# Clinical evaluation for vaccines

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/d9d000a7-1670-44f8-9a44-e35ceee33ce3
Type: Detailed Guide
Published: May 19, 2024
Updated: July 16, 2024

> The Vaccine Development and Evaluation Centre (VDEC), part of the UK Health Security Agency (UKHSA), provides specialized clinical evaluation services to support the development of vaccines and therapeutic medicines. The organization operates under a regulatory framework compliant with Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) standards, ensuring high-quality data for clinical trials from Phase I to Phase IV. VDEC's core capabilities include the development and validation of analytical methods and the use of Biosafety Level 3 (BSL3) facilities to conduct live virus neutralization assays. These facilities allow for a more accurate assessment of vaccine efficacy against live pathogens compared to surrogate models. Key activities highlighted include supporting SARS-CoV-2 clinical trials and monitoring variants of concern. Current priorities involve preparing for potential avian influenza pandemics and supporting the deployment of respiratory syncytial virus (RSV) vaccines. While the document does not list specific inspection dates or violations—as it is an overview of service capabilities rather than an enforcement report—it outlines the required actions for partners. Interested organizations from industry, academia, and government are encouraged to contact the UKHSA to access their GxP-compliant facilities and expertise to further the goals of the global 100 Days Mission for pandemic preparedness.

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## Content

The Vaccine Development and Evaluation Centre ( VDEC ) supports scientists at every stage of the vaccine and therapeutic medicine development process. VDEC ’s clinical evaluation team provides expertise in immunological and functional assays used to support clinical trials (Phase I to IV). Speak to our clinical evaluation team We work with industry, academia and government. Contact UKHSA today to see how we can help you. Get in touch What the clinical evaluation team does We offer 3 main capabilities. These are: expertise in the development and validation of analytical methods the ability to be able to conduct analysis at high-containment biosafety level ( BSL ) 3, meaning that neutralisation assays can be conducted using a live virus rather than pseudovirus or surrogates an enhanced quality management system which enables work to be performed to support good manufacturing practice ( GMP ) and good clinical practice ( GCP ) studies These capabilities support the UKHSA ’s science strategy . They position us uniquely to support the development of vaccines and therapeutics against potential pandemic threats, and contribute towards the 100 Days Mission . Our work on COVID-19 We provide live virus neutralisation and other immunological assay data in support of SARS-CoV-2 GCP compliant clinical trials to inform UK government policy decisions, vaccine development and licensure. We isolate and introduce SARS-CoV-2 variants of concern into our analytical methods, enabling an assessment of the potential for these variants of concern ( VOCs ) to escape vaccines currently in use in the UK. How UKHSA ’s Vaccine Development and Evaluation Centre use microneutralisation assays (MNA) Current priorities Our current priorities include: the qualification of seasonal influenza assays (hemagglutination inhibition assay ( HAI ), microneutralisation, and enzyme-linked immunosorbent assay ( ELISA )) to assist in preparedness to manage a potential avian influenza pandemic qualifying assays for respiratory syncytial virus ( RSV ) to support the testing and deployment of current and new vaccines How we work with partners We have the ability to deploy our fully-trained workforce and GxP compliant facilities. We offer these services on a commercial basis to partners from non-governmental organisations ( NGOs ) and industry to support strategic product development goals. Scientist evaluating the results from a qualified microneutralisation assay