Ensuring vaccine safety: Case studies of falsified influenza vaccines detected in Brazil

Autor: Jaline Alves Cabral da Costa, Maria de Lourdes Aguiar-Oliveira, David Brown, Jorge Antonio Zepeda Bermudez, Eduardo Jorge Rabelo Netto, Ozéias de Lima Leitão, Antonio Eugenio Castro Cardoso de Almeida, Marilda Mendonça Siqueira
Jazyk: angličtina
Rok vydání: 2023
Předmět:
Zdroj: Vaccine: X, Vol 14, Iss , Pp 100343- (2023)
Druh dokumentu: article
ISSN: 2590-1362
DOI: 10.1016/j.jvacx.2023.100343
Popis: Falsifications related to health technologies—including vaccines—are a growing threat to patient safety and health systems on a global scale and can cause serious harm to the population (especially vulnerable groups). In Brazil, the manufacturing and spread of counterfeit medicines are prevented through joint actions between different government agencies. In this study, we analyzed three cases of influenza vaccines suspected of counterfeiting. The samples were seized by officials and received by the National Institute for Quality Control in Health (INCQS), the national quality control reference laboratory of the Ministry of Health of Brazil, in 2010, 2017, and 2020. We report the results of our analytical investigations and emphasize the importance of strengthening the partnerships between various national agencies. The seized samples were visually inspected, and their information was compared with that of genuine vaccines (as recorded in the INCQS database). The specific analytical tests were based on quality control tests for biological products. Our results confirmed that all seized samples were falsified. We emphasize the importance of fostering international and intra-national collaborations between various national agencies (such as drug regulatory authorities, official laboratories, customs departments, police forces, and civil society). As demonstrated here, such collaborative actions are essential for combating the release of falsified medical products, safeguarding public health, and strengthening health systems.
Databáze: Directory of Open Access Journals