A committee of subject matter experts established by the Comptroller General of Drugs of India (DCGI) to review COVID-19 vaccine proposals, recommended an “interim efficacy analysis for Covaxin.” The vaccine was developed by Bharat Biotech in collaboration with the Indian Council for Medical Research (ICMR). The expert committee asked a Hyderabad-based drug manufacturer to expedite the recruitment of volunteers, according to PTI sources.
In considering Bharat Biotech’s application, the SEC noted that “the ongoing clinical trial is large with 25,800 subjects of which 22,000 have been enrolled, including subjects with comorbid conditions, which has demonstrated safety to date, but efficacy is not yet. has been shown”.
“After detailed deliberation, the committee recommended that the company should try to speed up recruitment and may conduct an interim efficacy analysis for further consideration of the restricted emergency use approval,” said an official source. PTI.
The committee recommended the approval of the emergency market for Covishield from the Serum Institute of India with some passengers, according to mint sources. The SEC met for the second time in a week to analyze data provided by the Serum Institute and Bharat Biotech for an emergency use license. Serum Institute of India and Bharat Biotech had requested emergency use of their coronavirus vaccines last month.
Covaxin has been derived from a strain of the new coronavirus isolated by the National Institute of Virology in Pune. Bharat Biotech developed an “inactivated” vaccine at its high-containment facility in the Genome Valley in Hyderabad. “Once the vaccine is injected into a human being, it has no potential to infect or replicate, as it is a killed virus. It only serves the immune system as a killed virus and generates an antibody response to the virus,” he said. formerly Bharat Biotech.
The drugmaker has already produced about 10 million doses of its Covaxin injection, ahead of an anticipated launch in the middle of next year. It has a current annual capacity of 300 million shots and expects India to deploy the first 100 million.
Bharat has spent around $ 60 million to $ 70 million so far on developing Covid vaccines. Early data from the trial suggested that Covaxin has efficacy rates of at least 60%, according to reports.
The final decision will be made by the Comptroller General of Medicines of India (DCGI) on the approval of the vaccine.
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