New Delhi:
A panel of government experts will meet today to review Bharat Biotech’s request for the emergency use of its Covaxin vaccine, India’s first COVID-19 jab developed indigenously in collaboration with the country’s leading medical research body. country, ICMR.
The development comes a day after the Subject Matter Experts Committee cleared Oxford Covishield and sent it to the Comptroller General of Drugs of India (DCGI) for final approval.
Three vaccine manufacturers have applied for emergency use approval in India. The Serum Institute of India (SII) is manufacturing the Covishield vaccine developed by the University of Oxford and leading drugmaker AstraZeneca. Pfizer, whose vaccine has been approved by the World Health Organization, had sought more time to present its data to the expert panel.
However, Bharat Biotech is still in the process of recruiting volunteers for the final tests. Although the process has started across India, it has not attracted much interest in many centers, including those in Mumbai and Delhi, which have not received enough volunteers.
The drug maker was expected to complete its tests before December 31, but has extended the registration date, which is ongoing.
According to officials, as of December 22, Bharat Biotech had only been able to recruit 13,000 of the 26,000 candidates required for the final stage tests.
Experts have said that Bharat Biotech’s Covaxin is unlikely to get approval as its phase 3 data, demonstrating its efficacy, is not available. Their phase 1 and 2 data show that the vaccine is safe and has no side effects.
While India awaits a vaccine, simulations or simulations of the inoculation process have been started across the country to fill the gaps and verify the operational feasibility in the field of the CoWIN application, a digital platform to implement and scale up the vaccination campaign.
As the exercise continues in multiple districts across 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 reviewed in detail. Initially when the polio vaccine was launched, even then rumors had arisen,” he said while visiting the GTB hospital in Delhi to review the trial. Feedback from the four-state trial earlier this week has been used to improve the government’s 150-page guideline, he said.
India has 1.03 crore of coronavirus cases with 1.5 lakh deaths and 29 cases of the even more virulent UK strain of Covid.
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