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HomeHealthCovaxin shows 81% interim efficacy in preventing Covid, Bharat Biotech says

Covaxin shows 81% interim efficacy in preventing Covid, Bharat Biotech says

Bharat Biotech's phase-3 trial was conducted on 25,800 participants between 18-98 years of age, including 2,433 over the age of 60 and 4,500 with comorbidities.

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New Delhi: Bharat Biotech Ltd’s Covaxin has shown an interim efficacy of 81 per cent in preventing Covid-19, the company said in a statement Wednesday, two months after the vaccine got approval for restricted use in India.

The efficacy has been found in those without prior infection after the second dose has been administered. Efficacy is an estimate of how unlikely a person’s chances of getting a disease are after vaccination.

In its statement, Bharat Biotech said, “Data from 25,800 participants, received a vaccine or placebo in a 1:1 ratio showed that the vaccine candidate was well tolerated. COVAXIN® demonstrated 81% interim efficacy in preventing COVID-19 in those without prior infection after the second dose.”

It added, “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.”

Covaxin has been produced indigenously and is made up of a whole virus that has been inactivated in order to expose the body to the virus but not its virulence. That was among the reasons for its early approval as experts felt as a whole virus-based vaccine it is more likely to act against mutant strains.

However, there remains hesitancy in some quarters about the vaccine. Chhattisgarh has refused to use it. That may change now that the efficacy data has come.


Also read: Many trial participants still unsure about vaccine or placebo status, SII info only on request


Study details

The Phase-3 study enrolled 25,800 participants between 18-98 years of age, including 2,433 over the age of 60 and 4,500 with comorbidities.

The first interim analysis is based on 43 Covid-19 cases, of which 36 were observed in the placebo group versus seven observed in the vaccine group, resulting in a point estimate of vaccine efficacy of 80.6 per cent, the company said.

“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,” Krishna Ella, Chairman and Managing Director, Bharat Biotech, said in the statement.

“COVAXIN® demonstrates high clinical efficacy trend against COVID-19 but also significant immunogenicity against the rapidly emerging variants,” Ella added.

The interim analysis included a preliminary review of the safety database, which showed that severe, serious, and medically attended adverse events occurred at low levels and were balanced between vaccine and placebo groups.

Analysis from the National Institute of Virology indicates that vaccine-induced antibodies can neutralise the UK variant strains and other heterologous strains, which has been published in bioRxiv.


Also read: India has shown capacity to make Covid vaccines on global scale, says WHO chief scientist


 

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