7,580 adverse cases reported during first phase of Covid-19 vaccination drive: Centre

As many as 7,580 adverse events following immunisation (AEFI) have been reported in India during the first phase of the Covid-19 vaccination drive, till January 31, Health Minister Harsh Vardhan told Lok Sabha on Friday.

Of these, 12 incidents were fatal, i.e. 0.000319 per cent of the total number of those vaccinated till last month.

“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,” Vardhan said in a written reply in Parliament.

Meanwhile, the Union Health Ministry also claimed that India was the first country to vaccinate 5 million people in just 21 days. Nearly 53 lakh beneficiaries have been administered Covid-19 shots under the countrywide inoculation exercise till Friday evening, the ministry said.

As far as AEFIs are concerned, Vardhan said most of the cases are minor AEFIs like anxiety, vertigo, giddiness, dizziness, fever, pain, rashes, and headache, which are self-limiting and all people have recovered. He further said that 14 instances of hospitalisation have been reported till January 31.

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 added.

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 the vaccination process or not.