Monday, July 15, 2024

EU’s Bold New Plan to Revolutionize Vaccine Assessment

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Vaccine assessment is a crucial component of immunization systems across EU Member States, determining not only when and which vaccines are included in National Immunization Programmes but also whether they are funded by the government. The appraisal of vaccines in the European Union (EU) currently involves many different decision-making bodies and processes. The objective of this study was to help inform the development of standardized methodology and vaccine-specific processes for use in the EU Regulation on health technology assessment (HTA).

In the context of the EU Regulation on HTA, which will enter into force in January 2025, this paper discusses how the joint EU HTA framework can contribute to unlocking the full value of vaccination as the main tool for primary disease prevention. It aims to address the significant variations that currently exist in vaccine evaluations and decision-making processes. Literature reviews and expert consultation were conducted to identify current practices and gaps related to vaccine appraisals and to develop guiding principles for the joint clinical assessment of vaccines.

Guiding Principles and Recommendations on Vaccine Assessment

It is found that significant variation exists across the EU Member States in the decision-making processes when clinically evaluating vaccines. Three guiding principles consisting of 13 recommendations were developed to help inform the development of decision-making frameworks for the joint clinical assessment of vaccines in the EU. These guiding principles aim to standardize assessment processes and methodologies for vaccines and ultimately reduce inequalities in population access to vaccines.

Support the creation of appropriate terminology and measurements for clinical appraisals of vaccines. This involves developing consistent and accurate language and metrics to ensure clarity and uniformity in vaccine assessments across different Member States. Develop inclusive, timely, and transparent vaccine appraisal processes to support stronger evidence generation for vaccine decision-making and appraisal. This principle emphasizes the importance of involving all relevant stakeholders in the appraisal process and ensuring that the process is conducted transparently and efficiently.

Vaccine Assessment

Implementation of Standardized Methodologies

Improve the collection and interoperability of real-world data, including robust surveillance, to foster evidence generation and support the standardization of vaccine clinical appraisals. Enhancing data collection efforts and ensuring that data can be easily shared and used across Member States is crucial for generating robust evidence to inform vaccine assessments. Given the significance of vaccines for public health, there is an urgency to develop standardized and vaccine-specific methodologies and processes for use in the EU joint HTA framework.

The proposed guiding principles could support the effective implementation of the EU Regulation on HTA for vaccines and have the potential to ensure consistent, transparent, and timely access to new vaccines in the EU. With standardized methodologies, vaccine assessments can be more accurately conducted, promoting equitable access and improving overall public health outcomes across EU Member States. By fostering collaboration and uniformity in vaccine appraisal processes, the EU can lead the way in efficient and fair vaccine distribution and utilization.


Resource: Value in Health Journal, June 27, 2024

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