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A team of BHU researchers conducted a one-year follow-up study on Bharat Biotech's Covaxin and found that almost one-third of the participants reported adverse events of special interest (AESI). Additionally, nearly half of the 926 participants complained of infections, mainly viral upper respiratory tract infections. The study focused on the long-term safety of the BBV152 vaccine in adolescents and adults and found that serious AESI, such as stroke and Guillain-Barre syndrome, were reported in only one percent of the individuals. The study, published in Springer Nature, comes after AstraZeneca admitted that their Covid vaccine can cause rare side-effects in UK court. The study involved 635 adolescents and 291 adults who received the BBV152 vaccine and were interviewed telephonically about long-term adverse events of special interest after one year of vaccination. The three most common disorders observed were new-onset skin and subcutaneous disorders, general disorders, and nervous system disorders.
The study found that adolescents commonly experienced subcutaneous disorders (10.5%), general disorders (10.2%), and nervous system disorders (4.7%) as AESIs. In adults, the most common AESIs were general disorders (8.9%), musculoskeletal disorders (5.8%), and nervous system disorders (5.5%). Female participants experienced menstrual abnormalities in 4.6% of cases, while ocular abnormalities and hypothyroidism affected 2.7% and 0.6% of participants, respectively. The study reported four deaths in adults who had pre-existing diabetes, hypertension, and a history of pre-vaccination COVID-19. Two fatalities were due to stroke, one was caused by post-COVID-19 rhinocerebral mucormycosis, and the fourth death was of an unidentified etiology. While no conclusions can be drawn from these events, extended surveillance of vaccinated individuals is necessary to understand the course and outcomes of late-onset AESIs. Unusual occurrences that require heightened attention and extensive research are needed to fully comprehend the frequency of immune-related events following vaccination for COVID-19.
