The Indian Council of Medical Research (ICMR) has disassociated itself from a study on the Covaxin vaccine, citing serious methodological flaws and an erroneous acknowledgment of ICMR's support.
The study, titled “Long-Term Safety Analysis of the BBVl52 Coronavirus Vaccine in Adolescents and Adults: Findings from a 1-Year Prospective Study in North India'' by Kaur et al., was published in the journal Drug Safety.
ICMR's Director General, Rajiv Bahl, has written to the authors of the paper and the editor of the journal Springer Nature, requesting the immediate removal of the acknowledgment to ICMR and the publication of an erratum.
Bahl highlighted the poor methodology and design of the study, which undermined its findings. The study had acknowledged ICMR for research support without any prior approval or intimation, which Bahl deemed inappropriate and unacceptable.
Covaxin, the anti-Covid-19 vaccine, was developed by Bharat Biotech in collaboration with ICMR's National Institute of Virology. The study's flaws included the absence of a control group of unvaccinated individuals, making it impossible to attribute reported events solely to the Covaxin vaccine.
There was no provision for background rates of observed events, preventing an assessment of changes in incidence post-vaccination. Additionally, baseline information of the participants was missing, and the tool used for the study did not align with the ‘Adverse Events of Special Interest (AESI)’ standards referenced in the paper.
Data collection was conducted via telephone a year after vaccination without verification through clinical records or physician examination, introducing significant bias.
Bahl also noted that similar acknowledgments to ICMR have been made in previous papers without permission, raising concerns about the authors’ practices. He urged the authors to immediately rectify the acknowledgment to ICMR and publish an erratum. Failure to do so may prompt ICMR to consider legal and administrative action.
The editor has been asked to retract the paper, which implicitly makes conclusions on vaccine safety that are not supported by evidence. This incident underscores the importance of rigorous methodology and ethical practices in scientific research, especially when it pertains to public health.
Earlier this month, amid reports over potential rare side effects of the AstraZeneca-Oxford COVID-19 vaccine, Bharat Biotech, which developed Covaxin, stated that the vaccine was developed with a “single-minded focus on safety first.”
They emphasised that Covaxin was the only Covid vaccine in the Indian government's immunisation program to have conducted efficacy trials in India.
ICMR's disassociation from the Covaxin safety study by Kaur et al. due to methodological flaws and inappropriate acknowledgment highlights the need for stringent research standards and ethical conduct in scientific publications.
The incident also emphasises the collaborative efforts and rigorous testing that underpin the development of vaccines like Covaxin, ensuring their safety and efficacy for public use.
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