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May 17, 2024

Covaxin Boasts Excellent Safety Record Amid Study Highlighting Adverse Events, Says Bharat Biotech

Bharat Biotech has reaffirmed the safety of its COVID-19 vaccine, Covaxin, following a recent study that reported a significant incidence of adverse events of special interest (AESI) among participants. The company, which developed India’s first indigenous COVID-19 vaccine, emphasized the extensive safety data supporting Covaxin’s excellent track record.

In a statement issued on Thursday, Bharat Biotech addressed concerns raised by a study indicating that approximately one-third of participants experienced AESIs. The company highlighted the necessity of specific data points to ensure the integrity and effectiveness of vaccine studies, including the prior AESI safety profiles of participants, comparison with non-vaccinated subjects, and comparison with those who received other vaccines.

“For a study to be truly effective and free from bias, comprehensive data collection is essential,” Bharat Biotech stated. “This includes the AESI safety profiles of subjects before participation, continuous follow-up of all participants during the study, and comparisons with non-vaccinated individuals and those vaccinated with other products.”

Bharat Biotech underscored its commitment to vaccine safety, noting that several studies have been conducted and published in peer-reviewed journals, all demonstrating Covaxin’s robust safety record. The company stressed that these studies included thorough follow-ups and extensive data analysis.

The observational study in question, led by Sankha Shubhra Chakrabarti at Banaras Hindu University and published in the journal Drug Safety (Springer), focused on the risk of AESIs in adolescents and adults following Covaxin vaccination. The study found that female adolescents and individuals with a history of allergies faced higher risks of AESIs. Notably, many of these adverse events persisted even after a year.

Out of 1,024 participants, including 635 adolescents and 291 adults, various AESIs were documented over the course of a year. These included viral upper respiratory tract infections, new-onset skin disorders, menstrual abnormalities in female participants, and serious conditions such as stroke and Guillain–Barre Syndrome. The study particularly highlighted increased risks for adolescents, females, and those with prior allergic reactions or post-vaccination typhoid.

Responding to these findings, Bharat Biotech reiterated that Covaxin is safe and devoid of significant side effects. The company stated that the vaccine was developed with a “single-minded focus on safety first,” followed by efficacy. Bharat Biotech pointed out that Covaxin was evaluated in over 27,000 subjects during its licensure process and under restricted use in clinical trial mode, involving detailed safety monitoring of several hundred thousand individuals. This evaluation was conducted in collaboration with the Union Ministry of Health.

The company’s statement aligns with its previous declarations, emphasizing that Covaxin underwent rigorous safety assessments before and after its deployment. Bharat Biotech’s reaffirmation of Covaxin’s safety comes at a crucial time, reinforcing public confidence in the vaccine amid ongoing concerns about vaccine-related adverse events.

In summary, Bharat Biotech has robustly defended the safety of Covaxin, backed by extensive research and data, despite recent reports highlighting adverse events. The company continues to advocate for comprehensive and unbiased research methodologies to ensure the accurate assessment of vaccine safety and efficacy.

Jhumpa Lahiri

Jhumpa Lahiri

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