 "Covaxin")
Bharat Biotech has said its Covid vaccine Covaxin has shown an "excellent safety track record" in various studies.
The company, which developed India’s first indigenous vaccine, gave a statement on Thursday after reports cited a study to say that a third of the participants of an observational study on Covaxin reported adverse events of special interest (AESI).
Bharat Biotech emphasised the importance of specific data points, including the AESI safety profile of participants prior to study enrollment, for effective and unbiased research.
The company said that for such a study to be effective, informative and to avoid investigator bias, some data points are required, including the "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 (and) comparison of safety profile of subjects who received other vaccines during the course of the study."
According to Bharat Biotech, all study participants should be followed up during the course of the study, instead of only a subset. Vouching for the safety of the vaccine, the company said, "Several studies have been executed on its safety and published in peer-reviewed journals, demonstrating an excellent safety track record."
Covaxin 'side effects'
A study conducted by Sankha Shubhra Chakrabarti and his team at Banaras Hindu University and published in Drug Safety (Springer), said that female adolescents and individuals with a history of allergies faced a heightened risk of AESI post-Covaxin vaccination. The majority of AESIs persisted even at the one-year follow-up.
Out of 1,024 participants, 635 adolescents and 291 adults were followed up over a year, revealing various AESIs, including viral upper respiratory tract infections and new-onset skin disorders.
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Menstrual abnormalities were noted in a percentage of female participants, while serious AESIs like stroke and Guillain–Barre Syndrome were identified in a fraction of the people under study. The study also highlighted increased risks among adolescents, females, and those with a history of allergies or post-vaccination typhoid.
Focus on safety: Bharat Biotech
In a statement earlier this month, Bharat Biotech had said that Covaxin is safe and did not have any side effects. The company said Covaxin was developed with a “single-minded focus on safety first”, followed by efficacy.
The vaccine was evaluated in more than 27,000 subjects as part of its licensure process, Bharat Biotech stated. It was licensed under restricted use in clinical trial mode, where detailed safety reporting was carried out for several hundred thousand subjects, it noted, adding that the vaccine was also evaluated by the Union Ministry of Health.
