Using Population-Based Structures to Actively Monitor AEFIs during a Mass Immunization Campaign—A Case of Measles–Rubella and Polio Vaccines

Joan Tusabe,Dan Kajungu,Victoria Nambasa,Beate Kampmann,Michael Muhoozi,Jim Todd

doi:10.3390/vaccines9111293

Abstract

Active vaccine pharmacovigilance complements the standard passive or spontaneous surveillance system, which suffers from low reporting rates. This study aimed at utilizing population-based structures to report and profile adverse events following immunization (AEFI) with the measles and rubella vaccine (MR), or MR in combination with the bivalent oral polio vaccine (bOPV 1&3) (MR & bOPV), during mass vaccination in Uganda. Caretakers of children at home (less than 5 years) and schoolgoing children were followed up on and encouraged to report any AEFIs on day one, 2–3 days, 10 days, and 14 days after vaccination at school by their teachers and at-home, community-based village health teams. Out of 9798 children followed up on, 382 (3.9%) reported at least one AEFI, and in total, 517 AEFIs were reported. For MR, high temperature (21%), general feeling of weakness (19.3%), and headache (13%) were the most reported AEFIs, though there were variations on the days when they were reported. For the combination dose of MR & bOPV, high temperature (44%), rash (17%), general feeling of weakness (13%), and diarrhoea (8%) were the most common adverse events following immunization reported by caretakers. All 382 children cleared the AEFIs within 2 days, with 343 (90%) children reporting mild or moderate AEFIs and only 39 (10%) reporting severe AEFIs. The reported AEFIs are known and are mentioned in the vaccine leaflets with similar severity classification. Rates of AEFIs differed with the number of days after receiving the immunization. Conclusion: Active surveillance for AEFIs provides additional important information to national vaccine regulatory bodies. It reassures the public that vaccines are safe and that their safety is being taken seriously in Uganda, which would improve vaccine acceptability and confidence in the health system. Piggybacking on existing structures such as village health team members (for children at home) and teachers (for schoolgoing children) facilitates reaching vaccine recipients and increases reporting rates. Therefore, studies using active reporting of AEFIs should be conducted at regular intervals to report the overall incidence of AEs and to monitor trends and changes.

Highlights

Vaccination is one of the most cost-effective interventions for global health, which has led to protection against transmissible infections in recent decades, leading to an expressive impact on child morbidity and mortality [1,2,3,4]
National immunization programs aim at increasing uptake of vaccines in the population to mitigate the impact of vaccine-preventable diseases (VPDs)
It is important to differentiate these types of concerns by implementing appropriate surveillance systems for adverse event following immunization” (AEFI), with timely and thorough scientific assessment

Summary

Introduction

Vaccination is one of the most cost-effective interventions for global health, which has led to protection against transmissible infections in recent decades, leading to an expressive impact on child morbidity and mortality [1,2,3,4]. Despite these significant contributions, the general public has concerns about potential vaccine-associated risks, including adverse events following immunization, which can undermine such successes. Concerns related to vaccine safety, which may be baseless or legitimate, tend to emerge These concerns may be falsely attributed to the memorable immunization event or may be real vaccine-induced reactions [6]. It is important to differentiate these types of concerns by implementing appropriate surveillance systems for AEFIs, with timely and thorough scientific assessment

Objectives

Methods

Results

Conclusion