Ensuring vaccine safety: Case studies of falsified influenza vaccines detected in Brazil
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 thr...
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| Format: | Article |
| Language: | English |
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Elsevier
2023-08-01
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| Series: | Vaccine: X |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2590136223000840 |
| _version_ | 1827875669789376512 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Jaline Alves Cabral da Costa |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-12T17:11:15Z |
| format | Article |
| id | doaj.art-5fc36f35edba41e2a1357786046037c2 |
| institution | Directory Open Access Journal |
| issn | 2590-1362 |
| language | English |
| last_indexed | 2024-03-12T17:11:15Z |
| publishDate | 2023-08-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Vaccine: X |
| spelling | doaj.art-5fc36f35edba41e2a1357786046037c22023-08-06T04:38:18ZengElsevierVaccine: X2590-13622023-08-0114100343Ensuring vaccine safety: Case studies of falsified influenza vaccines detected in BrazilJaline Alves Cabral da Costa0Maria de Lourdes Aguiar-Oliveira1David Brown2Jorge Antonio Zepeda Bermudez3Eduardo Jorge Rabelo Netto4Ozéias de Lima Leitão5Antonio Eugenio Castro Cardoso de Almeida6Marilda Mendonça Siqueira7National National Institute for Quality Control in Health (INCQS), Oswaldo Cruz Foundation, Av. Brazil, 4365, Manguinhos, Rio de Janeiro CEP 21040-360, Brazil; Corresponding author at: Oswaldo Cruz Foundation, Avenida Brasil 4365, Rio de Janeiro, RJ 21040-360, Brazil.Laboratory of Respiratory Virus and Measles, Oswaldo Cruz Institute, Oswaldo Cruz Foundation, Av. Brazil, 4365, Manguinhos, Rio de Janeiro CEP 21040-360, BrazilLaboratory of Respiratory Virus and Measles, Oswaldo Cruz Institute, Oswaldo Cruz Foundation, Av. Brazil, 4365, Manguinhos, Rio de Janeiro CEP 21040-360, BrazilSergio Arouca National School of Public Health (ENSP), Oswaldo Cruz Foundation, Av. Brazil, 4365, Manguinhos, Rio de Janeiro CEP 21040-360, BrazilNational National Institute for Quality Control in Health (INCQS), Oswaldo Cruz Foundation, Av. Brazil, 4365, Manguinhos, Rio de Janeiro CEP 21040-360, BrazilNational National Institute for Quality Control in Health (INCQS), Oswaldo Cruz Foundation, Av. Brazil, 4365, Manguinhos, Rio de Janeiro CEP 21040-360, BrazilNational National Institute for Quality Control in Health (INCQS), Oswaldo Cruz Foundation, Av. Brazil, 4365, Manguinhos, Rio de Janeiro CEP 21040-360, BrazilLaboratory of Respiratory Virus and Measles, Oswaldo Cruz Institute, Oswaldo Cruz Foundation, Av. Brazil, 4365, Manguinhos, Rio de Janeiro CEP 21040-360, BrazilFalsifications 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.http://www.sciencedirect.com/science/article/pii/S2590136223000840Falsified vaccineInfluenza vaccineBrazilQuality controlPublic health |
| spellingShingle | 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 Ensuring vaccine safety: Case studies of falsified influenza vaccines detected in Brazil Vaccine: X Falsified vaccine Influenza vaccine Brazil Quality control Public health |
| title | Ensuring vaccine safety: Case studies of falsified influenza vaccines detected in Brazil |
| title_full | Ensuring vaccine safety: Case studies of falsified influenza vaccines detected in Brazil |
| title_fullStr | Ensuring vaccine safety: Case studies of falsified influenza vaccines detected in Brazil |
| title_full_unstemmed | Ensuring vaccine safety: Case studies of falsified influenza vaccines detected in Brazil |
| title_short | Ensuring vaccine safety: Case studies of falsified influenza vaccines detected in Brazil |
| title_sort | ensuring vaccine safety case studies of falsified influenza vaccines detected in brazil |
| topic | Falsified vaccine Influenza vaccine Brazil Quality control Public health |
| url | http://www.sciencedirect.com/science/article/pii/S2590136223000840 |
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