Immunobiological cold chain performance assessment in Brazil: mixed methods research
Gabriela Gonçalves Amaral1,2, Ione Carvalho Pinto3,4, Thayane Ingrid Xavier de Andrade5
1Graduate Program in Public Health Nursing, University of São Paulo at Ribeirão Preto College of Nursing, Ribeirão Preto, São Paulo, Brazil. g.amaral@usp.br.
BMC Health Services Research
|June 25, 2026
Summary
The immunobiological cold chain in Brazil is performing inadequately, with factors like vaccination coverage and urban location influencing performance. Challenges include structural, logistical, and financial issues across diverse regions.
Area of Science:
- Public Health
- Vaccine Logistics
- Healthcare Management
Background:
- Effective cold chain maintenance is crucial for preserving the composition, efficacy, and potency of immunobiologicals.
- Ensuring immunogenicity relies heavily on the integrity of the cold chain throughout vaccine distribution.
Purpose of the Study:
- To evaluate the performance of the immunobiological cold chain within vaccination rooms at Primary Health Care units in Brazil.
- To identify factors influencing the adequate performance of the vaccine cold chain in Brazil.
Main Methods:
- A mixed-methods study utilizing a sequential explanatory design (QUAN→qual) in Brazilian vaccination rooms (2021-2022).
- Quantitative phase: Cross-sectional study with the Immunobiological Agent Conservation Assessment Scale and municipal indicators; logistic regression analysis.
- Qualitative phase: Descriptive-exploratory study with semi-structured interviews of managers and nursing professionals, analyzed using thematic content analysis.
Main Results:
- National-level cold chain performance was classified as inadequate.
- Factors associated with adequate performance included DTPw-HB/Hib vaccination coverage and urban location.
- Qualitative data highlighted structural, logistical, and organizational challenges, including regional inequalities, transportation issues, infrastructure deficits, and financial constraints.
Conclusions:
- The immunobiological cold chain performance in Brazil is inadequate, influenced by the country's vast territory and climate diversity impacting transportation.
- Limitations in physical infrastructure, regional financial disparities, and weaknesses in municipal management contribute to inadequate cold chain performance.
Related Concept Videos
01:13Bioequivalence studies: Biowaivers
In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
01:15Bioequivalence Experimental Study Designs: Repeated Measures, Cross-Over, Carry-Over, and Latin Square Designs
Bioequivalence experimental study designs play a pivotal role in testing the effectiveness of various treatments. Key among these are the repeated measures, cross-over, carry-over, and Latin square designs. In the repeated measures design, each subject receives all treatments, allowing for temporal comparisons. This type of design is useful in reducing variability but requires careful planning to avoid bias.The cross-over design, an economical method, involves sequential administration of...
01:20Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs
Bioequivalence experimental study designs are crucial methodologies used in evaluating and comparing the bioavailability of different drug products. These designs are categorized into various types: completely randomized, randomized block, repeated measures, cross and carry-over, and Latin square designs.Completely randomized designs involve randomly allocating treatments to all subjects participating in the experiment. This allocation is achieved by assigning unique random numbers to subjects...
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...
01:22Development of Immunocompetence
The initiation of cell-mediated immunity can be observed as early as the third month of fetal growth, with active antibody-mediated immunity following approximately one month later.
The initial cells that migrate from the fetal thymus settle within the skin and epithelial tissues lining the mouth, digestive tract, and in females, the uterus and vagina. These cells, including skin-based dendritic cells, serve as antigen-presenting cells, playing a key role in T cell activation.
Subsequent T...
The initial cells that migrate from the fetal thymus settle within the skin and epithelial tissues lining the mouth, digestive tract, and in females, the uterus and vagina. These cells, including skin-based dendritic cells, serve as antigen-presenting cells, playing a key role in T cell activation.
Subsequent T...