Bharat Biotech’s Covaxin shows 81% efficacy after second dose in phase 3 trials

• Hyderabad-based Bharat Biotech released phase 3 results of its Covid-19 vaccine — Covaxin — today
• Covaxin is one of two coronavirus vaccines approved by the India drug regulator.
• Earlier, the Indian drug regulator's approval triggered a row of criticism from experts pointing to a lack of efficacy data at that time.
• Check out the latest news and updates on Business Insider.

Hyderabad-based Bharat Biotech released phase 3 results of its Covid-19 vaccine — Covaxin — today. The vaccine demonstrated 81% interim efficacy in preventing COVID-19, in those without prior infection, after the second dose.

"Clinical trial to continue through to final analysis at 130 confirmed cases in order to gather further data and to evaluate the efficacy of Covaxin in additional secondary study endpoints," the company said in a statement.


This comes two days after Indian Prime Minister Narendra Modi was administered a dose of Covaxin as he kicked off the largest phase of COVID-19 vaccination in India. Covaxin is one of two coronavirus vaccines approved by the India drug regulator. The drug had earlier received clearance for emergency use.

Bharat Biotech conducted a study on 25,800 participants who received a vaccine or placebo in a 1:1 ratio. The results showed that the vaccine candidate was well tolerated. It conducted the trials in partnership with India’s medical research organisation, ICMR.

Earlier, the Indian drug regulator's approval triggered a row of criticism from experts pointing to a lack of efficacy data at that time.

The Drugs Controller General of India (DCGI) also came under flak from various quarters for approving Covaxin even before the completion of Phase 3 trials. Critics wondered how the regulator could approve the vaccine in the absence of the data from Phase 3. Allaying the apprehensions associated with the vaccine's safety, S. Eswara Reddy, Joint Drugs Controller, Central Drugs Standard Control Organisation (CDSCO), had then clarified that Covaxin has satisfactory efficacy levels and there is nothing to worry about.

Indicating at Covaxin's efficacy meeting the WHO standard, Reddy had then said, "We assure that the vaccine is safe and the efficacy (of Covaxin) is to the satisfaction."

The country has so far administered nearly 1.48 crores doses of COVID-19 vaccines.

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