WHO panel likely to discuss emergency use of Covaxin today
A World Health Organization technical committee is scheduled to meet on Wednesday for a closely watched decision on giving an emergency use listing (EUL) to Covaxin, which will amount to a recognition and help pave the way for people who have taken the dose to qualify for vaccine mandates in other countries.
Bharat Biotech has been stuck in a regulatory loop, with independent technical experts of the UN health body taking longer to analyse the data that previously disclosed timelines. The panel, WHO’s Technical Advisory Group for Emergency Use Listing (TAG-EUL), sought more clarification from the vaccine maker on October 26.
A person aware of the matter said Bharat Biotech responded with the clarifications this past weekend, submitting additional data that included immunogenicity response in people 60 years and above, and separate data for responses in men and women.
“More data that was asked for has been submitted, and now it is for the technical team to assess and take a decision,” this person added.
Earlier, a decision on Covaxin EUL was expected on October 5, after WHO representatives sought additional information on September 27.
TAG-EUL is an independent advisory group that provides recommendations to WHO on whether a Covid 19 vaccine can be listed for emergency use under the EUL procedure.
Experts said it may just be a matter of time before a EUL is granted to Covaxin. “It looks like the company will be granted EUL soon as it has been submitting whatever data is sought from them. It looks like a minor issue,” said Dr NK Mehra, senior immunologist and former dean, All India Institute of Medical Sciences, Delhi.
In a media briefing last week, Union health minister Mansukh Mandaviya gave some details of the stage of Covaxin’s assessment at WHO.
“WHO has a system in place under which one technical committee observes the data, followed by another technical committee further analysing the data. The first committee has approved the data and the approval for Covaxin will be granted on the basis of what the second committee recommends,” said Mandaviya.
On October 5, WHO announced through a series of tweets that emergency use approval for Covaxin was a week away, and also that a vaccine recommended by it for emergency use must be evaluated thoroughly.
“We are aware that many people are waiting for WHO’s recommendation for Covaxin to be included in the COVID19 Emergency Use Listing, but we cannot cut corners - before recommending a product for emergency use, we must evaluate it thoroughly to make sure it is safe and effective,” tweeted WHO.
It clarified that the time frame for emergency approval depended on how quickly a company produced the required data.
“The time frame for the WHO Emergency Use Listing procedure is dependent on how quickly a company producing the vaccine is able to provide the data required for WHO to evaluate the vaccine’s quality, safety, efficacy and its suitability for low- and middle-income countries,” read another tweet.
Covaxin has shown 77.8% effectiveness against the disease, and 65.2% protection against the new highly transmissible delta variant. It is the second-most widely used coronavirus vaccine in India after Serum Institute of India’s Covishield.