Periodic Reporting for period 3 - VACCELERATE (VACCELERATE - European Corona Vaccine Trial Accelerator Platform)
Periodo di rendicontazione: 2024-01-28 al 2025-01-27
The COVID-19 pandemic, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has placed an unprecedented burden on individuals and societies worldwide. Despite global efforts, including lockdowns and public health interventions, the virus led to over a hundred million infections and millions of deaths. The development and deployment of vaccines have proven to be the most effective preventive measure against the virus; however, several critical public health questions remained unanswered. These included uncertainties regarding the long-term immune response, safety, and efficacy of COVID-19 vaccines, particularly in vulnerable populations and against emerging SARS-CoV-2 variants.
Although numerous clinical trials demonstrated vaccine safety and efficacy, Europe has played a limited role in these studies, making it less attractive for vaccine developers. The European vaccine development landscape has been fragmented, challenging to access, and lacking a strategic forum to address urgent vaccination-related questions. As a result, there has been a pressing need to establish a cohesive European approach to guide clinical vaccine trials and enhance pandemic preparedness.
To address these challenges, the VACCELERATE project was established as a pan-European clinical research network aimed at accelerating phase 2 and 3 vaccine development and strengthening Europe’s preparedness for future pandemics. Funded by the European Union under the Horizon 2020 program, VACCELERATE sought to streamline and harmonise clinical trial efforts across Europe, facilitating rapid access to trial sites, expert teams, and standardised protocols.
The primary objectives of VACCELERATE included building a clinical trial network, expediting vaccine research, engaging the public, harmonising data collection, capacity building, and including underrepresented populations, such as children and the elderly, in vaccine research.
Since its inception, VACCELERATE has successfully developed a robust, pan-European vaccine trial network, bridging gaps in clinical research and providing an essential platform for future pandemic preparedness. The network has improved accessibility to clinical trials, facilitated cross-border collaborations, and established best practices for data harmonisation and regulatory alignment.
Although EU funding for VACCELERATE ended on 27 Jan 2025, the established infrastructure and partnerships are expected to continue supporting vaccine research and public health initiatives. The project’s outcomes have laid the groundwork for a more coordinated and resilient European response to emerging infectious diseases, ensuring that Europe is better prepared for future public health challenges.
Although numerous clinical trials demonstrated vaccine safety and efficacy, Europe has played a limited role in these studies, making it less attractive for vaccine developers. The European vaccine development landscape has been fragmented, challenging to access, and lacking a strategic forum to address urgent vaccination-related questions. As a result, there has been a pressing need to establish a cohesive European approach to guide clinical vaccine trials and enhance pandemic preparedness.
To address these challenges, the VACCELERATE project was established as a pan-European clinical research network aimed at accelerating phase 2 and 3 vaccine development and strengthening Europe’s preparedness for future pandemics. Funded by the European Union under the Horizon 2020 program, VACCELERATE sought to streamline and harmonise clinical trial efforts across Europe, facilitating rapid access to trial sites, expert teams, and standardised protocols.
The primary objectives of VACCELERATE included building a clinical trial network, expediting vaccine research, engaging the public, harmonising data collection, capacity building, and including underrepresented populations, such as children and the elderly, in vaccine research.
Since its inception, VACCELERATE has successfully developed a robust, pan-European vaccine trial network, bridging gaps in clinical research and providing an essential platform for future pandemic preparedness. The network has improved accessibility to clinical trials, facilitated cross-border collaborations, and established best practices for data harmonisation and regulatory alignment.
Although EU funding for VACCELERATE ended on 27 Jan 2025, the established infrastructure and partnerships are expected to continue supporting vaccine research and public health initiatives. The project’s outcomes have laid the groundwork for a more coordinated and resilient European response to emerging infectious diseases, ensuring that Europe is better prepared for future public health challenges.
In the beginning of the project, significant progress was made in establishing the network infrastructure. Key components such as the Coordination Office, National Coordinators, and advisory boards were set up, with all of these meeting regularly to discuss project objectives and pandemic developments. Communication channels, including a website and educational materials in multiple languages, were launched to engage stakeholders and the public. The Site Network and the Volunteer Registry expanded across Europe to facilitate recruitment for vaccine trials. Additionally, standardised protocols and assays were developed to streamline trial design and data comparability. The network also provided support to vaccine developers through consultations and trial site matching. Over the course of the whole project, the network expanded further. The Volunteer Registry reached out to 26 countries, and awareness campaigns continued. The Site Network saw increased participation, expanding to over 500 sites in 57 countries. Further consultations with vaccine developers helped optimise trial setups. VACCELERATE successfully conducted three multinational vaccine clinical trials addressing public health questions on COVID-19 vaccines.
The project prioritised broad dissemination and exploitation of results, making findings openly accessible through peer-reviewed publications, open data, international conferences, a dedicated website, press releases, and social media. Furthermore, the Site Network and Volunteer Registry will continue to exist beyond the end of the project. These efforts meant to engage diverse stakeholders, ensuring the long-term impact of the network. By fostering collaboration and knowledge-sharing, VACCELERATE significantly advanced Europe's capacity for vaccine clinical trials and pandemic preparedness, laying the groundwork for future research and policy influence.
The project prioritised broad dissemination and exploitation of results, making findings openly accessible through peer-reviewed publications, open data, international conferences, a dedicated website, press releases, and social media. Furthermore, the Site Network and Volunteer Registry will continue to exist beyond the end of the project. These efforts meant to engage diverse stakeholders, ensuring the long-term impact of the network. By fostering collaboration and knowledge-sharing, VACCELERATE significantly advanced Europe's capacity for vaccine clinical trials and pandemic preparedness, laying the groundwork for future research and policy influence.
VACCELERATE has significantly advanced vaccine research in Europe by accelerating clinical trial processes, standardising methodologies, and strengthening pandemic preparedness. By establishing a structured and sustainable vaccine trial platform, the project has streamlined recruitment, enhanced data harmonisation, and facilitated collaboration between academic and industry stakeholders. A key achievement is the Volunteer Registry, which has proven to markedly accelerate participant recruitment, while reducing logistical barriers and ensuring efficient trial enrolment. Alongside this, the Site Network has expanded across Europe, providing a robust infrastructure of qualified clinical trial sites that ensures broader access to research opportunities and fosters cross-border collaboration. Additionally, the project has addressed misconceptions about clinical trials through targeted educational efforts, thereby improving public engagement. Until its conclusion, VACCELERATE has provided critical results from three vaccine trials, answering pressing public health questions on booster dose intervals, vaccination strategies for the elderly, and immunisation in previously infected children. These findings have the potential to strengthen long-term pandemic preparedness. By fostering collaboration, ensuring data comparability, and establishing a sustainable trial network, VACCELERATE has laid the foundation for a more efficient and coordinated response to future health crises.