Introduction of Respiratory Syncytial Virus Vaccine for Pregnant Women in Brazil's National Immunization Program: Cost-Effectiveness Analysis and Equity

• Grant number: 24/07223-0
• Support Opportunities: Scholarships in Brazil - Doctorate (Direct)
• Start date: February 01, 2025
• End date: January 31, 2028
• Field of knowledge: Health Sciences - Collective Health - Public Health
• Principal Investigator: Patricia Coelho de Soárez
• Grantee: Sophia Aguiar Monteiro Borges
• Host Institution: Faculdade de Medicina (FM). Universidade de São Paulo (USP). São Paulo , SP, Brazil

Abstract

Respiratory Syncytial Virus (RSV) is a major cause of pneumonia and bronchiolitis in infants and children in Brazil and worldwide, leading to significant hospitalizations during early childhood. Currently, the only preventive measure available through the Unified Health System (SUS) is the monoclonal antibody palivizumab. However, recent advancements in vaccine development have led to promising results with the bivalent prefusion RSV F protein vaccine (RSVpreF). This vaccine, after successful phase 3 clinical trials in 2023, received approval from the National Health Surveillance Agency (ANVISA) in April of this year. Its potential introduction into the National Immunization Program (PNI) prompts an evaluation of its cost-effectiveness, safety, and impact on public health. This study aims to assess the cost-effectiveness of incorporating the RSV vaccine into the PNI's immunization schedule for pregnant women, considering both health system and societal perspectives, as well as its broader implications for equity. Through a systematic literature review of economic evaluation studies, epidemiological estimates, and resource utilization related to RSV-associated illnesses in children under 1 year, this research seeks to inform decision-making regarding the introduction of the RSV vaccine into the national immunization program. From documents, guidelines, databases, and published studies, epidemiological estimates and resource utilization related to bronchiolitis, pneumonia, and severe acute respiratory syndrome caused by RSV in children under 1 year will be made. This will allow the evaluation of the cost-effectiveness of vaccination in the national calendar of the Unified Health System (SUS). Subsequently, an Extended Cost-Effectiveness Analysis will be conducted, considering health benefits, protection against financial risks, costs, and equity - the distributive consequences of vaccination across different income quintiles of the population.