Participant-centred active surveillance of adverse events following immunisation: a narrative review

Abstract

The importance of active, participant-centred monitoring of adverse events following immunisation (AEFI) is increasingly recognised as a valuable adjunct to traditional passive AEFI surveillance. The databases OVID Medline and OVID Embase were searched to identify all published articles referring to AEFI. Only studies which sought participant response after vaccination were included. A total of 6060 articles published since the year 2000 were identified. After the application of screening inclusion and exclusion criteria, 25 articles describing 23 post-marketing AEFI systems were identified. Most countries had a single system: Ghana, Japan, China, Korea, Netherlands, Singapore, Brazil, Cambodia, Sri Lanka, Turkey and Cameroon except the USA (2), Canada (4) and Australia (6). Data were collected from participants with and without AEFI in all studies reviewed with denominator data enabling AEFI rate calculations. All studies considered either a single vaccine or specified vaccines or were time limited except one Australian system, which provides continuous automated participant-centred active surveillance of all vaccines. Post-marketing surveillance systems using solicited patient feedback are emerging as a novel AEFI monitoring tool. A number of exploratory systems utilising e-technology have been developed and their potential for scaling up and application in low and middle income countries deserves further investigation.

Adverse events following immunisation (AEFI) reports from the Zimbabwe expanded programme on immunisation (ZEPI): an analysis of spontaneous reports in Vigibase® from 1997 to 2017

“…In addition, complementary increases in internal funding and resources such as fully functional, identifiable sentinel AEFI reporting sites, the linkage of AEFI data with immunisation registers, and the use of national vaccine safety experts may also enhance patient follow-up, AEFI investigations and the timeliness and completeness of ICSRs [36]. Furthermore, the use of participant-centred active surveillance of AEFIs can be utilised instead of passive surveillance as it is sustainable, relatively affordable and provides timely signal detection opportunities especially for post-marketing vaccine pharmacovigilance [37]. Given the shift towards vaccine development for tropical and other health challenges in resource limited settings, active, participant-centred safety surveillance may offer a unique solution to provide complete, timely and useful AEFI data.…”

Evaluation of the adverse events following immunization surveillance system in Guruve District, Mashonaland Central 2017

“…There is need to consider complementing the passive surveillance system with a participant-centred active surveillance system where caregivers can send an SMS or use other communication technologies such as WhatsApp. Such innovations have been tried in low resource countries such as Cameroon and Cambodia with notable improvement in AEFI reporting [16, 17]. The fear of reporting for health workers, coupled with the inconvenience of travelling back to the clinic for caregivers, made the surveillance system not acceptable.…”

Timeliness of signal detection for adverse events following influenza vaccination in young children: a simulation case study

“…Actively seeking the input of consumers renders the gathering of AEFI data accessible to the public and potentially increases trust. By having active surveillance, which directly surveys the consumers in near real time and makes the results publicly available, active surveillance systems address transparency concerns and contribute to public confidence in the whole immunisation programme 2…”

“…Historically, pharmacovigilance has relied on passive surveillance for the detection of adverse events following immunisation (AEFI) with seasonal influenza vaccines. Until recently, post-marketing vaccine safety surveillance in Australia has been passive with several important and well-described limitations1–3 resulting in substantial delays. This was clearly illustrated in 2010 following an unprecedented increase in febrile seizures in young children ultimately determined to be associated with one brand of trivalent influenza vaccine (TIV), Fluvax (CSL Biotherapies) 4–6.…”