Delay in submitting virus inactivation data pushes WHO nod for Covaxin

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Express News Service

NEW DELHI:  It’s the lack of complete details of the virus inactivation process, used for making Covaxin, that is pushing its emergency use listing by the World Health Organisation (WHO), sources have told this newspaper. The WHO has sought “additional clarifications” from Covaxin maker Bharat Biotech for a final assessment on November 3.

Sources in the Union health ministry said since Covaxin is a whole inactivated virus based vaccine, the WHO has been seeking data meticulously to ensure that the inactivation process is complete and without any loopholes.

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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”. 

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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. 



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