The World Health Organisation on Friday approved emergency use listing of Covid vaccine Covovax, produced by the Serum Institute of India under licence from Novavax and part of the Covax facility portfolio.
"This is yet another milestone in our fight against Covid-19. Covovax is now WHO approved for emergency use, showing excellent safety and efficacy. Thank you all for a great collaboration," Serum Institute of India CEO Adar Poonawala said.
Covovax has a two-dose regimen and is the ninth to receive emergency use approval from the WHO. However, it is yet to be granted emergency use authorisation (EUA) by the top drug regulator, the DCGI, in India.
The listing aims to increase access particularly in lower-income countries, 41 of which have still not been able to vaccinate 10 per cent of their populations, while 98 countries have not reached 40 per cent, said the global health body.
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.
The Technical Advisory Group for Emergency Use Listing (TAG-EUL), convened by the 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 in a statement.
The Covovax vaccine, developed by the SII in partnership with the US-based Novavax, is the third India-related vaccines to be approved by the WHO. The other two vaccines are Covishield and Covaxin. Covaxin is India's first indigenous Covid vaccines, while Covishield is Indian version of Britain's AstraZeneca jab.