Raipur: According to a study conducted by Banaras Hindu University (BHU), covaxin increased the risk of pneumonia, menstrual irregularities, Guillain-Barre syndrome, stroke, and respiratory tract infections. It was discovered in the study that ‘adverse events of special interest’ (AESI) were recorded by almost one-third of those who received Covaxin from Bharat Biotech.
Approximately half of the 926 participants in the study, which was published in the journal Springer Nature, reportedly. complained of having illnesses throughout the follow-up period, with viral upper respiratory tract infections predominating.
The most common AESIs among teenagers were nervous system problems (4.7%), general disorders (10.2%), and newly developed skin and subcutaneous disorders (10.5%). 1% of people had a report of a major AESI, which included stroke and Guillain-Barre syndrome.
In 4.6% of the female subjects, irregular menstruation was seen. In 2.7% and 0.6% of subjects, respectively, ocular anomalies and hypothyroidism were noted. The study also noted that four adult deaths—three of them female and one of them male—were reported.
Bharat Biotech, however, stated on Thursday that a number of trials on Covaxin had shown a strong safety record. The Hyderabad-based pharmaceutical company stated in a statement that “multiple studies have been performed on the safety of Covaxin and have been published in peer-reviewed journals, demonstrating a strong safety track record.”
AESI (adverse events of special interest) safety profile of the individuals before participation in the study has to be kept in mind, according to the business, for such a safety study to be successful, instructive, and free from investigator bias. According to Bharat Biotech, “all study participants should be followed throughout the study, instead of just a subset, and comparisons of the safety profiles of individuals who received other vaccines during the course of the study, as well as comparisons of the safety profiles of subjects who were not vaccinated during the course of the study,”
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