- Adolescent girls and those with comorbidities are at a higher risk of adverse events after receiving Bharat Biotech’s BBV152 (Covaxin) vaccine against COVID-19, according to a report published in Springer Nature recently.
- Nearly a third of the participants of an observational study on the vaccine reported adverse events of special interest (AESI).
- The one-year follow-up study titled ‘Long-term safety analysis of the BBV152 coronavirus vaccine in adolescents and adults: Findings from a one-year prospective study in North India’, was conducted by a team of researchers at Banaras Hindu University.
- Serious adverse events may occur in 1% of BBV152 recipients, and extended surveillance is warranted following the administration of the vaccine.
| Bharat Biotech emphasised the need for comprehensive unbiased safety studies AESI safety profile of the subjects prior to their participation. A comparison of the safety profile of non-vaccinated subjects. Comparison of the safety profile of subjects who received other vaccines. All study participants should be followed during the course instead of subset. |
According to the study, Viral upper respiratory tract infections were reported by 304 (47.9%) adolescents, new onset skin and subcutaneous disorders (10.5%), general disorders (10.2%), and nervous system disorders (4.7%) were the common AESIs in adolescents.
- Menstrual abnormalities were noticed in 4.6% of female participants. Ocular abnormalities and hypothyroidism were observed in 2.7% and 0.6% of the participants, respectively.
- Among the serious AESIs (1%), stroke and Guillain-Barre syndrome were identified in 0.3% and 0.1% of the participants, respectively.
| Pandemic of Covid-19 and VaccinesViral vector and mRNA-based COVID-19 vaccines were distributed on a large scale, worldwide.In India, the BBV152 was the only vaccine that was initially granted permission for mass roll-out in adolescents in the 15-18 years age group. The short-term safety of COVID-19 vaccines approved for adolescents was shown to be favourable in controlled settings. |
Dig Deeper: Read concerns raised by various safety studies of different vaccines and comparative analysis.
