Vaccines Guidance Document

08 November 2022

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

Manufacturer / Name of Vaccine NRA of Record Platform EOI Pre-submission Dossier accepted Status of assessment** Decision
WHO EUL holder accepted meeting held for review* date***
1. BNT162b2/COMIRNATY EMA Nucleoside modified mRNA Finalized: 31/12/2020
Tozinameran (INN)
Additional sites:
BioNTech Manufacturing − Baxter Oncology GmbH Germany (DP) 30/06/2021
GmbH − Novartis Switzerland 08/07/2021
− Mibe (Dermapharm) Germany (DP) 16/07/2021
− Delpharm, Saint-Remy FRANCE (DP) 17/09/2021
− Sanofi-Aventis Deutschland GmbH Germany 18/062021
(DP)
− Siegfried Hameln GmbH, Germany (DP) 11/11/2021
− Patheon Italia S.p.A, Italy (DP) 07/12/2021
− Catalent Agnani 21/01/2022
− Exela Pharma Sciences, LLC, NC 16/03/2022
12/09/2022
− Sanofi-Aventis Deutschland GmbH (DP)

Diluent suppliers:
20/09/2021
− Pfizer Perth, Australia
20/09/2021
− Fresenius Kabi, USA
30/11/2021
− Pfizer Manufacturing Belgium
14/01/2022
− Kwang Myung Pharm Co., Ltd.

Shelf life extension: 15 months at -70 to -90°C 29/08/2022

(PBS/Sucrose)
Shelf life extension: 12 months at -70 to -90°C 18/05/2022
PBS/Tris
Booster dose approved for adults 18 years of age 17/12/2021
and older
Age extension to adolescents 12-15 08/09/2021
Age extension to children 5 – 11 years of age 12/02/2022

Bivalent booster Original/Omicron BA.1 for 19/10/22

individuals 12 years of age and older
USFDA Finalized 16/07/2021
− Pharmacia & Upjohn, Kalamazoo (DP)
− PGS McPherson (DP) 16/07/2021
− Exelead, Inc. Indianapolis USA 16/07/2021
30/09/2021
2. AZD1222 Vaxzevria EMA Recombinant ChAdOx1 adenoviral Core data finalized 16 April 2021
vector encoding the Spike protein
AstraZeneca, AB antigen of the SARS-CoV-2. Booster dose approved for adults 18 years of age 19 July 2022
and older
Finalized: 16/04/2021
Additional sites:
− SK-Catalent 30/04/2021
− Wuxi (DS) 30/04/2021
− Chemo Spain 04/06/2021
− Amylin Ohio US (DP) 23/07/2021
− WuXi Biologics, Germany (DP) 08/03/2022
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08 November 2022

Manufacturer / Name of Vaccine NRA of Record Platform EOI Pre-submission Dossier accepted Status of assessment** Decision
WHO EUL holder accepted meeting held for review* date***
3. MFDS KOREA Recombinant ChAdOx1 adenoviral Finalized 15/02/21
vector encoding the Spike protein
antigen of the SARS-CoV-2.
4. Japan MHLW/PMDA Recombinant ChAdOx1 adenoviral Finalized 09/07/21
vector encoding the Spike protein Additional sites:
antigen of the SARS-CoV-2. Nipro Pharma Corporation Ise, Japan 11/10/21
5. Australia TGA Recombinant ChAdOx1 adenoviral Finalized 09/07/21
vector encoding the Spike protein Additional site:
antigen of the SARS-CoV-2. Siam Bioscience Co., Ltd Thailand 11/10/21

6. COFEPRIS (Mexico) Recombinant ChAdOx1 adenoviral Finalized 23/12/21

ANMAT (Argentina) vector encoding the Spike protein
antigen of the SARS-CoV-2.

7. Covishield DCGI Recombinant ChAdOx1 adenoviral Finalized 15 Feb 2021

(ChAdOx1_nCoV-19) vector encoding the Spike protein DS and DP Manjari Bk Pune 12 Nov 2021
Serum Institute of India Pvt. antigen of the SARS-CoV-2.
Ltd

8. Ad26.COV2.S EMA Recombinant, replication- Core data finalized (US +NL sites) 12 March 2021
incompetent adenovirus type 26 - Additional sites: Aspen RSA (DP)
(Ad26) vectored vaccine encoding - Catalent Agnani Italy (DP) 25 June 2021
the (SARS-CoV-2) Spike (S) protein - Grand River Aseptic Manufacturing Inc., USA 02 July 2021
- MSD (Merck(, West Point/PA, USA (DP) 17 sept 2021
Janssen–Cilag International
- Sanofi Pasteur France (DP)
NV
- Biological E Ltd India (DP) 05 Nov 2021
27 Jan 2022
Storage conditions extension at 2-8 °C from 4,5 07 July 2022
months to 11 months within the 24 months of
shelf-life at -25°C to -15°C 16/03/2022

Booster dose approved for adults 18 years of age

and older 25/03/2022

DCGI Recombinant, replication- Ongoing To be confirmed

incompetent adenovirus type 26
(Ad26) vectored vaccine encoding
the (SARS-CoV-2) Spike (S) protein
9. mRNA-1273/Spikevax EMA mRNA-based vaccine encapsulated Finalized 30 April 2021
in lipid nanoparticle (LNP)
Shelf life extension to 09 months -20±5°C 14 Feb 2022
Moderna Biotech USFDA mRNA-based vaccine encapsulated Finalized 06 August 2021
in lipid nanoparticle (LNP) - ModernaTx. Norwood (DS)
- Catalent Indiana, LLC (DP)
- Lonza Biologics, Inc. Portsmouth, USA (DS)
- Baxter, Bloomington, USA (DP)
MFDS mRNA-based vaccine encapsulated Finalized 23 December
in lipid nanoparticle (LNP) 2021
10. 1 SARS-CoV-2 Vaccine NMPA Inactivated, produced in Vero cells Finalized 07 May 2021
Sinopharm / BIBP
(Vero Cell), Inactivated 2 and 5 dose presentation (new manufacturing 28 December
(lnCoV) site) 2021
Beijing Institute of Biological
Products Co., Ltd. (BIBP)
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Manufacturer / Name of Vaccine NRA of Record Platform EOI Pre-submission Dossier accepted Status of assessment** Decision
WHO EUL holder accepted meeting held for review* date***
11. COVID-19 Vaccine (Vero NMPA Inactivated, produced in Vero cells Finalized 01 June 2021
Sinovac Life Sciences Co., Ltd. Cell), Inactivated/ 2 dose presentation 30/09/21
Sinovac Life Sciences Co., Ltd. CoronavacTM
Age extension to 3-17 02/11/22
12. SARS-CoV-2 Vaccine, DCGI Finalized 03 November
Inactivated (Vero Cell)/ Whole-Virion Inactivated Vero Cell 2021
COVAXIN SUPPLY OF
Bharat Biotech, India VACCINE
SUSPENDED
13. NVX-CoV2373/Covovax DCGI Recombinant nanoparticle Finalized 17 December
prefusion spike protein formulated 2021
with Matrix-M™ adjuvant
14. NVX- EMA Recombinant nanoparticle Finalized 20 December
CoV2373/Nuvaxovid prefusion spike protein formulated 2021
with Matrix-M™ adjuvant Additional sites:
SK Bioscience Co., Ltd., (DS) 1/09/2022
15. Ad5-nCoV/Convidecia NMPA Recombinant Novel Coronavirus Finalized 19 May 2022
Vaccine (Adenovirus Type 5 Vector)
16. Sputnik V Russian NRA Human Adenovirus Vector-based Additional information Several meetings “Rolling” Process restarted, awaiting completion of rolling Anticipated date
Covid-19 vaccine submitted have been and submission submission and CAPAs to last inspection will be set once
continue to be incomplete. all data is
held. submitted and
follow-up of
inspection
observations
completed.
17. CoV2 preS dTM-AS03 EMA Recombinant, adjuvanted Rolling data Ongoing To be confirmed
vaccine started 30 July
2021

18. Clover Biopharmaceuticals SCB-2019 NMPA Novel recombinant SARS-CoV-2 Rolling data Ongoing To be confirmed
Spike (S)-Trimer fusion protein started 20
September
19. Zhifei Longcom, China Recombinant Novel NMPA Recombinant protein subunit Rolling data Ongoing To be confirmed
Coronavirus Vaccine started 28 March
（CHO Cell) 2022
20. Iran Food Drug Rolling data Ongoing To be confirmed
Administration started 3 August
Shifa Pharmed - Barkat CovIran® vaccine Inactivated, produced in Vero cells
(IFDA) 2022

21. CIGB Abdala CECMED Protein subunit Rolling data Ongoing To be confirmed
started 7 June
2022
22. SK Bioscience Nuvaxovid prefilled MFDS (RoKorea) Recombinant nanoparticle Rolling data Ongoing To be confirmed
syringe prefusion spike protein formulated pending
with Matrix-M™ adjuvant
23. Biological E Corbevax DCGI India RBD antigen of SARS CoV-2 (Covid- Rolling data Ongoing To be confirmed
19) started 10th of June
24. SK Bioscience GBP510 MFDS (RoKorea) Ongoing To be confirmed
Recombinant protein subunit

25. WestVac Biopharma Recombinant COVID-19 EOI under review

Recombinant SARS-CoV-2 S-RBD
Vaccine NMPA China
protein
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Manufacturer / Name of Vaccine NRA of Record Platform EOI Pre-submission Dossier accepted Status of assessment** Decision
WHO EUL holder accepted meeting held for review* date***
26. Nanogen Nanocovax Drug Administration EOI under review
of Vietnam Recombinant Spike protein

27. Cinnagen SpikoGen Iran Food Drug EOI under review

Administration Recombinant Protein
(IFDA)
28. R-PHARM Vaccine R-COVI Russian NRA Recombinant ChAdOx1 adenoviral EOI under review
vector encoding the Spike protein
antigen of the SARS-CoV-2.
29. Arcturus Therapeutics ARCT-154 Drug Administration EOI under review
of Vietnam RNA Vaccine

30. Bio-Manguinhos/Fiocruz AZD1222 ANVISA Recombinant ChAdOx1 adenoviral EOI under review
vector encoding the Spike protein
antigen of the SARS-CoV-2.
31. Vaxxinity UB-612 FDA EOI under review
Protein-peptide vaccine

32. Sinocelltech, Ltd SCTV01C NMPA EOI received

Recombinant Protein

33. Razi Vaccine & Serum Razi Cov Pars Vaccine Iran Food Drug EOI received
Research Institute Administration Recombinant Protein
(IFDA)
34. Valneva VLA2001 EMA EOI received
Inactivated

35. Medigen MVC-COV1901 TGA CHO cell derived spike protein EOI received
(Subunit)
36. HIPRA BIMERVAX EMA EOI received
Recombinant Protein

37. Stelis Biopharma Limited AKS-452 Vaccine DCGI India EOI received
(AmbiVax -CTM) Protein subunit

38. PT Biofarma SARS CoV-2 RBD Badan Pom EOI received

Indonesia Recombinant Protein Vaccine

39. Medicago COVIFENZ® Health Canada Plant-based virus-like particle [VLP], Application withdrawn
recombinant, adjuvanted by applicant
40. Zorecimeran (INN) EMA mRNA-based vaccine encapsulated Application
concentrate and solvent in lipid nanoparticle (LNP) withdrawn by
for dispersion for manufacturer
injection; Company
code:
CVnCoV/CV07050101
41. 2
Inactivated SARS-CoV-2 NMPA Inactivated, produced in Vero cells Rolling data Dossier withdrawn on 7 September 2022
Sinopharm / WIBP Vaccine (Vero Cell) started 23 July
2021
42. Vector State Research Centre EpiVacCorona Russian NRA Peptide antigen Letter received not EOI.
of Viralogy and Biotechnology Reply sent on
15/01/2021
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43. IMBCAMS, China SARS-CoV-2 Vaccine, NMPA Inactivated Not accepted, still
Inactivated (Vero Cell) under initial
development
44. BioCubaFarma - Cuba Soberana 01, CECMED SARS-CoV-2 spike protein Awaiting information on
Soberana 02 conjugated chemically to strategy and timelines
Soberana Plus meningococcal B or tetanus toxoid for submission.
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: [email protected]