Pharmacovigilance in Vaccines: Importance, Main Aspects, Perspectives, and Challenges-A Narrative Review.

Autor: Hodel KVS; SENAI Institute of Innovation (ISI) in Health Advanced Systems (CIMATEC ISI SAS), SENAI CIMATEC University Center, Salvador 41650-010, Bahia State, Brazil., Fiuza BSD; SENAI Institute of Innovation (ISI) in Health Advanced Systems (CIMATEC ISI SAS), SENAI CIMATEC University Center, Salvador 41650-010, Bahia State, Brazil., Conceição RS; Department of Medicine, College of Pharmacy, Federal University of Bahia, Salvador 40170-115, Bahia State, Brazil., Aleluia ACM; SENAI Institute of Innovation (ISI) in Health Advanced Systems (CIMATEC ISI SAS), SENAI CIMATEC University Center, Salvador 41650-010, Bahia State, Brazil.; Department of Natural Sciences, Southwestern Bahia State University (UESB), Campus Vitória da Conquista, Vitória da Conquista 45031-300, Bahia State, Brazil., Pitanga TN; SENAI Institute of Innovation (ISI) in Health Advanced Systems (CIMATEC ISI SAS), SENAI CIMATEC University Center, Salvador 41650-010, Bahia State, Brazil.; Laboratory for Research in Genetics and Translational Hematology, Gonçalo Moniz Institute, FIOCRUZ-BA, Salvador 40296-710, Bahia State, Brazil., Fonseca LMDS; SENAI Institute of Innovation (ISI) in Health Advanced Systems (CIMATEC ISI SAS), SENAI CIMATEC University Center, Salvador 41650-010, Bahia State, Brazil., Valente CO; SENAI Institute of Innovation (ISI) in Health Advanced Systems (CIMATEC ISI SAS), SENAI CIMATEC University Center, Salvador 41650-010, Bahia State, Brazil., Minafra-Rezende CS; Faculty of Veterinary and Animal Science, Federal University of Goiás, Goiânia 74690-900, Goiás State, Brazil., Machado BAS; SENAI Institute of Innovation (ISI) in Health Advanced Systems (CIMATEC ISI SAS), SENAI CIMATEC University Center, Salvador 41650-010, Bahia State, Brazil.
Jazyk: angličtina
Zdroj: Pharmaceuticals (Basel, Switzerland) [Pharmaceuticals (Basel)] 2024 Jun 19; Vol. 17 (6). Date of Electronic Publication: 2024 Jun 19.
DOI: 10.3390/ph17060807
Abstrakt: Pharmacovigilance plays a central role in safeguarding public health by continuously monitoring the safety of vaccines, being critical in a climate of vaccine hesitancy, where public trust is paramount. Pharmacovigilance strategies employed to gather information on adverse events following immunization (AEFIs) include pre-registration data, media reports, clinical trials, and societal reporting. Early detection of AEFIs during clinical trials is crucial for thorough safety analysis and preventing serious reactions once vaccines are deployed. This review highlights the importance of societal reporting, encompassing contributions from community members, healthcare workers, and pharmaceutical companies. Technological advancements such as quick response (QR) codes can facilitate prompt AEFI reporting. While vaccines are demonstrably safe, the possibility of adverse events necessitates continuous post-marketing surveillance. However, underreporting remains a challenge, underscoring the critical role of public engagement in pharmacovigilance. This narrative review comprehensively examines and synthesizes key aspects of virus vaccine pharmacovigilance, with special considerations for specific population groups. We explore applicable legislation, the spectrum of AEFIs associated with major vaccines, and the unique challenges and perspectives surrounding pharmacovigilance in this domain.
Databáze: MEDLINE
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