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The World Health Organization (WHO) is likely to take a decision on granting Emergency Use Listing (EUL) to Covaxin, Bharat Biotech’s vaccine against Covid-19, next week. When contacted, Dr Soumya Swaminathan, chief scientist at WHO, told The Indian Express, “wait till next week.”
The country’s indigenous Covid-19 vaccine has not yet received emergency use approval from WHO. WHO and an independent group of experts are scheduled to meet next week to carry out the risk/benefit assessment and arrive at a decision on granting EUL to Covaxin.
In a tweet, the organisation said that it has been submitting data, and has also submitted additional information, on WHO’s request, on September 27. “WHO experts are currently reviewing this information and if it addresses all questions raised, WHO assessment will be finalised next week.” the UN health agency said in its tweet.
According to WHO, the Emergency Use Listing process — done by WHO and the Technical Advisory Group of independent experts — is centred on determining if a manufactured product (in this case the vaccine) is quality-assured, safe and effective.
The Hyderabad-based company had applied for WHO approval on April 19 by providing an Expression of Interest. The UN health agency had, however, delayed emergency use authorisation for the vaccine as it had more technical queries that Bharat Biotech is required to answer before it gets the approval.
The WHO move on Covaxin, if it comes next week, will come as a huge relief to thousands of people who have got both doses of Covaxin but are still treated as unvaccinated by many countries, as the WHO is yet to approve the vaccine. As a result, these people are either not allowed to fly out to some countries, or are made to quarantine.
A Strategic Advisory Group of Experts, which met on Tuesday and concluded on Wednesday, also discussed the issue. At the meeting, Bharat Biotech gave a presentation on the vaccine’s safety and efficacy data of clinical trials (phase 1-3 trial results and post-marketing), risk management plans and other implementation considerations, according to Bharat Biotech officials.
Meanwhile, India’s cumulative Covid-19 vaccine coverage crossed 92 crore beneficiaries recently. Covaxin, along with Covishield and Sputnik V, is being used in the nationwide inoculation programme. Bharat Biotech officials told The Indian Express that till date, more than 100 million doses have been supplied to the Government of India and other countries.
In an earlier tweet, the firm had said that Covaxin clinical trial data has been fully compiled and made available in June this year. “All data submitted for EUL application to WHO in early July. We have responded to any clarifications sought by WHO and awaiting further feedback,” Bharat Biotech tweeted.
