Vacinação de cães e gatos e o alinhamento entre bulas comerciais e diretrizes científicas

Abstract

Introduction: Immunoprophylaxis is a cornerstone of preventive Veterinary Medicine, essential for the control of infectious and zoonotic diseases in dogs and cats, being a determining factor for the healthy aging and longevity of these animals. However, the Brazilian scenario is marked by a notable discrepancy between the information contained in commercial veterinary vaccine package inserts and international scientific guidelines. This lack of alignment raises concerns regarding the immunological efficacy and safety of adopted clinical protocols, especially in vulnerable populations such as geriatrics, demanding an in-depth analysis to identify and discuss the technical-regulatory, clinical, ethical, and legal implications. Objectives: The present study aimed to comparatively analyze the information contained in 40 veterinary vaccine package inserts marketed in Brazil (23 for dogs, 7 anti-rabies for dogs and cats, and 10 for cats) against international guidelines from WSAVA, AAHA, and AAFP, in light of recent scientific evidence and national regulations, identifying technical-regulatory divergences and convergences, and discussing their clinical, ethical, and legal implications for veterinary practice, with a focus on promoting healthy aging. Methodology: A conformity study was conducted through a comparative documentary analysis of 40 veterinary vaccine package inserts valid in Brazil until November 2025, obtained from manufacturers' websites and validated by registration with MAPA. The information was confronted with international guidelines (WSAVA 2024, AAHA 2022, AAFP 2020) and national regulations, focusing on composition, periodicity, safety, and clinical applicability. The conformity classification was established as: Conformant (information fully aligned), Partially Conformant (information present but incomplete or with caveats), and Non-Conformant (information absent, contradictory, or not recommended). Results and Discussion: The package inserts showed 100% conformity in the composition of core antigens, but non-conformity in vaccination periodicity (91% prescribing annual boosters without considering the Duration of Immunity - DoI). Non-conformity was observed in the inclusion of non-recommended antigens (48% of inserts with CCoV and Giardia duodenalis) and in the absence of conditioning the use of non-core vaccines on risk assessment. No package insert (0%) demonstrated conformity in providing specific guidelines for geriatric, pregnant, immunosuppressed animals, or shelter populations, indicating a complete gap in these special conditions. The absence of any mention of serological testing as a clinical decision-support tool in the package inserts represents complete non-conformity. Brazilian federal and state legislations still support annual anti-rabies campaigns, demonstrating normative fragmentation in the face of scientific evidence supporting longer intervals. Conclusion: The results confirm that veterinary vaccine package inserts marketed in Brazil remain outdated relative to evidence-based international recommendations, which impacts the ability to promote the healthy aging of animals. This regulatory and technical non-conformity reinforces the need for greater integration among the veterinary pharmaceutical industry, regulatory bodies, and the scientific community. The critical and evidence- based role of the veterinarian is indispensable for adapting vaccination protocols, ensuring immunological safety, and promoting ethical, rational, and globally aligned immunoprophylaxis, contributing to the longevity and well-being of animals at all life stages.