Vacinas de Hepatite B monovalente produzidas por diferentes fabricantes: estudo comparativo da qualidade das vacinas no período pré e após o prazo de validade

Renata Faria de Carvalho; Simone Ferreira Teixeira Bastos; Fernando Fingola; Kátia Christina Leandro; Catia Ines Costa

doi:10.53393/rial.2015.v74.33461

Vol. 74 No. 2 (2015), ORIGINAL ARTICLE

Vol. 74 No. 2 (2015)

Hepatitis B monovalent vaccines produced by different manufacturers: comparative study on the quality of vaccine in period before and after the shelf life

ORIGINAL ARTICLE

https://doi.org/10.53393/rial.2015.v74.33461

Published 2016-03-28

Renata Faria de Carvalho⁺⁻
Simone Ferreira Teixeira Bastos⁺⁻
Fernando Fingola⁺⁻
Kátia Christina Leandro⁺⁻
Catia Ines Costa⁺⁻

Renata Faria de Carvalho

Fundação Instituto Oswaldo Cruz, Instituto Nacional de Controle de Qualidade em Saúde, Departamento de Imunologia, Laboratório de Vacinas Virais, Rio de Janeiro, RJ

Simone Ferreira Teixeira Bastos

Fundação Instituto Oswaldo Cruz, Instituto Nacional de Controle de Qualidade em Saúde, Departamento de Imunologia, Laboratório de Vacinas Virais, Rio de Janeiro, RJ

Fernando Fingola

Fundação Instituto Oswaldo Cruz, Instituto Nacional de Controle de Qualidade em Saúde, Departamento de Toxicologia e Farmacologia, Rio de Janeiro, RJ

Kátia Christina Leandro

Fundação Instituto Oswaldo Cruz, Instituto Nacional de Controle de Qualidade em Saúde, Departamento de Química, Rio de Janeiro, RJ

Catia Ines Costa

Fundação Instituto Oswaldo Cruz, Instituto Nacional de Controle de Qualidade em Saúde, Departamento de Imunologia, Laboratório de Vacinas Virais, Rio de Janeiro, RJ

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Keywords

hepatitis B vaccine
quality control
shelf life
potency
stability

How to Cite

1.

Carvalho RF de, Bastos SFT, Fingola F, Leandro KC, Costa CI. Hepatitis B monovalent vaccines produced by different manufacturers: comparative study on the quality of vaccine in period before and after the shelf life. Rev Inst Adolfo Lutz [Internet]. 2016 Mar. 28 [cited 2024 Jul. 22];74(2):97-103. Available from: https://periodicos.saude.sp.gov.br/RIAL/article/view/33461

Abstract

For over 20 years, the hepatitis B (HB) vaccine has been produced by the expression of the viral gene encoding the hepatitis B surface antigen (HBsAg) in yeast. According to the data from WHO, the hepatitis B vaccines are generally stable for up to three years when stored at 2 ºC to 8 ºC. The purpose of this study was to evaluate whether the hepatitis B vaccine, at the time of their release, the quality criteria of this product were maintained seven years after the expiration date. Vaccine vials in multi-dose (10 and 05 doses) and three lots from each manufacturer (A, B and C) were analyzed. All batches were assayed for visual appearance, potency, bacterial endotoxin, thiomersal amount, aluminum hidroxyde contents and pH by means of validated tests. The nine lots evaluated seven years after the expiration date showed similar concentrations when compared to those demonstrated at the time of batches release by the National Institute for Quality Control in Health (INCQS). No significant change in the quality of the hepatitis B vaccine after the expiration date was confirmed. These data might be useful to subsidize a future evaluation for reviewing an extension of the vaccines shelf life.

https://doi.org/10.53393/rial.2015.v74.33461

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