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Adverse events following COVID-19 vaccination: A comprehensive analysis of spontaneous reporting data in Ghana. | LitMetric

AI Article Synopsis

  • - Vaccines played a crucial role in combating the COVID-19 pandemic in Ghana, with five receiving Emergency Use Authorization and presenting safety data from real-life deployment.
  • - An analysis of adverse events following immunization (AEFIs) showed a low overall incidence of AEFIs (25 per 100,000 vaccinated), with most being non-serious and more common in individuals under 50 years, especially females.
  • - Only a small percentage (14%) of serious AEFIs were linked to the vaccines, suggesting a need for public education on vaccine safety to enhance trust and acceptance.

Article Abstract

Vaccines are important public health tools and formed part of the fight against the COVID-19 pandemic. Five COVID-19 vaccines were given Emergency Use Authorization in Ghana and deployed during the pandemic. Early phase trials of the vaccines were mostly not conducted in Africans. This study examines safety data during their deployment under real-life conditions in Ghana. This study analysed secondary data on COVID-19 vaccine-related adverse events following immunization (AEFI) reported to the Ghana Food and Drugs Authority (GFDA) between March 2021 and June 2022 using STATA. AEFIs were coded with their Preferred Terms using the Medical Dictionary for Regulatory Activities, version 24.0. Statistical tests examined associations between demographic characteristics, vaccine types, seriousness, and AEFI outcomes. Binary logistic regression model assessed factors associated with serious AEFIs, while the GFDA's Joint COVID-19 Vaccine Safety Review Committee provided causality assessments of serious AEFIs. Overall cumulative incidence of AEFIs was about 25 per 100,000 persons vaccinated. Across the five vaccines, majority of the AEFIs reported were not serious (98.7%) with higher incidences in those below 50 years (74.0%) and females (51.2%). The most common AEFIs recorded were headache (52.9%), pains (44.4%), pyrexia (35.1%), chills (16.7%) and injection site pain (15.6%). Relative to those 50 years and above, the odds of serious AEFI were 60% less among those aged <30 years (aOR = 0.40, CI: [0.19, 0.86], p = 0.019). However, a causality assessment of the 57 serious AEFIs indicated only 8 (14%) were vaccine product-related. There was a low incidence of AEFIs following deployment of the vaccines in Ghana with a much lower incidence of serious AEFIs. Informing the public about the safety of the vaccines and potential side effects may increase trust and acceptance, decreasing hesitancy in current and future vaccination programmes.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11432875PMC
http://dx.doi.org/10.1371/journal.pgph.0003770DOI Listing

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