COVID-19 vaccine Covaxin can drop ‘clinical trial mode’ label, consent forms not needed

New Delhi: Bharat Biotech’s COVID-19 vaccine, Covaxin, will no longer have to carry the ‘clinical trial mode’ label, NITI Aayog member (Health) Dr V K Paul announced on Thursday (March 11, 2021). At a weekly press conference at the national capital, Paul said that Covaxin has been granted permission for restricted use in an emergency situation in the public interest.

It has also directed the company to submit a revised summary of the characteristics of the drug. Also, those who take the vaccine will now not be needed to go through seven-day monitoring by medical teams, the Centre informed.

“Both Covaxin and Covishield vaccines now have the same intensity of licensure. Therefore, it is a great day. Covaxin has now been given to more than 19 lakh people and there have been only 311 cases of side-effects. Covaxin has stood the test of time,” Dr VK Paul, Head of India’s Vaccine administration Committee said.

Notably, central drug panel’s decision is based on the interim efficacy data, the regulator has asked Bharat Biotech to keep providing it data from its phase 3 trials.

Covaxin was approved for emergency use by Drugs Controller General of India without efficacy data being made public. It has been found to be 81% effective in preventing COVID-19. 

Though, Serum Institute of India’s Covishield already has this status.

While, on Tuesday, the medical journal Lancet declared the drug ‘safe, immunogenic with no serious side effects’. It, however, said efficacy cannot be determined by phase 2 trials.

According to Bharat Biotech, the trial had a little over 25,000 people. Among this sample, 43 people contracted COVID-19. Out of them, 36 had been given a placebo, and seven had been given Covaxin.

The government-backed vaccine has been developed by Bharat Biotech, a 24-year-old vaccine maker, which 16 vaccines to its name and exports to 123 countries.

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