NEW DELHI: Days after a Banaras Hindu University (BHU) study reported long-term “adverse events of special interest (AESI)” in a group of over 926 persons a year after they were administered Bharat Biotech’s Covaxin, the Indian Council of Medical Research (ICMR) on Monday called it a “poorly designed study with critical flaws” and threatened researchers with legal consequences for wrongly acknowledging the institute as a partner in the study.
The ICMR said the study had no control group of unvaccinated individuals to prove that the side-effects were only associated with vaccination.
Published in journal Springer Nature, the study has stated that new-onset skin and subcutaneous disorders, general disorders, and nervous system disorders are common AESIs in adolescents. The ICMR listed four critical flaws in the study.