 Vaccines Guidance Document

20 January 2021

Status of COVID-19 Vaccines within WHO EUL/PQ evaluation process (20 January 2021)
EOI Pre-submission Dossier accepted for
Manufacturer Name of Vaccine NRA of Record Platform Status of assessment** Anticipated decision date***
accepted meeting held review*

BNT162b2/COMIRNATY
1. EMA Nucleoside modified mNRA Finalized 31/12/20
(INN tozinameran)
Recombinant Novel Coronavirus Not accepted
2. Zhifei Longcom, China NMPA Recombinant protein subunit Product in Phase I/II
Vaccine (CHO Cell）

SARS-CoV-2 Vaccine, Inactivated Not accepted, still

3. IMBCAMS, China NMPA Inactivated under development
(Vero Cell)
In progress
recombinant replication Core data Earliest by EMA End of
defective Non-Covax. Jan-Feb 2021 (non- Covax)
Core – EMA Non-
4. AZD1222 chimpanzee adenovirus
COVAX
expressing the SARS-CoV-2 S Covax data to be Additional nodes in March/
surface glycoprotein reviewed as EMA post April for Covax
approval change
SK BIO Tentative 18 and
29 Jan 2021
Core data (non-Covax)
5. AZD1222 MFDS KOREA = (CMC for SK Bio) Earliest 2nd half Feb 2021
in progress

recombinant, replication- Rolling data to Not yet started.

incompetent adenovirus type EMA: Dec, Feb,
6. Ad26.COV2.S EMA 26 (Ad26) vectored vaccine Apr (critical data), Use abridged Earliest May – June 2021
encoding the (SARS-CoV-2) May procedure relying on
Spike (S) protein EMA
SARS-CoV-2 Vaccine (Vero Cell), Inactivated, produced in Vero
7. Sinopharm / BIBP
2 NMPA End of Dec 2020 In progress Earliest March
Inactivated (lnCoV) cells

SARS-CoV-2 Vaccine (Vero Cell), Inactivated, produced in Vero 13Jan2021

8. NMPA Earliest March
Inactivated cells (under screening)
Additional 22Jan2021
Human Adenovirus Vector- information discussion on
9. Sputnik V Russian NRA
based Covid-19 vaccine submitted – under content and
assessment format
Vector State Research Centre of Letter received not
10. EpiVacCorona Russian NRA Peptide antigen
Viralogy and Biotechnology EOI
Recombinant Novel Additional
11. Ad5-nCoV Coronavirus Vaccine information 26Jan 2021
(Adenovirus Type 5 Vector) requested
mNRA-based vaccine
Expected in Feb
12. mRNA-1273 EMA encapsulated in lipid Estimated end of Feb 2021
2021
nanoparticle (LNP)
recombinant ChAdOx1
13 Jan
adenoviral vector encoding the
13. Serum Institute of India Covishield (ChAdOx1_nCoV-19) DCGI 08Jan 2021 (Under Mid Feb 2021
Spike protein antigen of the
screening)
SARS-CoV-2
1 No pre-submission meeting yet
14. Sinopharm / WIBP NMPA
No pre-submission meeting yet
15. EMA

* 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.
1. Wuhan Institute of Biological Products Co Ltd
2. Beijing Bio-Institute of Biological Products Co-Ltd