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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.
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Rapid In Vivo Assessment of Adjuvant's Cytotoxic T Lymphocytes Generation Capabilities for Vaccine Development

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Anti-COVID-19 Vaccination in the Italian General Population: Proactive Clinical Risk Analysis Using Failure Mode,

Beatrice Balestracci¹, Giuseppe Candido², Lorenzo Federici³

¹Independent Researcher, 54023 Filattiera, Italy.

Healthcare (Basel, Switzerland)

|January 8, 2025

Summary

Patient safety in COVID-19 vaccination requires managing risks like severe allergic reactions and ensuring teams have updated knowledge. Proactive risk assessment is key for successful mass vaccination campaigns.

Keywords:

COVID-19 pandemic FMECA SARS-CoV-2 patient safety proactive management quality assurance vaccination campaign

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Area of Science:

Public Health
Epidemiology
Healthcare Risk Management

Background:

Large-scale COVID-19 vaccination was essential for pandemic control.
Ensuring patient safety during mass vaccination presented significant challenges.
This study aimed to identify and assess patient safety threats in COVID-19 vaccination.

Purpose of the Study:

To proactively identify and analyze risks in the COVID-19 vaccination process.
To assess patient safety threats using the Failure Mode, Effects, and Criticality Analysis (FMECA) technique.
To prioritize interventions based on identified critical failure modes.

Main Methods:

Failure Mode, Effects, and Criticality Analysis (FMECA) was applied to the COVID-19 vaccination process.
A risk scoring system evaluated severity, frequency, and detectability of potential failures.
Risks were prioritized using the Risk Priority Number (RPN) in an Italian Public Health Authority.

Main Results:

Critical risks were identified primarily in the operational phase of vaccination.
The highest risk (RPN 60) involved failure to manage severe allergic reactions.
Inadequate knowledge management for vaccination teams was also a significant risk (RPN 36).

Conclusions:

Effective clinical risk management and patient safety are paramount in mass vaccination.
Addressing critical failure modes, such as managing allergic reactions and team training, is vital.
Prioritizing safety measures builds and maintains public trust essential for vaccination success.