The general objective of FastVac is to produce a comprehensive set of predictive rules that will enable accelerated development, evaluation, production & release of emergency vaccines. The "blueprints" produced will inform the parallel processes of vaccine development & process design, through to phase 1 clinical testing & support for GMP production. By providing evidence-based rules to aid the production of contingency emergency vaccines, FastVac ultimately aims to have a significant effect on the long term health of the human population, both in the EU & internationally. Specific objectives are to develop: evidence-based rules for rapid vaccine design, production & release; & apply principles for vaccine candidate design based on COPs; & apply principles for the use of COPs in vaccine pre-clinical testing & licensure; production principles that will accelerate vaccine production & release; to consolidate a strategic alliance to respond collectively to vaccine-preventable public health emergencies & to build a strategic framework for uptake of novel concepts for vaccine licensure.
Strategically, the outputs from FASTVAC will underpin vaccine development and production by public health agencies to enhance development of “niche market” vaccines which could be transferred to commercial manufacturers. The principles laid down by FASTVAC for the rational design and production of vaccines should reduce the commercial risk for investing R&D effort in niche diseases and encourage commercial vaccine manufacturers to enter this arena. Work by FASTVAC to allow the rational selection of suitable animal models for testing emergency vaccines and to speed vaccine production and release through rational scale up and the use of process analytical technology, will have significant regulatory implications. By working together with the relevant EU regulators throughout the project and beyond, it is anticipated that some of the FASTVAC rules will gain regulatory acceptance and be adopted by the regulators as appropriate for use in marketing authorizations of future emergency vaccines.
The approaches taken to deliver an integrated programme of analytical and experimental work are: 1) SYSTEMATIC LITERATURE REVIEW (SLR) of the scientific record will be carried out to identify predictors of vaccine success or failure. 2) EXPERT REVIEW GROUPS (ERG) will critically review the inputs and outputs of the SLR and contribute information that is not available in the public domain. 3) EXPERIMENTAL WORK-VACCINE DESIGN & EVALUATION: The outputs from the SLR and ERGs will be applied to rationally design candidate vaccines. 4) EXPERIMENTAL WORK-PROCESS SCALE-UP & CONTROL: Based on the SLR and historical and current laboratory data from the ERGs, rules for a) the rational scale up of production processes and b) the control of production runs and release of intermediate vaccine product by use of PAT, will be tested and refined by experiment.
A new and faster approach to vaccine development will have profound regulatory effects. Dialogue will be maintained with the EU regulatory structures (EMEA, ECDC) and relevant stakeholders through teleconferences and meetings and workshops.
The principles for successful vaccine design and rapid manufacture established by FASTVAC will provide a unique and invaluable resource to deliver more reliable vaccines more quickly. In the event of a future outbreak of a new or re-emerging disease in Europe, application of these principles will support the EU in providing a vaccine in a timely manner, shortening the timeline between the outbreak of disease and the availability of effective vaccine countermeasures. It is anticipated that the availability of open access “blueprints” for manufacture of successful emergency vaccines will be attractive to both public-sector and commercial vaccine manufactures.
A public health initiative such as FastVac, will provide the intellectual rule book to enable candidate vaccines to be rapidly taken forward through pre-clinical testing and process development to clinical testing, production and licensure, providing Europe with a rapid response against new and emerging health threats.