A study conducted by researchers at Banaras Hindu University (BHU) discovered that nearly 30% of the 926 participants who received Bharat Biotech’s Covaxin reported experiencing adverse events of special interest (AESI). These AESIs included conditions like stroke and Guillain-Barre syndrome, affecting 1% of the participants. Adults faced various issues such as general, musculoskeletal, and nervous system disorders, while adolescents frequently encountered skin, subcutaneous, and nervous system disorders. Notably, 4.6% of women experienced menstrual abnormalities.
The study also reported four deaths among adults, all of whom had underlying health conditions such as diabetes and hypertension. The findings indicated that adults who received three doses or just one dose of Covaxin were at a higher risk of AESIs compared to those who received two doses. Conducted between January 2022 and August 2023, the study noted that close to 50% of participants reported infections, with viral upper respiratory tract infections being the most common.
Bharat Biotech responded by highlighting the numerous studies published in peer-reviewed journals that demonstrate Covaxin’s excellent safety track record. They emphasized the need for comparative assessments of the safety profile between vaccinated and non-vaccinated individuals.
This study emerged shortly after AstraZeneca withdrew its Covishield vaccine in India due to rare side effects like blood clotting. Bharat Biotech reiterated the rigorous safety evaluations conducted for Covaxin, underscoring its commitment to ensuring the vaccine’s safety for the Indian population.