Adult participants encountered a range of issues such as general disorders, musculoskeletal disorders, and nervous system disorders.
Among the adolescents, the most common AESIs were: Skin and subcutaneous disorders, general disorders, and nervous system disorders.
About 4.6 per cent of women faced menstrual abnormalities, the study said.
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."
Four deaths (three female individuals, one male individual) were reported in adults, the study said, according to PTI.
A study conducted by a team of researchers at the Banaras Hindu University (BHU) states that nearly 30 per cent of the 926 recipients of Bharat Biotech's Covaxin reported experiencing “adverse events of special interest" or AESI. The AESI included stroke and Guillain-Barre syndrome – a disorder that causes weakness in nerves in arms and legs – found in one per cent of the participants.
Adult participants encountered a range of issues such as general disorders, musculoskeletal disorders, and nervous system disorders. Among the adolescents, the most common AESIs were: Skin and subcutaneous disorders, general disorders, and nervous system disorders. About 4.6 per cent of women faced menstrual abnormalities, the study said.
The study mentions: “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."
Four deaths (three female individuals, one male individual) were reported in adults, the study said, according to PTI. All four had diabetes, while hypertension in three, and a history of pre-vaccination COVID-19 was present in two of them, it said.
"Interestingly, adults receiving three doses and those receiving one dose of BBV152 were respectively at four and two times higher risk of AESIs compared with adults receiving two doses of the Covaxin," the study said.
WHAT DID BHARAT BIOTECH SAY?
The study was conducted from January 2022 to August 2023. It indicated that close to 50 percent of the sample size reported infections, with viral upper respiratory tract infections being the most common.
When asked, Bharat Biotech said that several studies have been "executed on the safety of Covaxin, and published in peer-reviewed journals, demonstrating an excellent safety track record".
It also listed some points that are required for such a study. It included an assessment of the AESI profile of the participants. It said there should be a comparison of safety profile of non-vaccinated subjects during the course of the study.
The study on Covaxin comes a few days after AstraZeneca withdrew its Covid-19 vaccine, provided in India as 'Covishield', following reports of rare side-effects such as blood-clotting.
(With PTI inputs)
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