Congress leader Manish Tiwari on Tuesday hit out at the Centre for prematurely rolling out Covaxin, Bharat Biotech International Limited’s locally developed vaccine for Covid-19, without the completion of its phase III trials.
The Drugs Controller General of India on Sunday announced that it has approved Covaxin along with the Oxford University-AstraZeneca vaccine manufactured in India by the Serum Institute of India. The immunisation roll-out will begin with the Oxford-AstraZeneca vaccine.
“A number of eminent etymologists and other medical practitioners have expressed surprise with regard to the fact that this vaccine has been cleared without phase III trials having been completed,” Tiwari said. “This obviously raises questions with regard to the efficacy of the vaccine.”
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Tiwari added it would have been more prudent for the government to have waited for the completion of the entire process in accordance with the established norms, protocols, and rules before authorising the vaccine. “Emergency authorisation or not, all the protocols should have been followed.”
There have been widespread concerns expressed by the medical community regarding the manner in which the vaccine has been granted approval. Experts have cautioned against the shorter duration of human trials and lack of data available.
The AstraZeneca-Oxford vaccine has been granted emergency use approval, while Covaxin restricted emergency use authorisation.
Tiwari is the third Congress leader after former union ministers Shashi Tharoor and Jairam Ramesh to express concerns regarding Covaxin. “In other words, those Indians who would be administered Covaxin would, in effect, be volunteers for the required third stage clinical trial – without the mandatory ‘informed consent’. This is, to put it mildly, highly unusual. It is also ethically dubious,” Tharoor said.
In a tweet, Ramesh 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.”
Congress leader Anand Sharma-led parliamentary standing committee on home affairs has also advised caution in granting emergency approval to the vaccines.
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