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21 December 2021 Departmental news Geneva

The World Health Organization issued an emergency use listing (EUL) for NuvaxovidTM, following its assessment and approval by the European Medicines Agency (EMA) earlier today.

The new vaccine was developed by Novavax and the Coalition for Epidemic Preparedness Innovations (CEPI), and is the originator product for the CovovaxTM vaccine that received WHO emergency use listing on 17 December.

Both vaccines are made using the same technologies. They require two doses and are stable at 2 to 8 °C refrigerated temperatures.

WHO’s Strategic Advisory Group of Experts on Immunization has also issued policy recommendations for NuvaxovidTM / CovovaxTM.

Policy Recommendations for NuvaxovidTM

WHO emergency use listing

The emergency use listing (EUL) procedure assesses the suitability of novel health products during public health emergencies. The objective is to make medicines, vaccines and diagnostics available as rapidly as possible to address the emergency while adhering to stringent criteria of safety, efficacy and quality. The assessment weighs the threat posed by the emergency as well as the benefit that would accrue from the use of the product against any potential risks.

The EUL pathway involves a rigorous assessment of late phase II and phase III clinical trial data, as well as substantial additional data on safety, efficacy, quality and a risk management plan. These data are reviewed by independent experts and WHO teams who consider the current body of evidence on the vaccine under consideration, the plans for monitoring its use, and plans for further studies.

As part of the EUL process, the company producing the vaccine must commit to continue to generate data to enable full licensure and WHO prequalification of the vaccine. The WHO prequalification process will assess additional clinical data generated from vaccine trials and deployment on a rolling basis to ensure the vaccine meets the necessary standards of quality, safety and efficacy for broader availability.

See all EUL listings.

COVID-19 vaccines WHO EUL issued

Vaccine WHO EUL Holder NRA of record Recommendation issued
COMIRNATY®
COVD-19 mRNA Vaccine (nucleoside modified)
BioNTech  Manufacturing GmbH European Medicines Agency

Food and Drug Administration

31 December 2020

 

16 July 2021

Vaxzevria
COVID-19 Vaccine (ChAdOx1-S [recombinant]) 
AstraZeneca AB / SK Bioscience Co. Ltd

 

AstraZeneca AB

 

 

 

 

 

 

 

 

 

 

European Medicines Agency

European Medicines Agency

Ministry of Health, Labour and Welfare

Therapeutic Goods Administration

Health Canada

15 February 2021
15 April 2021

09 July 2021

09 July 2021

21 August 2021

 

 

COVISHIELD™
COVID-19 Vaccine (ChAdOx1-S [recombinant]) 
Serum Institute of India Pvt. Ltd Central Drugs Standard Control Organization 15 February 2021
COVID-19 Vaccine  (Ad26.COV2-S [recombinant]) Janssen–Cilag International NV European Medicines Agency 12 March 2021
Spikevax
COVID-19 mRNA Vaccine (nucleoside modified)
Moderna Biotech

ModernaTX, Inc

European Medicines Agency

Food and Drug Administration

30 April 2021

06 August 2021

 

Inactivated COVID-19 Vaccine (Vero Cell) Beijing Institute of Biological Products Co., Ltd. (BIBP) National Medicinal Products Association 07 May 2021
CoronaVac
COVID-19 Vaccine (Vero Cell), Inactivated
Sinovac Life Sciences Co., Ltd National Medical Products Administration 01 June 2021
COVAXIN®
Covid-19 vaccine (Whole Virion Inactivated Corona Virus vaccine)
Bharat Biotech International Ltd Central Drugs Standard Control Organization 03 November 2021
COVOVAX™
COVID-19 vaccine (SARS-CoV-2 rS Protein Nanoparticle [Recombinant])
Serum Institute of India Pvt. Ltd Central Drugs Standard Control Organization 17 December 2021
NUVAXOVID™
COVID-19 vaccine (SARS-CoV-2 rS [Recombinant, adjuvanted])
Novavax CZ a.s. European Medicines Agency 20 December 2021

 

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