In a win for Indian-manufactured COVID-19 vaccines, Covovax, manufactured by the Serum Institute of India under the licence of Novavax, has been approved for emergency use by the World Health Organisation. With this, Covovax becomes the ninth COVID-19 vaccine to receive Emergency Use Listing (EUL) by the WHO.
The vaccine was approved for emergency use after the WHO assessed the vaccine under various parameters. “The Technical Advisory Group for Emergency Use Listing (TAG-EUL), convened by WHO and made up of experts from around the world, 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,” the WHO said.
“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%,” WHO Assistant-Director General for Access to Medicines and Health Products Dr Mariângela Simão said.
“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,” CEO and owner of the Serum Institute, Adar Poonawalla, tweeted.
Earlier, Poonawalla said that the SII plans to launch the Covovax vaccine for children in the next six months. He said that the vaccine is under trial and would offer protection to children as young as three-years-old.
The Novavax vaccine, which will be sold as Covovax in India, is 90% effective at preventing COVID-19 illness, according to results from a Phase 3 clinical trial. In addition to being highly effective in preventing Covid illness of any severity, the vaccine was 100% effective in preventing moderate and severe disease that required hospitalisation, revealed the study published in the New England Journal of Medicine.
For the trial, the team from University of Maryland included nearly 30,000 adult volunteers at 113 clinical sites in the US and six sites in Mexico.
Approximately 20,000 participants received two doses of the vaccine spaced three weeks apart and 10,000 received placebos. The trial was conducted during the first few months of 2021, and tested only against Alpha variant, which was the predominant circulating strain.
(With IANS inputs)