COVID-19 vaccination: 447 recipients across India suffer adverse events post inoculation; how AEFI is tracked, reported
With COVID-19 making the immunisation of adults necessary, the Centre has involved cardiologists, neurologists, general physicians, and pulmonologists in the AEFI committees at national, state, and district levels
The nationwide inoculation programme started on Saturday (16 January).
Addressing a press briefing, the Union health ministry said of the 447 cases, only three required hospitalisation.
"One of the hospitalised beneficiaries is under observation at AIIMS Rishikesh and is stable. Two others have been discharged from Delhi's Northern Railway hospital and AIIMS Delhi."
The ministry added that most of the AEFIs reported were minor and included fever, nausea, and headache.
On Saturday, the ministry hailed the exercise conducted in 3,352 vaccination sites across the country as a "success".
However, reports emerged on Saturday evening of AEFIs in Delhi (52), Maharashtra (22), West Bengal (14), Rajasthan (21), and Telangana (11).
One beneficiary each in Delhi and Kolkata were hospitalised on Saturday after receiving the vaccine.
In Delhi, a security guard who was administered a dose of COVAXIN had to be hospitalised after he developed a severe AEFI. Additionally, in West Bengal, which reported 14 AEFI cases, a 35-year-old nurse in Kolkata was hospitalised after falling unconsciousness following the jab.
The adverse reactions are being closely tracked through India's existing surveillance framework, especially in the context of questions surrounding the safety of Bharat Biotech's Covaxin.
The extent and severity of such adverse events is expected to have a major bearing on public confidence towards the vaccination drive, which is likely to stretch for several years, say experts.
What is an AEFI?
An AEFI is defined as "any untoward medical occurence which follows immunisation and which doesn't necessarily have a causal relationship with the usage of the vaccine. The adverse event may be any unfavourable or unintended sign, abnormal laboratory finding, symptom or disease".
This definition is according to the Union health ministry's revised guidelines on AEFI reporting in 2015.
Adverse reactions to a vaccine are broadly categorised based on their cause, severity, and frequency. The categories based on severity and frequency are: (a) Common minor reactions and (b) Serious and severe vaccine reactions.
Meanwhile, the cause-specific reactions are: vaccine product-related reaction and vaccine quality defect-related reaction.
Here is an overview of the mechanism for tracking adverse events linked to the coronavirus vaccines in India.
The Hindu quoted Dr NK Arora, head of the operations research unit of the ICMR's National Task Force for COVID-19 , as saying that the monitoring is being carried out based on the country's existing vaccine safety surveillance mechanism under the Universal Immunisation Programme (UIP).
The AEFI framework under UIP includes doctors, data and public health specialists. "The vaccine safety surveillance network extends up to every district, where a panel of doctors and health workers monitor events of concern after getting any vaccine, investigate and report to state and national level," Arora told The Hindu.
However, with COVID-19 making the immunisation of adults necessary, the Centre has involved "cardiologists, neurologists, general physicians, and pulmonologists in the AEFI committees at national, state, and district levels," Arora added.
So far, India's immunisation and monitoring systems was largely focused on infants and children for drives like polio.
The AEFI tracking network is strengthened from ground-up. ASHA workers, Aanganwadi workers, auxiliary nurse midwives (ANM), health supervisors, and medical officers — collectively called 'peripheral health workers' — at primary health care (PHC) and community health care (CHC) centres play an important role in tracking and reporting AEFIs.
The 2015 guidelines instruct the medical officer in charge to report all severe AEFIs immediately and send the report to the district immunisation officer (DIO) in 24 hours. The DIO will then verify the report and forward it to state- and national-level committees within 24 hours.
A research paper entitled Vaccine pharmacovigilance in India: Current context and future perspective, 2019 by Meher BR noted that the various stakeholders involved in AEFI reportage are: Peripheral health workers, peripheral medical officers, private practitioners, DIOs, state immunization officer, AEFI secretariat, national AEFI committee, marketing authorisation holder (MAH).
Loopholes in AEFI reporting
The Universal Immunisation Programme in India started in 1985. However, the efficiency of the system was "suboptimal", research papers said.
To bolster the system, the Centre issued the National AEFI Surveillance and Response Operational Guidelines in 2005-2006, which were then distributed to medical officers in the public sector across the country.
The latest guidelines were issued in 2015.
A major pitfall of the current framework, as observed by researchers, is the low participation by doctors and medical health professionals in the private sector.
"While there is a system for AEFI reporting from government sector in India based on the operational guidelines, there is limited awareness about the reporting system in the private sector resulting in inadequate reporting.
"(Increased surveillance) is possible through information dissemination and better collaboration with professional bodies (like Indian Academy of Pediatrics (IAP)) and Government of India. The improved AEFI surveillance and reporting system in India will go in a long way to increase and retain the faith of the community in the existing and new vaccines and increasing the immunization coverage in India" noted research paper Adverse Event Following Immunization (AEFI) Surveillance in India: Position Paper of Indian Academy of Pediatrics, 2013.
The paper by Meher BR quoted data as saying that around 10 to 20 percent of the routine immunisation in India is provided by private pediatricians, "and the numbers are even higher for the vaccines which are not included in the UIP".
The paper also noted that training in reporting cases of AEFI for peripheral healthcare workers is inadequate.
"Although requisite periodical training has been prescribed for them in the guideline, there is not much research data available in public domain pertaining to health-care professional's knowledge, skill, attitude, and practice toward reporting of AEFI," the paper said.
Reports of AEFIs across India after COVID-19 immunisation
Soon after the exercise ended on Saturday, one "severe" and 51 "minor" cases of adverse reactions were reported in Delhi.
District officials said most of the persons who developed "minor" AEFI post vaccination complained about dizziness and headache. They will be monitored for a few days to ensure their normal state of health, PTI reported.
According to AIIMS director Randeep Guleria, the security guard who had to be hospitalised on Saturday is in his 20s and complained of palpitations soon after receiving the jab. He also developed an allergic skin rash within 15 to 20 minutes after being inoculated and was admitted to the facility.
Eleven cases of "minor" AEFI were reported from south and southwest districts, showed official data. The "minor" AEFI cases were reported from all districts except northeast and Shahdara districts.
On Saturday evening, The Indian Express reported that Maharashtra had recorded 14 cases of adverse events, however, none were fatal.
A separate report by The Indian Express also quoted Telangana public health director G Srinivasa Rao as saying that 11 mild cases of adverse reactions were noted. They experienced "pain, giddiness, and sweating, which are the most common in any vaccination program," he said.
The Union health ministry said more than 1.91 lakh healthcare and sanitary workers had been vaccinated at 3,352 sites across the country.
The vaccines that were administered were 'COVAXIN', which has been developed by Bharat Biotech in collaboration with the ICMR and Oxford-AstraZeneca's vaccine 'Covishield', which is being manufactured by the Serum Institut-e of India (SII). COVAXIN has been given the green light without the completion of its Phase 3 trials.
Meanwhile, Norway cautioned against side-effects of the Pfizer COVID-19 vaccine as 29 people — most of them senior citizens and terminally-ill — died after receiving their first shot of the Pfizer-BioNTech vaccine. Reacting to the deaths, Pfizer, said that "the number of incidents so far is not alarming, and in line with expectations."
With inputs from agencies
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