HomeCURRENT AFFAIRSCongress leaders question covaxin's approval, say stage-3 trials given A Miss

Congress leaders question covaxin’s approval, say stage-3 trials given A Miss

As the new Covid-19 vaccine “Covishield” and “Covaxin” are approved in India by the Indian drug regulation body. The opposition parties are raising their concerns over the process of the testing and approval. The Congress party asked today that the government must explain why mandatory protocols and verification of data from stage-3 trails were not provided as per the norms.
The Congress raised the issue on a day India’s drug regulator approved two vaccines for coronavirus, Covishield and Covaxin, for restricted use. “We’ll never approve anything if there is slightest of safety concern. The vaccines are 100 per cent safe,” Drug Controller General of India VG Somani said while announcing the approval.

Covishield has been developed by Oxford University and pharma major AstraZeneca and is being manufactured in India by The Serum Institute of India. Hyderabad-based Bharat Biotech, in collaboration with the Indian Council of Medical Research, is the producer of the other drug, Covaxin, which was Okayed today.

“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,” Shashi Tharoor of the Congress tweeted today.

A little earlier, his party colleague Jairam Ramesh, too, had raised similar issues.
Party leader Salman Nizami went to the extent of tweeting: “Vaccine is a fraud.”
Senior Congress leader Anand Sharma, meanwhile, said that according to submissions made before the expert panel, phase-3 trials of Covaxin have not been completed and, therefore, data on safety and efficacy had not been reviewed, PTI reported.

“The Health ministry needs to give cogent reasons for dispensing with the mandatory protocols and requirements in this case, since it involves the health and safety of those frontline workers who will be vaccinated under the restricted category,” Mr Sharma, who heads the Parliamentary panel on Home Affairs, according to PTI.

Earlier in the day, the Union Ministry for Health and Family Welfare released a detailed statement about the approvals. The release said that the panel that approved the vaccines had recommended having more options for vaccinations “in public interest as an abundant precaution”.
Referring to Covaxin, it said, “The Phase III efficacy trial was initiated in India…and the vaccine has been found to be safe as per the data available till date…The clinical trial ongoing within the country by the firm will continue.”

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