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 Peer-Reviewed Study The study at the centre of the controversy is a post-marketing safety analysis of Covaxin, one of India's homegrown Covid-19 vaccines.

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.

Within days of its publication, the government's premier biomedical research organisation, the Indian Council of Medical Research, which co-developed Covaxin, quickly distanced itself from the study.

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." These limitations are well-known in post-marketing studies.

The authors went to great lengths to discuss the limitations of the study in the article, as well as recommend larger studies to elucidate harms.

The Lawsuit In July 2024, the vaccine manufacturer, Bharat Biotech International Limited launched defamation proceedings in the civil court of Hyderabad, India, against the 11 study authors and the chief editor of Drug Safety, Mr Nitin Joshi.

The authors called for further studies and said they couldn't be held responsible for the way journalists reported on the study in the media.

Joshi, despite reviewing the study before it was published, stated that he intended to retract the article because he "No longer has confidence in the conclusions." In private emails, all authors were asked to agree or disagree with the decision to retract the article, but those reasons would not be included in the public retraction notice.

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and patients have signed an open letter addressed to BBIL, ICMR and the editor at Drug Safety, demanding the lawsuit be withdrawn, and the study remains published. 

https://brownstone.org/articles/journal-pressured-to-retract-study-on-covid-19-vaccine-harms/