Made In India Covaxin shows interim vaccine efficacy of 81% in Phase 3 trial

New Delhi, March 04: Hyderabad-based pharma company Bharat Biotech has released the result of the phase 3 trials of the Covaxin vaccine. According to the result, the Made in India Vaccine has demonstrated an interim efficacy of 81% against COVID-19 in those without prior infection after the second dose. This a milestone in the field of vaccine discovery and India's fight against contagion.

 

 

The company said the trials involved 25,800 subjects, the largest ever conducted in India, in partnership with ICMR. The data taken from the 25,800 participants who received vaccine or placebo in a 1:1 ratio showed that the vaccine candidate was well tolerated.

 

Moreover, the clinical trial to continue through to final analysis at 130 confirmed cases together further data and evaluate the efficacy of COVAXIN in additional secondary study endpoints.

 

“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,” said Dr. Krishna Ella, Chairman & Managing Director, Bharat Biotech.

 

 

 

The primary endpoint of the Phase 3 clinical trial is based on the first occurrence of PCR-confirmed symptomatic (mild, moderate, or severe) COVID-19 with onset at least 14 days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline.

 

The efficacy rate of the vaccine was determined through a first interim analysis of 43 cases of COVID-19. 36 of these cases belonged to the placebo group of the vaccine trial, meaning that out of the individuals given the vaccine, 7 contracted COVID-19, resulting in the estimate of an 80.6% efficacy rate.

 

According to the ICMR, "The results, evaluated by an independent data safety and monitoring board, show that the vaccine (COVAXIN) is well-tolerated and efficacious against SARS-CoV-2 across a wide range of age groups and variants in the country."

 

 

 

More importantly, this vaccine is also significant immunogenicity against the rapidly emerging variants. As per the analysis of the National Institute of Virology, the vaccine-induced antibodies can also neutralize the UK variant strains and other heterologous strains.

 

It should be noted that Pune's Serum Institute's Covidshield has reported an efficacy range of 62-90%, depending on the vaccine does deploy. Earlier, on Monday PM Modi took the first shot of the Covaxin vaccine..
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