European journal of clinical pharmacology · 2026
Most COVID-19 vaccine adverse events detected within 48 hours in Ethiopia: implications for cohort event monitoring efficiency in resource-limited settings.
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Gebreyesus Tigist Dires, Shute Teshita, Alemu Asnakech, Berha Alemseged Beyene, Maru Mehiret, Gashaw Habtamu, Kifle Meron, Doherty Julie, Figueras Albert
Аннотация
BACKGROUND: The World Health Organization recommends cohort event monitoring with a 30-day follow-up period for vaccine safety surveillance in low- and middle-income countries (LMICs). However, in resource-limited settings, operational and logistical constraints necessitate evaluation of the efficiency and feasibility of this follow-up duration.
METHODS: We conducted an analysis of a prospective active surveillance study of 10,948 adults who received the Pfizer COVID-19 vaccine in Ethiopia (August 2021-June 2022), using immediate observation and telephone follow-up on days 2, 4, 7, 14, 21, and 30.
RESULTS: Among 10,948 participants, 4,236 (38.7%; 95% CI: 37.8-39.6%) reported at least one adverse event following immunisation (AEFI), with 6,174 total events recorded. Of all events, 88.2% were detected within 48 h (1.8% immediate, 86.4% at day 2), while 11.8% were identified during subsequent follow-up between days 4 and 30. Seven reactogenic symptoms comprised 93.8% of AEFIs. No serious AEFIs or adverse events of special interest were identified. Over nine months, 138 healthcare professionals captured predominantly mild, expected reactions through extended surveillance.
CONCLUSIONS: Most COVID-19 vaccine adverse events in Ethiopia occurred within 48 h of vaccination, empirically suggesting that extended full-cohort CEM could yield diminishing informational returns in low- and middle-income country settings. A hybrid surveillance approach combining intensive short-term active surveillance during the first 48 h, enhanced passive reporting, and sentinel hospital networks with adequate diagnostic capacity could offer a more sustainable and operationally realistic framework. These findings are offered as an evidence-based reference for national regulatory authorities planning or conducting emergency vaccine safety surveillance in comparable contexts, supporting a transition from product-centred extended monitoring towards patient-centred, resource-adapted pharmacovigilance.
CLINICAL TRIAL NUMBER: Not applicable.
METHODS: We conducted an analysis of a prospective active surveillance study of 10,948 adults who received the Pfizer COVID-19 vaccine in Ethiopia (August 2021-June 2022), using immediate observation and telephone follow-up on days 2, 4, 7, 14, 21, and 30.
RESULTS: Among 10,948 participants, 4,236 (38.7%; 95% CI: 37.8-39.6%) reported at least one adverse event following immunisation (AEFI), with 6,174 total events recorded. Of all events, 88.2% were detected within 48 h (1.8% immediate, 86.4% at day 2), while 11.8% were identified during subsequent follow-up between days 4 and 30. Seven reactogenic symptoms comprised 93.8% of AEFIs. No serious AEFIs or adverse events of special interest were identified. Over nine months, 138 healthcare professionals captured predominantly mild, expected reactions through extended surveillance.
CONCLUSIONS: Most COVID-19 vaccine adverse events in Ethiopia occurred within 48 h of vaccination, empirically suggesting that extended full-cohort CEM could yield diminishing informational returns in low- and middle-income country settings. A hybrid surveillance approach combining intensive short-term active surveillance during the first 48 h, enhanced passive reporting, and sentinel hospital networks with adequate diagnostic capacity could offer a more sustainable and operationally realistic framework. These findings are offered as an evidence-based reference for national regulatory authorities planning or conducting emergency vaccine safety surveillance in comparable contexts, supporting a transition from product-centred extended monitoring towards patient-centred, resource-adapted pharmacovigilance.
CLINICAL TRIAL NUMBER: Not applicable.