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Row over approval, Cong wants no nod till successful trials

The grant of approval to Bharat Biotech’s Covid-19 vaccine for “emergency use” has kicked a major controversy with several senior Congress leaders raising serious concern over the way the approval has been granted. The party has officially lauded the scientists and researchers for the achievement.

Senior Congress leaders and former Union Ministers Anand Sharma, Jairam Ramesh and Shashi Tharoor sought to know from the Health Minister why mandatory protocols and verification of data “had been dispensed with”.

Samajwadi Party leader Akhilesh Yadav had on Saturday termed the anti-Covid vaccine to be rolled out in the country as a “vaccine of the BJP” and said he would not take the shot. On Sunday, the former Uttar Pradesh Chief Minister said the Covid-19 vaccination programme is a “sensitive process”, and the Government should not treat it as a “cosmetic” event as it is a matter of lives.

Sharma, who heads the Parliamentary panel on Home Affairs which dealt with the issue at length, said the matter of granting authorisation for vaccine use needs to be taken up carefully as no country has dispensed with the mandatory phase 3 trials and verification of data.

In its report submitted on December 21 to Rajya Sabha chairman and Vice President M Venkaiah Naidu, the committee noted that the CDSCO has given no emergency use authorisation in the past.

The report  suggested that all necessary and mandatory requirements must be duly fulfilled and all trial phases completed.

“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,” Sharma said on Sunday.

“The restricted use emergency authorisation for the Bharat Biotech vaccine presently undergoing Phase 3 trials raises bonafide concerns. Standard protocols and mandatory requirement of publication of data on safety and efficacy which is reviewed and verifiable is important for the integrity of the process,” said the former Commerce Minister.

Tharoor said the approval is premature and Covaxin’s use should be avoided as it could be dangerous. “The Covaxin has not yet had Phase 3 trials. Approval was premature and could be dangerous. 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,” tweeted Tharoor, a former Minister in then Manmohan Singh Government.

Jairam Ramesh asked Health Minister Harsh Vardhan to clarify why internationally-accepted protocols on phase 3 trials “are being modified”. “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 Harsh Vardhan should clarify,” he said on Twitter.

However, Congress chief spokesperson Randeep Surjewala tweeted, “Kudos to our scientists and researchers of Bharat Biotech on approval of the indigenously developed corona vaccine and Serum Institute and its scientists too. India has always led the way in path-breaking innovations in the past and will continue to do the same. Great start for New Year.”

Monday, 04 January 2021 | PNS | New Delhi

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