Bharat Biotech's Covaxin shows over 77% efficacy in phase 3 trials

Now that the data from phase 3 trials has been reviewed by the drug regulator of the country of origin, the firm can present it before the World Health Organization
Bharat Biotech’s Covaxin, India’s first indigenous vaccine against Covid-19, has shown 77.6 per cent efficacy in the final analysis of phase 3 clinical trials, according to sources in the expert panel that reviewed the data.

The vaccine has shown an efficacy rate of 93 per cent against severe disease and 60 per cent against asymptomatic Covid-19.

The Hyderabad-based vaccine manufacturer sought a full marketing authorisation for Covaxin after presenting the final analysis of phase 3 data before the Subject Expert Committee (SEC), which is advising the Drugs Controller General of India (DCGI), a source said.

“A full marketing authorisation has not yet been recommended by the SEC. More data on safety has been sought before a full authorisation can be granted,” the person cited above said. The SEC will now pass on the data to the DCGI for review.

Bharat Biotech did not comment on the matter.

Now that the data from phase 3 trials has been reviewed by the drug regulator of the country of origin, the firm can present it before the World Health Organization (WHO). Bharat Biotech is set to present the data before the WHO on Wednesday as it seeks to be part of the WHO-Emergency Use List (EUL).

Once Covaxin features in the WHO-EUL, it would address concerns around those vaccinated with this jab travelling abroad as most countries are allowing travelers who are vaccinated by one of the doses that feature in the list.

Bharat Biotech indicated earlier that it was engaging with the WHO and presenting data from the analysis of trials from time to time. The company has said it expects a WHO nod between July and September.

Bharat Biotech has noted on its website that “Covaxin demonstrated 78 per cent vaccine efficacy against mild, moderate, and severe Covid-19 disease. The efficacy against severe Covid-19 disease was 100 per cent with an impact on reduction in hospitalisations”.

Of the 25,800 participants in the phase 3 trials, over 2,400 volunteers were above 60 years of age and over 4,500 with comorbid conditions.

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