This piece was updated on May 22 at 5:05 pm to add the response of Springer Nature group of Journals.
New Delhi: The Indian Council of Medical Research (ICMR) has distanced itself from the Covaxin safety study done by a group of researchers at the Banaras Hindu University (BHU).
The study led to sensational headlines in the media saying 33% of its participants had encountered adverse events of special interest (AESIs), or certain special side effects, after the vaccination by Covaxin.
The study had pointed out that AESIs like alopecia (hair fall), respiratory infections, typhoid fever, hypothyroidism, Guillain-Barre syndrome (a serious disorder of the nerves that can lead to paralysis) and even four deaths had occured among the participants after vaccination with Covaxin.
The study, in the acknowledgement section ‘thanks’ the ICMR for its research support.
The ICMR said it had been incorrectly and misleadingly acknowledged in the controversial paper.
“You have acknowledged ICMR for research support without any prior approval or intimation to ICMR, which is inappropriate and unacceptable,” the medical research body said in its letter dated May 18 to the paper’s co-authors, Dr Upinder Kaur and Dr Shankha Shubra Chakrabarti.
It asked them to get the acknowledgement removed from the paper.
The letter was released to the media on May 20 – two days after it was sent out.
It has asked the two faculty members working with the Institute of Medical Sciences (IMS) at BHU to explain why the ICMR should not take legal and administrative action against them.
In a statement, the university said the IMS was looking into the matter. “The individuals have communicated their responses to the ICMR.”
The ICMR issued another letter to Nitin Joshi, editor of the journal Drug Safety – the journal in which the study was published – on May 18.
It has asked the editor to retract the paper or to remove the reference to the ICMR in the light of the flaws it pointed out.
The Wire wrote to Joshi seeking his response.
Responding to the emailed query of The Wire on May 22, a spokesperson for the ‘Springer Nature’ group of journals, which publishes Drug Safety, said the paper would be investigated.
“I can confirm that the [ICMR’s] letter has been received and [the] concerns will now be carefully investigated by the journal in accordance with Committee on Publication Ethics (COPE) guidelines,”
the spokesperson said.
The COPE guidelines are a set of practices that are globally adopted for ethical publication of scientific papers, and an investigation of a published paper by the journal’s editor if a complaint is lodged.
The spokesperson said there couldn’t be any time frame for the investigation as it would depend on ‘multiple factors’. “We do, of course, work to ensure it moves as quickly as possible whilst ensuring
it is rigorous and follows best practice,” the spokesperson added.
Flaws in study
The ICMR pointed to various problems in the methodology of the study – some of which The Wire had also explained in an analysis published on May 18.
One of such flaws was the recall bias of the participants – that is, whether the participants were accurately able to recall the adverse events that they had suffered after taking the jabs.
The study was conducted by interviewing 926 participants from January 2022 and August 2023 via phone.
“[The] study participants were contacted telephonically one year after vaccination and their responses recorded without any confirmation with clinical records or by physician examination,” the ICMR said.
Dr Aviral Vatsa, who is a general practitioner and scientist working with the National Health Service-Scotland and who was not involved in the study, had also told The Wire that the participants’ risk bias could have skewed the results, and therefore the study’s conclusion too.
The other thing that the ICMR pointed out was that the study did not even provide background rates of observed events in the population. In other words, the ICMR meant that the study failed to say if prior to the vaccination, the participants had any of the conditions which the researchers seemed to conclude they had developed after the vaccination.
This makes it impossible to assess whether the participants suffered from the issues highlighted in the paper in the post-vaccination period only, as their baseline information was missing, the ICMR said.
The ICMR also stated that the study tool used was inconsistent with the definition of AESIs in the reference provided in the paper.
Difference in letter and spirit
The Wire‘s analysis had noted how the final ‘results’ drawn in the paper – which were highly sensationalised in some media reports – were not in spirit with the ‘limitations’ mentioned in the study.
What also led to the fear-mongering against vaccination was the fact most of the media reporting seems to have happened by referring just to the paper’s ‘results’ and without going into its limitations.
A screenshot of the collage of news items on the Covaxin study; taken at 8:05 pm on May 17.
For example, the paper mentioned in its ‘results’ that nearly half of the enrolled participants had reported respiratory infections. This was a very high number. But in the limitations, the authors state that no investigation was conducted to ascertain what type of respiratory infection they had.
A screenshot of the collage of news items on the Covaxin study; taken at 8.05 pm on May 17.
This was an important loophole, because it was possible that the participants could have developed COVID-19 after vaccination, which is also a respiratory infection.
No tests for the confirmation of the incidence of COVID-19 were conducted in the participants either.
Now, this is significant because COVID-19 was common during the time the study was being conducted, irrespective of whether one had taken the jabs or not.
It must be clarified that none of the COVID-19 vaccines were developed to prevent infection, but only the serious form of disease and death.
As a result, to state in the results that nearly 50% of the participants developed a COVID-19 infection seemed disingenuous without the background checks.
The researchers also said in the paper’s conclusion that some participants reported getting typhoid fever after inoculation. But in the limitations section of the paper, they say that the same test can confirm both typhoid fever and COVID-19.
So there was no surety that a certain number of patients developed typhoid fever only, post-vaccination.
Many of the disorders the authors seemed to present as outcomes of vaccination were also the ones that one could develop after recovering from a COVID-19 infection – which are classified as ‘Long COVID’, Vatsa had told The Wire. And Long COVID can happen with or without vaccination.
The Wire has pointed out many such grey areas, which can be read about here.
BHU’s statement also said the university was aware of the series of reactions that poured in after the study.
“We are working to strengthen the research ecosystem of the university,” it added.
The paper attracted sharp criticism from many scientists on social media, who questioned its methodology – some of which the ICMR’s letter pointed out.
They questioned why the paper should be taken seriously in light of what they identified as its ‘flaws’.
The Wire reached the paper’s corresponding author, Upinder Kaur, to know her response to the ICMR’s letters.
She said the ICMR’s letters are treated with utmost respect and as confidential.
“We do not wish to make any other statements as we are scientists and do not like getting involved in unnecessary public controversies,” Kaur said, adding that her response had been mailed to the ICMR.
