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Bharat Biotech announces Covaxin 81% effective in interim phase 3 trials


The Hyderabad-headquartered vaccine maker Bharat Biotech announced phase 3 clinical trial results of its indigenously-made Covid-19 vaccine ‘Covaxin’ on Wednesday. In Phase 3 clinical trial results, the company says its indigenously developed coronavirus vaccine Covaxin has demonstrated an interim vaccine efficacy of 81% against novel coronavirus.

The data come from 25,800 participants who received a vaccine or placebo in a 1:1 ratio and showed that the vaccine candidate was well-tolerated, the company stated. The trials were conducted in partnership with the Indian government’s medical research body ICMR.

“The clinical trial will 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 further stated.

“Today is an important milestone in vaccine discovery, for science and our fight against coronavirus. With today’s results from our Phase 3 clinical trials, we have now reported data on our COVID-19 vaccine from Phase 1, 2, and 3 trials involving around 27,000 participants,” Bharat Biotech Chairman and Managing Director Krishna Ella said.

Covaxin demonstrates a high clinical efficacy trend against COVID-19 but also significant immunogenicity against the rapidly emerging variants, he added.

36 of the 43 cases were recorded in participants who received a placebo, compared with 7 cases in people who were given the Bharat Biotech vaccine, pointing to an efficacy rate of 80.6 percent, the company said.

The findings cement Bharat Biotech’s claims of the vaccine being safe and may help overcome vaccine hesitancy as India gears up to ramp the Covid-19 vaccination drive.

Covaxin is one of the two Covid-19 vaccines approved for emergency use in India for its mega vaccination drive, which started on 16 January 2021 and is now in the next phase. The other one is the Serum Institute of India’s locally-made Oxford-AstraZeneca’s COVID 19 vaccine, Covishield.

Covaxin has been administered to hundreds of Indian citizens already including to PM Narendra Modi, who took the first shot on Monday marking the beginning of the 2nd phase of vaccinations in the country for elderly citizens above 60 years of age and those above 45 years of age with comorbidities.

According to sources, some of the European countries have shown interest in the vaccine. Earlier this week, the French Ambassador visited the Bharat Biotech facility in Hyderabad. While it was said to be a courtesy visit, speculations are rife that at a time when EU countries are jostling to secure enough vaccines to cover the entire population, Bharat Biotech, with phase 3 data, maybe a vaccine of choice for some countries.

Last week Brazil signed an agreement with the Hyderabad-based company for the supply of 20 million doses of the Covaxin vaccine. “The company is delighted to partner with Brazil in its battle against Covid-19 and aid its immunization program against the virus. It has signed an agreement for delivery of COVAXIN during Q2 (April to June) and Q3 (July to September) (of) 2021,” the company said in a statement.

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