Project Type: Prospective Cohort Study
Focus Area: Adverse Event Monitoring for COVID-19 Vaccines
Ciheb-Kenya, in partnership with stakeholders, conducted a Cohort Event Monitoring (CEM) study to assess the safety profile of COVID-19 vaccines in real-world use. The goal was to identify the incidence, severity, and patterns of adverse events following immunization among vaccine recipients in Kenya.
Study Overview
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Target sample size: 17,000 participants
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Enrolled: 9,288 participants
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Study focused on individuals who received approved COVID-19 vaccines under the national rollout.
Vaccine Distribution among Participants
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Janssen (J&J): 55.6%
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Pfizer (Grey Cap): 44.2%
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Pfizer (Purple Cap): 0.2%
Adverse Event Reporting
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A total of 6,265 adverse events were reported from 2,987 participants (approximately 32% of those enrolled).
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These events were assessed using MedDRA—a standardized global medical terminology used to classify and analyze adverse events by:
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System Organ Class (SOC)
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High-Level Group Term (HLGT)
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High-Level Term (HLT)
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Preferred Term (PT)
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Lowest Level Term (LLT)
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Current Status
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Data analysis and reporting have been completed.
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A manuscript is currently under peer review, with findings set to inform future vaccine safety policy and practice.