The emergency use authorisation (EUA) for Bharat Biotech’s Covid-19 vaccine Covaxin has once again been delayed by the World Health Organisation, said sources. The sources further said that the UN public health agency has asked for more data from Bharat Biotech for Covaxin. This delay will affect Indians especially students and who have international travel plans.
The EUA is important because without it Covaxin will not be accepted by most countries. The Strategic Advisory Group of Expert on Immunization (SAGE) will be meeting on October 5. Earlier in an exclusive interview to ANI Dr Pravin Bharati Pawar, Minister of State for Union Ministry of Health and Family Welfare said, “There is the procedure of submitting the documents for approval. WHO’s emergency use authorisation is expected soon.” The EUA is important because without it Covaxin will not be accepted by most countries. “As a responsible manufacturer with past approvals for our other vaccines, we do not find it appropriate to speculate or comment on the regulatory approval process and its timelines. We are diligently working with the WHO to obtain EUL at the earliest,” Bharat Biotech said in a statement. Earlier, WHO’s nod for Covaxin was expected by 5 October, ANI had earlier stated. Meanwhile, Bharat Biotech last Friday said it has submitted all the data to the World Health Organisation (WHO) for Emergency Use Listing (EUL) of its COVID-19 vaccine Covaxin and is awaiting feedback from the UN Public Health Agency. In a series of tweets, Bharat Biotech said that Covaxin clinical trial was fully compiled and available in June 2021.
