New Delhi: Bharat Biotech announced the results of the Phase 3 trials of Covaxin on Saturday (July 3, 2021), claiming an overall vaccine efficacy of 77.8 percent.
The Hyderabad-based company stated that Covaxin was found to be’safe’ in India’s largest efficacy trial and shared the final Phase-3 Pre-Print data, which was published on medRxiv.
Between November 16, 2020, and January 7, 2021, over 25,798 participants were recruited and randomly assigned to Covaxin or placebo groups, with 24,419 receiving two doses of the vaccine.
In a case-driven analysis, 130 cases of symptomatic COVID-19 were reported in 16,973 (0.77 percent) participants with at least two weeks of follow-up after the second vaccination, with 24 occurring in the vaccine group and 106 in placebo recipients, for an overall vaccine efficacy of 77.8 percent.
Sixteen cases, one vaccinee and 15 placebo recipients, met the severe symptomatic COVID-19 case definition, resulting in a 93.4 percent vaccine efficacy.
The data, on the other hand, indicated that the efficacy against asymptomatic COVID-19 was 63.6 percent.
Covaxin provided 65.2 percent protection against COVID-19’s Delta variant (B.1.617.2).
“Covaxin was well tolerated, with no clinically or statistically significant differences between vaccine and placebo groups in the distributions of solicited, unsolicited, or serious adverse events. There were no reports of anaphylaxis or vaccine-related deaths “According to the data.
Covaxin’s efficacy, safety, and immunological lot consistency were evaluated in a double-blind, randomised, multicenter, phase 3 clinical trial conducted in 25 Indian hospitals.
Bharat Biotech International Limited funded the research, which was co-funded by the Indian Council of Medical Research.