巴西疫苗采用决策过程中的多重挑战：儿童肺炎球菌结合疫苗的案例

IF 4.7 3区医学 Q1 INFECTIOUS DISEASES

Journal of Infection and Public Health Pub Date : 2025-05-08 DOI:10.1016/j.jiph.2025.102812

Ana Marli Christovam Sartori , Patrícia Coelho de Soárez , Hillegonda Maria Dutilh Novaes , Thayssa Veiga da Fonseca Victer , Ana Catarina de Melo Araujo , Greice Madeleine Ikeda do Carmo , Marcelo Yoshito Wada , Eder Gatti Fernandes

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引用次数: 0

摘要

本文的目的是审查一个中等收入国家采用新疫苗的过程。方法采用一项内在解释性案例研究，分析巴西儿童免疫计划中将10价肺炎球菌结合疫苗（PCV10）转换为PCV13的最新决策过程。我们分析了Conitec （comisso Nacional de incorporated a o de tecologias no Sistema Único de Saúde）的官方文件。结果2022年11月，Conitec全体会议首先建议从PCV10转向PCV13，考虑到PCV13与PCV10的非劣效性和相似的安全性，惠氏/辉瑞提出的价格低于目前的做法，以及惠氏/辉瑞进行的经济分析中观察到的可能的资源节约情况。在2023年4月的第二次会议上，根据国家免疫规划提供的额外科学、行政和技术数据，主要是流行病学数据显示近期肺炎球菌病（PD）没有增加，Conitec最终决定当时不引入PCV13。需要增加疫苗接种覆盖率，以更好地控制帕金森病，并在全国范围内对疫苗可预防的细菌性疾病实施哨点监测，以更好地评估帕金森病负担和血清型替代，以及国家技术发展和疫苗生产自给自足。结论我们的案例表明，采用新疫苗的决策过程因国家而异，涉及多个层面的政治优先次序和复杂的技术方面，并取决于强大的公共卫生机构的存在。

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Multidimensional challenges in Brazil's decision-making process of vaccines adoption: The case of childhood pneumococcal conjugate vaccines

The objective of this paper was to examine the process of adopting new vaccines in a middle-income country.

Methods

We used an intrinsic explanatory case study to analyze the recent decision-making process of switching 10-valent Pneumococcal Conjugate Vaccine (PCV10) to PCV13 in the Brazilian childhood immunization schedule. We analyzed Conitec (Comissão Nacional de Incorporação de Tecnologias no Sistema Único de Saúde) official documents.

Results

In November 2022, the Conitec plenary recommended, at first, switching from PCV10 to PCV13, considering PCV13 non-inferiority and similar safety profile to PCV10, the price proposed by Wyeth/Pfizer, below the currently practiced, and the scenario of possible resource savings observed in an economic analysis conducted by Wyeth/Pfizer. In a second meeting, in April 2023, Conitec final decision was not to introduce PCV13 at that moment, based on additional scientific, administrative and technical data presented by the National Immunization Program, mainly epidemiological data showing no recent increase of pneumococcal disease (PD), the need to increase vaccination coverage to better control PD and to implement a sentinel surveillance of vaccine-preventable bacterial diseases with nationwide representation to better evaluate PD burden and serotypes replacement, and the country technological development and self-sufficiency in vaccine production.

Conclusions

Our case showed the decision-making process of adopting new vaccines is country-specific and involve many levels of political prioritization and complex technical aspects, and depends on the presence of strong public health institutions.

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来源期刊

Journal of Infection and Public Health PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH -INFECTIOUS DISEASES

CiteScore

13.10

自引率

1.50%

发文量

203

审稿时长

96 days

期刊介绍： The Journal of Infection and Public Health, first official journal of the Saudi Arabian Ministry of National Guard Health Affairs, King Saud Bin Abdulaziz University for Health Sciences and the Saudi Association for Public Health, aims to be the foremost scientific, peer-reviewed journal encompassing infection prevention and control, microbiology, infectious diseases, public health and the application of healthcare epidemiology to the evaluation of health outcomes. The point of view of the journal is that infection and public health are closely intertwined and that advances in one area will have positive consequences on the other. The journal will be useful to all health professionals who are partners in the management of patients with communicable diseases, keeping them up to date. The journal is proud to have an international and diverse editorial board that will assist and facilitate the publication of articles that reflect a global view on infection control and public health, as well as emphasizing our focus on supporting the needs of public health practitioners. It is our aim to improve healthcare by reducing risk of infection and related adverse outcomes by critical review, selection, and dissemination of new and relevant information in the field of infection control, public health and infectious diseases in all healthcare settings and the community.