The World Health Organization (WHO) today approved an emergency use listing (EUL) for NVX-CoV2373, bringing the total number of WHO-validated vaccinations against the SARS-CoV-2 virus to seven. 

The CovovaxTM vaccine is produced under license from Novavax by the Serum Institute of India and is part of the COVAX facility portfolio, providing a much-needed boost to ongoing efforts to vaccinate more people in low-income nations.

The EUL process, developed by the World Health Organization, evaluates the quality, safety, and effectiveness of COVID-19 vaccines and is a requirement for COVAX vaccine delivery. It also permits nations to speed their own regulatory clearance for COVID-19 vaccine import and administration.
 

“Even with new variants emerging, vaccines remain one of the most effective tools to protect people against serious illness and death from SARS-COV-2,” said Dr. Mariângela Simão, WHO Assistant-Director General for Access to Medicines and Health Products.

‘This listing aims to increase access particularly in lower-income countries, 41 of which have still not been able to vaccinate 10% of their populations, while 98 countries have not reached 40%.”

The WHO-convened Technical Advisory Group for Emergency Use Listing (TAG-EUL), comprised of specialists from throughout the world, found that the vaccine satisfies WHO requirements for COVID-19 protection, that the vaccination's benefits significantly exceed any dangers, and that the vaccine can be used internationally.

Novavax and the Coalition for Epidemic Preparedness Innovations created CovovaxTM, a component of the vaccine (CEPI). It is stable from 2 to 8 °C refrigerated temperatures and requires two doses. The vaccine is made using a unique platform in which an engineered baculovirus with a gene for a modified SARS-CoV-2 spike protein is created.

The European Medicines Agency is now reviewing Novavax's NuvaxovidTM, the company's original product (EMA). Once the EMA has delivered its recommendation, the WHO will finish its own evaluation of the vaccine.