A section of the Congress leadership Sunday questioned the drug regulator’s “premature” approval for Bharat Biotech’s Covaxin, pointing out that the indigenously-developed Covid-19 vaccine was yet to complete the final stage of human clinical trials.
Senior Congress leaders Anand Sharma, Shashi Tharoor and Jairam Ramesh asked the government to explain why it was “bypassing mandatory protocols” and “compromising” safety standards. But Congress communication department head Randeep Surjewala congratulated the Hyderabad-based company’s scientists and researchers for the approval. Similarly, while spokesperson Gourav Vallabh said the party has full faith in the scientific community, former Law Minister Ashwani Kumar said the matter must not be politicised.
The differing responses from the opposition party came hours after the Drug Control General of India approved the Oxford Covishield vaccine, manufactured by Serum Institute of India Pvt. Ltd, and Covaxin, developed by Bharat Biotech, for restricted emergency use in the country.
“The government needs to explain. How can you go on the basis of phase 2 data? And there is no peer review either. It has to be peer-reviewed in a scientific journal… The government needs to explain the situation which necessitated dispensing with the mandatory requirement of completion of phase three trial and publication of the data, both on safety and efficacy, which has been peer-reviewed,” Sharma told The Indian Express.
Sharma added: “The government needs to justify why they are bypassing the mandatory protocols and compromising the safety standards which will put a large number of human lives at risk. When phase 3 trials have not been completed… no vaccine anywhere in the world has been given emergency use authorisation without the completion of phase 3 trials and publication of the safety and efficacy data. Where is the phase 3 data?”
Sharma said the press conference of the Drugs Controller General of India V G Somani on Sunday was puzzling. He also asked the government to put out in the public domain the final data of global safety and efficacy trials of the Oxford-AstraZeneca vaccine, a variant of which is being manufactured under license in India by Pune-based Serum.
His party colleague and Rajya Sabha MP Jairam Ramesh also raised concerns. “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 tweeted.
Tharoor concurred. “The 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,” he said.
Surjewala, on the other hand, tweeted: “Kudos to our scientists & researchers of Bharat Biotech on approval of the indigenously developed Corona vaccine & Serum Institute & its scientists too. India has always led the way in path breaking innovations in the past & will continue to do the same. Great start for New Year.”
At a press conference, spokesperson Vallabh said: “The Congress has full belief in our scientific community and on our institutions of science… Whatever they are deciding, we are going to follow them… we don’t have an iota of distrust to our scientific and medical community. But we want the best vaccine, free of charge to each and every citizen of our country after completing all scientific protocols which are required as per the scientists and medical community of our country.”
Meanwhile, Kumar said: “We must salute the nation’s resolve and the untiring endeavours of all those who have helped to produce in record time, our own vaccine against Covid 19.”
“State agencies and regulators are entitled to have their judgment respected as far as the introduction and regulation of its use is concerned ,unless there is concrete evidence to the contrary.. We need to give hope to the people in these difficult times and not politicize this moment.The magnitude of the challenge that confronts us all leaves little room for narrow politics,” he said.