“On Covaxin, the technical advisory group that reviews all the data for a potential emergency use listing are indeed reviewing that data today. Now if all is in place, and all goes well, and if the committee is satisfied, we would expect a recommendation within the next 24 hours or so," WHO official Dr Margaret Harris said during a press briefing.
The WHO has so far approved Covid-19 vaccines of Pfizer-BioNTech, AstraZeneca, Johnson & Johnson-Janssen, Moderna, and Sinopharm for emergency use.
The WHO had earlier emphasized that it must evaluate a vaccine thoroughly to make sure it is "safe and effective".
Hyderabad-based Bharat Biotech, which has developed Covaxin, had submitted EOI (Expression of Interest) to the WHO on April 19 for the vaccine's Emergency Use Listing (EUL).
On the delay of approval, WHO has said it cannot cut corners - before recommending a product for emergency use. "We must evaluate it thoroughly to make sure it is safe and effective."
The WHO EUL procedure is a risk-based procedure for assessing and listing unlicensed vaccines with the ultimate aim of expediting the availability of these products to people affected by a public health emergency.
This will assist interested UN procurement agencies and member states in determining the acceptability of using specific products, based on an essential set of available quality, safety, and efficacy and performance data.
Bharat Biotech has been submitting Covaxin data on a rolling basis and WHO experts have reviewed these data as it came. The global health agency said the timeframe for its EUL procedure is dependent on how quickly a company producing the vaccine is able to provide the data required to evaluate the vaccine’s quality, safety, efficacy and its suitability for low- and middle-income countries.
If granted, the approval will hold importance of people in India vaccinated with covaxin as WHO’s approval will facilitate international travel for Indians who have received the home-made vaccine under India’s national covid vaccination programme.
The delay has been impacting students and businessmen who want to travel to countries where a vaccination certificate for WHO-approved vaccines is mandatory.
The Covaxin has demonstrated 77.8% effectiveness against symptomatic Covid-19 and 65.2% protection against the new Delta variant. In June, the company said it concluded the final analysis of Covaxin efficacy from Phase 3 trials.
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