Leading in a Crisis

In a year turned upside-down by the COVID-19 pandemic, the world looked to science for answers—and the FNIH was a leader in accelerating the search for solutions. Convening and directing the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership in April 2020, the FNIH has supported and guided the efforts of multiple U.S. government agencies, nonprofit organizations and industry partners, all working together to develop COVID-19 vaccines and treatments.

With hundreds of potential therapeutic interventions under consideration, many of them initiated by research institutions in small, underpowered, non-randomized trials, a first order of business was to identify and focus critical resources on the most promising candidates. ACTIV sifted through hundreds of potential therapeutic candidates to prioritize those most suitable for clinical development and then helped develop a robust, centralized suite of “master protocol” clinical trials sponsored by NIH and funded by Operation Warp Speed, in which to test them. Master protocols allow researchers to evaluate multiple treatment options at once against a single control arm, making trials much more efficient and getting potentially lifesaving treatments evaluated at multiple hospitals and clinics more effectively. ACTIV was critical to identifying, prioritizing and standardizing the resources needed to perform preclinical testing on promising therapeutic agents prior to testing in humans.

ACTIV also enabled vaccine developers to collaborate in the development of harmonized protocols for vaccine efficacy trials so that findings could be more easily compared and assisted FDA in understanding the requirements for Early Use Authorizations for these vaccines. In concert with government and company efforts, ACTIV played an important supporting role in the development of COVID-19 vaccines in a breathtaking 11 months, compared with the ten years or more often required.

The scale and speed of the ACTIV collaboration is unprecedented, and in convening it the FNIH helped its partners rise to meet the urgent need to address the global pandemic. Using its deep experience in managing public-private research partnerships, the FNIH quickly brought together the people and organizations with the right knowledge, abilities and viewpoints to address this global public health emergency and provided an environment to facilitate their combined knowledge. ACTIV has demonstrated that we can indeed make rapid progress to address COVID-19—as well as the other biomedical challenges of our era—by working together in the right partnership framework.