# How VDEC develops and evaluates vaccines

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/dad10d68-71fb-4425-8802-cf923aa3ad10
Type: Detailed Guide
Published: May 19, 2024

> The Vaccine Development and Evaluation Centre (VDEC), part of the UK Health Security Agency (UKHSA), provides a comprehensive framework for supporting vaccine and therapeutic development across five stages. While the provided text is an informational overview and does not contain specific inspection dates or regulatory violations, it outlines the scientific and ethical standards required for collaboration. In the pre-clinical and clinical phases, VDEC assists partners in navigating complex regulatory requirements and provides advanced tools for monitoring and evaluation. Post-licensure, the organization works with public health agencies to maintain robust surveillance systems for tracking real-world safety and effectiveness. Although no specific corrective actions are mandated in this service description, the document emphasizes the importance of continuous evaluation and public education to address vaccine hesitancy. VDEC’s facilities and expertise in antimicrobial resistance and pathogen characterization serve as the primary regulatory and scientific foundation for developers in industry and academia. This integrated approach ensures that vaccines not only meet technical benchmarks during development but also demonstrate sustained efficacy and safety following widespread public use.

---

## Content

The Vaccine Development and Evaluation Centre ( VDEC ) supports scientists at every stage of the vaccine and therapeutic medicine development process. The stages of vaccine development are: Discovery and surveillance Antimicrobial resistance (AMR) Pre-clinical Clinical Post-licensure Discovery and surveillance We provide cutting-edge resources and expertise to help researchers unlock the secrets of viruses and bacteria. Our state-of-the-art laboratories and experienced team assist with techniques like viral isolation and characterisation. These enable scientists to pinpoint vulnerabilities that a vaccine can exploit. See more information on VDEC ’s discovery and surveillance services Antimicrobial resistance (AMR) VDEC responds strategically to AMR pathogens and new emerging threats (fungi, viruses, and bacteria), by determining the most appropriate research goals to combat these pathogens. See more information on VDEC ’s antimicrobial resistance (AMR) services Pre-clinical Before a vaccine candidate can be tested in humans, it needs to prove its potential in a safe and controlled environment. This is the pre-clinical stage. At the pre-clinical stage, VDEC provides: a wide range of animal models, from small rodents to non-human primates expertise in designing and conducting pre-clinical trials the ability to handle pathogens at the appropriate level of containment the development of assays with a smooth transition to the clinical testing phase See more information on VDEC ’s pre-clinical services Clinical Clinical trials test how well new vaccines and therapeutics work in humans. VDEC acts as a trusted partner throughout this critical phase. Our team possesses extensive experience in designing and conducting analyses that support clinical trials. We: guide researchers through complex regulations ensure work adheres to the highest ethical and scientific standards provide state-of-the-art facilities for conducting work on materials from trials provide access to advanced monitoring and evaluation tools See more information on VDEC ’s clinical services Post-licensure The post-licensure phase ensures the vaccine continues to be safe and effective in the real world. Robust surveillance systems track vaccine safety and effectiveness after widespread use. We collaborate with public health agencies that monitor for any adverse events and analyse long-term data. This vigilance allows for continuous evaluation and potential adjustments to optimise the vaccine’s impact. UKHSA also provides vaccine education. We work with healthcare professionals and the public to address vaccine hesitancy and promote informed decisions. VDEC does not just help develop vaccines; we help them thrive in the real world. See more information on VDEC ’s post-licensure services Work with VDEC We work with industry, academia and government. Contact UKHSA today to see how we can help you. Get in touch Or send an email to vdec@ukhsa.gov.uk Scientist pipetting in an assay development laboratory