Claims of Health Problems Among Vaccinated Individuals Raise Concerns; ICMR Demands Clarification
M Alam
NE DELHI– A recent study by researchers from Banaras Hindu University (BHU) has stirred controversy, claiming significant health issues among individuals vaccinated with Bharat Biotech’s Covaxin. The Indian Council of Medical Research (ICMR) has strongly objected to these findings, issuing notices to the researchers and warning of potential legal and administrative repercussions.
The year-long study, conducted by the Departments of Pharmacology and Geriatrics at BHU, suggested that approximately one-third of Covaxin recipients experienced adverse health effects. The study indicated that teenagers were particularly affected, with reported issues ranging from skin conditions to neurological disorders. Following the publication of these findings, there has been significant public concern and suspicion regarding the vaccine.
Notice and Objections from ICMR
The ICMR has issued a formal notice to Prof. Shubh Shankh Chakraborty, Head of the Department of Geriatrics, and Dr. Upinder Kaur from the Department of Pharmacology, demanding explanations and corrections. Dr. Rajeev Bahl, Director General of ICMR, stated, “The council is not associated with this study or its findings. The researchers have been asked to remove any reference to the ICMR from their report and to issue a public apology.”
The ICMR’s notice outlined several critical objections to the study:
1. Lack of Comparative Analysis: The report did not clarify whether a comparative study was conducted between vaccinated and unvaccinated individuals, making it difficult to establish a direct link between the vaccine and the reported health issues.
2. Pre-Existing Conditions Not Addressed: The study did not account for whether the health problems existed prior to vaccination, raising questions about the validity of attributing these issues to Covaxin.
3. Inadequate Study Methods: The methodology used did not align with the standards for reporting Adverse Events of Special Interest (AESI).
4. Data Collection Flaws: Data was collected via telephone interviews one year post-vaccination without clinical verification, suggesting potential biases and inaccuracies.
Internal Investigation at BHU
In response to the controversy, BHU’s Vice Chancellor Prof. Sudhir Jain has requested a comprehensive report from Prof. S.N. Sankhwar, Director of the Institute of Medical Sciences. Prof. Sankhwar acknowledged the hasty execution of the research and has appointed IMS Dean of Research, Prof. Gopalnath, to lead a four-member committee to investigate the study’s conduct and findings.
“The formation of the committee is a crucial step towards understanding the veracity and methodology of the research,” stated Prof. Jain. “We need to ensure that academic rigour and ethical standards are upheld in all our research activities.”
Researchers’ Defense
Prof. Chakraborty and Dr. Kaur have defended their study, asserting that their findings are based on thorough research and genuine health concerns reported by participants. “Our primary objective was to bring to light the potential side effects of Covaxin, which we believe are significant enough to warrant further investigation,” Prof. Chakraborty commented.
Dr. Kaur added, “We followed all ethical guidelines and obtained necessary approvals for our research. The health and safety of the public are paramount, and our study aimed to ensure transparency and accountability in vaccine administration.”
Public and Medical Community Reactions
The study’s findings have elicited mixed reactions from the public and the medical community. Some individuals have expressed heightened anxiety regarding the vaccine, while others, including medical professionals, have called for a more balanced interpretation of the data.
Dr. Anita Sharma, a general practitioner in Varanasi, remarked, “While it is important to investigate any potential side effects, we must also consider the overwhelming evidence supporting the safety and efficacy of Covaxin. Panic and misinformation can be detrimental to public health efforts.”