Hindustan Times, New Delhi


The first enrollment for Phase 3 trial was done on November 11 after the Drugs Controller General of India (DCGI) gave its approval in October. (Reuters file photo)

 
 
 
 

 

Hyderabad-based pharmaceutical firm Bharat Biotech on Monday applied to the central drug regulator seeking emergency use authorisation for its Covid-19 vaccine Covaxin, news agency Press Trust of India quoted an official as saying.

Covaxin is being indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).

It wasn’t immediately clear whether the authorisation request was based on trial data from Phase 1 and Phase 2 of human trials – the results for which were reported as a success but haven’t been released in the public domain – or the ongoing Phase 3.

However, the timelines involved in Phase 3 suggest that the use of this data was unlikely. The first enrollment for Phase 3 trial was done on November 11 after the Drugs Controller General of India (DCGI) gave its approval in October.

According to the trial procedure, after the first dose, a second dose is administered 28 days later, and the evaluation is conducted another two weeks after that. This suggests that the first reliable data from Phase 3 is unlikely to be available before December 23.

On December 4, Prime Minister Narendra Modi expressed hope that a Covid-19 vaccine could be ready in a few weeks. That evening, the Indian arm of US pharmaceutical giant Pfizer sought emergency use approval for its vaccine from DCGI. The Serum Institute of India sought a similar nod for the Oxford-AstraZeneca Covid-19 vaccine, Covishield, on December 6. The Phase 3 data of these vaccines has shown 95% (Pfizer) and up to 90% (Oxford) efficacy respectively, according to data released by them.