Covaxin to no longer carry 'clinical trial mode' label, no consent forms needed

Bharat Biotech's COVID-19 vaccine, Covaxin, will no longer have to carry the 'clinical trial mode' label. Serum Institute of India's Covishield already has this status. Earlier, Covaxin was granted restricted emergency use authorisation before the completion of trials.  

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.

Addressing a weekly press conference on Thursday, NITI Aayog member (Health) Dr V K Paul said Covaxin has been granted permission for restricted use in an emergency situation in the public interest.

"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 earlier today.

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.

Timeline on Covaxin

Covaxin was approved for emergency use without efficacy data being made public. It is 81% effective in preventing COVID-19.

The manufacturer of the vaccine, Bharat Biotech said on March 4, that it can also work against the UK variant of the virus.

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 DCGI decision is based on the interim efficacy data released by the company.

The regulator has asked Bharat Biotech to keep providing, data from the ongoing phase 3 trials.

It has also directed the company to submit a revised summary of the characteristics of the drug.  

Apart from the consent form waiver, those who take the vaccine will now not be needed to go through seven-day monitoring by medical teams.

What 'clinical trial mode' label means

The 'clinical trial mode' label meant that the manufacturer of Covaxin, Bharat Biotech had to seek informed consent before administering its vaccine to those eligible for the government’s ongoing vaccination drive.

It also meant the company had to submit updates on the safety, immunogenicity, and efficacy of the vaccine from its phase 1, 2, and 3 clinical trials more regularly than SII, which has had to submit such data every 15 days so far.