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,