Is USFDA's rejection of Bharat Biotech's Covaxin a setback?
The United States has decided not to give Emergency Use Authorisation (EUA) to Bharat Biotechs Covaxin. Covaxin, Indias first indigenous Covid-19 vaccine will not be used in the US at least for now. The rejection, however, is not a reason for alarm. 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. The hitch, therefore, is purely procedural. The makers of Covaxin, one of India's largest exporters of vaccines, are certain this is not a setback. 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 were 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. Covaxin is still working towards prequalification from the WHO needed for global acceptability and to be part of the COVAX initiative especially in an age of vaccine passports. The government though says that the decision on vaccine passports has not been taken. There is some confusion about Covaxin, we are consulting with the WHO and will stabilise COVID passport rules Lav Agarwal, Joint Secretary Health said at a press briefing today. The government also said that phase 3 data for Covaxin will be released by June 20. Also read: Covaxin to be given only to second dose beneficiaries in 18-44 age group: Delhi govt  Also read: With govt centres shut and private hospitals pricey, Delhis youngsters left without Covid vaccines