Congress leaders raise concern about Centre flaunting protocols in approving Covaxin

They find it unique that the Centre had decided to forego internationally approved protocols to approve a vaccine that has not yet come out of phase III
Congress leaders raise concern about Centre flaunting protocols in approving Covaxin

In a turn of events, the Congress leader and Thiruvananthapuram MP has tweeted against the Drug Controller General of India giving approval to Bharat Biotech’s Covaxin. “The Covaxin has not yet had Phase 3 trials. Approval was premature and could be dangerous. Union Minister for Health Dr Harsh Vardhan should please clarify. Its use should be avoided till full trials are over. India can start with the AstraZeneca vaccine in the meantime,” Tharoor said.

However, Tharoor isn’t the first person to do so. The former Union Minister and senior Congress leader Jairam Ramesh has also pointed out this problem. “Bharat Biotech is a first-rate enterprise, but it is puzzling that internationally-accepted protocols relating to Phase-3 trials are being modified for Covaxin. Health Minister Dr Harsh Vardhan should clarify.

In their press release, the authorities claim that they provided a separate category of approval to Serum Institute of India’s Covishield and Covaxin. For SII (Oxford-AstraZeneca) vaccine, it is a “grant of permission for the emergency restricted use of the vaccine, subject to multiple regulatory conditionalities”. While the UK had given its approval for the vaccine, the European Medicines Agency is still waiting on the situation.

In the case of Bharat Biotech’s Covaxin, the expert committee recommended, “Grant of permission for restricted use in an emergency situation in the public interest as an abundant precaution, in clinical trial mode, especially in the context of mutant strains.”

Along with these political leaders, others have raised similar concerns. Many vaccine trackers have not yet listed Bharat Biotech in the post-clinical trial phase, with many more still keeping it in Phase III. Moreover, others allege that there are no conclusive reports submitted to medical journals by the company on the efficacy of Covaxin.

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