Serum’s Covovax gets WHO nod for emergency use

The WHO has added a ninth vaccine to the globally-approved basket, by issuing an Emergency Use Listing to Covovax from American biotech company Novavax, but produced under licence by India’s Serum Institute.

The vaccine can now be supplied to the WHO-supported COVAX facility that supplies vaccines to low- and middle-income countries. The development comes at a time when gross inequity in vaccine distribution is being witnessed across the world.

Significantly, the two companies had said earlier this year that the EUL filing to the WHO would be based on Serum Institute’s submission to the Indian regulator, the Drug Controller General of India. “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 carried out by the DCGI,” the WHO said.

The Technical Advisory Group for EUL convened by the WHO (made up of experts from around the world) has determined that the vaccine meets WHO standards for protection against COVID-19 and that the benefit far outweighed risks, the WHO said.

Covovax is still to get a go-ahead in India, but it is the second licensed vaccine from the Serum Institute stable to get a greenlight from the WHO – the first being the AstraZeneca-OxfordUniversity vaccine, supplied in India as Covishield. As for India, this would be the third vaccine that’s made here to get an EUL, the last one approved being Covaxin from Bharat Biotech.

Serum Institute chief Adar Poonawalla called the latest development “another milestone” in the fight against Covid-19. Just earlier this month, the vaccine-maker had shipped supplies of the Novavax vaccine to Indonesia.

The WHO’s EUL procedure allows countries that do not have elaborate regulatory infrastructure in place to adopt a safe and quality vaccine. Another advantage of the two-dose vaccine is that it is stable at refrigerated temperature of 2 to 8 degrees C. Dr Mariângela Simão, WHO Assistant-Director General for Access to Medicines and Health Products said,‘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%.” With new variants emerging, she said, vaccines remain one of the most effective tools to protect people against serious illness and death from SARS-COV-2. Other vaccines that have received the WHO endorsement include those from Pfizer-BioNTech, AstraZeneca-OxfordUniversity (also supplied by S.Korea’s SKBio), Moderna, Johnson and Johnson, SinoPharm and Sinovac.