Shashi Tharoor of the Congress tweeted: “Covaxin has not yet had Phase 3 trials. Approval was premature and could be dangerous.”
The Congress party today asked that the Indian government must explain why mandatory protocols and verification of data from stage-3 trials have been dispensed with while granting permission for the emergency use of the two COVID-19 vaccines. The opposition party said the issue is pertinent since no other country has apparently dispensed with these key processes.
Drug Controller General of India VG Somani, while announcing the approval, had said: “We’ll never approve anything if there is slightest of safety concern. The vaccines are 100 per cent safe.”
However, Shashi Tharoor of the Congress tweeted: “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.”
Jairam Ramesh, the senior Congress leader, said: “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 @drharshvardhan should clarify.”
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 @drharshvardhan should clarify. pic.twitter.com/5HAWZtmW9s
— Jairam Ramesh (@Jairam_Ramesh) January 3, 2021
Senior Congress leader Anand Sharma, reiterating the same party stand, 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 was quoted as saying by news agency PTI.
The Union Ministry for Health and Family Welfare, earlier in the day, released a detailed statement about the approvals. In its statement, it said that the panel that approved the vaccines had recommended having more options for vaccinations “in the 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.”
As an independent media platform, we do not take advertisements from governments and corporate houses. It is you, our readers, who have supported us on our journey to do honest and unbiased journalism. Please contribute, so that we can continue to do the same in future.
