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Covaxin approval after due evaluation of data: Harsh Vardhan to Chhattisgarh

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Union Health Minister Dr Harsh Vardhan Thursday told the Chhattisgarh government that the drug regulator has granted permission to manufacture the Bharat Biotech’s Covaxin based on the “prescribed procedure” and “after due evaluation of pre-clinical and clinical trial data”.

The Union minister wrote to the Chhattisgarh Health Minister that both Covaxin and Serum Institute’s Covishield vaccines are “safe and immunogenic” and “should be used expeditiously” to “rapidly confer protection to prioritized beneficiaries”.

The letter came after the state government expressed concerns regarding supplies of Covaxin citing “unavailability of phase 3 data and also lack of display of expiry date on the vial”. “Your concern regarding the unavailability of expiry date on Covaxin vial is also completely unfounded and without basis, as the same is mentioned on the label of vaccine vials,” Vardhan wrote.

Vardhan highlighted that the state has already achieved 69.87 per cent coverage of its healthcare workers. “…You would appreciate that this coverage needs to improve significantly since the adequate quantity of both the vaccines are available with the state,” he said. “…Both these vaccines being supplied to states are safe and immunogenic and should be used expeditiously to rapidly confer protection to prioritised beneficiaries thereby mitigation the impact of the pandemic at the earliest,” Vardhan wrote.

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