WHO gives approval to Novavax-Serum Institute's Covavax Covid vaccine for emergency use

The World Health Organisation (WHO) on Friday gave emergency approval to Covovax, Serum Institute of India’s version of Novavax Inc`s COVID-19 vaccine.

CEO of the Pune-based world's largest manufacturer Adar Poonawalla hailed the WHO for giving approval for emergency use.

“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,” he tweeted.

Covavax—a two-dose vaccine— will also likely be used for children aged above 3 years and it would be launched in mid-2022, Poonawalla had said earlier.

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) 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 global health body said.

The agency said that Novovax’s own vaccine is currently under assessment by the European Medicines Agency, and it will complete its own assessment of this vaccine once the EMA has issued its recommendation.

Novavax’s COVID-19 vaccine had shown 90 per cent efficacy at preventing Covid 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 per cent effective in preventing moderate and severe disease that required hospitalisation, revealed the study published in the New England Journal of Medicine.

(With inputs from agencies)