Hyderabad: The final analysis of Covaxin’s efficacy from phase 3 clinical trials have been released. The overall efficacy of the COVID-19 is 77.8 per cent, said Bharat Biotech.
Covaxin efficacy on Delta variant
The vaccine was found to provide 65.2 per cent protection against the B.1.617.2 (Delta) variant, which was first found in India and is the dominant strain now.
Efficacy:
Severe COVID-19 infections: 93.4 per cent
Asymptomatic cases: 63 per cent
Overall mild, moderate, and severe cases: 78 per cent
Delta variant: 65 per cent
“We are proud to put India on the global map with scientific conviction, competence and commitment. Covaxin scores 10 world-class publications endorsing Innovation, clinical research, data, safety, efficacy. Thank collaborators & Positive BB teamwork enduring a pandemic (sic),” Bharat Biotech co-founder Suchitra Ella said through a late-night tweet.
COVAXIN® Proven SAFE in India’s Largest Efficacy Trial. Final Phase-3 Pre-Print Data Published on https://t.co/JJh9n3aB6V pic.twitter.com/AhnEg56vFN
— BharatBiotech (@BharatBiotech) July 2, 2021
According to the company, this was “India’s largest efficacy trial”.
>> Over 25,798 between 18 and 98 years of age participated.
>> 24,419 individuals were given two doses of vaccine or placebo 4 weeks apart.
>> 130 cases of symptomatic COVID-19 infections were reported in 16,973 (0.77 per cent) participants at least two weeks after the 2nd dose.
>> 24 infections occurred in the vaccine group and 106 in placebo recipients giving the vaccine an overall efficacy of 77.8 per cent.
>> 16 cases, one vaccinated and 15 placebo recipients got severe COVID-19, bringing the vaccine efficacy to 93.4 per cent.
Covaxin has been granted emergency use authorizations in 16 countries, including, Brazil, the Philippines, Iran and Mexico.
The WHO is yet to approve the vaccine. The preprint data of this efficacy report has not been certified by peer-review, according to Medrxiv.
The company currently makes 2.3 crore doses a month.