Whole-of-Government Effort Will Develop Next Generation of COVID-19 Treatments, Better Prepare U.S. to Respond to Future Virus Threats.
Thanks to the American Rescue Plan, the Biden Administration is investing more than $3 billion to accelerate the discovery, development and manufacturing of antiviral medicines as part of the Biden Administration’s whole-of-government strategy to develop the next generation of COVID-19 treatments.
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. It also will 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.
Even as hundreds of millions of Americans get vaccinated against COVID-19 and cases, hospitalizations and death rates fall, the Biden Administration remains committed to identifying effective treatment options that can prevent people diagnosed with COVID-19 from progressing to serious illness and death. Highly effective oral antiviral medicines that can be taken at home early in the course of infection, similar to antiviral treatment for influenza, would save lives both here and abroad and prevent overwhelming surges in hospitalizations. This plan will support research to identify and accelerate availability of breakthrough treatment options to ensure the public has access to viable medicines.
“New antivirals that prevent serious COVID-19 illness and death, especially oral drugs that could be taken at home early in the course of disease, would be powerful tools for battling the pandemic and saving lives,” said Dr. Anthony Fauci, chief medical adviser to the President and NIAID Director. “Through multidisciplinary collaborations among leading scientists in academia and industry, this investment from the American Rescue Plan to create the Antiviral Program for Pandemics will help inspire medical innovation and build on the extraordinary success we have seen in developing the COVID-19 vaccines.”
This plan accelerates and expands the Administration’s ongoing efforts to support clinical trials to test prioritized drug candidates for COVID-19 and to support the advanced development of promising therapies. Working through an unprecedented public-private partnership called ACTIV (Accelerating COVID-19 Therapeutics and Vaccines), 19 therapeutic agents have been prioritized for testing in rigorous clinical trials for outpatients and inpatients with COVID-19. Having additional FDA-authorized antiviral medicines available within a year would be a major breakthrough in ongoing efforts to combat COVID-19 and protect the public, which is why last week the Administration announced it would procure more than 1.5 million regimens of a Merck investigational antiviral treatment, should it receive emergency use authorization.
“With the President’s leadership, this Administration has vaccinated millions of people. Even with very effective vaccines, some people may remain vulnerable to the virus, including people who are immunosuppressed or who are unvaccinated,” said Dr. David Kessler, Chief Science Officer for the Biden Administration’s COVID-19 Response. “An easily administered oral antiviral drug would be an important part of our therapeutic arsenal that would complement the great success of our vaccine efforts. Our Administration is going to harness the power of American ingenuity to spur the creation and development of these drugs that can save lives both here in the United States and around the world.”
“The remarkable and rapid development of vaccines and testing technology has shown how agile scientific discovery can be when we combine the resources of public agencies, private entities, and our nation’s most brilliant and creative minds,” said Dr. Francis S. Collins, NIH Director. “We will leverage these same strengths as we construct a platform for the discovery and development of effective antivirals that will help us defeat COVID-19 and better prepare us for potential future viral pathogens.”
As part of the plan announced today, 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.
“This plan builds on the long, successful partnership between BARDA and NIH to develop vaccines, therapeutics and diagnostics, from combatting Ebola, anthrax and smallpox, to now tackling COVID-19,” said BARDA Director Gary Disbrow, Ph.D. “Throughout this public health emergency, we have worked with industry to develop treatments to reduce severe illness, hospitalizations, and deaths, and this proposal will help us go even further to accelerate and deliver more safe and effective treatments that are easy to administer.”
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 that will 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.