Adverse Events Following Immunization (AEFI) Secretariat
While vaccines are generally safe, as with other medicines, adverse events may rarely occur following the use of vaccines. Apprehensions around risks associated with vaccines are a barrier to acceptance of vaccines. A functional AEFI surveillance system ensures vaccines are safe by monitoring AEFIs reported and investigated in districts. Adverse events following any vaccination including those given in the private sector, to adults, for international travel, to prevent rabies, etc. should be reported to the AEFI surveillance system.
AEFIs are reported into a reporting and management software called SAFE-VAC (Surveillance and Action For Events following Vaccination). All serious AEFIs are investigated by the DIO and causality assessments done by the state and national AEFI committees. Following causality assessments, AEFIs are classified as causally related to the vaccine or vaccination process (vaccine product related, vaccine quality defect related, anxiety reactions, immunization error related) or coincidental (not related to vaccine or vaccination process, due to something other than the vaccine), indeterminate or unclassifiable.
The AEFI Secretariat at ITSU is a dedicated team which supports the Immunization Division, MOHFW in managing the AEFI surveillance system. It maintains the AEFI surveillance data base, follows up with states for completion of investigations and causality assessments. It supports the MoHFW in making policy decisions and provides a strategic vision to improve AEFI surveillance and vaccine safety under the guidance of the National AEFI Committee and National AEFI Technical Collaborating Centre at Lady Hardinge Medical College (LHMC), New Delhi. It facilitates causality assessments of cases at the national level. The national AEFI surveillance guidelines are developed and updated by the AEFI Secretariat with the support of the National AEFI Technical Collaborating Center, the national AEFI committee and the WHO-India Country Office. Please find the National AEFI Surveillance Response Operational Guidelines – 2024 here.
The country’s AEFI surveillance database currently has approximately 23,500 serious and severe AEFI cases (regular vaccinations and COVID-19 vaccinations) reported since 2012. The approved results of causality assessments of AEFIs and reports of special investigations conducted by central teams are available here on the MOHFW website.
The AEFI Secretariat provides support to the states to strengthen AEFI surveillance through trainings, capacity building activities and regular feedback and follow up through the Senior AEFI Zonal Consultants. The AEFI Secretariat also works with experts to bring out guidelines to prevent and manage expected AEFIs such as the use of injection adrenaline for early management of suspected anaphylaxis cases following vaccination at the session sites by vaccinators. The Anaphylaxis guidelines and film for training purposes were developed by the AEFI Secretariat. Guidelines for supply and disbursement of syrup paracetamol instead of tablets to infants at session sites for management of fever and local injection site pain and swelling after vaccinations are available here. The AEFI Secretariat has also developed a ranking system for states and UTs, based on key performance indicators related to reporting and investigation of AEFI cases in the districts and conducting state AEFI committee meetings and causality assessments by the state. These are shared with states every quarter to encourage healthy competition.
Data and information related to vaccine safety is shared as per agreed protocol between the AEFI Secretariat and the Drug Controller General of India/ Central Drugs Standard Control Organization, Indian Pharmacopeia Commission, National Technical Advisory Group on Immunization, etc.
Training materials on AEFI surveillance for vaccinators, health workers and medical officers in the form of presentations as well as the formats (Case Reporting Forms, Case Investigation Forms, verbal autopsy forms for children and adults, and Lab Request Forms) can be accessed here. Members of the state AEFI committees are trained on monitoring of AEFI surveillance in the districts using AEFI surveillance data and conducting causality assessments.
Specific resource materials on crisis communication and risk communication such as Communication Guidelines on building Vaccine confidence around AEFIs and AEFI media communication protocol have been developed. A training film (Renuka: The Health Worker) depicting the entire process of reporting, investigations, and roles of health workers, PHC doctors, DIO and the district AEFI committee is available in English, Hindi, and four major languages of South India.
A State Guidance Document for AEFI Surveillance Processes has activities sequentially described as SoPs to undertake activities to improve AEFI surveillance activities. A similar document has been developed for activities at district level (Demonstration of Model AEFI Surveillance Processes).
The National Quality Assurance Standards for AEFI surveillance was developed in 2016 in collaboration with the Quality Improvement Division of the National Health Systems Resource Centre, New Delhi. The processes and systems of the national AEFI Secretariat is quality certified under NQAS till June 2027. The Quality Management System is now being implemented in all states /UTs of the country. This system is expected to improve AEFI surveillance processes in districts and states through internal and peer audits at the PHC/sessions sites, district and state levels in coordination with the state and district Quality Assurance committees. Following an external audit, the state will be quality certified.
One of the key functions of the AEFI Secretariat is to coordinate the meetings of the National AEFI Committee and its four sub-committees (causality assessment, investigation, media and communication and laboratory subcommittee). The investigation subcommittee guides and assists in conducting special investigations. SoPs for special investigation of AEFIs, especially those occurring in clusters have been developed for use by investigating teams at national, state, and district levels.A pilot to set up AEFI surveillance system within medical colleges and other tertiary care hospitals with linkages to the DIO office was conducted in 32 medical colleges in eight states. The learnings are expected to lead to SOPs for DIOs and Facility Nodal Officers for AEFI surveillance to work together to enhance reporting of hospitalized AEFI cases into the surveillance system.
It is important to look for previously unknown or new adverse events following vaccinations. Such events are called signals. The process of detecting, verifying and assessing signals is called signal management. The AEFI database is reviewed by the AEFI Secretariat regularly for potential signals which are assessed and presented to the experts of the Signal Review Panel for recommendations. Recommendations (programmatic and regulatory) are shared with the national AEFI committee and the Ministry for further communication to vaccine vigilance stakeholders such as DCGI/CDSCO and manufacturers. Considerations of risk-benefit with regard to the impact on patients’ or public health are kept in mind throughout the decision-making process. Signal management systems are important to detect and assess potential signals when new vaccines are introduced into the programme. Active surveillance studies (Cohort Event Monitoring/sentinel studies) may be required to provide additional information regarding vaccine safety for new vaccines. AEFI Secretariat has contributed to a White Paper on the Safety of Rotavirus Vaccine in India.
COVID-19 vaccines
Guidance for modifying and strengthening the existing AEFI surveillance system to enhance vaccine safety surveillance of COVID-19 vaccines was included in the COVID-19 vaccination Operational guidelines. Integration of SAFE-VAC with CoWIN enabled reporting of minor, serious and severe AEFIs by the vaccinators and DIOs. AEFIs can be reported by beneficiaries through COWIN portal accessed here. Advisories were issued for detecting, managing and reporting Thrombosis with Thrombocytopenia Syndrome (TTS) to the states.
Information related to COVID-19 vaccine safety has been regularly shared with the national drug regulator and international organizations coordinating vaccine safety activities. The AEFI Secretariat also conducted an active vaccine safety study in the form of sentinel surveillance for Adverse Events of Special Interest following COVID-19 vaccination through 16 medical colleges across India.