Bharat Biotech halfway through in one of country's largest phase-3 trials

Pfizer yet to submit data to regulator while Serum Institute has provided all additional information for emergency use authorisation

Hyderabad-based Bharat Biotech, one of the three vaccine candidates to have applied for emergency use authorisation, has recruited half the number of volunteers it needs for phase-3 human clinical trials of Covaxin. 

The company, along with Pune’s Serum Institute of India, had been asked to provide additional safety and efficacy data of its phase-3 trials by the drug regulator after the first presentation was made to the subject expert committee.  

V K Paul, member-health Niti Aayog and head of national expert group on vaccines said that Pfizer has not yet submitted its data to the subject expert committee. He said, “New data has been given by at least one company and it is being examined...Process is sacrosanct. Let us see where it takes us.”

Pfizer which has claimed 95 per cen efficacy for its vaccine had earlier sought more time for making the presentation before the subject expert committee. 

According to industry sources, Serum Institute which had requested approval for the Oxford-Astra Zeneca vaccine Covishield has provided all the information and data that it was asked to support its application for emergency use authorisation including safety data from the ongoing phase three trials in the country. 

Bharat Biotech which had presented data from its initial trials was asked to share safety and efficacy data from its vaccine candidate’s ongoing Phase-3 clinical trials in India. 

Suchitra Ella, joint managing director of Bharat Biotech said, “This is an unprecedented vaccine trial ever to take place in India, and we are overwhelmed with the steady rise in participation.”

A statement from the company said on Tuesday that it had recruited 13,000 out of 26,000 participants for Phase-3 clinical trial of Covaxin across multiple sites in India. This is one of the largest efficacy trials held in the country.  

While the phase three trials began in November, Bharat Biotech had evaluated 1,000 subjects in Phase I and Phase II clinical trials “with promising safety and immunogenicity results and acceptance in international peer reviewed scientific journals.”

The company is developing the covid antidote Covaxin in collaboration with the Indian Council of Medical Research and National Institute of Virology.