Scientific community comes together to support and promote ethical scientific dialogue in India.
To,
Managing Director, Bharat Biotech International Ltd (BBIL)
Director General, Indian Council of Medical Research (ICMR)
Editor, Drug Safety, Official Journal of the International Society of Pharmacovigilance (ISoP)
Sub: Open Letter in Solidarity with Researchers being Prosecuted by Vaccine Manufacturer
We are a group of scientists, researchers, ethicists, doctors, patients, and civil society members who are shocked to hear about the defamation suit filed by Bharat Biotech International Ltd (BBIL) against the authors of a paper studying what symptoms of interest were reported by people receiving the BBV152 vaccine (known as Covaxin) when spoken to after a year of vaccine administration.
Like most research studies, this study has various limitations which the authors acknowledge within the paper. It is common in science for starting from broad, simple studies and drawing on the results of these to go into more targeted and directed studies. In the case of COVID-19 vaccines which were universally rolled out, the bare minimum one can do is to carefully document what has happened to people who have taken the vaccine(s). Moreover, in a petition challenging mandatory vaccination, the Supreme Court of India had specifically asked for collecting data about adverse events even if they are not already known to be caused by vaccine:
"[...] information relating to adverse effects following immunisation is crucial for creating awareness around vaccines and their efficacy, apart from being instrumental in further scientific studies around the pandemic. Recognising the imperative need for collection of requisite data of adverse events and wider participation in terms of reporting, the Union of India is directed to facilitate reporting of suspected adverse events by individuals and private doctors on an accessible virtual platform. These reports shall be made publicly accessible, without compromising on protecting the confidentiality of the persons reporting, with all necessary steps to create awareness of the existence of such a platform and of the information required to navigate the platform to be undertaken by the Union of India at the earliest." (Source: SCI, in Jacob Puliyel vs Union of India, 2 May 2022)
The government machinery was fully spent up in addressing the pandemic and it fell on researchers like the team from BHU to examine this issue. In this study they are documenting adverse events of special interest (AESI) reported by people in telephonic follow-up one year after vaccination. As a phase IV clinical research using an observational method, it was conducted after obtaining the relevant approval from the Institutional Ethics Committee. The results were published in Drug Safety, the official journal of the International Society of Pharmacovigilance after a peer review process required and facilitated by the journal itself. And unsurprisingly, the study showed that 99% of the people did not have any serious events.
This was an opportunity for the government and its divisions like ICMR to bolster people's trust in vaccine science. They could have thanked the researchers and set up follow-up studies to examine the causal relationship between any reported adverse events and the vaccine. They could have reassured the public about how low the rate of serious events after vaccination were, even if they are later discovered to be caused by the vaccine. But unfortunately things went in a very different direction.
There were several media reports which misread the study and reported it as the vaccine causing side effects in 1/3rd of the individuals. No such claims could be made from the study because it was not set up to examine a causal link between the vaccine and the adverse events. This put ICMR and the vaccine manufacturer BBIL on a defensive mode. ICMR attacked the study and demanded retraction from the journal. BBIL has now filed a defamation suit in the court. The journal, owned by Springer, is now moving towards retraction of the paper which is currently accessible here.
In our view, the actions of ICMR and BBIL are short-sighted and punitive. Scientific disagreements have to be articulated as counterpoints in scientific fora. Forcing the journal to retract the paper, or filing a 5 crore defamation suit leads to a chilling effect on researchers, and is harmful for science and the trust people have on the institution of science. We wish to call out this intimidation and express solidarity with the researchers from BHU who are being prosecuted. We demand a mature, open-minded, and more confident response from scientific bodies like ICMR. We demand for the lawsuit to be withdrawn, for the paper to be reinstated in the journal, and for constructive engagement from all stakeholders.
Yours sincerely,
Akshay S Dinesh, Public health researcher
Amar Jesani, Editor, Indian Journal of Medical Ethics
Dr. Sylvia Karpagam, Public health doctor
R Srivatsan, Retired academic in health care
Prabir KC, Public health practitioner
Veena Johari, Lawyer
Veena Shatrugna, National Institute of Nutrition, Scientist (Rtd)
The open letter has also been signed by 604 public health researchers, advocates, and concerned citizens.
Image by Janvi Bokoliya.
