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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 | 31 December 2020
16 July 2021 |
| Vaxzevria COVID-19 Vaccine (ChAdOx1-S [recombinant]) |
AstraZeneca AB / SK Bioscience Co. Ltd
AstraZeneca AB
|
European Medicines Agency
Ministry of Health, Labour and Welfare |
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 | 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 |
