Bharat Biotech completes Phase-3 trial for covaxin, claims 77.8% efficacy

Hyderabad-based Bharat Biotech on Saturday announced that it has completed a final analysis for its vaccine Covaxin efficacy from phase-3 clinical trial. The pharmaceutical company claimed it’s vaccine is 77.8 percent effective against Covid-19.

Bharat Biotech’s also added that Covaxin demonstrates 65.2 per cent protection against the SARS-CoV-2, B.1.617.2 Delta variant, which is one the most predominant strain in India.

Against severe symptomatic Covid-19 cases, it claims to provide 93.4% effectiveness, while it gives an efficacy of 63.6% against asymptomatic Covid-19 patients, Bharat Biotech said at the conclusion of its Phase-3 efficacy trial.

Safety analysis indicates adverse events reported were similar to placebo, with 12 percent of subjects experiencing common side effects and less than 0.5 percent of subjects feeling severe adverse events, according to the pharmaceutical company.

Published in the medExiv pre-print server, the Covaxin Phase-3 analysis was reportedly conducted across 25 hospitals in India as trial sites.

The Hyderabad-based vaccine maker claimed Covaxin was well tolerated and the Data Safety Monitoring Board did not reported any safety concerns related to the vaccine, adding, “The overall rate of adverse events observed in Covaxin was lower than that seen in other COVID-19 vaccines. Bharat Biotech has so far not sought indemnity for Covaxin from the governments.”

The drugmaker company further stated that its committed to continuous improvement of Covaxin is well underway with additional clinical trials to provide safety and efficacy in children between the age group of 2-18 years.

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