Covid-19 vaccine Covaxin approval: WHO seeks more data from Bharat Biotech for Emergency Use Licensing

The EUL process is done by WHO and the Technical Advisory Group of independent experts who determine if the vaccine is quality-assured, safe and effective.

The World Health Organisation’s (WHO) Emergency Use Licensing (EUL) for Bharat Biotech’s Covid-19 vaccine, Covaxin, has been delayed. The independent Technical Advisory Group (TAG) of the WHO, which met on October 26 to consider the emergency licensing, has sought additional clarifications from vaccine maker, Bharat Biotech on Covaxin.

Soumya Swaminathan, WHO chief scientist tweeted that TAG had asked for additional clarifications from the company to conduct a final EUL risk-benefit assessment for global use of Covaxin. “It will reconvene for the final assessment on November 3 if data received soon,” Swaminnathan said.

The EUL process is done by WHO and the Technical Advisory Group of independent experts who determine if the vaccine is quality-assured, safe and effective.
According to the WHO, Bharat Biotech had been submitting data to WHO on a rolling basis and also submitted additional information at WHO’s request on September 27. Experts at WHO are reviewing this information and if it addresses all question raised, the WHO assessment would be finalised. Bharat Biotech first submitted data to the WHO on July 6, 2021.

The WHO EUL is required for exporting the Covid-19 vaccines to low and middle income countries. WHO had made it clear that while people were waiting for it recommendation for Bharat Biotech’s Covaxin, it would not cut corners and had to evaluate its safety and effectiveness before allowing emergency licensing.