Study Reveals Over 30% of Covaxin Recipients Experience Adverse Events: Nervous System Disorders and Menstrual Abnormalities Reported

The recent study conducted by researchers at Banaras Hindu University (BHU) has shed light on concerning findings regarding adverse events associated with Bharat Biotech’s Covaxin. The study, encompassing 926 recipients of Covaxin, revealed that nearly 30% of participants reported experiencing adverse events of special interest (AESI), including nervous system disorders and menstrual abnormalities.

Among the AESIs documented, notable conditions such as stroke and Guillain-Barre syndrome, a disorder affecting nerves causing weakness in limbs, were observed in around one percent of participants.  The study mentions: “Close to one-third of the individuals developed AESIs. New-onset skin and subcutaneous disorders, general disorders, and nervous system disorders were the three most common disorders observed in adolescents after receiving the vaccine.”

Furthermore, a significant proportion of adults and adolescents encountered various issues ranging from general disorders to musculoskeletal disorders.

Of particular concern were the reported menstrual abnormalities affecting approximately 4.6% of female recipients. Additionally, the study highlighted that four deaths were reported among adults, with underlying conditions such as diabetes and hypertension prevalent among the deceased.

An intriguing finding of the study was the increased risk of AESIs among adults receiving three doses compared to those receiving two doses of Covaxin. This underscores the importance of further investigation into the safety profile of the vaccine, particularly in light of the study’s duration spanning from January 2022 to August 2023.

In response to inquiries, Bharat Biotech emphasized that numerous studies have been conducted on Covaxin’s safety, boasting a strong safety track record published in peer-reviewed journals. The company underscored the necessity for comprehensive assessments of AESIs and a comparison of safety profiles with non-vaccinated subjects over the study period.

The timing of this study is significant, coinciding with AstraZeneca’s decision to withdraw its Covid-19 vaccine, Covishield, due to rare side-effects such as blood clotting. These developments underscore the critical importance of ongoing vigilance and rigorous evaluation of vaccine safety to ensure public health and confidence in vaccination programs.