Approval of Bharat Biotech's Covid-19 vaccine criticised over lack of data

The row took a political dimension with Congress and Left leaders accusing the Modi government of short-circuiting clinical trial protocols

As India approved two Covid-19 vaccines on Sunday for a restricted commercial roll out, a huge controversy broke out on the permission accorded to Hyderabad-based Bharat Biotech’s home-grown vaccine that was given the nod without any efficacy data in violation of standard clinical practice.

While there was no such issue with the other vaccine manufactured by Serum Institute, Drugs Controller General of India's V G Somani did not specify what are the conditions with which the Serum vaccine (Covishield) was allowed for “restricted use in emergency situation”.

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“After adequate examination, the Central Drug Standards Control Organisation has decided to accept the recommendations of the expert committee and accordingly, vaccines of Serum Institute of India and Bharat Biotech are being approved for restricted use in emergency situations and permission is being granted,” Somani said. The ongoing clinical trial for both vaccines would continue.

"The vaccines are 110% safe,” he added later while talking to the media.

Such an astounding claim from India’s drug regulator in the middle of two ongoing clinical trials, the approval given to Bharat Biotech’s Covaxin, and subsequent attempts to justify the decision citing risks posed by the UK mutant have come under widespread criticism.

"Bharat Biotech’s vaccine has been given the emergency authorisation use license in a preemptive manner because of the new variant strain. The whole virus vaccine (Covaxin is based on an inactivated SARS-CoV-2 virus) can provide an armament to tackle the emergent strain,” Balram Bhargava, director general of Indian Council of Medical Research told DH.

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Bhargava received support from AIIMS director Randeep Guleria who said that the central procurement would mainly be Covishield and Covaxin would be considered as a backup. Both are part of the government’s core scientific advisory panel on Covid-19.

"The distinction made in the approvals for the SII vaccine and the ICMR-Bharat Biotech one adds to the lack of clarity about what exactly the terms of approval are. And for government officials to imply that approval is warranted because the vaccine candidate 'may' do this or that flies in the face of basic regulatory principles,” countered Satyajit Rath, a visiting faculty at the Indian Institute of Science, Education and Research, Pune and a former scientist at the National Institute of Immunology.

The row took a political dimension with Congress and Left leaders accusing the Narendra Modi government of short-circuiting clinical trial protocols while the ministers resolutely backed the approval process.

A subject expert committee constituted by the Central Drug Standards Control Organisation met for long hours on Friday and Saturday to review the data presented by the two companies and recommended emergency commercial use of the two vaccines, which would initially be administered to one crore healthcare and two crore front-line workers free of cost.

"The SEC argument is that Covaxin would work as some sort of insurance against the UK variant, but I am completely unaware of any data on Cavaxin’s efficacy on any strain of SARS-CoV-2, let alone any special efficacy against the variant strain. It is quite a stretch to say it would work against the UK variant,” said Gagandeep Kang, a professor at Christian Medical College Vellore and one of India’s leading vaccine researchers.

While approving the emergency use, the DCGI has asked Bharat Biotech to submit safety data in every 15 days for the first two months and once in a month after that period.