In the year 2012, a dedicated and independent AEFI Secretariat was established within the Immunization Technical Support Unit (ITSU) by the Ministry of Health & Family Welfare (MoHFW), Government of India. The aim was to strengthen AEFI surveillance in the country. ITSU acted as a Secretariat to the National AEFI committee and the four national sub-committees on media, laboratory, causality assessment and investigation.

Historically, the AEFI surveillance programme had been initiated in the late 1980’s under the Universal Immunization Programme. As part of the surveillance, some alarms and deaths were recorded although a lot of cases were getting missed and the surveillance mechanisms were not as robust. Once the AEFI surveillance guidelines were developed in 1991–1992 and other AEFI formats finalized in 2005 a lot of case reporting became easier. These guidelines were later updated in 2010 and 2012.

The AEFI Secretariat has about 20 people comprising the data team, those following up on case completion, case detection and analyzing trends apart from zonal and external consultants. Since 2012, much progress has been made, even though a lot more needs to be done. A major focus of the team has been to step up case investigations. More and more AEFI cases are being reported, systems are being set up for states to report and record and state and district AEFI committees have been involved in conducting case investigations on the field.

The MoHFW reaches out to ITSU with request to send teams at the state and district level to investigate cases and AEFI related deaths. Over the last 6-7 years, approximately 20–30 deaths have been reported and a repository of 12,000–13,000 cases reported. Analysis of data and even batch-wise analysis is being done. This kind of close partnership between MoHFW and ITSU demonstrates confidence and trust which the ministry has in ITSU and the AEFI Secretariat.

The AEFI secretariat’s work can largely be divided into the pre COVID-19 and post COVID-19 phase. In the pre COVID phase, work was largely focused on routine immunization (RI) as adverse events, vaccinating more than 85% and administering vaccines through the government health system. Most RI cases were recorded through the government health system. Few private institutions too shared their data. Till September 2020 all focus was on RI. Post October 2020, gears shifted to modify AEFI surveillance system for adults and COVID-19 vaccines.

At the central and state level data is analyZed and investigations, causality assessment done. Allergic reactions are common. The AEFI Secretariat developed a system to provide early management for support at the vaccination site itself. This has been done also while rolling out the new vaccines like Rotavirus vaccine (RVV), Measles Rubella (MR) and Pneumococcal conjugate vaccine (PcV) to see what adverse events to look out for. Special sensitisation has been done of District Immunization Officers (DIO) on reporting/recording cases. Any anticipated adverse events or those that get reported such as intestinal blocking are duly trained. Also ITSU staff and MoHFW personnel are invited to attend trainings and capacity building sessions at state, district, sub-district level.

ITSU developed healthy partnerships with donor agencies, grassroots NGOs, research organizations and academia like the Lady Hardinge Medical college. ITSU was also invited to represent India in Global Safety Meetings to share its experience. The data generated, compiled and analyzed by ITSU remains one of its key strengths and is shared regularly with several national and international bodies like the Comptroller General of India, National Technical Advisory Group on Immunization (NTAGI), regulators of other bodies, government, WHO and international agencies working in immunization. The AEFI Secretariat is called upon to respond to the Right to Information (RTI), Parliamentary questions and other media related queries. The team works closely with the communication team and the health ministry to develop key messages related to advocacy and behaviour change.

ITSU has been  hailed as a success in India and has served as a reliable technical arm of the ministry. Several countries with a similar health system and population are reaching out to ITSU in India to guide them and help them set up a similar entity with a view to strengthen and expand their immunization coverage.