Accelerating COVID-19 Therapeutic Interventions & Vaccines (ACTIV)

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Accelerating COVID-19 Therapeutic Interventions & Vaccines (ACTIV)

Mission: To develop a research strategy for prioritizing and speeding development of the most promising COVID-19 vaccines and therapeutics.

In March 2020, as the rapidly developing threat of the COVID-19 pandemic became clearer, officials of the U.S. National Institutes of Health (NIH) and the Foundation for NIH (FNIH) speedily assembled a government-industry-academia coalition to coordinate research and clinical testing efforts to counter the virus. The resulting partnership is called ACTIV (Accelerating COVID-19 Therapeutic Interventions and Vaccines) and includes eight U.S. government agencies, 20 biopharmaceutical companies and several nonprofit organizations.

ACTIV replaced a plethora of small individual trials—many too small or inadequately designed to produce meaningful results—with a national research agenda for developing therapeutic countermeasures to the pandemic and provided support for vaccine development efforts. ACTIV stands as a model for how the biomedical research community can be effectively mobilized in response to a global public health crisis.

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11
master protocols approved by FDA
800+
total agents reviewed and prioritized
37
therapeutic agents tested
620+
trial sites activated in partnership with multiple networks
107
preclinical assets prioritized
4
guidance documents developed for in vitro and in vivo therapeutic testing
17,000+
therapeutic activity data points tracked for all variants and subvariants
4
vaccine development programs that achieved EUAs supported to develop harmonized protocols
2
guides to vaccine regulatory pathways developed
8.10M
viral sequences analyzed in a harmonized protocol

Unprecedented Global Crisis

The scale of the SARS CoV-2 public health emergency required innovative, expedited research, leveraging public and private scientific capabilities and resources. By late March, hundreds of preclinical and human studies of potential treatments had begun at biopharmaceutical companies, academic institutions, and government laboratories across the world, and would number in the thousands by August 2020. But the vast majority of these clinical studies were small, non-randomized, underpowered efforts that lacked the rigor and scale to deliver credible results.

A collaboration between government and the private sector to accelerate research on therapeutics and vaccines promised a better way forward. ACTIV established the U.S. national research agenda for therapeutic countermeasures to COVID-19, coordinating well-designed trials that would result robust scientific evidence for the efficacy or futility of particular therapies.

Goals

Coordinate and streamline preclinical development of potential treatments
Identify the most promising therapeutic agents and design highly efficient trials in which to test them
Improve clinical trial capacity and effectiveness
Accelerate the development and authorization of vaccines

Working Groups

Early on, ACTIV leaders organized their mission into four working groups:

Preclinical Working Group:

Provided a path for streamlined preclinical development of promising therapies and promoted effective use of limited resources for testing, including animal studies

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Clinical Trial Capacity Working Group:

Identified and qualified potential clinical trial sites

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Therapeutics Clinical Working Group:

Screened potential drug candidates, prioritized them for further study, and coordinated their testing in multiple clinical trials

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Vaccines Working Group:

Informed and harmonized the approaches for generating and evaluating safety and efficacy data

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When viral variants began to emerge at the end of 2020, ACTIV pivoted its preclinical efforts to the TRACE (Tracking Resistance and Coronavirus Evolution) initiative, designed to collect sequence data on emerging variants, provide further animal and lab testing of them, and publish the resulting information for use by the entire scientific community via a comprehensive data portal hosted at NIH.