DELHI, NEW DELHI: According to sources, the World Health Organization (WHO) is pushing Covaxin’s emergency use listing due to a lack of complete details of the virus inactivation process used in its production. The WHO has requested “additional clarifications” from Covaxin manufacturer Bharat Biotech in preparation for a final assessment on November 3.
According to sources in the Union Health Ministry, because Covaxin is a whole inactivated virus-based vaccine, the WHO has been meticulously gathering data to ensure that the inactivation process is complete and without any gaps.
They also pointed out that the company has WHO approval for three out of nearly 12 vaccines it manufactures but no inactivated virus based vaccine made by the firm has got the approval till now.
“Therefore, WHO approval for Covaxin will be a first for the company if it gets the nod and that’s the reason the company needs to show a meticulously documented inactivation process,” said an official.
A query seeking response from Bharat Biotech on delay in WHO EUL has remained unanswered so far.
A vaccine expert in Delhi pointed out that while there may not be problems with the “the inactivation process itself, it is possible that the company might not have documented the procedure carefully”.
India has been pushing for WHO recognition of Covaxin as without it, the two-dose vaccine is struggling to be accepted as a valid vaccine globally and has complicated travel plans for Indians who have received it. The UN health body had on October 18 made it clear that it “cannot cut corners” and “must evaluate it thoroughly to make sure it is safe and effective” before recommending the product for emergency use.
The WHO rigour on the vaccine inactivation process comes in the backdrop of Brazil’s health regulator rejecting an application to give Covaxin a certificate of Good Manufacturing Practices following an inspection of the company’s site in Hyderabad earlier in April this year.
