Covaxin Can Be Taken Off “Clinical Trial Mode”, Expert Panel Recommends

COVID-19 vaccination: Bharat Biotech is the manufacturer of Covaxin

New Delhi:

Bharat Biotech’s COVID-19 vaccine Covaxin can be taken off clinical trial mode, a subject expert committee that has been monitoring the vaccine development has recommended to the country’s drugs regulator DCGI.

If Covaxin is no longer administered under clinical trial mode, people don’t have to sign a consent form to take the vaccine.

The subject expert committee recommended Covaxin to be given emergency use authorisation after going through the Indian vaccine’s phase 3 trial data.

In clinical trial mode, people needed to sign a consent form to take Covaxin, one of the two vaccines allowed for use in India, the other being Oxford-AstraZeneca’s Covishield, developed by the Serum Institute of India.

Covaxin is 81 per cent effective in preventing COVID-19 and can work against the UK variant of the virus, Bharat Biotech said on March 4, after it announced a “first interim analysis” of phase 3 trial results.

Its 81 per cent success or efficacy rate was based on this: the trial had a little over 25,000 people. Among this sample, 43 people contracted COVID-19 – of them, 36 had been given a placebo and seven had been given Covaxin.

Delhi AIIMS chief Dr Randeep Guleria had said the data was “very encouraging” but more data needs to be collected with at least 130 people testing positive. The current information is based on 43 people who contracted COVID-19.

The homegrown Covaxin was on Tuesday declared “safe, immunogenic with no serious side effects” by top medical journal Lancet, which published its phase 2 results.

Lancet has said that efficacy cannot be determined by phase 2 trials but the vaccine made by Hyderabad-based Bharat Biotech is “safe/immunogenic”.

Covaxin was granted emergency approval under clinical trial before its final stage testing in early January, which raised concerns about safety and effectiveness.

After reluctance in the first round of vaccination, Prime Minister Narendra Modi taking the injection on March 1 helped shore up confidence.