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O-16 Safety Reporting of COVID-19 Vaccines in the Caribbean through Regional and Global Systems in 2021

Author(s): R Extavour , K Ottley
Type Of Study:
  • Observational Study
Country(ies) Of Focus:
  • CARICOM Countries
Year of Presentation: 2022

Abstract

Objective: The objectives of this study are to: (i) identify the COVID-19 vaccines included in CARICOM adverse events following immunization (AEFI) reports in 2021, (ii) identify commonly reported AEFIs, and adverse events of special interest (AESIs), and (iii) describe the reporting rates of AEFIs and AESIs from CARICOM in 2021.

Methods: A cross-sectional census of case safety reports of AEFIs from CARICOM to the regional and global databases in 2021 was conducted. Counts and percentages of vaccines reported and reactions were calculated. For countries reporting to the global database, AEFIs and AESIs per 100,000 doses were determined.

Results: AEFI reports involved COVID-19 vaccine AstraZeneca (76%), Tozinameran (Pfizer-BioNTech, 19%), BIBP-Sinopharm (2.7%), COVID-19 Janssen (1.2%), and Sputnik V (0.4%). Commonly reported reactions (>10%) were: headache, pyrexia, fatigue, chills, dizziness, myalgia, arthralgia, vaccination site pain, malaise, and nausea. AESIs reported were: anaphylaxis (36% of AESI reports), ageusia (15%), Bell’s palsy (15%), thrombosis (11%), seizures (11%), anosmia (6%), arrhythmia (2%), myocarditis (2%), pericarditis (2%), Guillain-BarrĂ© syndrome (2%), and vasculitis (2%). Based on doses administered, there were 73 AEFI reports per 100,000 doses, and 3 AESI reports per 100,000 doses in 2021.

Conclusion: The CARPHA VigiCarib network provides CARICOM states with opportunities to strengthen COVID19 vaccine safety surveillance by collection and sharing of information on COVID-19 vaccine safety reports. Underreporting at local levels, and underrepresentation by CARICOM states in the regional or global programmes for safety monitoring continue to be key challenges.

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