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A study, led by Banaras Hindu University (BHU), claimed that Covaxin raised the risk of stroke, and Guillain-Barre syndrome, respiratory tract infections, and menstrual abnormalities, among others. The study has found that nearly one-third of individuals who received Bharat Biotech’s Covaxin reported ‘adverse events of special interest’ (AESI). Menstrual abnormalities were noticed in 4.6 per cent of female participants, according to a PTI report.
Out of 926 participants of the study, which was published in the journal Springer Nature, around 50 per cent reportedly complained of infections during the follow-up period, which was dominated by viral upper respiratory tract infections.
The most prevalent AESIs in adolescents included new-onset skin and subcutaneous disorders (10.5 per cent), general disorders (10.2 per cent), and nervous system disorders (4.7 per cent). Serious AESI, which included stroke and Guillain-Barre syndrome, was reported in one per cent of individuals.
On Thursday, however, Bharat Biotech said several studies on Covaxin have demonstrated an excellent safety track record. “Several studies have been executed on the safety of Covaxin, and published in peer-reviewed journals, demonstrating an excellent safety track record,” the Hyderabad-based drug maker said in a statement.
The company noted that for such a study in safety to be effective, informative and to avoid investigator bias: “AESI (adverse events of special interest) safety profile of the subjects prior to participation in the study has to be kept in mind. Comparison of the safety profile of non-vaccinated subjects during the course of the study, comparison of the safety profile of subjects who received other vaccines during the course of the study, and all study participants should be followed during the course of the study, instead of only a subset,” Bharat Biotech added.
Also Read: AstraZeneca’s Covishield Vaccine Can Lead To Rare Blood Clots As Side Effect: Know All About TTS
Recently, AstraZeneca admitted in the UK High Court about a rare risk of blood clot disorder due to its Covid vaccine called Thrombotic Thrombocytopenic Syndrome (TTS).
(With Agency inputs)
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