COVID-19 vaccine: Emergency approval not recommended for Covaxin; panel asks more data

  • The committee recommended emergency market approval for Serum Institute of India's Covishield with some riders

Edited By Anulekha Ray
Updated1 Jan 2021
Covid-19 vaccine: Covaxin is now undergoing phase-3 trials.
Covid-19 vaccine: Covaxin is now undergoing phase-3 trials.

A subject expert committee set up by Drugs Controller General of India (DCGI) to examine COVID-19 vaccine proposals, recommended 'interim efficacy analysis for Covaxin'. The vaccine was developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR). The expert committee asked Hyderabad-based drugmaker to expedite volunteer recruitment, according to PTI sources.

While considering Bharat Biotech's application, the SEC noted that the" ongoing clinical trial is a large one with 25,800 subjects of which 22,000 have been enrolled, including subjects with comorbid conditions, which has demonstrated safety till date but efficacy is yet to be demonstrated."

"After detailed deliberation, the committee recommended that the firm should try to expedite the recruitment and may perform interim efficacy analysis for further consideration of restricted emergency use approval," an official source told PTI.

The committee recommended emergency market approval for Serum Institute of India's Covishield with some riders, according to Mint sources. The SEC met for the second time in a week to look at data provided by Serum Institute and Bharat Biotech for emergency use licensure. Serum Institute of India and Bharat Biotech had applied for emergency use of their coronavirus vaccines last month.

Covaxin has been derived from a strain of the novel coronavirus isolated by the National Institute of Virology in Pune. Bharat Biotech developed an “inactivated" vaccine at its high-containment facility at Genome Valley in Hyderabad. “Once the vaccine is injected into a human, it has no potential to infect or replicate, since it is a killed virus. It just serves to the immune system as a dead virus and mounts an antibody response towards the virus," Bharat Biotech earlier said.

The drugmaker has already produced about 10 million doses of its Covaxin shot, ahead of an anticipated roll out by the middle of next year. It has a current annual capacity of 300 million shots and expects the first 100 million to be deployed by India.

Bharat has spent about $60 million to $70 million so far developing Covid vaccines. The early trial data suggested Covaxin has efficacy rates of at least 60%, according to reports.

The final decision will be taken by the Drugs Controller General of India (DCGI) on vaccine approval.

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