Stage-3 Trials Given A Miss: Congress Leaders On Covid Vaccine Approval

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 Congress party asked today. The issue is pertinent since no other country has apparently dispensed with these key processes, the opposition party said.

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.

The panel had earlier recommended to the government that any vaccine against COVID-19 should be granted emergency use authorisation only after proper consideration and conducting its trials on a sufficient sample size.

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 to have 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."

On Saturday, Dr Randeep Guleria, director of New Delhi's All India Institute of Medical Sciences, told NDTV that Serum Institute's Covishield will be the main vaccine in India, whereas Covaxine would be considered only a backup for emergency use in cases of reinfection.

Meanwhile, Hardeep Singh Puri, Union Minister with the independent charge of Civil Aviation, today attacked those from the opposition who criticised the approvals.

Responding to Mr Puri, the Congress Mr Tharoor reiterated that "short-circuiting the process is unprecedented, inadvisable &risks lives," and cited an All India Drug Action Network statement seeking withdrawal of the approval for Covaxin.  

Even as the Congress party raised its queries over trials, the BSP welcomed the approvals to the two "swadeshi" vaccines and urged the central government to make them available for free for the poor. Her backing came a day after the SP's Akhilesh Yadav said, "How can I trust the vaccine, which will be used for vaccination by the BJP? We cannot get vaccinated by the BJP's vaccine."