Covaxin completes Final Phase-3 trial, proven SAFE in India’s largest efficacy trial

Bengaluru: Bharat Biotech has completed the analysis of its vaccine for Covid-19 and announced the safety and efficacy analysis data from phase 3 clinical trials on Saturday.

BBV152 was well tolerated with no clinically or statistically significant differences in the distributions of solicited, unsolicited, or serious adverse events between vaccine and placebo groups.

Bharat Biotech’s Covaxin was found 77.8 per cent effective against symptomatic Covid-19.

These phase 3 clinical trials of covaxin were carried out at 25 places across the country.

“We did a double-blind, randomised, multicentre, phase 3 clinical trial in 25 Indian hospitals to evaluate the efficacy, safety, and immunological lot consistency of BBV152. Healthy adults (age 18 to 98 years) randomised 1:1 using a sponsor-supplied randomisation scheme received two intramuscular doses of vaccine or placebo administered four weeks apart.

It was done with an analysis of 130 symptomatic covid-19 cases, reported at least two weeks post second dose.”

“The primary outcome was laboratory confirmed symptomatic COVID 19, occurring at least 14 days after the second dose. Secondary outcomes were efficacy in subgroups for age (18 to < 60 years and >=60 years) and in participants with pre-existing stable medical conditions.

24 subjects were observed in the vaccine group, while another 106 were given placebo.”

Efficacy against asymptomatic COVID 19 was 63.6% (29.0, 82.4). BBV152 conferred 65.2% (95% CI: 33.1, 83.0) protection against the SARS CoV 2 Variant of Concern, B.1.617.2 (Delta).

Bharat Biotech is also carrying out a clinical trial to find out the safety of Covaxin in children below 18 years and above 2 years of age.

The company also wants to reach the capacity of 1 billon does before the year ends.