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'Premature approval': Shashi Tharoor questions authorisation for Covaxin vaccine

"Its use should be avoided till full trials are over," Tharoor said

Shashi Tharoor PTI Shashi Tharoor | PTI

Immediately on the back of the Drug Controller General of India (DCGI) approving Bharat Biotech's Covaxin and the Oxford-Astrazeneca vaccine for "restricted use in emergency situations", Congress MP Shashi Tharoor warned against the use of Covaxin, saying its approval was premature. "The Covaxin has not yet had Phase 3 trials. Approval was premature and could be dangerous. @drharshvardhan should please clarify. Its use should be avoided till full trials are over. India can start with the AstraZeneca vaccine in the meantime." Phase 3 trials are the large-scale trials where the immunogenicity of the vaccine is really put to the test. 

Bharat Biotech, which reportedly started its Phase 3 clinical trials in mid-November, has recruited 23,000 volunteers and continued to progress towards achieving the goal of 26,000 participants. Covaxin is being developed by Bharat Biotech jointly with the Indian Council of Medical Research (ICMR)- National Institute of Virology (NIV).

What did CDSO expert panel say on Covaxin?

While considering Bharat Biotech's application, the Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) had 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," PTI had reported.

They had recommended "grant of permission for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, specially in the context of infection by mutant strains, to Bharat Biotech," the health ministry had stated.

The firm had presented safety and immunogenicity data, including serious adverse event data from the Phase 1 and 2 clinical trial along with the data from the ongoing phase 3 clinical trial in the country.

Covaxin has been evaluated in approximately 1,000 subjects in Phase 1 and 2 clinical trials, with promising safety and immunogenicity results and acceptance in international peer reviewed scientific journals. The indigenous, inactivated vaccine is manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) bio- containment facility here, one of its kind in the world, the company had stated.

-Inputs from agencies

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