Covaxin shows 77.8% efficacy in Phase III trials, DCGI may approve it today

Bharat Biotech’s Covaxin has shown 77.8 per cent efficacy after the Subject Expert Committee (SEC) under the drug regulator reviewed its Phase III trials data on Tuesday, according to sources. The Hyderabad-based COVID vaccine manufacturing company had submitted data from the Phase III clinical trials of Covaxin to the Drugs Controller General of India (DCGI) over the weekend.

Bharat Biotech’s ‘pre-submission’ meeting with the World Health Organization (WHO) will take on Wednesday for the approval for Covaxin.

Covaxin is one of the three vaccines which are currently being used in India. The phase III data of its vaccine has been questioned various times and this is what makes the data that ascertains the efficacy of the vaccine crucial.The company has developed the vaccine in association with the Indian Council of Medical Research (ICMR).

Meanwhile, the Drugs Controller General of India (DCGI) is likely to approve Phase III trial data of Covaxin on Tuesday, sources said. The Subject Expert Committee (SEC) under the drug regulator reviewed Covaxin’s Phase III trial data on Tuesday and the vaccine’s efficacy has turned out to be 77.8 per cent. Covaxin is an indigenous Covid-19 vaccine produced by Bharat Biotech.

The Hyderabad-based company had submitted data from the Phase III clinical trials of Covaxin to DCGI over the weekend. The sources said that Bharat Biotech’s ‘pre-submission’ meeting with the World Health Organization (WHO) will take place on Wednesday for approval for Covaxin.

Covaxin is one of the three Covid-19 vaccines which have been given authorisation in the country for vaccination against Covid-19. The company has developed the vaccine in association with the Indian Council of Medical Research (ICMR).

WITH ANI INPUTS