Bharat Biotech has lauded the safety track record of its Covid vaccine Covaxin, underlining the importance of specific data points to ensure rigorous and unbiased research. The company stresses the necessity of analyzing the Adverse Events of Special Interest (AESI) safety profile of participants before study enrollment, comparing the safety profile of non-vaccinated subjects during the study, and evaluating individuals who received other vaccines throughout the research process. By emphasizing that all study participants should be consistently monitored during the study rather than just a subset, Bharat Biotech aims to enhance the credibility and thoroughness of the research conducted.
In a study conducted by Sankha Shubhra Chakrabarti and colleagues at Banaras Hindu University, it was found that post-Covaxin vaccination, female adolescents and individuals with a history of allergies faced an increased risk of AESIs. The study observed that a majority of adverse events persisted even at the one-year follow-up, with outcomes revealing various AESIs such as viral upper respiratory tract infections and new-onset skin disorders among the participants. Noteworthy findings of the study included menstrual abnormalities in some female participants and the identification of serious AESIs like stroke and Guillain–Barre Syndrome in a segment of the population under review, highlighting heightened risks among adolescents, females, and those with a history of allergies or previous typhoid vaccination.
Bharat Biotech has reiterated its stance on the safety of Covaxin, noting its development with a strong emphasis on safety first, followed by efficacy. The company disclosed that Covaxin underwent evaluation in over 27,000 subjects during the licensure process, was licensed for restricted use under clinical trial mode with detailed safety reporting for hundreds of thousands of subjects, and was further assessed by the Union Ministry of Health. The company's commitment to robust safety protocols and continuous monitoring underscores its dedication to ensuring the safety and effectiveness of the Covaxin vaccine.