A total of 7,580 adverse events following immunisation, which translates to 0.2 per cent cases, have been reported out of total vaccinations till January 31 under the COVID-19 inoculation drive across the country, Health Minister Harsh Vardhan told Lok Sabha on Friday. Responding to a question on the adverse side-effects of COVID-19 vaccines, Vardhan said 12 deaths i.e. 0.000319 per cent fatalities cases out of the total number vaccinated till January 31 not causally related to vaccination presently, have also been reported.
"These deaths were investigated and examined by the experts and as per current evidence none of these deaths have causal relationship with COVID-19 vaccination," he said in a written reply. As far as AEFIs are concerned, he said most of these are minor AEFIs like anxiety, vertigo, giddiness, dizziness, fever, pain, rashes, and headache, which are self-limiting and all people have recovered, Vardhan said in response to a question regarding adverse side-effects of COVID-19 vaccines.
He said 14 hospitalisations i.e. 0.000372 per cent hospitalisation cases have been reported out of total number vaccinated till January 31. Vardhan said, in addition, measures have been put in place like availability of anaphylaxis kits at each vaccination site, immediate referral to AEFI management center and observation of vaccine recipients for 30 minutes at session site for any adverse events so as to take timely corrective measure.
On whether COVID-19 vaccine was allegedly tested on citizens/candidates without their consent, Vardhan said, "It is not a fact that COVID-19 vaccine was allegedly tested on citizens/candidates without their consent. During clinical trials, all vaccines were tested only after obtaining consent of the clinical trial participants under a prescribed procedure." The New Drugs and Clinical Trials Rules 2019 clearly prescribe the modalities of payment of compensation in specific instances. The AEFI system of the country has been put in place so as to capture all the AEFIs to analyse for any causal relationship with COVID-19 vaccination, he said.
Clinical trials of vaccines are required to be conducted in human subjects in compliance with the provisions prescribed in the New Drugs and Clinical Trial Rules, 2019 and Good Clinical Practices (GCP) guidelines. A National Expert Group on Vaccine Administration for COVID-19 (NEGVAC) has been established, which provides guidance on all aspects of COVID-19 vaccination, including prioritisation of population groups, procurement and inventory management, vaccine selection, vaccine delivery and tracking mechanism. The NEGVAC has also recommended the prioritisation of population groups for COVID-19 vaccination. The prioritised groups comprise healthcare workers, frontline workers, persons above the age of 50 years and persons below 50 years with associated comorbidities. Vardhan further said that AEFIs are monitored through a well-structured and robust AEFI surveillance system.
AEFI is any untoward medical occurrence, which follows immunisation and may not necessarily have a causal relationship with the vaccine. Causality assessment by the designated AEFI committee helps in determining if AEFI is related to vaccine or vaccination process or otherwise.
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