Avaliação do controle da qualidade realizado nos produtos vacinais para sarampo, caxumba e rubéola utilizados no programa nacional de imunizações do Brasil no período de 1999 a 2007 / Evaluation of the quality control data records for the measles, mumps, rubella vaccine products used in the Brazilian national immunization program in the period from 1999 to 2007

Os registros de controle da qualidade dos produtos vacinais contra sarampo, caxumba e rubéola (VSCR), utilizados no Programa Nacional de Imunizações do Brasil, no período de 1999 a 2007, foram avaliados por meio de levantamento de dados provenientes do Sistema de Gerenciamento de Amostras do Instituto Nacional de Controle de Qualidade em Saúde da FIOCRUZ. Foram analisados 512 lotes da vacina, produzidos por nove laboratórios distintos, quanto ao registro de dados do controle de qualidade das VSCR, por meio dos seguintes parâmetros: (i.) análise dos protocolos de produção e de controle de qualidade do produto emitidos pelo fabricante; (ii.) ensaio de potência; (iii.) ensaio de identidade; (iv.) ensaio de termoestabilidade; (v.) ensaio de esterilidade bacteriana e fúngica; e (vi.) teor de umidade residual. Resultados insatisfatórios foram encontrados nos lotes de vacinas utilizadas nos anos de 1999 e 2001, com desvios nos parâmetros de qualidade e de conformidade em 12 lotes utilizados em 1999 e 11 lotes, em 2001, produzidos por quatro diferentes laboratórios. Os registros da qualidade de lotes de vacinas, empregadas a partir de2002, apresentaram parâmetros satisfatórios, o que indica conformidade com a Farmacopeia Brasileira e assegura a qualidade do produto utilizado no país.

This study aimed at evaluating the quality control protocols attested on the measles, mumps and rubella vaccines by manufacturers, and being used in the Brazilian National Immunization Program from 1999 to 2007. Analytical data on the protocols of 512 vaccine batches attested by respective manufacturers, and kept at INCQS/FIOCRUZ - Sample Management System, were analyzed. Vaccines produced by nine different laboratories , were evaluated considering: (i) potency testing, (ii) identity assay, (iii) thermo stability, (iv) bacterial and fungal sterility assay, (v) residual humidity contents, and (vi) vaccine production and respective quality control protocols stated by manufacturers. Unsatisfactory findings on quality were detected in 12and 11 vaccine batches, produced by four laboratories, which were employed by Vaccination Program in 1999 and 2001, respectively. From 2002 on, all the vaccines quality data have been satisfactory, and in compliance with the Brazilian Pharmacopeia parameters.

Imunogenicidade da cepa avirulenta RV194-2 do vírus rábico em camundongos / Immunogenicity of the RV194-2 rabies virus avirulent strain in mice

RV194-2 rabies virus, an avirulent mutant of CVS strain, induces an inapparent infection limited to the central nervous system (CNS) in adult mice inoculated intracerebrally. This fact suggest that immune response of the host is able to eliminate the virus in CNS. For this reason, we have studied the induction of interferon and the humoral immune responses in BALB/c mice after RV194-2 inoculation. These mice presented high levels of interferon in the plasma and in the brain, with elevated levels of neutralizing antirabies antibodies. The 2-5A synthetase, an enzyme marker of interferon action, was analyzed in the brain of inoculated animals. Its enhancement in parallel to the interferon production in the brain, showed biochemical evidence that this interferon is active. Forty five days after RV194-2 virus inoculation, mice were protected against a challenge with the CVS virulent strain. The results presented herein show that RV194-2 strain has a high level of immunogenicity.