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Bharat Biotech’s Covaxin goes off clinical trial mode

Bharat Biotech’s Covaxin on Wednesday got the nod from the subject expert committee (SEC), an independent panel set up by the Drugs Controller General of India (DCGI) to advise it, for a restricted emergency use of the Covid-19 vaccine.

Covaxin was granted restricted use approval in ‘clinical trial mode’ in January by the DCGI. At that time, the phase 3 trial on 25,800 volunteers was underway.

“The decision to allow a restricted emergency use of Covaxin is based on the interim data from phase 3 trials,” said a source. The SEC met on Wednesday to review the application of Bharat Biotech.

The removal of the tag ‘clinical trial mode’ may result in greater acceptance of the vaccine, which has not found many takers. States like Chhattisgarh and Union Territories like Chandigarh had indicated in January that they were not comfortable with using Covaxin on their healthcare and frontline workers (part of the beneficiaries in the initial rounds) until complete data about the efficacy of the vaccine was available.

Earlier this month, the Hyderabad-based firm had released interim data from its phase 3 clinical trials, showing the vaccine had 81 per cent efficacy.

The approval in ‘clinical trial mode’ meant that beneficiaries would have to give their consent and there would be regular follow-ups. Such people would not receive the placebo.

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The drug regulator’s decision had created a furore among the medical community and citizens. The government machinery had to spring into action to clear the air, with the director general of the Indian Council of Medical Research (ICMR), Balram Bhargava, saying that while phase 3 was still ongoing, “immunogenicity data generated through phase 2 clinical trials serves as a surrogate for efficacy”.

The ICMR has developed the vaccine along with Bharat Biotech.

Krishna Ella, chairman and managing director of Bharat Biotech, had shown confidence in his product and said Covaxin had demonstrated 100 per cent results in animal challenge studies (non-human primates). This means that when exposed deliberately to the pathogen after vaccination, animals did not get the disease. Covaxin has also shown to generate an immune response against the UK strain of the virus.

The whole virion (virus) inactivated Covid-19 vaccine candidate has shown efficacy of 80.6 per cent in a phase 3 study covering participants between 18 and 98 years of age. This included 2,433 people over the age of 60 and 4,500 people with co-morbidities.

The interim analysis included a preliminary review of the safety database, which showed that severe, serious, and medically attended adverse events occurred at low levels and were balanced between vaccine and placebo groups. Business Standard