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Covaxin shows 77.8% efficacy in phase 3 trial data in review by expert committee

Covaxin, India’s only homemade COVID-19 vaccine, has shown 77.8 per cent efficacy in phase 3 trial data in review by the DCGI’s Subject Expert Committee, source said this afternoon.

Hyderabad-based Bharat Biotech, the manufacturer of the made-in-India COVID-19 vaccine, recently submitted phase 3 trial data to DCGI, the country’s apex drug regulator.

Covaxin, the indigenously-developed COVID-19 vaccine, is among the three vaccines currently being used in the country to inoculate people against the viral infection.

In April this year, Bharat Biotech had said Covaxin has shown efficacy of 78 per cent against mild, moderate and severe cases of COVID-19, as per Phase III interim analysis results.

The Hyderabad-based vaccine maker has been under sharp criticism over the delay in releasing the phase 3 clinical trials of the vaccine. The DCGI had approved Covaxin for restricted emergency use in India in January based on its phase 1 and 2 clinical trials.

Amid growing clamour to release the Covaxin findings urgently, an early study claimed that the Covishield vaccine produces more antibodies against coronavirus infection than the Bharat Biotech’s vaccine.

The study showed that after two shots of the vaccines, 98 per cent recipients of Covishield showed antibody response, while the same was 80 per cent among Covaxin recipients.

However, Bharat Biotech downplayed the study and said that the preliminary research has “a lot of flaws” and was conducted on an ad hoc basis. The pharma firm had also said the study was not peer-reviewed and was not scientifically designed.

“A recent comparative report on the evaluation of immunogenicity responses to spike protein after 1st and 2nd dose of Indian manufactured vaccines study had a lot of flaws….It’s not a peer-reviewed publication, nor statistically and scientifically designed study. The study design and conduct reflect an ad hoc analysis, rather than a predetermined hypothesis,” Bharat Biotech had said in its statement.

 

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