to vaccinate
children ages 6 months – 4 years or 6 months – 5 years
 The goal is an efficient rollout resulting in equitable vaccine access for young
children in the initial weeks when demand is likely to be higher
CDC. Updated Pediatric COVID-19 Vaccination Operational Planning Guide – Information for the COVID-19 Vaccine for Children 6 Months through 4 years old and/or COVID-19
Possible Network of Providers for Children ages <5 years
~4,000 pharmacies
~18,000 non- that have ~85% of children <5
pharmacy expressed interest years live within 5
providers that in administering miles of a vaccine
have administered vaccine to children provider
the 5-11 vaccine <5 years
Acceptability: Summary of the Available Evidence
 A child’s health care provider is the top trusted source of child vaccine
information for parents across community types
 As of early May 2022, more than two-thirds of Vaccines For Children
(VFC) program providers were enrolled as COVID-19 vaccine providers
 Continued coordination through jurisdictions and identifying priority
locations to vaccinate young children will facilitate efficient rollout
resulting in equitable vaccine access for this age group
 Nearly all young children will live within 5 miles of a vaccine provider for
COVID-19 vaccines
Acceptability
Are mRNA COVID-19 vaccines acceptable to key stakeholders?
• Are there key stakeholders that would not accept the distribution of benefits
and harms?
• Are there key stakeholders that would not accept the undesirable effects in
the short term for the desirable effects (benefits) in the future?

EtR Domain: Feasibility
Moderna COVID-19 vaccine product for children ages 6
months – 5 years
Moderna COVID-19 Vaccine Products
6 years through 11 years
(Primary Series)
6 years through 11 years
(Primary Series)
12 years and older
(Primary Series)
 The Moderna vaccine for children
Age Group
6 months through 5 years
(Primary Series) Currently unavailable
(Use the vial with dark blue 18 years and older 18 years and older
ages 6 months – 5 years:
cap and a label with a purple (Booster Dose) (Booster Dose)
– Ships at -20°C
border)
Vial Cap Color Dark Blue Dark Blue Dark Blue Red
Vial Label Border
– Different color border (magenta)
MAGENTA TEAL PURPLE LIGHT BLUE
Color
– Different concentration than adult

Vial Image
primary series (25µg/0.25mL)
– New national drug code (NDC)
– Does not require diluent
Primary Dose
0.25 mL 0.5 mL 0.5 mL 0.5 mL
Volume
Booster Dose
None None 0.5 mL 0.25 mL
Volume
CDC. Updated Pediatric COVID-19 Vaccination Operational Planning Guide – Information for the COVID-19 Vaccine for Children 6 Months through 4 Years Old and/or COVID-19
Pfizer-BioNTech COVID-19 vaccine product for children ages
6 months – 4 years
Pfizer-BioNTech COVID-19 Vaccine Products2
 The Pfizer-BioNTech vaccine for

children ages 6 months – 4 years:
– Ships at -80°C
– Different color cap (maroon)
– Different amount of diluent added
(2.2mL)
– New national drug code (NDC)1
1. CDC. Updated Pediatric COVID-19 Vaccination Operational Planning Guide – Information for the COVID-19 Vaccine for Children 6 Months through 4 Years Old and/or
COVID-19 Vaccine for Children 6 Months through 5 Years Old. https://www.cdc.gov/vaccines/covid-19/downloads/Pediatric-Planning-Guide.pdf Accessed June 1, 2022
2. CDC. Pfizer-BioNTech COVID-19 Vaccine Products. https://www.cdc.gov/vaccines/covid-19/downloads/Pfizer-Pediatric-Reference-Planning.pdf Accessed June 16, 2022
Packaging configuration and ancillary supplies for Pfizer-
BioNTech and Moderna COVID-19 vaccines for children
 The packaging configuration for both vaccine products is 10-dose vials in

cartons of 10 vials each (100 doses total) with a minimum order quantity
of 100 doses per product
 Ancillary supplies will be provided for both vaccine products, including
1- inch needles and syringes to support 100 doses of vaccine
– Diluent will be provided with ancillary supplies to support 100 doses per kit for the
Pfizer vaccine
CDC. Updated Pediatric COVID-19 Vaccination Operational Planning Guide – Information for the COVID-19 Vaccine for Children 6 Months through 4 Years Old and/or COVID-19
Feasibility: Summary of the Available Evidence
 Pfizer-BioNTech vaccine for children ages 6 months–4 years

– Similar product configuration to other Pfizer-BioNTech pediatric products, but with a
maroon cap
– May be more familiar to pediatric healthcare providers
– Long term storage requires an ultra-low temp (-80oF freezer)
– Requires diluent
 Moderna vaccine for children ages 6 months–5 years

– May be less familiar to pediatric healthcare providers
– Product able to be stored at traditional freezer temperatures
– Does not require diluent
Feasibility
Is the Moderna COVID-19 vaccine feasible to implement among
children ages 6 months – 5 years?
• Is the Moderna COVID-19 vaccine program sustainable?
• Are there barriers that are likely to limit the feasibility of implementing the
Moderna COVID-19 vaccine or require considerations when implementing it?
• Is access to Moderna COVID-19 vaccine an important concern?

Feasibility
Is the Pfizer-BioNTech COVID-19 vaccine feasible to implement
among children ages 6 months – 4 years?
• Is the Pfizer-BioNTech COVID-19 vaccine program sustainable?
• Are there barriers that are likely to limit the feasibility of implementing the
Pfizer-BioNTech COVID-19 vaccine or require considerations when
implementing it?
• Is access to Pfizer-BioNTech COVID-19 vaccine an important concern?

EtR Domain: Resource Use
Resource Use: Review of the available evidence
 No studies were found that evaluated cost-effectiveness of COVID-19
vaccination among children
 Studies in adults have shown COVID-19 related healthcare costs could be billions or
trillions of dollars1,2. Given this, COVID-19 vaccines overall are likely cost-saving3-5.
 In a study conducted by Pfizer, they estimated that Pfizer-BioNTech COVID-19 vaccine
use in individuals ages ≥12 years in 2021 averted 9 million symptomatic cases, almost
700,000 hospitalizations and over 110,00 deaths resulting in $30.4 billion direct
healthcare cost savings6
 At this time, vaccine will be available at no cost to the recipient
 Cost-effectiveness not a primary driver for decision making during a pandemic, but
will be reassessed in the future
1 Bartsch et al https://www.healthaffairs.org/doi/full/10.1377/hlthaff.2020.00426 2 Cutler and Summers. JAMA https://jamanetwork.com/journals/jama/fullarticle/2771764
3 Bartsch et al. JID https://academic.oup.com/jid/article/224/6/938/6267841?login=true 4 Kohli et al. Vaccine https://www.sciencedirect.com/science/article/pii/S0264410X2031690X
5 Li et al. Int JID https://www.sciencedirect.com/science/article/pii/S1201971222001680
6 Di Fusco et al Full article: Public health impact of the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) in the first year of rollout in the United States (tandfonline.com)
Resource Use
Are mRNA COVID-19 vaccines among children ages 6 months – 5
years a reasonable and efficient allocation of resources?
• What is the cost-effectiveness of mRNA COVID-19 vaccines?
• How does the cost-effectiveness of mRNA COVID-19 vaccines change in
response to changes in context, assumptions, etc.?

EtR Domain: Equity
COVID-19 weekly cases per 100,000 population by race and
ethnicity and age group, United States
March 1, 2020 – May 28, 2022
Children ages 0 – 4 years
700
600
500
400
300
200
100
0
Mar April May Jun Jul Aug Sept Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Jan Feb Mar Apr May
20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 21' 21' 21' 21' 21' 21' 21' 21' 21' 21' 21' 21' 22' 22' 22' 22' 22'
American Indian/Alaska Native, NH Asian/Pacific Islander, NH Black, NH Hispanic White, NH

NH = Non-Hispanic
CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#demographicsovertime Accessed May 31, 2022

National Immunization Survey-Child COVID Module (NIS-CCM) , May 2022
By Race/Ethnicity By Metropolitan Statistical Area

Hispanic 26.8 48.0 25.1
Urban 35.6 39.3 24.6
Black 30.3 40.9 28.8
Suburban 35.3 39.0 25.6
White 34.9 33.5 31.4
Other/Multiple 47.0 37.1 14.9 Rural 20.2 37.7 42.1
0 20 40 60 80 100 0 20 40 60 80 100
By Household Income/Poverty Level
By Receipt of Influenza Vaccination since July 1
>= $75k/year 45.9 31.7 22.3
< $75k/year 25.5 46.3 28.2 No Flu Vax 17.7 34.0 48.3
Below Poverty 19.2 43.4 36.8
Not reported 27.1 41.9 30.7 Received Flu Vax 41.8 41.1 16.9
0 20 40 60 80 100
May: Interviews May 1-28, 2022, n=3465 0 20 40 60 80 100
Vaccination intentions of parents of children under 5
HHS/ASPA Focus Groups, COVID-19 Public Education Campaign
 Focus Group Details

– 18 focus groups with 4-6 participants in each group
– Varied demographics of parents including Black, Hispanic/Latino, and Overall
population
– Some groups composed of parents ‘Ready to Vaccinate’ others ‘Waiting to Vaccinate’
 Format
– COVID-19 Context, Attitudes, and Behaviors
• Participants share thoughts and opinions about the COVID-19 pandemic regarding their child
– Vaccination intent
• Participants share thoughts and opinions about getting their child a COVID-19 vaccine when
it is authorized and available
CDC/NCIRD, VTF Research Team, HHS/ASPA COVID-19 Public Education Campaign, Unpublished data
Parents of children ages 6 months – under 2 years
Black parents
• Noted that child’s pediatrician did not have a strong stance on receiving a COVID-19 vaccine, despite having a strong
stance on vaccines in general – making them second guess whether the COVID vaccine is necessary for kids
• Young children can’t talk/say what’s going on or how they feel, contributing to concerns about vaccinating kids
• The only thing that will make them trust is time
•Hispanic/Latino parents
• Want to wait a couple of months perhaps; but want the pediatrician to specifically advise it
• Some parents have talked to their doctor about the options and didn’t get a strong recommendation
• If things get worse, that will motivate them to vaccinate their child – like higher cases, worse scenario
Overall population
• Clinical trial data – how many children didn’t get COVID after being vaccinated, how many didn’t get symptoms
• Complication rate – how many complications per set amount of children
• Lots of mixed information on COVID vaccines for children under 5 – they don’t know who to believe
Parents of children ages 2 years – 4 years
Black parents
• COVID is such a new virus, they are still learning about it
• Long term side effects are the big concern –child will be living a long time, want to know that they are safe
• One person admits that they make an intentional choice to NOT pay attention to the news/get information on
COVID because it will make them worry too much
Hispanic/Latino parents
• One parent feels like COVID is so new that the information medical professionals have might not be totally right
• One parent would get their young child vaccinated right away based on the experience from themselves and other
child – a smaller dose makes them more comfortable
• One parent would rather not get for their child unless they had to – questions need based on case counts
Overall population
• Want to know about the efficacy – to see if it’s worth it or not
• Waiting until there is a requirement and mandate
• Parents know the vaccines made them feel bad (short-term side effects) – so they don’t want their kids to suffer the
same side effects
Major themes of vaccination intentions among parents of
children under 5 years
 Parents personal experience with COVID (for themselves and for their children)
informs how they view the importance of the vaccine
– If their children already had COVID, and it was mild, they aren’t worried about immediately
vaccinating
– If they or their child had severe COVID, they are more amenable to getting vaccinated to avoid that
experience from recurring
 Pervasive idea that kids are not at high risk of getting COVID or having severe
outcomes from COVID
 Time is a major barrier for most parents
– Time the vaccines have been in production
– Myth of the vaccines being rushed
– Others mention wanting time for their children to grow and develop
– Many parents mention taking time after approval to see how things go for other people before
making a final decision
What can be done to improve vaccination intention among
parents of children under 5 years
 CDC, doctors are trusted sources for providing information regarding vaccination and
COVID-19
– Some participants have been told mixed information by providers about whether to vaccinate their
children under 5 years of age
 Parents want to discuss both pros and cons of vaccination and avoid messages that are
overly simplistic or positive
– Incorporate more information into communications that provide reassurance about possible side effects
 Ads need to include imagery that is representative of the specific age group
– Include diversity in racial and ethnic groups, gender, parents (moms and dads should be shown)
 Public health and clinical trial research must be inclusive of historically marginalized
populations, from before research initiation through completion and dissemination
What communities can do to improve equity in childhood
vaccination
 Pediatricians are often the providers who vaccinate children, and many do this
through the federally funded Vaccines for Children (VFC) program
– However, pediatricians are not the only providers who can vaccinate children
 In many areas, pharmacies and community clinics – such as Federally Qualified
Health Centers, rural health clinics, and community health centers also administer
vaccines for children, and some of these are also VFC providers
 Many schools and school districts partner with health departments, pharmacies,
other healthcare providers and trusted community representatives to hold vaccine
clinics in schools to vaccinate children who may not otherwise have access
 Community organizations, including faith-based organizations, can serve as
vaccination sites or as informational resources to help families find community-based
vaccination sites
CDC Vaccines and Immunizations. Equity in Childhood COVID-19 Vaccination. https://www.cdc.gov/vaccines/covid-19/planning/children/equity.html Accessed June 1, 2022
Equity
What would be the impact of mRNA COVID-19 vaccines in young
children on health equity?
• Are there groups or settings that might be disadvantaged in relation to COVID-
19 disease burden or receipt of mRNA COVID-19 vaccines?
• Are there considerations that should be made when implementing the mRNA
COVID-19 vaccine program to ensure that inequities are reduced whenever
possible, and that they are not increased?
o Reduced o Probably reduced o Probably no impact

o Probably increased o Increased o Varies o Don’t know
Summary
EtR Domain Question Work Group Judgments
Public Health Is COVID-19 disease among children ages 6 months – 5 years of public health
Yes
Problem importance?
How substantial are the desirable anticipated effects? Large
Benefits and How substantial are the undesirable anticipated effects? Small
Harms Do the desirable effects outweigh the undesirable effects (Moderna)? Favors intervention
Doe the desirable effects outweigh the undesirable effects (Pfizer)? Favors intervention
Does the target population feel the desirable effects are large relative to the
Varies
Values
Probably important uncertainty or
Is there important variability in how patients value the outcomes?
variability
Acceptability Are mRNA vaccines acceptable to key stakeholders? Yes
Is the Moderna COVID-19 vaccine feasible to implement among children
Yes
ages 6 months – 5 years?
Feasibility
Is the Pfizer-BioNTech COVID-19 vaccine feasible to implement among
Probably yes
children ages 6 months – 4 years?
Are mRNA COVID-19 vaccines among children ages 6 months – 5 years a
Resource Use reasonable and efficient allocation of resources?
Yes
What would be the impact of mRNA COVID-19 vaccines in young children on

Equity health equity?
Probably no impact
116
Work Group Interpretation
 Work Group discussed each mRNA COVID-19 vaccine primary series
compared to no vaccine
 Both mRNA COVID-19 vaccine primary series in young children met the
non-inferiority endpoints, provide protection against symptomatic
COVID-19 disease, and are expected to provide higher protection against
severe disease
 Two vaccine options in this population may allow parents and providers
a choice, which may increase uptake and acceptability
Summary: Work Group Interpretations (Moderna)
Undesirable Undesirable The balance Desirable Desirable

consequences consequences between consequences consequences There is
clearly probably desirable and probably clearly insufficient
Balance of outweigh outweigh undesirable outweigh outweigh evidence to
consequences desirable desirable consequences undesirable undesirable determine the
consequences consequences is closely consequences consequences balance of
in most in most balanced or in most in most consequences
settings settings uncertain settings settings
Two doses of 25µg Moderna COVID-19 vaccine

118
Summary: Work Group Interpretations (Moderna)
We recommend the
Type of We do not recommend intervention for individuals We recommend the
recommendation the intervention based on shared clinical intervention
decision-making
Two doses of 25µg Moderna COVID-19 vaccine

119
Summary: Work Group Interpretations (Pfizer-BioNTech)
Undesirable Undesirable The balance Desirable Desirable

consequences consequences between consequences consequences There is
clearly probably desirable and probably clearly insufficient
Balance of outweigh outweigh undesirable outweigh outweigh evidence to
consequences desirable desirable consequences undesirable undesirable determine the
consequences consequences is closely consequences consequences balance of
in most in most balanced or in most in most consequences
settings settings uncertain settings settings
Three doses of 3µg Pfizer-BioNTech COVID-19 vaccine

120
Summary: Work Group Interpretations (Pfizer-BioNTech)
We recommend the
Type of We do not recommend intervention for individuals We recommend the
recommendation the intervention based on shared clinical intervention
decision-making
Three doses of 3µg Pfizer-BioNTech COVID-19 vaccine

121
Summary
 Since the beginning of the COVID-19 pandemic, among U.S. children ages
6 months – 4 years of age, there have been
Over 2 million cases
Over 20,000 hospitalizations
Over 200 deaths
 COVID-19 can cause severe disease and death among children, including
children without underlying medical conditions
 Future surges will continue to impact children, with unvaccinated children
remaining at higher risk of severe outcomes
Summary
 As with all other age groups, priority is vaccination of unvaccinated

individuals
 Expansion of vaccine recommendations down to children 6 months of
age would allow 18.7 million children to receive primary COVID-19
vaccine series
Children who are NOT moderately or severely immunocompromised
Pfizer-BioNTech At least
(6 months–4 years) 3-8 weeks
Dose 1 Dose 2 8 weeks Dose 3
(primary) (primary) (primary)
Moderna
4-8 weeks
(6 months–5 years) Dose 1 Dose 2
(primary) (primary)
Children who ARE moderately or severely immunocompromised

Pfizer-BioNTech At least
3 weeks 8 weeks
(6 months–4 years) Dose 1 Dose 2 Dose 3
Moderna At least
(6 months–5 years) 4 weeks 4 weeks
Dose 1 Dose 2 Dose 3
Summary
 Current data are for a 2-dose (Moderna) or 3-dose (Pfizer-BioNTech)

primary series
 Post-authorization effectiveness studies can help determine subsequent
timing and need of boosters
– Immunocompromised children may also need additional doses for optimal protection
Continued monitoring is critical
 As with all ages, post-authorization safety and effectiveness monitoring
will be critical
 Platforms are in place to monitor vaccine effectiveness; results will be
communicated publicly as soon as possible
– Timing will depend on vaccine uptake, as well as COVID-19 incidence
 COVID-19 vaccines are being administered under the most intensive vaccine
safety effort in U.S. history
Smartphone-based safety monitoring for COVID-19 vaccines
v-safe is a CDC smartphone-based monitoring program for COVID-19 vaccine safety in the U.S.
• A parent must be registered with v-safe in order to

add a child to their account
• If a parent is already registered, they can access their
account to add a child
• To register or access your account go to
https://vsafe.cdc.gov/en/
161
v-safe uses text messages and web surveys to check in
• Parents complete surveys on behalf of their child

• Surveys solicit how the child feels after COVID-19
vaccination
– Local injection site reactions (i.e., pain, redness, swelling)
– Systemic reactions (i.e., fatigue, headache, joint pain)
– Health impacts (unable to perform normal daily activities,

missed school or work, or received care)
• Surveys have specific questions for young, non-verbal

children
Promoting v-safe in practice– we need help!
How:
• Direct patients to https://vsafe.cdc.gov/en/
– Ideally this should occur before vaccination
• Provide v-safe information sheet to patients
• Display posters about v-safe
https://www.cdc.gov/coronavirus/2019ncov/vaccines/safety/vsafe/printresources.html
Questions to ACIP
 Should vaccination with Moderna COVID-19 vaccine (2-doses, 25µg, IM)

be recommended for persons 6 months – 5 years of age, under an
Emergency Use Authorization?
 Should vaccination with Pfizer-BioNTech COVID-19 vaccine (3-doses, 3µg, IM)

be recommended for children 6 months – 4 years of age, under an
Emergency Use Authorization?
Acknowledgments
 Monica Godfrey  Valerie Morelli
 Katherine Fleming-Dutra  Hannah Rosenblum
 Megan Wallace  Sierra Scarbrough
 Danielle Moulia  Eddie Shanley
 Lauren Roper  JoEllen Wolicki
 Elisha Hall  Megan Lindley
 Sarah Meyer  Tammy Santibanez
 Evelyn Twentyman  VTF ACIP WG Team
 Ruth Link-Gelles  ACIP COVID-19 Vaccines Work Group
 Tara Anderson  Vaccine Task Force
 Amy Blain  Epi Task Force
 Mary Chamberland  Data Analytics and Visualization Task Force
 Susan Goldstein  Respiratory Viruses Branch
 MIS-C unit
 Stephen Hadler
 CICP TF’s Monitoring and Evaluation
For more information, contact CDC
1-800-CDC-INFO (232-4636)
TTY: 1-888-232-6348 www.cdc.gov
The findings and conclusions in this report are those of the authors and do not necessarily represent the
official position of the Centers for Disease Control and Prevention.

CDC 118387 DS1

Uploaded by

Copyright:

Available Formats

CDC 118387 DS1

Uploaded by

Document Information

Original Description:

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

CDC 118387 DS1

Uploaded by

Copyright:

Available Formats

Evidence to Recommendation Framework:

Moderna COVID-19 vaccine in children

Sara Oliver, MD, MSPH

 Structure to describe information considered in moving from evidence to

 Should vaccination with Moderna COVID-19 vaccine (2-doses, 25µg, IM)

 Should vaccination with Pfizer-BioNTech COVID-19 vaccine (3-doses, 3µg, IM)

Symptomatic laboratory confirmed COVID-19

EtR Domain Question(s)

Benefits and Harms

Acceptability Use of mRNA COVID-19

Benefits and Harms

January 23, 2020 – June 14, 2022

Source: COVID Data Tracker, https://covid.cdc.gov/covid-data-tracker/#trends_dailytrendscases. Accessed 6/16/2022

1600 <1 year 578,168

Case earliest date by end of week

Source: COVID-NET, https://gis.cdc.gov/grasp/COVIDNet/COVID19_3.html. Accessed 5/21/2022

Source: COVID-NET, https://gis.cdc.gov/grasp/COVIDNet/COVID19_3.html. Accessed 5/21/2022

200 Young children 6 months – 4 years:

1. Certain conditions originating in the perinatal period 272.1 10294

Shading indicates confidence intervals for each trend line.

Prior infection before one vaccine dose

Prior infection before three vaccine doses

Is COVID-19 disease among children ages 6 months – 5 years of public health

o No o Probably no o Probably yes o Yes o Varies o Don’t know

 Moderna COVID-19 vaccine

 Pfizer-BioNTech COVID-19 vaccine

 RR 0.62 (0.49, 0.79)

RR= relative risk

 Serious concerns of indirectness because immunogenicity is a surrogate

 Evidence type: Moderate certainty (type 2)

 Asymptomatic SAR-CoV-2 infection is identified by absence of symptoms

 RR 0.84 (0.60, 1.19)

RR= relative risk

Events/Vaccine % SAE Events/Placebo % SAE Associated with

Moderna, unpublished 15/1761 0.85% 1/589 0.17% 1f

Moderna, unpublished 9/3031 0.30% 2/1007 0.20% 0

Moderna, unpublished 24/4792 0.50% 3/1596 0.19% 1f

 RR 2.67 (0.80, 8.84)

RR= relative risk

Any local (either dose) 84/4774 1.8% 6/1582 0.4%

 RR 1.87 (1.44 to 2.42)

RR= relative risk

 Efficacy seen after two doses of Moderna COVID-19 vaccine in children

 Antibody levels after 2 doses in children ages 6 months–5 years

 Reactogenicity post-vaccine consistent with other recommended

Population Vaccine Placebo Total

determined by the investigator

6–23 months (3 doses, 3 µg) 16–25 years (2 doses, 30 µg)

2–4 years (3 doses, 3 µg) 16–25 years (2 doses,30 µg)

month after dose two.

 RR 0.2 (0.05, 0.77)

RR= relative risk

 Ages 2–4 years

 Serious concerns of indirectness because immunogenicity is a surrogate

 Safety population, approximately 1700 ages 6–23 months

Pfizer/BioNTech RCT 17/1178e 1.4 14/598f 2.3 0

Pfizer/BioNTech RCT 29/3013 1.0 22/1504 1.5 1

symptoms due to unspecified viral infection