Expert Panel Reviews Bharat Biotech Vaccine For Emergency Use

A panel of government experts met today to review Bharat Biotech's application for emergency use of its vaccine Covaxin - India's first COVID-19 jab developed indigenously in collaboration with the country's top medical research body ICMR.

The meeting was called a day after the Subject Expert Committee cleared Oxford's Covishield and sent it to the Drugs Controller General of India (DCGI) for final approval.

Three vaccine makers have applied for emergency use approval in India. The Serum Institute of India (SII) is making the vaccine Covishield developed by Oxford University and pharma major AstraZeneca. Pfizer, whose vaccine has been approved by the World Health Organisation, had sought more time to present their data to the panel of experts.

However, Bharat Biotech is still in the process of recruiting volunteers for the final trials. Though the process has started across India, it has failed to garner much interest with many centres, including those in Mumbai and Delhi, not getting enough volunteers.

The drug maker was expected to complete its trials by December 31, but has extended the date for registration, which is ongoing.

According to officials, till December 22, Bharat Biotech had only been able to recruit 13,000 out of the required 26,000 candidates for the final-stage trials.

Experts have said Bharat Biotech's Covaxin is unlikely to get approval as its phase 3 data, which proves efficacy, is unavailable. Its phase 1 and 2 data shows that the vaccine is safe and has no side effects.

As India waits for a vaccine, dry run or mock drills of the inoculation process has started across the country to plug gaps and check on-field operational feasibility of the CoWIN app - a digital platform to roll out and scale up the vaccination drive.

As the exercise continues across multiple districts in all states, Health Minister Dr Harsh Vardhan said there should be no misconceptions about the safety of the vaccine India plans to use.

"Everything has been checked in detail. Initially, when the polio vaccine was rolled out, even then rumours had floated," he said as he visited Delhi's GTB hospital to review the dry run. The feedback from dry run in four states earlier this week has been used to improve the government's 150-page guideline, he said.

India has 1.03 crore coronavirus cases with 1.5 lakh deaths, and 29 cases of the even more virulent UK Covid strain.