Over 30% of Covaxin takers experienced nervous system disorders, menstrual abnormalities, suggests study

A recent study conducted by researchers at the Banaras Hindu University (BHU) says that nearly 30 per cent of the 926 recipients of Bharat Biotech's Covaxin reported experiencing adverse events of special interest (AESI).

The adverse events reported by the recipients include 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 experienced various issues, including general disorders, musculoskeletal disorders, and nervous system disorders.

For adolescents, the most frequent AESIs were skin and subcutaneous disorders, general disorders, and nervous system disorders. Additionally, approximately 4.6 percent of women reported menstrual abnormalities, according to the study.

The study further mentions, “Around 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, one male) were reported in adults, the study said, as reported by PTI. All four had diabetes, while hypertension was found inthree, and a history of pre-vaccination COVID-19 was present in two of them, it said.

"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 added.

Bharat Biotech’s response

The study was conducted from January 2022 to August 2023 andindicated that around 50 percent of the sample size reported infections, with viral upper respiratory tract infections being the most common.

When asked Bharat Biotech to respond, it 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 outlined several requirements for such a study, including an assessment of the AESI profile of the participants.

Additionally, it stated that there should be a comparison of the safety profile of non-vaccinated subjects throughout 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 inputs from agencies)