Journal pressured to retract study on Covid-19 vaccine harms

A vaccine manufacturer based in India launched defamation proceedings against researchers who published a study that reported adverse events in people following Covid-19 vaccination.  

The manufacturer also sued the editor of the international journal which published the study and demanded that the offending article be retracted immediately.

The study at the centre of the controversy is a post-marketing safety analysis (phase IV) of Covaxin, one of India’s homegrown Covid-19 vaccines.

The researchers concluded that serious adverse events of special interest (AESI) after vaccination “might not be uncommon” and that the majority of AESIs in people persisted “for a significant period.”

Of the 635 participants involved, one-third reported developing AESIs such as new-onset skin disorders, nervous system disorders, menstrual and ocular abnormalities.

Serious AESI, such as stroke and Guillain-Barre syndrome, were experienced by 1% of participants, but no causal link could be established in the study.

The researchers called for “enhanced awareness and larger studies” to carefully examine the potential for long-term harms of the vaccine.

On May 18, 2024, ICMR wrote to the journal wanting a retraction of the article and of the “acknowledgement” the researchers made to ICMR for its support.

The letter criticised the rigour of the study – it said there was no control arm, there were no baseline values of participants, and that collecting participant data by telephone interviews created a “high risk of bias.”

On Aug 28, 2024, Nitin Joshi, chief editor of Drug Safety, wrote to the authors to say a “post-publication review” had been conducted and that he now agreed with the criticisms of the paper.

Joshi, despite reviewing the study before it was published, stated that he was intending to retract the article because he “no longer has confidence in the conclusions.”

So far, over 250 scientists, researchers, ethicists, doctors and patients have signed an open letter addressed to BBIL, ICMR and the editor at Drug Safety, demanding the lawsuit be withdrawn, and the study remain published.

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Source: Maryanne Demasi, 23 September 2024