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When will Covaxin get WHO nod? Rolling data submission to begin in July

Starting from July, Bharat Biotech will submit rolling data of all its clinical trials to the World Health Organization.
By hindustantimes.com | Written by Poulomi Ghosh
PUBLISHED ON JUN 30, 2021 11:42 AM IST
Bharat Biotech will have to submit all clinical trial data to WHO starting from July, following which a tentative date of approval will be announced. (REUTERS)

Bharat Biotech's Covaxin inches a step closer to get approval from the World Health Organization as rolling data submission will begin in July, as per the WHO website. The pre-submission meeting has been held and as this data submission begins, Covaxin will only be one step away from getting the nod — which is the evaluation that may take some time. The Hyderabad-based company earlier said it expects the emergency use listing to arrive by September.

What is the evaluation process?

WHO's emergency use listing is a standard list that every country is more or less accepting. Though there is no vaccine passport yet, many countries have decided to allow travellers vaccinated with WHO-listed vaccines. So, getting recognised by WHO is crucial for Bharat Biotech's Covaxin. And the sooner the result comes, the better for Indian travellers vaccinated with Covaxin.

Fauci’s institute backs Covaxin, funded its efficacy booster

For EUL, the vaccine maker first needs to apply which is the submission of the expression of interest, which involves some amount of paperwork. Once the EOI is accepted, a pre-submission meeting is held between the company and the WHO. Covaxin has reached this stage.

Now, the vaccine maker will have to present all clinical trial data conducted in all sites to WHO, which will be evaluated simultaneously. Then WHO will give an anticipated date when the approval is likely to be given only when all data is submitted and follow-up inspection observations are also completed.

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What WHO examines whether the product has been able to eradicate the disease or prevent outbreaks and whether the manufacturing is compliant with Good Manufacturing Practices.

Covaxin and controversies

At home and abroad, Covaxin has been the centre of several controversies beginning its approval in India in January in the "absence of adequate data". After the vaccine makers provided their latest data, its high price in India came on the radar as the vaccine in the private market costs more than Covishield and Sputnik V. Meanwhile, Brazil has suspended the purchase of the vaccine from Bharat Biotech following allegations of corruption in the deal.

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