All India Institute of Medical Sciences director Dr Randeep Guleria said that the Corona vaccine made by Bharat Biotech will be used only as a back-up for now.
The statement just came after India approved two Covid-19 vaccines – Serum Institute of India’s locally produced Oxford Covid-19 vaccine Covishield and Bharat Biotech’s indigenously manufactured Covaxin – for emergency use in the country.
He said that Hyderabad-based Bharat Biotech’s vaccine can be used when “we’re not sure how efficacious the Serum Institute vaccine is going to be.”
“In an emergency situation when there is a sudden increase in cases and we need to vaccinate, Bharat Biotech vaccine will be used. It can also be used as a backup when we’re not sure how efficacious the Serum Institute vaccine is going to be,” Guleria told.
“Approval clearly says ’emergency situation’ keeping in mind the circulating variant strains and at the same time, they have to continue the trial and get the data in. Once that data comes in, we’ll be more confident as far as safety and efficacy is concerned,” Guleria said.
“Initially, Serum Institute’s vaccine will be given. They already have 50 million doses available and they’ll be able to give that in initial phase where we’ll vaccinate around 3 crore people. Gradually, we’ll build on it and by that time Bharat Biotech data will also be available,” he informed.
Bharat Biotech announced successful recruitment of 23,000 volunteers and continued progress towards achieving the goal of 26,000 participants for the phase 3 trial of its coronavirus vaccine candidate Covaxin in India.
“Phase-3 human clinical trials of Covaxin began mid-Nov, targetted to be done in 26,000 volunteers across India, this is India’s first and only phase-3 efficacy study for Covid-19 vaccine, and largest phase-3 efficacy trial ever conducted for any vaccine in India,” the company said.
“Initially, Serum Institute vaccine will be given. They already have 50 million doses available and they will be able to give that in initial phase where we will vaccinate around 3 crore people. Gradually, we will build on it and by the time,” Dr Guleria added.
As per reports the Drugs Controller General of India granted the approval on the basis of recommendations by a Covid-19 Subject Expert Committee of the Central Drugs Standard Control Organisation.
“After adequate examination, CDSCO has decided to accept the recommendations of the Expert Committee and, accordingly, vaccines of M/s Serum and M/s Bharat Biotech are being approved for restricted use in emergency situations,” DCGI Dr V G Somani said.
