The regulator is justified in taking a decision to approve Bharat Biotech’s vaccine so that the country will have a weapon if the mutant strain emerges as a problem, but the opacity with which a decision was taken is a concern, said an expert.

“The Drugs Controller General of India (DCGI) has given only a special restricted emergency use approval to Covaxin. I interpret this as not a permission to use. Something to fall back on, if the mutant strain emerges as a problem,” said former Indian Council of Medical Research chief Nirmal Kumar Ganguly, who is also considered an authority in matters relating to clinical trials.

“Sometimes in a pandemic situation, the government is forced to take some hard decisions. But the government at the moment has not said that it will use this vaccine as the first vaccine. They have said it is Covishield (of Serum Institute of India) which will be used in the first phase of the programme,” Ganguly told BusinessLine.

At the same time, the (UK) mutant strain hasn’t surged so much that the government has to take such a call, he said.

The approval given to Bharat Biotech’s Covaxin by DCGI without efficacy data has been questioned by independent experts who also felt there was lack transparency and openness.

Anand Bhan, a medical doctor and an independent Bioethicist, questioned the decision saying that the process of giving approval was very opaque. “In such situations people are always going to ask you questions till the time you come forward with data. The regulator is putting out only statements, not clarifying what is the basis, is not taking questions and we have no clue who the subject experts are and what they looked at and how they came to their decision,” Bhan said.

“All of us are big supporters of Indian science. The fact that we have a vaccine right from R&D to manufacturing all done within the country is also something that we can showcase if we do it properly. We are actually losing that chance,” Bhan said.

He said the argument that Covaxin is only a back-up vaccine does not hold water . Because if such a situation arises, the regulator can convene another meeting of the subject expert committee. “Right now we are not in such a situation,” Bhan said.

Responding to criticism from various sources, Health Minister Harsh Vardhan said Covaxin will only be an option for the government if the mutant strain becomes a problem and even then the vaccine will be used in a clinical trial mode, in which all beneficiaries who receive it will be followed up properly as in the case of a clinical trial.

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