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ICMR Denounces BHU Study on Covaxin's Long-term Adverse Effects

The ICMR has called the BHU study “poorly designed” and identified multiple critical flaws that undermine its credibility.

• By Pooja Chaturvedi Sah
• New Delhi
• May 21, 2024

News

The Indian Council of Medical Research (ICMR) has strongly criticized a study from Banaras Hindu University (BHU) that claimed long-term adverse events in individuals vaccinated with Bharat Biotech’s Covaxin. 

The study, which involved over 900 participants, suggested various side effects, raising significant concerns. However, ICMR has called this study “poorly designed” and identified multiple critical flaws that undermine its credibility. 

The controversy has led to ICMR demanding a retraction of the paper and issuing warnings of possible legal action. 

The director-general of the apex medical research body has also written to the authors of the paper and the editor of the journal in which it was published, stating that it “incorrectly and misleadingly” acknowledges ICMR, even though the body did not offer any financial or technical support for the paper. “ICMR cannot be associated with this poorly designed study,” say the letters. 

ICMR's Criticism and Response 

The ICMR identified four critical flaws in the study. 

First, the absence of a control group of unvaccinated individuals to compare adverse events. Second, the study lacked frequency data on how often these adverse events were reported, making it difficult to associate them with the vaccination. Third, the study's tools did not align with globally accepted definitions of “adverse events of special interest.” 

Lastly, participant responses were recorded a year after immunization without clinical verification, increasing the risk of biased reporting. 

“The ICMR has been incorrectly and misleadingly acknowledged in the paper. ICMR is not associated with this study and has not provided any financial or technical support for the research,” said the letter written by Rajiv Bahl, Secretary, Director General, ICMR. 

“Further, you have acknowledged the ICMR for research support without any prior approval of or intimation to the ICMR, which is inappropriate and unacceptable.” 

Dr. Rajiv Bahl also highlighted that the study did not provide background rates of the observed events in the general population, making it impossible to assess the true incidence of these events post-vaccination. 

He noted the baseline information of study participants was missing, further questioning the study's reliability. 

Study Findings and Methodology 

The BHU study reported that over 40% of participants experienced upper respiratory tract infections not confirmed as COVID-19 over a one-year follow-up period. 

Additionally, 10.5% of adolescents developed new skin disorders, 4.7% had nervous system disorders, and among adults, 5.8% reported musculoskeletal disorders, and 5.5% had nervous system disorders. 

Other reported issues included menstrual abnormalities and rare conditions like strokes and Guillain Barre syndrome. 

According to the methodology mentioned in the paper, the researchers contacted over 1,000 adolescent and adult recipients of the vaccine telephonically 14 days after immunization to check whether they had experienced any side effects. 

The researchers again contacted the recipients one year later—when 926 of the 1,024 initial participants answered—to check whether any of the symptoms persisted or whether they had developed any other side effects of “special interest.” 

Dr. Bahl stated that “the methodology used for the current study cannot determine whether the symptoms were caused by the vaccine, the infection, or several other reasons that also cause these symptoms.” 

He emphasized that the study's design flaws prevent any definitive conclusions about the vaccine's safety. 

BHU's Response and Future Actions 

In response to ICMR's criticism, BHU acknowledged the concerns raised and is working on improving its research ecosystem. 

The university's Institute of Medical Sciences is reviewing the matter, and the individuals involved have communicated their responses to ICMR. “The university has taken note of a study in connection with Covaxin aftereffects, involving some members of BHU’s Institute of Medical Sciences, and a series of reactions in that regard,” a statement from BHU said. “The individuals have communicated their responses to the ICMR. Additionally, the Institute of Medical Sciences is also working on further strengthening and improving its research ecosystem.” 

ICMR's denouncement underscores the need for rigorous scientific methods and accurate representation in research, especially concerning public health issues like vaccine safety.

The incident highlights the critical role of robust, unbiased data in maintaining public trust in vaccination programs.