Bharat Biotech's Covaxin to be used as 'back up', says AIIMS chief

Amid opposition against the ‘quick’ approval of Bharat Biotech’s Covaxin by the Drugs Controller General of India (DCGI) for restricted  emergency use, Dr Randeep Guleria, chief of Delhi’s All-India Institute of Medical Science (AIIMS) has said that Covaxin is only a “back up” for “emergency use in case of reinfection.”

Dr Guleria said that Serum Institute of India’s (SII) Covishield vaccine, developed in collaboration with Oxford-AstraZeneca, which was approved on January 2, will be used while the completion of Covaxin Phase III trial results are awaited.

“Initially, Serum Institute’s 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 that time Bharat Biotech data will also be available,” Dr Guleria said.

“We are not sure how efficacious the Serum Institute vaccine is going to be,” he added.

Covaxin is an indigenously-developed vaccine by Bharat Biotech in collaboration with with the Indian Council of Medical Research (ICMR) and National Institute of Virology.

Also read: No plan to vaccinate the entire population against COVID, says Centre

Covaxin is currently undergoing Phase III clinical trial, with nearly 23, 000 of the 25,800 participants vaccinated, which has nevertheless been approved for restricted emergency use by DCGI.

Dr Guleria added that for the first few weeks Covishield will be in use until Covaxin clears its Phase III trial. “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,” Dr Guleria said.

Also read: India has experience, systems to fight COVID-19 efficiently: Health minister

Drug Controller General Dr VG Somani said Covaxin results show it is “safe and provides a robust immune response”.

The Health Ministry said that they would like to have “more options for vaccinations, especially in case of infection by mutant strains,” the ministry said, and clarified that the clinical trials of the vaccine will continue.

DCGI approved both Covishield and Covaxin on the basis of recommendations by the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO).

“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,”  Dr Somani said.