Covaxin now out of ‘clinical trial mode’
New Delhi:11.03.2021
The government said regular emergency use authorisation for Bharat Biotech’s Covaxin outside of ‘clinical trial mode’ was a validation of India's timely decision-making based on scientific evidence and production of Covaxin was likely to increase along with its use. Niti Aayog member (health) Dr V K Paul said Covaxin was granted permission for regular emergency use authorisation and both Covid-19 vaccines — Bharat Biotech's Covaxin and Serum Institute’s Covishield — had the same licence status now.
“The vaccine has stood the test of time in terms of great safety. It is a triumph for India’s science and technology enterprise and research and development enterprise as well as our industry and I congratulate the teams at ICMR and Bharat Biotech,” Paul said.
Both Covishield and Covaxin were given EUA on January
3. However, in the absence of efficacy data from phase 3 trials, Covaxin was granted EUA under ‘clinical trial mode’ which required vaccinators to take informed consent from recipients before inoculation. It also meant that Bharat Biotech was liable for compensation in case of adverse events under the clinical trial rules. TNN
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