The National Institutes of Health (NIH) and the Foundation for the NIH (FNIH) are bringing together more than a dozen leading biopharmaceutical companies, the Health and Human Services Office of the Assistant Secretary for Preparedness and Response, the Centers for Disease Control and Prevention, the U.S. Food and Drug Administration and the European Medicines Agency 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 develop a collaborative framework for prioritizing vaccine and drug candidates, streamlining clinical trials, coordinating regulatory processes and/or leveraging assets among all partners to rapidly respond to the COVID-19 and future pandemics. This is part of the whole-of-government, whole-of-America response the Administration has led to beat COVID-19.
Coordinated by the FNIH, ACTIV government and industry partners will provide infrastructure, subject matter expertise and/or funding (both new and in-kind) to identify, prioritise and facilitate the entry of some of the most promising candidates into clinical trials. Industry partners also will make available certain prioritized compounds, some of which have already cleared various phases of development, and associated data to support research related to COVID-19. The partnership is being developed with input from a steering committee managed by the FNIH which includes leaders from NIH, FDA and the research and development organisations of the companies.
The research community is currently striving to sift through more than 100 potential preventives and therapeutics for COVID-19. ACTIV will aim to provide guidance which can be used to prioritize the plethora of vaccine and therapeutic candidates in development and connect clinical trial networks to test new and repurposed candidates quickly and efficiently.
ACTIV will have four fast-track focus areas – standardise and share preclinical evaluation methods in an open forum that allows for comparison and validation; prioritise and accelerate clinical evaluation of therapeutic candidates with near-term potential; maximise clinical trial capacity and effectiveness; and advance vaccine development. Each of these focus areas will be led by a highly motivated working group of senior scientists representing government, industry and academia.