Opinion A study on side-effects of Covaxin and three lessons in public trust and research

The controversy started after the journal’s editor and authors were upbraided by the head of the Indian Council of Medical Research (ICMR) for “implicitly (making) conclusions about vaccine safety, unsupported by evidence.” Besides its flawed methodology, the apex research institution found the use of the term AESIs or “adverse events of special interest” to be inconsistent with its globally accepted definition. This is important because hinging on this is the question of how data on medical events is collated and interpreted. ICMR demanded the retraction of the paper. Then Covaxin’s manufacturer, Bharat Biotech, filed a suit against the journal’s editors and authors for causing “shock, alarm, and hesitancy about the safety and efficacy of Covaxin.”

A shot in the arm came in the form of an open letter issued by 600 academics and members of civil society, decrying the suit and strongly backing the need to promote independent research. The signatories quoted the Supreme Court’s direction to collect and share information on adverse events (related to Covid,) “even if they are not already known to be caused by vaccine…”

This reinforcement of academic freedom was short-lived because last month, the journal removed the disputed paper. This is disquieting. Bharat Biotech has, meanwhile, withdrawn the suit against the editors, which leaves the authors to fend for themselves.

What had the researchers done to invite such wrath? They used telephonic conversations to collect data on respondents’ health-related experiences post-vaccination. These were collated, analysed statistically and discussed disease by disease, condition by condition, in the now discredited paper. Several previous papers by this group of researchers also related to post-vaccine events had apparently created no controversy. Perhaps it was the grandiose title of the paper and its conclusion that “nearly one-third (33 per cent) of the study’s participants developed AESIs” that triggered alarmist reportage. The highly localised sample of less than 1,000 people, was hardly significant statistically, given that millions had been vaccinated across the country’s hugely dissimilar populations.

The episode raises important questions, which go beyond the paper.

The first is about editorial accountability. Did the journal not have a responsibility to defend its editorial decision? The researchers had followed a protocol approved by the BHU’s ethics committee and had acted on the advice of the journal’s peer reviewers. The paper was published within four months of submission, signifying extraordinary editorial receptivity. The journal’s u-turn needs an answer — not by criticising the paper (which should have been done before publication) but by explaining why obvious shortcomings went unnoticed.

The second question relates to ICMR, India’s highest body responsible for the formulation, coordination and promotion of biomedical research. Because ICMR has a role as the co-owner of the Covaxin patent for Covid-19, along with Bharat Biotech, it needs to remind the public about that role. It was ICMR’s National Institute of Virology that had provided the virus strains to Bharat Biotech. Conflict of interest questions were raised in 2021 but died down once Covaxin began to be used and was acknowledged as a great achievement of Indian science. But now, questions are being raised again in the wake of the BHU paper’s controversy. A recap would help.

The third question is for the researchers. Advising caution and monitoring is easy. The difficult part is to answer how and who should be cautioned, and who should supervise the exercise. Covaxin, or any other Covid vaccine, will only be used again if there is a serious outbreak of Covid-19 or its variants. Were that to happen, vaccination could be re-introduced to cover vulnerable groups. However, the administration of vaccines would still be managed by each state’s district health machinery. Among the slew of cautionary recommendations in the BHU, a large number pertain to upper respiratory infections (URIs), the bulk of the adverse events of special interest. Who are these recommendations addressed to? Who can exercise caution against coughs, colds, sinuses and sore throats which largely constitute URIs? Even more absurd are the cases of acne, myopia, hair loss and skin problems which have been placed under the rubric of safety monitoring. How can any policy confront these conditions? To be fair, the paper has not drawn any causal link with the vaccine but for the average reader such links were implied.

The BHU story has nevertheless flagged three larger concerns. First, if defamation cases against academics become a trend, as is happening in other countries, it will hurt independent research, especially on drugs and vaccines. The biggest losers would be consumers and that’s a huge concern. Second, ICMR and universities must see that medical research proposals are screened institutionally to avoid causing public mistrust or impacting the delivery of essential public health services, including vaccination. Third, medical research methodology must expect research to be mindful of drawing unworkable conclusions. Pursuing medical research is critical, but so also is staying down-to-earth.

The writer is former secretary, ministry of health. Views are personal