Serum-partnered Novavax COVID-19 vaccine gets emergency use approval from WHO

World Health Organization (WHO) announced on Friday that it has included Covovax COVID-19 vaccine under emergency use listing (EUL). The vaccine is produced by the Serum Institute of India (SII) under licence from Novavax and is part of the COVAX facility portfolio. This is the ninth COVID-19 vaccine that WHO has granted emergency use approval for.

Announcing the good news, Serum CEO Adar Poonawalla wrote on Twitter that the listing of Covovax is another milestone in the fight against COVID-19. "This is yet another milestone in our fight against COVID-19, Covovax is now W.H.O. approved for emergency use, showing excellent safety and efficacy. Thank you all for a great collaboration, @Novavax @WHO @GaviSeth @Gavi @gatesfoundation," tweeted Poonawalla.

This is yet another milestone in our fight against COVID-19, Covovax is now W.H.O. approved for emergency use, showing excellent safety and efficacy. Thank you all for a great collaboration, @Novavax @WHO @GaviSeth @Gavi @gatesfoundation https://t.co/7C8RVZa3Y4

— Adar Poonawalla (@adarpoonawalla) December 17, 2021

WHO's EUL procedure assesses the quality, safety and efficacy of COVID-19 vaccines and is a prerequisite for COVAX vaccine supply. It also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines.

"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 organisation also stated that Covovax was assessed under the WHO EUL procedure based on the review of data on quality, safety and efficacy, a risk management plan, programmatic suitability, and manufacturing site inspections carried out by the Drugs Controller General of India.

WHO noted that the Technical Advisory Group for Emergency Use Listing (TAG-EUL) has determined that the vaccine meets WHO standards for protection against COVID-19, that the benefit of the vaccine far outweighs any risks, and that the vaccine can be used globally.

Covovax is a subunit of the vaccine developed by Novavax and the Coalition for Epidemic Preparedness Innovations (CEPI). The vaccine requires two doses and is stable at 2 to 8 degree Celsius refrigerated temperatures. The vaccine uses a novel platform and is produced by creating an engineered baculovirus containing a gene for a modified SARS-CoV-2 spike protein.