Vaccines Guidance Document

15 July 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 assessment** Decision
WHO EUL holder accepted meeting held review* date***
1. BNT162b2/COMIRNATY EMA Nucleoside modified mNRA Finalized 31/12/2020
Tozinameran (INN)
Finalized:
− Baxter Oncology GmbH 30/06/2021
Germany (DP)
− Novartis Switzerland 08/07/2021
− Mibe (Dermapharm) Germany 16/07/2021
(DP)
− Pharmacia & Upjohn, 16/07/2021
Kalamazoo (DP)
− PGS McPherson (DP) 16/07/2021

Diluent suppliers:
− Pfizer Perth, Australia 18 June 2021
− Fresenius Kabi, USA 18 June 2021
2. AZD1222 EMA Recombinant ChAdOx1 Core data finalized 16 April 2021
adenoviral vector encoding
the Spike protein antigen of
the SARS-CoV-2. Data for Covax sites Finalized: SK-Catalent 16 April 2021
expected in April 2021 Wuxi (DS) 30 April 2021
onwards Chemo Spain 04 June 2021

− Westchester US (DP) Other sites: As submitted

− Ongoing − Ongoing
3. AZD1222 MFDS KOREA Recombinant ChAdOx1 Finalized 15 Feb 2021
adenoviral vector encoding
the Spike protein antigen of
the SARS-CoV-2.
4. Covishield (ChAdOx1_nCoV- DCGI Recombinant ChAdOx1 Finalized 15 Feb 2021
19) adenoviral vector encoding
the Spike protein antigen of
the SARS-CoV-2.
5. Ad26.COV2.S EMA Recombinant, replication- Core data finalized (US +NL sites) 12 March 2021
incompetent adenovirus type
26 (Ad26) vectored vaccine
encoding the (SARS-CoV-2) Additional sites:
Spike (S) protein - Aspen RSA (DP) - Finalized -25 June 2021
- Catalent Agnani Italy (DP) - Finalized - 02 July 2021
- Merck, Durham, UK (DS) - Future submission - As submitted
- Merck, West Point/PA (DP) - Future submission - As submitted
6. mRNA-1273 EMA mNRA-based vaccine Finalized 30 April 2021
encapsulated in lipid
nanoparticle (LNP) Additional sites, awaited:
- ModernaTx. Norwood (DS) • additional inf awaited - As submitted
- Catalent Indiana, LLC (DP) • additional inf awaited - As submitted
- Lonza Biologics, Inc. • additional inf awaited - As submitted
Portsmouth, USA (DS)
- Baxter, Bloomington, USA • additional inf awaited - As submitted
(DP)
 Vaccines Guidance Document
15 July 2021

Manufacturer / Name of Vaccine NRA of Record Platform EOI Pre-submission Dossier accepted for Status of assessment** Decision
WHO EUL holder accepted meeting held review* date***
7. 1 SARS-CoV-2 Vaccine (Vero NMPA Inactivated, produced in Finalized 07 May 2021
Sinopharm / BIBP
Cell), Inactivated (lnCoV) Vero cells

8. COVID-19 Vaccine (Vero NMPA Inactivated, produced in Finalized 01 June 2021

Cell), Inactivated/ Vero cells
CoronavacTM

9. Sputnik V Russian NRA Human Adenovirus Vector- Additional information Several meetings “Rolling” submission of Additional data (Non-CLIN, CLIN, Anticipated
based Covid-19 vaccine submitted have been and clinical and CMC data has CMC) Required. date will be
continue to be held. started. Following up on inspection set once all
observations. data is
submitted and
follow-up of
inspection
observations
completed.
10. AZD1222 Japan MHLW/PMDA Recombinant ChAdOx1 Submission from AZ Several meetings Finalized 09 July 2021
adenoviral vector encoding received on 15 June. held separately with
the Spike protein antigen of MHLW submiited review AZ and
the SARS-CoV-2. and GMP reports on 16 MHLW/PMDA
June 2021 and June 22.
11. AZD1222 Australia TGA Recombinant ChAdOx1 Submission from AZ Several meetings Finalized 09 July 2021
adenoviral vector encoding received on 11 June held separately with
the Spike protein antigen of AZ and TGA
the SARS-CoV-2.
12. Bharat Biotech, India SARS-CoV-2 Vaccine, DCGI Whole-Virion Inactivated Rolling data started 06 July Ongoing To be
Inactivated (Vero Cell)/ Vero Cell 2021 confirmed
COVAXIN

13. Ad5-nCoV NMPA Recombinant Novel Rolling data starting August

Coronavirus Vaccine 2021
(Adenovirus Type 5 Vector)
14. NVX-CoV2373/Covovax EMA Recombinant nanoparticle
prefusion spike protein
formulated with Matrix-M™
adjuvant.
15. 2
Inactivated SARS-CoV-2 NMPA Inactivated, produced in
Sinopharm / WIBP Vaccine (Vero Cell) Vero cells

16. Zorecimeran (INN) EMA mNRA-based vaccine Planned for Q4 of

concentrate and solvent for
dispersion for injection;
Company code:
CVnCoV/CV07050101
17. Sanofi Pasteur CoV2 preS dTM-AS03 vaccine
encapsulated in lipid 2021
nanoparticle (LNP)
EMA Recombinant, adjuvanted

18. Vector State Research Centre of EpiVacCorona Russian NRA Peptide antigen Letter received not EOI.
Viralogy and Biotechnology Reply sent on 15/01/2021

19. Zhifei Longcom, China Recombinant Novel NMPA Recombinant protein subunit Response to 2nd EOI sent
Coronavirus Vaccine（CHO 29 Jan 2021. Additional
Cell) information requested.
 Vaccines Guidance Document
15 July 2021

Manufacturer / Name of Vaccine NRA of Record Platform EOI Pre-submission Dossier accepted for Status of assessment** Decision
WHO EUL holder accepted meeting held review* date***
20. IMBCAMS, China SARS-CoV-2 Vaccine, NMPA Inactivated Not accepted, still under
Inactivated (Vero Cell) initial development
21. Clover Biopharmaceuticals SCB-2019 EMA Novel recombinant SARS- In discussion on
CoV-2 Spike (S)-Trimer fusion submission strategy and
protein timelines
22. BioCubaFarma - Cuba Soberana 01, CECMED SARS-CoV-2 spike protein Awaiting information on
Soberana 02 conjugated chemically to strategy and timelines for
Soberana Plus meningococcal B or tetanus submission.
Abdala toxoid or Aluminum
1. Beijing Institute of Biological Products Co-Ltd * Dossier Submission dates: more than one date is possible because of the rolling submission approach. Dossier is accepted after screening of received submission.
2. Wuhan Institute of Biological Products Co Ltd **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.

Please send any questions you may have to: WHOEUL@who.int