Bharat Biotech, the pioneering developer of India’s first indigenous COVID-19 vaccine Covaxin, has staunchly defended its product’s safety profile amidst recent study findings suggesting potential risks. In response to reports citing an observational study, the company reaffirmed Covaxin’s “excellent safety track record” while emphasizing the necessity of comprehensive data analysis for unbiased research.
The company’s statement comes in the wake of a study led by Sankha Shubhra Chakrabarti and his team at Banaras Hindu University, published in Drug Safety (Springer), which identified adverse events of special interest (AESI) among a subset of Covaxin recipients. Notably, the study pointed out a heightened risk of AESI, particularly among female adolescents and individuals with a history of allergies, with many adverse effects persisting even at the one-year follow-up mark.
Out of 1,024 participants observed over the course of a year, the study revealed various AESIs, including viral upper respiratory tract infections, new-onset skin disorders, menstrual abnormalities in some female participants, and rare serious events like stroke and Guillain–Barre Syndrome. Moreover, it underscored increased risks among adolescents, females, and individuals with pre-existing allergies or post-vaccination typhoid.
In response, Bharat Biotech underscored the importance of considering specific data points, including the AESI safety profile of participants prior to study enrollment, for accurate interpretation of findings. The company reiterated that for effective and unbiased research, comparisons should be made not only among vaccinated individuals but also with non-vaccinated subjects and those who received other vaccines during the study period.
Moreover, Bharat Biotech emphasized the necessity of comprehensive follow-up of all study participants throughout the research duration, asserting that such an approach ensures a robust evaluation of vaccine safety. Refuting claims of inadequate safety assessment, the company highlighted multiple studies published in peer-reviewed journals, attesting to Covaxin’s safety and efficacy.
Earlier assertions by Bharat Biotech had emphasized the vaccine’s meticulous development process, prioritizing safety as the foremost consideration. Covaxin underwent rigorous evaluation involving over 27,000 subjects during its licensure process, with detailed safety reporting conducted for several hundred thousand individuals under clinical trial conditions.
Acknowledging Covaxin’s licensure under restricted use in clinical trial mode, Bharat Biotech noted the comprehensive evaluation conducted by the Union Ministry of Health. The company’s commitment to ensuring the safety and efficacy of Covaxin remains unwavering, backed by ongoing research and stringent regulatory oversight.
In conclusion, while recent study findings raise questions about Covaxin’s safety profile, Bharat Biotech’s steadfast assurance of its vaccine’s safety underscores the complexities of vaccine research and the necessity of robust data analysis for informed decision-making in public health.
