Why is it in the news?

• According to a recent report published in Springer Nature, adolescent girls and individuals with comorbidities are at a higher risk of experiencing adverse events after receiving Bharat Biotech’s Covaxin vaccine against COVID-19.
• The report highlights that nearly a third of the participants in an observational study on the vaccine reported adverse events of special interest.

More about the news

• The study, titled ‘Long-term safety analysis of the Covaxin vaccine in adolescents and adults: Findings from a one-year prospective study in North India,’ was conducted by researchers at Banaras Hindu University. It reveals that serious adverse events may occur in 1% of Covaxin recipients, emphasizing the need for extended surveillance following vaccination.
• Certain adverse events of interest were more common in adolescents, including new onset skin and subcutaneous disorders, general disorders, and nervous system disorders. In adults, general disorders, musculoskeletal disorders, and nervous system disorders were more frequently observed. Menstrual abnormalities were noticed in 4.6% of female participants, while ocular abnormalities and hypothyroidism were observed in 2.7% and 0.6% of participants, respectively.
• Stroke and Guillain-Barre syndrome were identified as serious adverse events in 0.3% and 0.1% of participants, respectively. The study also found that certain factors, such as a history of allergy and post-vaccination typhoid, were associated with a higher risk of adverse events in adolescents.
• Bharat Biotech responded to the study, stating that safety studies on Covaxin have been conducted and published in peer-reviewed journals, demonstrating an excellent safety record for the vaccine.