Pharmacovigilance capacity strengthening for WHO prequalification: The case of the trivalent influenza vaccine manufactured by Instituto Butantan.

Instituto Butantan is a biomedical research center and vaccine manufacturer affiliated with the São Paulo State Secretary of Health in Brazil. In 2013, Instituto Butantan successfully licensed its trivalent influenza vaccine, in order to support the Brazilian National Immunization Program's influenza vaccination strategy, which was introduced in 1999. In order to respond to the increasing influenza vaccine demand worldwide, Instituto Butantan is undergoing prequalification of its trivalent influenza vaccine by the World Health Organization (WHO). A key requirement of the prequalification review was the submission of a pharmacovigilance plan, including an active surveillance evaluation, for the trivalent influenza vaccine, and proof of a functional pharmacovigilance system at Instituto Butantan. The aim of this paper is to describe the capacity strengthening process of the pharmacovigilance system at Instituto Butantan for the WHO prequalification of the trivalent influenza vaccine. This process was supported by PATH and the U.S. Federal Government Biomedical Advanced Research and Development Authority (BARDA). The key strategic axes for this capacity strengthening process included the improvement of organizational structure, human resources training, internal processes and procedures, appropriate documentation, and acquisition of an E2B compliant pharmacovigilance database. The project led to the establishment of a functional pharmacovigilance system compliant with international regulatory requirements.

Effectiveness of influenza vaccination of schoolchildren in the city of São Paulo, Brazil, 2009.

BACKGROUND: Children play an important role in maintaining the transmission of influenza. Evidence suggests that vaccination of school-age children can reduce transmission to unvaccinated household contacts. We evaluated the direct and indirect effectiveness of the 2009 inactivated seasonal influenza vaccine in vaccinated schoolchildren and their unvaccinated household contacts. METHODS: This was a double-blind cluster randomized trial involving 10 schools and 1742 schoolchildren as well as 5406 household contacts. The schools were randomly assigned to receive the influenza vaccine or the control vaccine. After vaccination, the schoolchildren and household contacts were followed for 6 months to identify cases of acute respiratory infection (ARI). Reverse-transcriptase polymerase chain reaction was performed for the diagnosis of influenza. RESULTS: A total of 632 ARI cases were detected. Of those, 103 tested positive for influenza virus (influenza virus A[H1N1]pdm09 virus in 55 and seasonal influenza viruses in 48). The effectiveness of the vaccine in protecting against seasonal influenza virus infection was 65·0% for the household contacts (95% CI, 19·6-84·3) and 65·0% for the schoolchildren (95% CI, 20·9-84·5). CONCLUSION: Vaccination of schoolchildren significantly protected them and their household contacts against seasonal influenza.

Effectiveness of the Brazilian influenza vaccination policy, a systematic review.

Since 1999, Brazil has undertaken annual influenza vaccine campaigns, free of charge, targeting the elderly population, health professionals, and immune-deficient patients. We conducted a systematic review of literature in order to evaluate the effectiveness of the initiative. We used the keywords influenza, vaccine, Brazil and effectiveness to search the main databases. Thirty-one studies matched our inclusion and exclusion criteria. Influenza vaccine coverage among the elderly is high, though not as high as suggested by the official figures. Estimates on effectiveness are scarce. The majority come from ecological studies that show a modest reduction in mortality and hospital admissions due to influenza-related causes. Such reduction is not evident in the North and Northeastern states of Brazil, a finding that is probably related to the different seasonal pattern of influenza in equatorial and tropical regions. Brazilian epidemiologists still owe society better-designed studies addressing the effectiveness of influenza vaccine campaigns.

Effectiveness of the Brazilian influenza vaccination policy, a systematic review / Efetividade da política brasileira de vacinação contra influenza, uma revisão sistemática

Since 1999, Brazil has undertaken annual influenza vaccine campaigns, free of charge, targeting the elderly population, health professionals, and immune-deficient patients. We conducted a systematic review of literature in order to evaluate the effectiveness of the initiative. We used the keywords influenza, vaccine, Brazil and effectiveness to search the main databases. Thirty-one studies matched our inclusion and exclusion criteria. Influenza vaccine coverage among the elderly is high, though not as high as suggested by the official figures. Estimates on effectiveness are scarce. The majority come from ecological studies that show a modest reduction in mortality and hospital admissions due to influenza-related causes. Such reduction is not evident in the North and Northeastern states of Brazil, a finding that is probably related to the different seasonal pattern of influenza in equatorial and tropical regions. Brazilian epidemiologists still owe society better-designed studies addressing the effectiveness of influenza vaccine campaigns.

Desde 1999 o Brasil realiza campanhas anuais de vacinação contra influenza. A vacinação é gratuita, e tem como grupos alvo os idosos, os profissionais de saúde e os pacientes com comprometimento imunitário. Nós realizamos uma revisão sistemática da literatura, com o propósito de avaliar a efetividade desta iniciativa. Foram usadas as palavras chave influenza, vacina, Brasil e efetividade, para a busca nas bases de dados mais relevantes. Trinta e um estudos se encaixaram nos nossos critérios de inclusão e exclusão. A cobertura vacinal nos idosos é alta, porém não tão alta como apresentado nos dados oficiais. Estimativas de efetividade são escassas. A maioria delas vem de estudos ecológicos, que demonstram um modesto efeito na redução da mortalidade e internações hospitalares por causas relacionadas à influenza. Esta redução não se evidencia nos estados do Norte e Nordeste do Brasil, achado que provavelmente relaciona-se ao padrão distinto de sazonalidade da influenza nas regiões equatoriais e tropicais. Os epidemiologistas brasileiros ainda devem à sociedade estudos com desenhos mais adequados à análise da efetividade das campanhas de vacinação contra influenza.