The brand-new vaccine is produced by the Serum Institute of India under license from US-based Novavax Laboratory and is part of the COVAX facility portfolio, giving a much-needed boost to ongoing efforts to vaccinate more people in low-income countries.

It also allows nations to expedite their own regulatory approval to import and administer Covid-19 vaccines.

“Even with the new variants emerging, vaccines remain one of the most effective tools to protect people from serious illness and death from SARS-COV-2,” said Mariângela Simão, WHO Assistant-Director General for Access to Medicines and Health Products.

CovovaxTM 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 conducted 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.

CovovaxTM 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.

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