WHO clears Indian-made Covovax vaccine for emergency use

World Health Organization (WHO) has issued an emergency use listing (EUL) for NVX-CoV2373, expanding the basket of WHO-validated vaccines against the SARS-CoV-2 virus now to nine vaccines.

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.

WHO Assistant Director-General for Access to Medicines and Health Products, Mariângela Simão, said that “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.”

She said WHO hoped the new Indian-produced shots would 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 yet to reach 40 per cent.

According to WHO, the procedure to qualify for emergency use assesses the quality, safety and efficacy of the vaccines. The approval also allows countries to expedite their own regulatory process.

The Technical Advisory Group for Emergency Use Listing (TAG-EUL), convened by WHO and made up of experts from around the world, determined that the vaccine meets WHO standards for protection against COVID-19, that the benefits far outweighs any risks and that it 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.

This week, a meeting of WHO’s Strategic Advisory Group of Experts on Immunisation (SAGE) also reviewed the vaccine.

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