Many of the side-effects lasted for longer periods; researchers recommend extended surveillance of COVID-19-vaccinated individuals
About 30% of all recipients of Bharat Biotech’s indigenous Covaxin suffered from side-effects, some of them serious. The side effects often lasted for longer periods, a study by Banaras Hindu University has found.
“Viral upper respiratory tract infections were reported by 304 (47.9%) adolescents and 124 (42.6%) adults in this period. 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 participants, respectively. Among serious AESIs (1%), stroke and Guillain–Barre syndrome were identified in 0.3% and 0.1% of 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 researchers reported in the journal Drug Safety. AESIs are adverse events of special interest.
Out of 1024 individuals enrolled for the study, 635 adolescents and 291 adults could be contacted during the 1-year follow-up. “The patterns of AESIs developing after BBV152 differed from those reported with other COVID-19 vaccines as well as between adolescents and adults. With the majority of AESIs persisting for a significant period, extended surveillance of COVID-19-vaccinated individuals is warranted to understand the course and outcomes of late-onset AESIs,” the researchers noted.
Bharat Biotech however has questioned the study on several grounds including lack of relevant data points. “For such a study in safety to be effective, informative and to avoid investigator bias, the following data points are also required: AESI safety profile of the subjects prior to participation in the study, comparison of safety profile of non-vaccinated subjects during the course of the study, comparison of safety profile of subjects who received other vaccines during the course of the study and all study participants should be followed during the course of the study, instead of only a subset.
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 in a statement.
