Active vaccine safety surveillance: Experience from a prospective cohort event monitoring study of COVID-19 vaccines in Kenya.

ABSTRACT: Although active vaccine safety surveillance (VSS) can complement passive VSS while overcoming the inherent limitations of spontaneous safety monitoring, it remains rare in sub-Saharan Africa. We conducted post-authorization active VSS of COVID-19 vaccines in Kilifi, Kenya using a cohort event monitoring study design. Participants were followed weekly over 13 weeks for adverse events. A subset was followed daily for one week for solicited systemic reactogenicity events (chills, fatigue, fever, headache, joint pain, malaise, muscle aches, nausea). The daily prevalence of reactogenicity events was compared to the 3-day pre-vaccine average using McNemar's test. The association of baseline characteristics with reactogenicity events was assessed using logistic regression. Between 28th September

SUBMITTER: Odhiambo DB 

PROVIDER: S-EPMC12622800 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature