As we enter the new year, the world is hopeful of the Coronavirus pandemic coming to an end. The optimism stems from the fact that the COVID-19 vaccination has already begun in many countries. India is expected to begin vaccinations in January 2021. However, as the COVID-19 vaccination campaign gathers steam around the world, certain challenges may begin to surface. One such will be instances of Adverse Event Following Immunization (AEFI), more commonly referred to as side effects or adverse reactions.
To address the problems posed by AEFI, India’s Ministry of Health and Family Welfare recently released the operational guidelines for COVID-19 vaccines. The document provides a glimpse into how the AEFIs will be prevented, reported, managed, recorded, and investigated throughout the country. The article below has summarized the guidelines into a reader-friendly format so that everyone can understand the preparations underway to deal with AEFIs. This will also help address the concerns of some people who are hesitant to get vaccinated.
What is an adverse event following immunization (AEFI)?
According to the World Health Organization (WHO), an adverse event following immunization (AEFI) is any untoward medical occurrence that follows immunization, which may or may not necessarily be a direct side effect of the vaccine.
The adverse event may be any unfavourable or unintended disease, symptom, sign, or abnormal laboratory finding. Reported adverse events can either be true adverse events, i.e. really a result of the vaccine or immunization process, or coincidental events that are not due to the vaccine or immunization process but are temporally associated with immunization.
For purposes of reporting, AEFIs will be classified as:
- Minor AEFI
- Severe AEFI
- Serious AEFI
Preventing AEFIs and anxiety reactions
To prevent and minimize the chances of occurrence of preventable AEFIs, Indian authorities have said that appropriate measures will be taken. Beneficiaries will be observed at the vaccine session site for at least 30 minutes post-vaccination to detect, manage, and treat immediate adverse reactions. At the immunization session sites, there would be separate areas for those waiting for vaccination, site of actual vaccination, and post-vaccination observation area, respectively. This will help avoid possibilities of anxiety reactions in individuals and clusters.
Vaccinators and supervisors at the vaccination site will provide primary treatment of all AEFIs. If needed, cases will be immediately referred to the nearest AEFI management centre and reported to the appropriate authority. COVID-19 vaccination sessions may be at fixed sites such as at government health facilities, identified private hospitals, nursing homes, etc.
- All beneficiaries will be counselled about adverse events that may occur after the COVID-19 vaccine. These are expected to be minor events such as local pain and swelling and mild to moderate fever, etc.
- In case of any type of discomfort or illness following COVID vaccination, the vaccine recipient will be asked to visit the nearest health care facility for treatment.
- At fixed session sites, an AEFI management kit or an emergency tray will be available for use.
- Outreach session sites will have an Anaphylaxis (a severe allergic reaction) kit.
- All vaccinators will be trained to suspect symptoms of anaphylaxis or severe allergic reaction, use the contents of the anaphylaxis kit, and arrange transportation of the patient to the nearest AEFI management centre for further treatment.
- Each outreach session site will be linked to an identified AEFI management centre to provide immediate treatment for serious AEFI cases.
- Adequate transportation will be available to transfer persons with serious adverse reactions to the nearest identified AEFI management centre.
Reporting and recording of AEFIs
Any adverse event following COVID-19 vaccination will be reported. There will be no time limit (between vaccination and onset of symptoms) for reporting AEFIs. If the health worker or the treating physician or anyone suspects the event to be due to vaccination, it will be reported.
State and district authorities will reach out to all health care service providers such as medical colleges, hospitals, and individual practitioners and sensitize them to report any adverse event following the COVID-19 vaccine as per guidelines.
Doctors will ask and record the history of COVID-19 vaccination in OPD prescriptions, casualty records, clinical treatment sheets, etc. Patients with a history of COVID-19 vaccination (any duration) in which the onset of symptoms occurs after COVID-19 vaccination will be considered as AEFIs. The AEFIs will be reported by the treating doctor to the District Immunization Officer.
- Immediate reporting of serious and severe AEFIs
Soon after the identification/notification of a serious and severe AEFI, a two-step process will be initiated.
(I) The first step involves reporting the serious and severe AEFI to the appropriate authority.
(II) The second step involves the investigation of all reported serious and severe AEFI by the District Immunization Officer or District AEFI Committee. All serious and severe AEFIs will be treated as a medical emergency and priority will be given to its management followed by its reporting and investigation on the standardized AEFI formats.
Investigation of AEFI Cases
All serious and severe AEFI cases after COVID-19 vaccines will be investigated as per the National AEFI Guidelines. The process of investigation will be expedited in order to collect accurate and complete clinical and epidemiological facts so that causality assessment can be completed as soon as possible.
- District AEFI committee meetings will be held at least one month prior to the start of COVID-19 vaccination. All members of the committee would be sensitized, and their services will be utilized to investigate the cases.
- The district AEFI committees will include drug inspectors and ensure their support in the investigations.
- Medical Officers of government and private health care facilities, where serious AEFI cases are expected to reach for treatment, will be informed and sensitized about AEFI surveillance for immediate reporting and cooperation in investigations.
Once investigations are complete for a serious/severe AEFI case and all supporting documents are available (hospital records, final outcome, etc.), trained experts of the state and national AEFI committees assess the case as per globally accepted causality assessment protocol and available evidence of safety profile of the vaccine to classify it as follows:
India will soon start one of the largest COVID-19 vaccination programs in the world. To ensure the smooth rollout of the vaccination program, the Indian Government has recently released the operational guidelines for COVID-19 Vaccines. The guidelines have laid a framework for identifying, reporting, managing, recording, and investigating cases of Adverse Event Following Immunization (AEFI). Proper implementation of the AEFI guidelines will play a key role in the COVID-19 vaccination program in India.
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