WHO grants emergency approval to Indian vaccine Covovax

GENEVA

The World Health Organization said Friday it has issued an emergency use listing for the Indian vaccine NVX-CoV2373, also known as Covovax, expanding the basket of WHO-validated vaccines against the COVID-19 pandemic to nine.

The vaccine, named Covovax, is produced by the Serum Institute of India under license 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."

"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. Mariangela Simao, WHO assistant director-general for access to medicines.

"This listing aims to increase access particularly in lower-income countries, 41 of which have still not been able to vaccinate 10% of their populations, while 98 countries have not reached 40%."

The WHO's EUL procedure assesses the quality, safety, and efficacy of COVID-19 jabs and is a prerequisite for vaccine supply under COVAX, a facility to boost vaccine equity.

Speeding up vaccine approval

It also allows countries to speed up their regulatory approval to import and administer COVID-19 vaccines.

Covovax was assessed under the WHO EUL procedure based on quality, safety, and efficacy data, a risk management plan, programmatic suitability, and manufacturing site inspections.

The Drugs Controller General of India carried it out.

The Technical Advisory Group for Emergency Use Listing, convened by WHO and made up of experts worldwide, has determined that the vaccine meets WHO standards for protection against COVID-19.

It found that the vaccine's benefit far outweighs any risks and that the doses can be used globally.

Covovax is a sub-unit of the vaccine developed by Novavax and the Coalition for Epidemic Preparedness Innovations.

It requires two jabs and is stable at 2 to 8 C refrigerated temperatures.

The vaccine uses a novel platform and creates an engineered baculovirus containing a gene for a modified SARS-CoV-2 spike protein.

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

WHO said it will complete its own assessment of this vaccine once the EMA has issued its recommendation.

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

SAGE formulates specific policies and recommendations for vaccines' use in populations like "recommended age groups, intervals between doses, particular groups such as pregnant and lactating women" and will issue recommendations for NuvaxovidTM/CovovaxTM in the coming days, said the WHO.

As part of the EUL process, the company producing the vaccine must commit to generating data to enable full licensure and WHO prequalification of the vaccine.