New Delhi, June 22
Regulatory experts on Tuesday reviewed and accepted Bharat Biotech’s phase-3 data that shows 77.8 per cent jab efficacy in a trial on 25,800 persons.
The study results are significant as they come on the eve of an important meeting Bharat Biotech representatives are expected to attend at the WHO tomorrow as a step towards Covaxin’s emergency use listing by the world body. Currently, only one India-made vaccine, Covishield, is mentioned in the WHO listing. Sources in the drug regulator’s office said Biotech had submitted vaccine efficacy data from phase-3 trials on the weekend and it was reviewed by subject experts today and accepted.
The regulator had in January this year granted emergency use approval to Covaxin in clinical trial mode with phase-3 data awaited. Bharat Biotech had earlier submitted its EUL application to the WHO. —TNS
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