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Overview

On April 17, 2020 the 2023 ÃÛÑ¿´«Ã½ (NIH) announced the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership to develop a coordinated research strategy for prioritizing and speeding development of the most promising treatments and vaccines.

Coordinated by the Foundation for the 2023 ÃÛÑ¿´«Ã½ (FNIH), ACTIV brings NIH together with its sibling agencies in the Department of Health and Human Services, including the Biomedical Advanced Research and Development Authority (BARDA), Centers for Disease Control and Prevention (CDC), and the U.S. Food and Drug Administration (FDA); other government agencies including the Department of Defense (DOD) and Department of Veterans Affairs (VA); Countermeasures Acceleration Group (formerly known as Operation Warp Speed); the European Medicines Agency (EMA); and representatives from academia, philanthropic organizations, and numerous biopharmaceutical companies.

Challenge

The COVID-19 pandemic is an unprecedented global crisis that has been met with a swift and extraordinary response. Since the novel coronavirus was first reported in late 2019, institutions and organizations around the world have launched hundreds of research studies on diagnosis, prevention, and treatment strategies—all of which are critical to the world’s ability to return to normal.

With limited resources, there is a need to coordinate and streamline processes to make the best use of biomedical research resources and testing of preclinical compounds.

The research community is sifting through more than 100 potential preventives and treatments. However, because so many studies are recruiting patients, many of those studies could fail to enroll enough participants to answer their research questions. In addition, lack of coordination could make interpretation and comparison of the results difficult. Meanwhile, healthcare providers on the front lines are taking care of critically ill patients every day. They need solid information grounded in research.

With limited resources, there is a need to coordinate and streamline processes to make the best use of biomedical research resources and testing of preclinical compounds. There is also a need to prioritize the most promising vaccine candidates and move them into clinical trials in a way that is safe and efficient.

Opportunity

Through the ACTIV initiative, NIH is pursuing five fast-track focus areas most ripe for opportunity, each of which is led by a working group of senior scientists representing government, industry, non-profit, philanthropic, and academic organizations.

Fast Track Area #1

Develop a collaborative, streamlined forum to identify preclinical treatments.

The Preclinical Working Group focused on:

• Establishing a centralized process and repository for harmonizing and sharing methods and evaluating animal models
• Extending access to high-throughput screening facilities, especially in biosafety level 3 (BSL-3) labs
• Increasing access to validated animal models
• Enhancing comparison of approaches to identify informative assays
• Generating a process to assess viral variant effects on vaccines and therapeutics

Fast Track Area #2

Accelerate clinical testing of the most promising vaccines and treatments.

The Therapeutics Clinical Working Group focused on:

• Establishing a steering committee with relevant expertise to set criteria for and rank potential candidates submitted by industry partners for testing
• 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

Fast Track Area #3

Improve clinical trial capacity and effectiveness.

The Clinical Trial Capacity Working Group focused on:

• Specializing in different populations and disease stages
• Leveraging infrastructure and expertise from across NIH and non-NIH networks and clinical research organizations
• Establishing a coordinated mechanism across networks to expedite trials
• Tracking incidence across sites and projecting future capacity

Fast Track Area #4

Accelerate the evaluation of vaccine candidates to enable rapid authorization or approval.

The Vaccines Working Group focused on:

• Harmonizing efficacy trial designs to facilitate consistent evaluation of vaccine candidates
• Assessing approaches to understand vaccine effectiveness against prevention of infection and transmission
• Creating a collaborative framework to understand correlates of protection across vaccines and share insights into natural immunity

Fast Track Area #5

Identify emerging variants and coordinate data sharing.

The TRACE Working Group is focused on:

• Monitoring global emergence and circulation of SARS-CoV-2 mutations
• Cross-referencing initial sequence data against database of experimentally or clinically characterized variants
• Characterizing prioritized variants in vitro (outside the animal) and in vivo (inside the animal) through critical-path assays
• Rapidly sharing activity data with the ACTIV membership and scientific community

Leadership Organizations

Through ACTIV, NIH brings together government agencies, nonprofit organizations, and numerous biopharmaceutical companies.

Organization Chart

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