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    Status Covid Vax 16feb2021

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    Bhagoo Hathey
    1. The document lists 15 COVID-19 vaccines in various stages of evaluation by the WHO for emergency use listing or prequalification, including information on the manufacturer, vaccine name, regulatory authority, vaccine platform, and status in the evaluation process. 2. The AstraZeneca/Oxford vaccine has been accepted for core data review by the EMA but not for Covax, and additional Covax data is expected in March 2021. Evaluation status and anticipated decision dates are provided for several candidates. 3. Inactivated vaccines produced by Sinopharm in Vero cells are under review by the Chinese regulatory authority, with earliest decisions expected in March, while additional data is expected in late February for the Modern

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    Status Covid Vax 16feb2021

    Uploaded by

    Bhagoo Hathey
    21 views2 pages
    1. The document lists 15 COVID-19 vaccines in various stages of evaluation by the WHO for emergency use listing or prequalification, including information on the manufacturer, vaccine name, regulatory authority, vaccine platform, and status in the evaluation process. 2. The AstraZeneca/Oxford vaccine has been accepted for core data review by the EMA but not for Covax, and additional Covax data is expected in March 2021. Evaluation status and anticipated decision dates are provided for several candidates. 3. Inactivated vaccines produced by Sinopharm in Vero cells are under review by the Chinese regulatory authority, with earliest decisions expected in March, while additional data is expected in late February for the Modern

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    1. The document lists 15 COVID-19 vaccines in various stages of evaluation by the WHO for emergency use listing or prequalification, including information on the manufacturer, vaccine name, regulatory authority, vaccine platform, and status in the evaluation process. 2. The AstraZeneca/Oxford vaccine has been accepted for core data review by the EMA but not for Covax, and additional Covax data is expected in March 2021. Evaluation status and anticipated decision dates are provided for several candidates. 3. Inactivated vaccines produced by Sinopharm in Vero cells are under review by the Chinese regulatory authority, with earliest decisions expected in March, while additional data is expected in late February for the Modern

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    21 views2 pages

    Status Covid Vax 16feb2021

    Uploaded by

    Bhagoo Hathey
    1. The document lists 15 COVID-19 vaccines in various stages of evaluation by the WHO for emergency use listing or prequalification, including information on the manufacturer, vaccine name, regulatory authority, vaccine platform, and status in the evaluation process. 2. The AstraZeneca/Oxford vaccine has been accepted for core data review by the EMA but not for Covax, and additional Covax data is expected in March 2021. Evaluation status and anticipated decision dates are provided for several candidates. 3. Inactivated vaccines produced by Sinopharm in Vero cells are under review by the Chinese regulatory authority, with earliest decisions expected in March, while additional data is expected in late February for the Modern

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     Vaccines Guidance Document

    16 February 2021

    Status of COVID-19 Vaccines within WHO EUL/PQ evaluation process


    Manufacturer Name of Vaccine NRA of Record Platform EOI Pre-submission Dossier accepted for Status of Anticipated
    accepted meeting held review* assessment** decision date***
    1. BNT162b2/COMIRNATY EMA Nucleoside modified mNRA Finalized 31/12/20
    Tozinameran (INN)

    2. AZD1222 Core – EMA Non- Recombinant ChAdOx1 adenoviral Accepted core data of AZ Non-Covax NA
    COVAX vector encoding the Spike protein – non-Covax Core data.
    antigen of the SARS-CoV-2.
    Data for Covax expected
    in March 2021 Awaited March – April
    2021
    3. AZD1222 MFDS KOREA Recombinant ChAdOx1 adenoviral Finalized 15 Feb 2021
    SK BIO vector encoding the Spike protein
    antigen of the SARS-CoV-2.

    4. Serum Institute of India Covishield (ChAdOx1_nCoV- DCGI Recombinant ChAdOx1 adenoviral Finalized 15 Feb 2021
    19) vector encoding the Spike protein
    antigen of the SARS-CoV-2.

    5. 1 SARS-CoV-2 Vaccine (Vero NMPA Inactivated, produced in Vero cells In progress Earliest March
    Sinopharm / BIBP
    Cell), Inactivated (lnCoV)

    6. SARS-CoV-2 Vaccine (Vero NMPA Inactivated, produced in Vero cells Additional expected end Earliest March
    Cell), Inactivated of Feb 2021

    7. mRNA-1273 EMA mNRA-based vaccine encapsulated Aditional data expected Estimated end of
    in lipid nanoparticle (LNP) week starting 15 Feb Feb 2021
    2021

    8. Ad26.COV2.S EMA Recombinant, replication- Rolling data to EMA – Not yet started. March - April 2021
    incompetent adenovirus type 26 Dec, 29 Jan and 15 Feb
    (Ad26) vectored vaccine encoding 2021 Use abridged
    the (SARS-CoV-2) Spike (S) protein procedure relying
    To submit for EUL on 19 on EMA
    Feb 2021
    9. Sputnik V Russian NRA Human Adenovirus Vector-based Additional Several meetings Rolling data started 09
    Covid-19 vaccine information held. and additional data
    submitted expected week starting
    15 Feb 2021.
    10. Ad5-nCoV NMPA Recombinant Novel Coronavirus Rolling data starting April
    Vaccine (Adenovirus Type 5 Vector) 2021
    11. Vector State Research Centre of EpiVacCorona Russian NRA Peptide antigen Letter received not
    Viralogy and Biotechnology EOI. Reply sent on
    15/01/2021
     Vaccines Guidance Document
    16 February 2021

    12. Zhifei Longcom, China Recombinant Novel NMPA Recombinant protein subunit Response to Second
    Coronavirus Vaccine（CHO EOI sent 29 Jan
    Cell) 2021.additional
    information
    requested.
    13. IMBCAMS, China SARS-CoV-2 Vaccine, NMPA Inactivated Not accepted, still
    Inactivated (Vero Cell) under initial
    development

    14. 2
    Inactivated SARS-CoV-2 NMPA No pre-submission meeting yet
    Sinopharm / WIBP Vaccine (Vero Cell)

    15. EMA No pre-submission meeting yet. Awaiting decision on


    submission.

    1. Beijing Bio-Institute of Biological Products Co-Ltd


    2. Wuhan Institute of Biological Products Co Ltd

    * Dossier Submission dates: more than one date is possible because of the rolling submission. Dossier is accepted for submission after screening of received submission
    **Status of assessment: 1. Under screening; 2. Under assessment; 3. Waiting responses from the applicant. 4. Risk-benefit decision 5. Final decision made
    *** Anticipated decision date: this is only an estimate because it depends on when all the data is submitted under rolling submission and when all the responses to the assessors’ questions are submitted.

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