A significant number of individuals who received Bharat Biotech’s Covaxin vaccine have reported adverse side effects, a study by SpringerLink has revealed.
This comes weeks after Anglo-Swedish drugmaker AstraZeneca acknowledged similar issues with its Covid-19 vaccine.
As per Economic Times, the study published on SpringerLink, revealed that nearly one-third of participants in an observational study on Covaxin experienced adverse events of special interest (AESI).
The study highlighted that female adolescents and individuals with a history of allergies are at a higher risk of AESIs after receiving COVID-19.
Among the 1,024 participants, which included 635 adolescents and 291 adults, 304 adolescents (47.9%) and 124 adults (42.6%) reported viral upper respiratory tract infections.
In adolescents, common AESIs included new-onset skin and subcutaneous disorders (10.5%), general disorders (10.2%), and nervous system disorders (4.7%). Adults reported general disorders (8.9%), musculoskeletal disorders (5.8%), and nervous system disorders (5.5%).
Additionally, menstrual abnormalities affected 4.6% of female participants, while ocular abnormalities and hypothyroidism were observed in 2.7% and 0.6% of participants, respectively.
The study also identified serious AESIs, with 1% of participants experiencing conditions such as stroke and Guillain-Barre Syndrome in 0.3% and 0.1% of cases, respectively. Adolescents, females, and those with a history of allergies or post-vaccination typhoid were found to be at higher risk of AESIs.
Most AESIs persisted at the one-year follow-up, particularly among females, adolescents with pre-vaccination Covid-19, those with comorbidities, and those who developed typhoid post-vaccination. Adults with comorbidities were found to have more than twice the odds of experiencing AESIs and persistent AESIs. The adverse event patterns varied between Covaxin and other Covid-19 vaccines, and between adolescents and adults.
Researchers recommended extended surveillance of COVID-19-vaccinated individuals to better understand the course and outcomes of late-onset adverse events.
In a statement earlier this month, Bharat Biotech maintained that Covaxin is safe and has no side effects.
The company emphasized that Covaxin was developed with a primary focus on safety, followed by efficacy, and was evaluated in over 27,000 subjects during the licensure process. It was licensed for restricted use in clinical trial mode, with detailed safety reporting conducted for several hundred thousand subjects, and was also evaluated by the Union Ministry of Health.
This statement came shortly after AstraZeneca admitted in a UK court that its vaccine could, in very rare cases, cause thrombosis with thrombocytopenia syndrome. The AstraZeneca vaccine, manufactured by the Serum Institute of India, is sold in the country under the name Covishield.