New Delhi: Drug Safety, a journal which published a study regarding safety of Covaxin, retracted the paper on September 24. It cited ‘no confidence’ in the conclusions drawn in the article.
The study led to sensational media reports with some even claiming that more than 33 per cent of the individuals who took the vaccine potentially faced serious safety concerns. A group of Banaras Hindu University’s researchers had authored the paper.
In the retraction note, the editor of the journal, and its publisher, Springer Nature group of journals, said, “The Editor has retracted this article as he no longer has confidence in the conclusions as stated in the article”
“Post-publication review concluded that the reported adverse events of special interest (AESIs) were presented in a way that could lead to ambiguous or incorrect interpretations regarding the relationship with the BBV152 vaccine [Covaxin]. Given these findings, the editor and the publisher have decided that this article should be removed on public health grounds,” the retraction note states.
The paper is no longer available on the website of the journal now. The note also said that the authors disagreed with the retraction.
Also read: BHU’s Covaxin Safety Study: Cautious Interpretation of Results Needed
A journal retracts an article on the basis of the internationally accepted ‘Committee on Publication Ethics (COPE)’ guidelines. These guidelines are meant for investigation of a published paper, should the journal’s editor receive a complaint.
The Indian Council of Medical Research (ICMR) had written to the editor of the journal on May 20,2024,claiming that the paper had various anomalies. A spokesperson of the Springer Nature group of journals had told The Wire on May 22 an investigation would be done as per the COPE measures.
The Wire has now written to the spokesperson asking which specific guideline[s] were violated. The response would be added if and when received.
Open letter to prevent withdrawal of paper
Incidentally, the retraction came the same day a group of 600-odd citizens released a letter to the media that they have written to the editor of the journal to prevent the withdrawal of the paper.
This was one of the rare instances where an open letter had been shot to the editor to prevent retraction. The signatories include medical practitioners, including clinicians, and epidemiologists and immunologists [non-clinicians].
A large number of the signatories to the letter also include social activists (from medical and non-medical backgrounds), public health researchers, homoeopathic practitioners, IT consultants, ayurveda experts, scientists (from medical and non-medical backgrounds), among others. Many individuals have signed the letter who identify themselves as ‘independent/aware citizens’.
The signatories have now put the onus on a large section of the media for incorrect reportage of the paper.
Screenshot of the collage of news items in May this year on the Covaxin study.
The letter states, “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.”
The causal link wasn’t spelt out in the paper explicitly, but the paper did go on to say:
“Nearly one-third of participants receiving the BBV152 [Covaxin] vaccination reported AESIs [Adverse Events of Special Interest].”
The Wire had reached the corresponding author of the paper, Upinder Kaur, seeking reaction on May 18, a few days after the paper was published (May 13).
“As we are scientists, our work is to bring information to the public domain after due peer-review. People can interpret all data as per their own expertise,” she replied and refrained from adding anything further, back then.
Also read: ICMR Trashes BHU Covaxin Study, Demands Its Retraction
Besides Kaur, who is associated with the department of pharmacology, BHU, one author each is associated with the department of geriatric medicine and community medicine and four with ayurveda. The affiliation of four authors are not known.
What the paper said
The AESIs, which the retracted paper referred to, are different from AEFIs [Adverse events following immunisation]. The latter are serious in nature.
The study said that a one-third of the studied recipients, who took Covaxin, developed AESIs like alopecia (hair fall), respiratory infections, typhoid fever, hypothyroidism, Guillain-Barre syndrome (a serious disorder of the nerves that can lead to paralysis). Four deaths had occurred among the participants after vaccination with Covaxin, they recorded.
The Wire, in an analysis, had explained how the ‘results’ mentioned in the paper were not in sync with ‘limitations’, thus leading to skewed overall interpretations.
About deaths, the paper adds though that the three of these deaths shared a ‘possible’ association with the vaccine and the cause of the fourth was ‘unclassifiable’.
About Guillain-Barre syndrome, the researchers say in the ‘limitations’ section, that vaccine-specific and multicentric studies would be needed for further confirmation.
Similarly, the paper mentioned in the ‘results’ segment that as many as half of the enrolled study participants developed respiratory infections after taking the vaccine. This was not a small number. But, again, in the ‘limitations’ section the authors said that no investigation was conducted to confirm which type of the respiratory infection the participants developed.
This gap was significant. For, the investigation might have made it clear whether it was a Covid-19 infection or any other. A Covid-19 infection was not uncommon when the study was being conducted between January 2022 and August 2023 – irrespective of the fact whether the recipient had got it with or without having the shots.
A Covid-19 infection after vaccination is quite a possibility because none of the vaccines were designed to prevent the infection, but only with a mandate to prevent the serious form of illness.
The researchers also said in the paper that some participants got a typhoid infection after vaccination. But, in the limitations section, they themselves don’t rule out a possibility that a Covid-19 infection got mis-classified as a typhoid infection. This can happen because the same test is used to detect typhoid fever and Covid-19.
Also read: Bharat Biotech Files Revised Covaxin Patent, Stresses ICMR Will Not Get Monetary Benefit
Many of these adverse effects that the authors seemed to present as outcomes of inoculation, also, may be a result of what is known as ‘Long Covid’– a set of long-term conditions that one gets as prolonged effects of the Covid infection itself. This can also happen with or without vaccination.
Methodology in question
Altogether, 926 recipients of Covaxin became study participants. The authors contacted them telephonically one year after they had taken the jabs. The ICMR alleged that this long gap might have resulted in the ‘recall bias’ – that is, the participants might not have been able to share their problems correctly.
The signatories to the letter, defended the methodology and put the ‘ethics committee’ also in the dock. Every institute through its ethics committee, in this case, BHU’s Institute of Medical Sciences – has to approve the study design before it is conducted.
“As a phase IV clinical research [post-approval study] using an observational method, it was conducted after obtaining the relevant approval from the Institutional Ethics Committee,” they said.
The ICMR, in its letter to the authors, and the editor, had pointed out that the researchers failed to gather if the participants, who were studied, had any pre-existing conditions, before they took the vaccine. In other words, the ICMR meant that since such a record wasn’t kept. it was improper to conclude whether the participants developed these conditions, mentioned in the paper, before or after the vaccination.
Appeal to Bharat Biotech
The signatories have also marked the letter to Suchitra M Ella, managing director of Bharat Biotech International Limited (BBIL).
The BBIL has filed a Rs 5 crore defamation case against the authors. The signatories have demanded that the case should be withdrawn.
“[This move] 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,” the letter states.
The signatories have also said it was incumbent upon the ICMR to conduct large-scale post-marketing research. Such a study evaluates whether after the approval of the vaccine and the mass inoculation, the recipients developed any serious side-effects.
The clinical trials, conducted before the vaccine is approved, are done in ‘controlled’ environments and with a few thousand of the people. A post-marketing study can be done in real-world conditions, and on a much larger scale.
Another criticism that the ICMR and the BBIL faced is its failure to publish the final results and the safety data, gathered in the phase-3 clinical trials, conducted before the approval of the vaccine. They had only published interim results in 2021. Till date, the final results are not available, which is an anomaly.
Equally important was the controversial and hastened roll-out of the vaccine in January 2021, in what the government described as ‘clinical trial ‘mode – even before the interim results were published. This move attracted sharp criticism, though the interim results were published later.
