An observational study on Bharat Biotech's Covaxin has reported that about one-third of participants experienced adverse events. This follows recent admissions by AstraZeneca regarding side effects from its own COVID-19 vaccine.
Nearly a third of participants in the study reported Adverse Events of Special Interest (AESI). The findings, published on SpringerLink, indicate that female adolescents and individuals with a history of allergies are at a higher risk of AESIs after receiving Covaxin.
What is Covaxin?
Covaxin is an inactivated virus-based COVID-19 vaccine developed by Bharat Biotech, an Indian biotechnology company. This vaccine induces an immune response against the SARS-CoV-2 virus, which causes COVID-19. Covaxin has been a crucial part of India's vaccination campaign, contributing to the global effort to combat the pandemic.
Covaxin utilises a traditional vaccine approach, where the virus is inactivated so it cannot replicate or cause disease but can still stimulate an immune response. Covaxin works by introducing inactivated SARS-CoV-2 virus particles into the body. These particles are incapable of causing illness but are sufficient to trigger the immune system to recognise and fight the virus.
Study Finds Side Effects Of Covaxin
The study followed 1,024 individuals over a year who had taken Covaxin. Here’s what the study found:
- 47.9% of adolescents and 42.6% of adults reported viral upper respiratory tract infections
- 10.5 % of adolescents experienced new-onset skin and subcutaneous disorders
- 10.2% of adolescents experienced general disorders
- 4.7% of adolescents experienced nervous system disorders
- 8.9% of adults experienced general disorders
- 5.8% of adults experienced musculoskeletal disorders
- 5.5% of adults faced nervous system disorders
- Menstrual abnormalities affected 4.6% of female participants
- 2.7% of women in the study experienced ocular abnormalities
- 0.6% of the participants experienced hypothyroidism
- 0.3% of participants experienced a stroke
- 0.1% of the participants experienced Guillain-Barre Syndrome
Risk Factors Of Covaxin Side Effects
The study highlighted that certain factors put the participants at a higher risk of experiencing the above disorders. The study noted these risk factors:
- Adolescents
- Females
- History of allergy
- History of post-vaccination typhoid
- Comorbidities
The study noted that most AESIs persisted at the one-year follow-up. The patterns of adverse events varied between Covaxin and other COVID-19 vaccines, as well as between adolescents and adults.
Also Read: Reports Claim New COVID Variant ‘FLiRT’ Can Escape Immune Defense: Can Vaccines Stop This Variant?
Bharat Biotech's Response and Recommendations
In response to the study, Bharat Biotech reiterated that Covaxin is safe and has undergone extensive testing for safety and efficacy. The company emphasised that Covaxin was developed primarily on safety and has been evaluated in over 27,000 subjects. Bharat Biotech highlighted that Covaxin was licensed under restricted use in clinical trial mode, which involved detailed safety reporting for hundreds of thousands of subjects. The vaccine was also evaluated by the Union Ministry of Health.
Given the persistence of adverse events observed in the study, researchers recommended extended surveillance of COVID-19-vaccinated individuals to better understand the course and outcomes of late-onset adverse events. This recommendation aligns with the need for ongoing monitoring to ensure the long-term safety of vaccines.