A recent study conducted by researchers at Banaras Hindu University has identified several long-term side effects of the Covaxin COVID-19 vaccine, particularly among specific groups. The study, published on Springer, reveals that females, adolescents with pre-existing COVID-19, individuals with co-morbidities, and those who contracted typhoid post-vaccination are at a higher risk of adverse events.
The study, spanning from January 2022 to August 2023, found that these groups experienced higher odds of side effects such as skin disorders, nervous system disorders, menstrual abnormalities, eye problems, and hypothyroidism. Specifically, females, adolescents with prior COVID-19, those with co-morbidities, and individuals who had post-vaccination typhoid had 1.6 times, 2 times, 2.7 times, and 3.2 times higher odds, respectively, of experiencing persistent side effects or “events of special interest.”
Titled “Long-Term Safety Analysis of the BBV152 Coronavirus Vaccine in Adolescents and Adults: Findings from a 1-Year Prospective Study in North India,” the report highlights that adults with co-morbidities had more than twice the odds of adverse events of special interest (AESIs) and persistent AESIs.
The study also noted distinct patterns of adverse events compared to other COVID-19 vaccines, with many AESIs persisting at the one-year follow-up. These side effects varied between adolescents and adults, with adolescents reporting higher rates of skin diseases, general disorders, and nervous system issues, while adults reported more general disorders, musculoskeletal problems, and nervous system disorders.
Bharat Biotech’s Response
Bharat Biotech, the manufacturer of Covaxin, released a statement emphasizing the need for comprehensive safety data to avoid bias and ensure effectiveness. The company highlighted the importance of comparing the safety profiles of vaccinated and non-vaccinated individuals, as well as those who received other vaccines. Bharat Biotech stated that several studies have confirmed Covaxin’s excellent safety record.
Key Findings of the BHU Study
The study involved 1,024 participants, including 635 adolescents and 291 adults, with follow-ups conducted telephonically over one year. Risk factors were identified if side effects persisted for at least one month. About 30% of participants reported viral upper respiratory tract infections, with 47.9% of adolescents and 42.6% of adults affected during the study period.
Common AESIs in adolescents included skin diseases (10.5%), general disorders (10.2%), and nervous system disorders (4.7%). Among adults, general disorders (8.9%), musculoskeletal issues (5.8%), and nervous system disorders (5.5%) were prevalent. Additionally, menstrual abnormalities were observed in 4.6% of females, while eye problems and hypothyroidism were noted in 2.7% and 0.6% of participants, respectively.
Serious AESIs, such as stroke and Guillain-Barré syndrome, were identified in 1% of participants, with 0.3% and 0.1% affected, respectively. Adolescents, females, those with a history of allergies, and those with post-vaccination typhoid were at higher risk of AESIs, with risk factors increased by 1.6, 2.8, and 2.8 times, respectively.
