The NIH and the Foundation for the NIH (FNIH) announced today an initiative to bring together governmental agencies and pharmaceutical companies in the U.S. and Europe to develop an international strategy for a coordinated research response to the COVID-19 pandemic.

The planned “Accelerating COVID-19 Therapeutic Interventions and Vaccines” (ACTIV) partnership will include more than a dozen biopharmaceutical companies, the Health and Human Services Office of the Assistant Secretary for Preparedness and Response, the CDC, the FDA, and the European Medicines Agency (EMA). The collaborative efforst will develop a framework to prioritize vaccine and drug candidates, streamline clinical trials, coordinate regulatory processes and/or leverage assets from all the partners as a way to quickly  develop COVID-19 vaccines and treatments and serve as platform that can respond to future pandemics.

“We need to bring the full power of the biomedical research enterprise to bear on this crisis,” said NIH Director Francis S. Collins, M.D., Ph.D., in a prepared statement. “Now is the time to come together with unassailable objectivity to swiftly advance the development of the most promising vaccine and therapeutic candidates that can help end the COVID-19 global pandemic.”

ACTIV will be coordinated by the FNIH, which will work with the government agencies and members of the pharmaceutical industry partners, to provide infrastructure, subject matter expertise and/or funding (both new and in-kind) as a means to advance the most promising vaccines and therapeutic candidates into clinical trials. Many of the identified candidates have already moved through different phases of clinical development and industry partners will make the data from these candidates available to further support COVID-19 research.

Development of the partnership, still in a very early phase, is being managed by a steering committee which includes leaders from NIH, FDA, and the research and development organizations of member companies.

“COVID-19 is the most significant global health challenge of our lifetime, and it will take all of us working together as a global community to put an end to this pandemic,” said Paul Stoffels, M.D., vice chairman of the executive committee and CSO, Johnson & Johnson. “We will need to harness the best ideas from multiple stakeholders, including governments, regulatory authorities, academia, NGOs and industry to stop COVID-19.”

Currently, there are more than 160 potential vaccines and therapies in development worldwide, according to Clinical OMICs’ sister publication Genetic Engineering and Biotechnology News (GEN). ACTIV’s role will be to wade through all the potential candidates to identify those that are most promising and connect the sponsors with clinical trial networks in order to speed testing.

“Battling the COVID-19 pandemic is far too great a challenge for any one company or institution to solve alone,” said Mikael Dolsten, M.D., Ph.D., Pfizer’s CSO and president, Worldwide Research, Development and Medical. “We are seeing an unprecedented level of collaboration across the innovation ecosystem to address this global health crisis, and this potentially powerful NIH initiative may allow us to further accelerate the delivery of much needed therapies to patients around the world.”

ACTIV will have four fast-track focus areas, each of which will comprise senior scientists representing government, industry, and academia:

1. Standardize and share preclinical evaluation methods in an open forum that allows for comparison and validation by:

• Establishing a centralized process and repository for harmonizing and sharing methods and evaluating models
• Extending access to high-throughput screening facilities, especially in biosafety level-3 laboratories, with a goal of testing all compounds that have been in human clinical trials to identify the potential to apply these compounds to COVID-19
• Increasing access to validated animal models
• Enhancing comparison of approaches to identify informative assays

2. Prioritize and accelerate clinical evaluation of therapeutic candidates with near-term potential by:

• Establishing a steering committee with relevant expertise and objectivity to set criteria for and rank potential candidates submitted by industry partners for first wave and subsequent evaluation
• Developing a complete inventory of potential candidates with different mechanisms of action and acceptable safety profiles
• Designing, launching and openly sharing master protocols with agreed upon endpoints, sampling and analysis for evaluating candidates
• Using a single control arm to enhance trial efficiency

3. Maximize clinical trial capacity and effectiveness by:

• Connecting existing networks of clinical trials to build capacity and capabilities, including specialization in different populations and disease stages
• Leveraging infrastructure and expertise from across NIH networks, including:
  • Adjuvant Discovery and Adjuvant Development Programs
  • AIDS Clinical Trials Network
  • Clinical and Translational Science Awards Program
  • Clinical Trials in Organ Transplantation
  • Cooperative Centers on Human Immunology
  • HIV Prevention Trials Network
  • HIV Vaccine Trials Network
  • Human Immunology Project Consortium
  • International Network for Strategic Initiatives for Global HIV Trials (INSIGHT) Network
  • National Cancer Institute Community Oncology Research Program
  • National Cancer Institute’s National Clinical Trial Network
  • Prevention and Early Treatment of Acute Lung Injury (PETAL) Clinical Trials Network
  • Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN)
  • T and B Cell Discovery Programs and Immune Epitope Database
  • Vaccine Treatment and Evaluation Units
• Establishing a coordination mechanism across networks to expedite trials, track incidence across sites and project future capacity

4. Advance vaccine development by:

• Creating a collaborative framework to share insights into natural immunity and vaccine candidate-induced immune response by:
  • Mapping epitopes and developing assays
  • Establishing protocols for sampling and immunological analyses and reagents
  • Collecting clinical data on immunological responses and endpoints, to enable meta-analysis of correlates of protection
  • Engaging with regulators on surrogate endpoints for clinical evaluation

“This powerful public-private partnership will focus and expedite R&D activities required to combat COVID-19,” says Maria C. Freire, Ph.D., President and Executive Director, FNIH. “Working in lock-step, the public and private sectors will maximize the chances of success and provide a roadmap to pre-emptively manage future threats.”