On Friday, the World Health Organisation approved the emergency use listing of the COVID-19 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 obtain emergency use authorisation (EUA) by India’s top drug regulator, the DCGI.
The listing aims to increase access, particularly in low-income countries, 41 of which have still not vaccinated 10% of their populations, while 98 countries have not reached 40%, said the global health body.
Covovax was assessed under the WHO EUL procedure based on data review 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, assessed the vaccine’s suitability. They have determined that the vaccine meets WHO’s standards for protection against COVID-19, that the vaccine’s benefit far outweighs any risks, and that the vaccine can be used globally, WHO said in a statement.
The Covovax vaccine, developed by the SII in partnership with the US-based Novavax, is the third vaccine associated with India to be approved by the WHO. The other two vaccines are Covishield and Covaxin. Covaxin is India’s first indigenous COVID-19 vaccine, while Covishield is an Indian version of Britain’s AstraZeneca jab.
Source: IANS