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. The report said that 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’, conducted by a team of researchers at Banaras Hindu University, also said that serious adverse events many occur in 1% of BBV152 recipients, and that extended surveillance is warranted following the administration of the vaccine.
Responding to a query from The Hindu on the study, Bharat Biotech maintained that for such a study in safety to be effective and informative, and for it to avoid investigator bias, some data points were also required, including the AESI safety profile of the subjects prior to their participation in the study; a comparison of the safety profile of non-vaccinated subjects during the course of the study; a comparison of the safety profile of subjects who received other vaccines during the course of the study; and that all study participants should be followed during the course of the study instead of only a subset.
“Additionally, several studies have been executed on the safety of Covaxin, and published in peer reviewed journals, demonstrating an excellent safety track record,’’ the company said.
According to the study, which had 1,024 individuals enrolled, 635 adolescents and 291 adults could be contacted during the one-year follow-up. Viral upper respiratory tract infections were reported by 304 (47.9%) adolescents and 124 (42.6%) adults, the study said.
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Also, new onset skin and subcutaneous disorders (10.5%), general disorders (10.2%), and nervous system disorders (4.7%) were the common AESIs in adolescents. General disorders (8.9%), musculoskeletal disorders (5.8%), and nervous system disorders (5.5%) were the common AESIs in adults. 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.
“Among adolescents, female individuals, those with a history of allergy and post-vaccination typhoid were respectively at 1.6, 2.8, and 2.8 times higher risk of AESIs. The majority of the AESIs persisted at the 1-year follow-up. Female individuals, adolescents with pre-vaccination COVID-19, those with comorbidities, and those with post-vaccination typhoid had respectively 1.6, 2, 2.7, and 3.2 times higher odds of persistent AESIs. Adults with comorbidities had more than 2 times higher odds of AESIs and persistent AESIs,” the paper said.
The worldwide COVID-19 vaccination programme started in December 2020 and early January 2021. Viral 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.
“In this context, we provided the first short-term safety data of BBV152 in adolescents and the comparative safety profile in adults. Despite nearly 2 years having elapsed since the approval of COVID-19 vaccines in adolescents, long-term data on the safety of these vaccines released in the public domain have been minimal. Here, in an extension of our previously published study, we provide data on the long-term safety of the BBV152 vaccine in adolescents and adults,” the paper said.
