The United States has decided not to give Emergency Use Authorisation (EUA) to Bharat Biotech’s Covaxin.
Covaxin, India’s first indigenous Covid-19 vaccine will not be used in the US at least for now.
The US Food and Drug Administration has said that they don’t have enough data yet to grant EUA and that the company should pursue a full license process that will take time and involve additional clinical trials.
Bharat Biotech has said, “The USFDA had earlier communicated that no new emergency use authorisation would be approved for new Covid-19 vaccines… Our US partner, Ocugen has received a recommendation from the FDA to pursue Biologics License Applications (BLA) path for COVAXIN®, which is full approval.”
“Every country has its own regulatory system. They have their own parameters. We respect them. Our country has its own system,” Dr VK Paul, member of Health, Niti Aayog said at a press conference today.
The hurdle comes weeks after Covaxin was praised by the US’s top pandemic expert, Dr Antony Fauci.” This is something where we’re still gaining data on a daily basis. But the most recent data was looking at convalescent Sera of Covid-19 cases and people who received the vaccine used in India, the Covaxin. It was found to neutralise the 617 variants,” Dr Fauci had said.
