WHO grants emergency use listing to COVID-19 vaccine COVAXIN, the eighth to win authorization

The World Health Organization (WHO) made its eighth emergency use listing (EUL) for a COVID-19 vaccine this week, granting that honor to Bharat Biotech’s COVAXIN.

COVAXIN is formulated from an inactivated SARS-CoV-2 — the virus that causes COVID-19 — antigen. Use of the vaccine by adults was recommended in two doses, four weeks apart, according to the WHO’S Strategic Advisory Group of Experts (SAGE). Among that broad age group, COVAXIN provided approximately 78 percent efficacy against COVID-19 two weeks or more after the second dose. Due to easy storage requirements, it’s also highly effective for low and middle-income countries.

A separate review by the regulatory experts of the Technical Advisory Group (TAG) determined the vaccine meets WHO standards for protection and that its benefits far outweigh its risks.

“This emergency use listing expands the availability of vaccines, the most effective medical tools we have to end the pandemic,” Dr. Mariângela Simão, WHO Assistant-Director General for Access to Medicines and Health Products, said. “But we must keep up the pressure to meet the needs of all populations, giving priority to the at-risk groups who are still waiting for their first dose, before we can start declaring victory.”

One caveat for listing was that the available clinical data does not include sufficient data on its safety among the pregnant. However, the vaccine has been given to more than 120,000 pregnant women in India with no short-term side effects, according to WHO. Further studies for this category are planned.

Meanwhile, WHO EUL will allow countries to speed their individual regulatory approval of COVAXIN, as well as allow its addition to the COVAX vaccine supply. COVAX is a collaborative organization run by WHO, the Coalition for Epidemic Preparedness Innovations (CEPI), and Gavi, the Vaccine Alliance, dedicated to ensuring equitable access to COVID-19 vaccines.