Lack of trial data, legal grey areas raise concerns

Even as India became the first country to give two Covid-19 vaccines the go-ahead for restricted use in emergency situations, public health experts and politicians raised concerns on the lack of transparency involving these decisions.

There is no transparency when it comes to the granular details on the trials and their efficacy, said S Srinivasan, co-convenor with the All India Drug Action Network (AIDAN). If the AstraZeneca-Oxford University vaccine has 70.42 per cent efficacy, as the Drugs Controller General of India (DCGI) says, that data should be made public for technical people to be able to review, he told BusinessLine. Serum Institute has a production and marketing alliance for the AstraZeneca-Oxford University vaccine in India.

Efficacy data

The approval for Bharat Biotech’s vaccine came in for sharp criticism from vaccine expert Gagandeep Kang, who told a business channel she was unaware of any efficacy data on the candidate. Kang is Professor, The Wellcome Trust Research Laboratory, CMC-Vellore.

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Also seeking clarification on the efficacy of the vaccine were Congress leaders Jairam Ramesh and Shashi Tharoor, who pointed out that the vaccine is still going through advanced Phase III trials.

AIDAN further raised concerns on whether data from Indian participants in the local trial were submitted for the review of the AZ-Oxford University vaccine.

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“The very objective of a bridging study to assess the vaccine candidate in an Indian population is lost if the data are not reviewed in the process of regulatory approval,” it said. How was the equivalence established between Serum Institute’s vaccine and that of AZ-Oxford University, it asked.

Clinical trial mode

Further, Srinivasan said it is unclear under what provisions in the law the authorisation was given.

In Bharat Biotech’s case, the permission given in “clinical trial mode” has raised the hackles of many in the scientific community. “So, if something goes wrong, will the volunteer get compensation as outlined in laws governing clinical trials? And what about the compensation provision if such a case arises in the post-licensure period, for both vaccines?” Srinivasan asked.

While AIIMS Director Randeep Guleria was seen explaining that Bharat Biotech’s vaccine is a back-up, and the Serum Institute vaccine will be rolled out first, Kang observed that there appears to be no distinction in the approvals given to the two vaccines.

She also appeared doubtful of the vaccine’s use against the mutant UK strain.