A recent study conducted by researchers at Banaras Hindu University (BHU) revealed that over 30% of individuals who received Bharat Biotech’s Covaxin reported adverse events. The one-year follow-up study, encompassing 926 participants, shed light on the long-term safety of the BBV152 vaccine, with serious adverse events of special interest (AESI) such as stroke and Guillain-Barre syndrome reported in one per cent of recipients.
Key findings of the study
The study, conducted from January 2022 to August 2023, indicated that nearly 50% of the sample reported infections during the follow-up period, primarily viral upper respiratory tract infections. Notably, Guillain-Barre syndrome, an autoimmune disorder causing nerve weakness, was among the serious AESI documented.
Response from Bharat Biotech
In response to the study, Bharat Biotech emphasised the comprehensive safety evaluation of Covaxin, highlighting numerous peer-reviewed studies that demonstrated its safety profile.
Study details and implications
The study involved 635 adolescents and 291 adults who received the Covaxin vaccine. Findings revealed that new-onset skin and subcutaneous disorders, general disorders, and nervous system disorders were among the common AESIs observed post-vaccination. Additionally, the study underscored the need for extended surveillance of vaccinated individuals to monitor late-onset adverse events.
Implications for future research
While the study provided valuable insights into Covaxin’s safety profile, researchers stressed the importance of larger-scale studies, particularly among adult populations, to comprehensively assess long-term safety. They also emphasised the need to explore ethnic differences in vaccine tolerability and compare adverse event rates between vaccinated and unvaccinated individuals for a more nuanced understanding.
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