 Vaccines Guidance Document

28 December 2020

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

EOI Pre-submission Dossier accepted Status of Anticipated

Manufacturer Name of Vaccine NRA of Record Platform
accepted meeting held for review* assessment** decision date***

Nucleoside modified
1. BNT162b2/COMIRNATY EMA In progress 30/12/20
mNRA

Recombinant Novel
Not accepted
Recombinant
2. Zhifei Longcom, China Coronavirus Vaccine NMPA Product in
protein subunit
Phase I/II
（CHO Cell）

Not accepted, still

3. IMBCAMS, China SARS-CoV-2 Vaccine, NMPA Inactivated under
Inactivated (Vero Cell) development
In progress Earliest by EMA
recombinant
Core data Feb 2021 (non-
replication defective
Non-Covax. Covax)
chimpanzee
Core – EMA Non-
4. AZD1222 adenovirus
COVAX Covax data to be
expressing the SARS-
reviewed as EMA Additional nodes
CoV-2 S surface
post approval in March April for
glycoprotein
change Covax

SK BIO Tentative end

Core data (non- Earliest end of Feb
5. AZD1222 MFDS KOREA = Jan 2021 (CMC
covax) in progress 2021
for SK Bio)
  Vaccines Guidance Document
28 December 2020

recombinant,
replication-
incompetent Rolling data to Not yet started.
adenovirus type 26 EMA – Dec, Feb,
April (critical Earliest May –
6. Ad26.COV2.S EMA (Ad26) vectored Use abridged
data), May June 2021
vaccine encoding procedure relying
the (SARS-CoV-2) on EMA
Spike (S) protein

SARS-CoV-2 Vaccine Inactivated,

Tentative end of
7. Sinopharm / BIBP
2 (Vero Cell), Inactivated NMPA produced in Vero Earliest March
Dec 2020
(lnCoV) cells
Inactivated,
SARS-CoV-2 Vaccine Tentative early
8. NMPA produced in Vero Earliest March
(Vero Cell), Inactivated Jan 2021
cells
Additional
Human Adenovirus
information Under screening
9. Sputnik V Russian NRA Vector-based Covid-
submitted – under – Non CTD.
19 vaccine
assessment
Vector State Research
Letter received
10. Centre of Viralogy and EpiVacCorona Russian NRA Peptide antigen
not EOI
Biotechnology
Recombinant Novel
Additional
Coronavirus Vaccine
11. Ad5-nCoV information
(Adenovirus Type 5
requested
Vector)
mNRA-based
vaccine Expected in Jan Estimated end of
12. mRNA-1273 EMA
encapsulated in lipid 2021 Feb 2021
nanoparticle (LNP)
  Vaccines Guidance Document
28 December 2020

recombinant
ChAdOx1 adenoviral
Covishield vector encoding the EOI Under
13. Serum Institute of India DCGI
(ChAdOx1_nCoV-19) Spike protein assessment
antigen of the SARS-
CoV-2.

1 No pre-submission
14. Sinopharm / WIBP NMPA
meeting yet

No pre-submission
15. EMA
meeting yet

1. Wuhan Institute of Biological Products Co Ltd

2. Beijing Bio-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.