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Published 06:38 IST, November 12th 2021

Bharat Biotech's Covaxin shows 70.8% efficacy against all COVID variants in Phase 3 trials

Bharat Biotech's COVID vaccine has also proven effective against the more transmissible Delta variant of the SARS-CoV-2 virus with an efficacy of 65.2%.

Reported by: Riya Baibhawi
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Covaxin
Image: AP | Image: self

Weeks after securing WHO’s Emergency Use Listing (ELU) for Covaxin, Bharat Biotech has now published data from Phase III trials of its coronavirus vaccine. In a press release, the Hyderabad based company said that following a safety and efficacy analysis of Covaxin, it was found that the jabs are 77.8% effective against symptomatic and 63.6% against asymptomatic cases of COVID-19.

Additionally, it was also found that Covaxin is the only vaccine that has proven effective against the more transmissible Delta strain of SARS-CoV-2 virus with an efficacy of 65.2%. The trial results have been published in the British medical journal The Lancet after being peer-reviewed.

Key highlights from the Covaxin trial

  • Efficacy analysis demonstrates Covaxin to be 77.8% effective against symptomatic COVID-19, through evaluation of 130 confirmed cases, with 24 observed in the vaccine group versus 106 in the placebo group
  • Efficacy analysis demonstrates Covaxin to be 93.4% effective against severe symptomatic 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 experiencing serious adverse events
  • Efficacy data demonstrates 63.6% protection against asymptomatic COVID-19
  • Efficacy data demonstrates 65.2% protection against the SARS-CoV-2 B.1.617.2 Delta
  • Efficacy data demonstrates 70.8% protection against all variants of SARS-CoV-2 virus

Notably, Covaxin is one of the highest published coronavirus vaccines in the world with trial data being published in more than 10- peer-reviewed journals from across the globe.

Speaking about the latest publication, Dr Krishna Ella, CMD of Bharat Biotech said, “The peer-review of Covaxin Phase III clinical trial data in The Lancet, an authoritative voice in global medicine validates our commitment to data transparency and meeting the stringent peer-review standards of world-leading medical journals. This accomplishment reflects the undeterred commitment by my team members at Bharat Biotech, our public partners, Indian Council of Medical Research, National Institute of Virology, and the trust imposed by our trial participants who made this happen.”

Covaixn Phase 3 trials

Covaxin’s phase III trials involved 25,800 volunteers from across the country. For this purpose, researchers conducted an event-driven analysis of more than 130 samples at 25 sites across India. After announcing the results, Bharat Biotech has announced that it was currently evaluating the vaccine  in “controlled clinical trials in children 2-18 years of age.”

(Image: AP)

Updated 11:14 IST, November 12th 2021