Serum Institute's Covovax 9th Covid vaccine to get WHO approval

Tribune News Service

New Delhi, December 17

India-made Covovax on Friday became the ninth Covid-19 vaccine to receive WHO’s emergency use listing approval, with manufacturer Serum Institute of India hailing the moment as another milestone.

The global body in a statement this evening said, “Today, the World Health Organization issued an emergency use listing (EUL) for NVX-CoV2373, expanding the basket of WHO-validated vaccines against the SARS-CoV-2 virus. The vaccine, named Covovax, is produced by the Serum Institute of India under licence from Novavax and is part of the COVAX facility portfolio, giving a much-needed boost to ongoing efforts to vaccinate more people in lower-income countries.”

Adar 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.”

Bharat Biotech made Covaxin and SII’s Covishield have already received EUL approvals from WHO.

WHO’s EUL procedure assesses the quality, safety and efficacy of COVID-19 vaccines and is a prerequisite for COVAX vaccine supply.

It 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.

The listing, WHO said, 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, the WHO-stated goals.

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 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.

Covovax is a subunit of the vaccine developed by Novavax and the Coalition for Epidemic Preparedness Innovations (CEPI). It requires two doses and is stable at 2 to 8 °C 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.

The originator product produced by Novavax is currently under assessment by the European Medicines Agency (EMA).

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