Bharat Biotech's Covaxin shows 77.8% efficacy in Phase 3 trial

New Delhi, July 03: The COVID-19 vaccine developed by Bharat Biotech has shown an overall efficacy of 77.8% in the phase 3 clinical trials on Saturday. The vaccine also showed 65.2% against the SARS-CoV-2, B.1.617.2 Delta variant.

The indigenously developed vaccine is 93.4% effective against severe symptomatic COVID-19 cases through evaluation of 130 confirmed cases, with 24 observed in the vaccine group versus 106 in the placebo group. Efficacy data also demonstrated 63.6% protection against asymptomatic COVID-19.

Safety analysis demonstrates adverse events reported were similar to placebo, with 12% of subjects experiencing commonly known side effects and less than 0.5% of subjects feeling serious adverse events.

Phase 3 trial date in brief

• Asymptomatic cases: 63% Covaxin efficacy
• Mild, moderate, and severe cases: 78% Covaxin efficacy
• Delta variant: 65% Covaxin efficacy
• Severe Covid-19 cases: 93% Covaxin efficacy

The Covaxin Phase-3 analysis was an event driven analysis of 130 symptomatic COVID-19 cases, reported at least two weeks after the second dose, conducted at 25 sites across India.

The Phase 3 trials were conducted between November 16, 2020 and January 7, 2021 with 25,798 participants who were randomised to BBV152 or placebo groups.

The whole virion inactivated vaccine against SARS-CoV2, was developed in partnership with Indian Council of Medical Research and National Institute of Virology in Pune.

Krishna Ella, Chairman and Managing Director of Bharat Biotech, said, "The successful safety and efficacy readouts of Covaxin as a result of conducting the largest ever COVID vaccines trials in India establishes the ability of India and developing world countries to focus towards innovation and novel product development. We are proud to state that Innovation from India will now be available to protect global populations."

What next for Covaxin

Anti-Covid-19 shot, Covaxin, is likely to be approved for children by September. The vaccine for children aged 6-12 will be administered by the intramuscular route in two doses on day 0 and day 28. The trial will assess the safety, reactogenicity and immunogenicity of the Covid-19 vaccine in children.

Covaxin, which has been developed by Hyderabad-based Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), is being used on adults in India's ongoing Covid vaccination drive, which started from January 16 this year.

Bharat Biotech has said that scientific standards and commitment of Covaxin are transparent, and the company has so far published nine research studies on its safety and efficacy.