Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state:
(a) whether all the vaccines developed for COVID-19 globally, including India, do not provide any guarantee of their side effects/adverse effects;
(b) if so, the details thereof; and
(c) if not, the reasons therefor?
ANSWER
THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND
FAMILY WELFARE
(DR. BHARATI PRAVIN PAWAR)
(a) to (c) All vaccines including those licensed for COVID-19 are associated with some adverse events. Most of the adverse events are mild in nature whereas very few are severe and may require hospitalization. Adverse events caused by vaccine candidates underdevelopment are assessed in detail in preclinical studies and phase I human clinical trials. The vaccine candidates with high proportion of severe adverse events are discarded in preclinical studies or after phase 1 safety assessment. Only the candidates which do well in initial safety assessments during preclinical studies and clinical trials are taken ahead.
New Drugs including Vaccines are approved under the provisions of New Drugs and Clinical Trials Rules, 2019 based on safety & efficacy profiles of product.