Biden Administration to Invest $3 Billion from American Rescue Plan as Part of COVID-19 Antiviral Development Strategy

On June 17, 2021, the Biden Administration announced it will invest more than $3 billion toward the discovery, development, and manufacturing of antiviral medicines.

Through collaboration within the U.S. Department of Health and Human Services (HHS), including the National Institutes of Health (NIH) and its National Institute of Allergy and Infectious Diseases (NIAID), and the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), this plan – called the Antiviral Program for Pandemics – will respond to the urgent need for antivirals to treat COVID-19 by spurring the availability of medicines to prevent serious illness and save lives. A Program goal is to also build sustainable platforms for discovery and development of antivirals for other viruses with pandemic potential, helping better prepare the nation to face future viral threats.

Working through a public-private partnership called ACTIV (Accelerating COVID-19 Therapeutics and Vaccines), 19 therapeutic agents have been prioritized for testing in clinical trials for outpatients and inpatients with COVID-19. The Administration is seeking additional FDA-authorized antiviral medicines within a year to combat COVID-19 and protect the public.  Towards this goal, last week, the Administration announced that it would procure more than 1.5 million regimens of a Merck investigational antiviral treatment, should it receive emergency use authorization.

As part of the plan, the NIH will evaluate, prioritize and advance antiviral candidates to Phase 2 clinical trials, using current and expanded contract resources and the NIH’s National Center for Advancing Translational Sciences laboratories to de-risk early stage development with sponsors and guide candidates along development paths. The plan provides more than $300 million for research and lab support, nearly $1 billion for preclinical and clinical evaluation, and nearly $700 million for development and manufacturing through NIAID and BARDA.

Additionally, the plan allocates up to $1.2 billion to support the creation of collaborative drug discovery groups called Antiviral Drug Discovery (AViDD) Centers for Pathogens of Pandemic Concern in order to harness the creativity of the biomedical research community and drive innovative antiviral drug discovery and development. These Centers will create platforms that will initially target coronaviruses, and then could be expanded to other viruses with pandemic potential – helping to better prepare the nation for future viral threats.