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Over 30% of Covaxin takers reported adverse events: BHU study on 926 individuals

New Delhi: Nearly one-third of 926 individuals who received Bharat Biotech’s anti-Covid vaccine Covaxin reported ‘adverse events of special interest,’ or AESI, according to a one-year follow up study conducted by a team of researchers at BHU.

Serious AESI, which included stroke and Guillain-Barre syndrome, were reported in one per cent of individuals, the study conducted by researchers from the Banaras Hindu University (BHU), which looked at long-term safety of the BBV152 (Covaxin) vaccine in adolescents and adults, claimed.

Guillain-Barre syndrome is an autoimmune disorder which causes weakness in nerves in arms and legs. The study, conducted from January 2022 to August 2023, stated that nearly 50 per cent of the sample size complained of infections during the follow-up period, predominated by viral upper respiratory tract infections.

However, Bharat Biotech in a statement in response to the study, said, “several studies have been executed on the safety of Covaxin, and published in peer-reviewed journals, demonstrating an excellent safety track record”. The study involved 635 adolescents and 291 adults, who received the BBV152 vaccine.

Published in the journal Springer Nature recently, the study comes against the backdrop of UK pharmaceutical giant AstraZeneca admitting its Covid vaccine can cause rare side-effects of blood clotting and lowering of platelet count in a UK court.

“Close to one-third of the individuals developed AESIs. New-onset skin and subcutaneous disorders, general disorders, and nervous system disorders were the three most common disorders observed in adolescents after receiving the vaccine,” the study said.

The participants were interviewed telephonically about long-term adverse events of special interest after one year of vaccination.

New-onset skin and subcutaneous disorders (10.5 per cent), general disorders (10.2 per cent), and nervous system disorders (4.7 per cent) were the common AESIs in adolescents.

General disorders (8.9), musculoskeletal disorders (5.8 per cent), and nervous system disorders (5.5 per cent) were the common AESIs in adults.

Menstrual abnormalities were noticed in 4.6 per cent of female participants.

Ocular abnormalities and hypothyroidism were observed in 2.7 per cent and 0.6 per cent of participants. Four deaths (three female individuals, one male individual) were reported in adults, the study added.

All four had diabetes, while hypertension in three, and a history of pre-vaccination COVID-19 was present in two of them. Stroke was the main contributor in two deaths and one fatality was due to post-COVID-19 rhinocerebral mucormycosis, which supposedly disseminated after vaccination as reported by the caregivers.

The fourth death happened in a woman with multiple episodes of unconsciousness post-vaccination, the etiology of which remained unidentified till death. In the absence of a definite causality association, no conclusions can be drawn from these events, the study said.

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