Bharat Biotech has emphasized the necessity of comprehensive data points to ensure the effectiveness and informativeness of safety studies, especially to avoid investigator bias. Key data points include the AESI (Adverse Events of Special Interest) safety profile of subjects prior to the study, comparisons with non-vaccinated subjects and those who received other vaccines, and continuous monitoring of all participants throughout the study.
The company noted, “Several studies have been executed on the safety of Covaxin, published in peer-reviewed journals, demonstrating an excellent safety track record.”
In a recent study involving 1,024 individuals, including 635 adolescents and 291 adults, follow-up data over one year revealed the following:
- Viral Upper Respiratory Tract Infections: Reported by 47.9% of adolescents and 42.6% of adults.
- Common AESIs in Adolescents: New onset skin and subcutaneous disorders (10.5%), general disorders (10.2%), and nervous system disorders (4.7%).
- Common AESIs in Adults: General disorders (8.9%), musculoskeletal disorders (5.8%), and nervous system disorders (5.5%).
- Specific Findings: Menstrual abnormalities in 4.6% of female participants, ocular abnormalities in 2.7%, and hypothyroidism in 0.6%.
- Serious AESIs: Stroke in 0.3% and Guillain-Barre syndrome in 0.1% of participants.
The study identified higher risks of AESIs among certain groups:
- Adolescents: Females, individuals with a history of allergy, and those with post-vaccination typhoid had a 1.6, 2.8, and 2.8 times higher risk of AESIs, respectively.
- Persistent AESIs: Higher odds were noted in female individuals, adolescents with pre-vaccination COVID-19, those with comorbidities, and post-vaccination typhoid cases.
For adults, those with comorbidities had over twice the odds of experiencing AESIs and persistent AESIs.
The global COVID-19 vaccination campaign commenced in December 2020, with widespread distribution of viral vector and mRNA-based vaccines. In India, BBV152 (Covaxin) was the first vaccine approved for mass roll-out among adolescents aged 15-18. Initial studies indicated favorable short-term safety in controlled settings.
“Our study offers the first long-term safety data of BBV152 in adolescents and comparative safety data in adults. Despite nearly two years since the approval of COVID-19 vaccines for adolescents, there has been minimal long-term safety data available in the public domain. This study extends our previously published work, providing valuable insights into the extended safety profile of the BBV152 vaccine,” the paper concluded.
