Covaxin provided 65.2 percent protection against COVID-19’s Delta version (B.1.617.2); Bharath Bio Tech

Bharat Biotech announced the findings of Covaxin’s Phase 3 trials on Saturday (July 3, 2021), claiming that the vaccine has an overall efficacy of 77.8%.

The Covaxin was found to be “safe” in India’s largest efficacy trial, according to the Hyderabad-based company, which also revealed the final Phase-3 Pre-Print data published on medRxiv.

Between November 16, 2020, and January 7, 2021, a total of 25,798 people 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) patients with follow-up at least two weeks following the second immunisation, with 24 in the vaccine group and 106 in the placebo group, yielding a vaccine effectiveness of 77.8%.

The vaccination efficacy was 93.4 percent in 16 cases, one vaccinee, and 15 placebo receivers who satisfied the severe symptomatic COVID-19 case classification.

The data, on the other hand, showed a 63.6 percent efficacy against asymptomatic COVID-19.

Covaxin provided 65.2 percent protection against COVID-19’s Delta version (B.1.617.2).

“Covaxin was well tolerated, with no clinically or statistically significant differences between the vaccine and placebo groups in the distributions of solicited, unsolicited, or major adverse events. There were no reports of allergy or vaccine-related deaths “The information stated.

Covaxin’s efficacy, safety, and immunological lot consistency were evaluated in a double-blind, randomised, multicentre, phase 3 clinical trial conducted in 25 Indian hospitals.

Bharat Biotech International Limited funded the research, which was also supported by the Indian Council of Medical Research.