Biden administration invests $3 billion from ARP as part of COVID-19 antiviral development strategy

Photo: Doug Mills-Pool/Getty Images

Drawing from the American Rescue Plan, President Joe Biden's administration is setting aside more than $3 billion to accelerate the discovery, development and manufacturing of antiviral medicines. The move is part of what the Biden Administration is calling a "whole-of-government" strategy to develop the next generation of COVID-19 treatments.

The plan, called the Antiviral Program for Pandemics, involves collaboration within the U.S. Department of Health and Human Services, 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).

The intent of the plan is to respond to the urgent need for antivirals to treat COVID-19 by spurring the availability of medicines to prevent serious illness. It also will seek to build sustainable platforms for the discovery and development of antivirals for other viruses with pandemic potential. The administration hopes and expects that this will help to better prepare the U.S. for future viral threats.

WHAT'S THE IMPACT?

Even as hundreds of millions of Americans get vaccinated against COVID-19, and cases, hospitalizations and death rates fall, the nation is on the hunt for 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 in the U.S. and abroad and prevent overwhelming surges in hospitalizations, HHS said Thursday. The plan would support research to identify and accelerate the availability of breakthrough treatment options to ensure the public has access to viable medicines.

The 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 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.

Having additional FDA-authorized antiviral medicines available within a year, HHS said, would represent a breakthrough in ongoing efforts to combat COVID-19 and protect the public. To that end, the administration announced last week it would procure more than 1.5 million regimens of a Merck investigational antiviral treatment, should it receive emergency use authorization.

The new plan calls for the NIH to 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.

In addition, 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. This is meant to tap into the biomedical research community to drive 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.

THE LARGER TREND

American Rescue Plan funds have been directed toward a number of programs and initiatives geared toward preventing disease outbreaks and decreasing disparities in care for disadvantaged communities.

Billions have been earmarked to date. In May, the administration said it was investing $7.4 billion in ARP funds to hire and train more public health workers with the goal of being better prepared for future pandemics. The funding is intended to expand the country's public health workforce and strengthen the national infrastructure by creating what the administration expects will be "tens of thousands of jobs." These jobs will support vaccinations, testing, contact tracing and community outreach.

Also in May, the Substance Abuse and Mental Health Services Administration said it was distributing $3 billion in ARP funding – the largest aggregate amount of funding to date for its mental health and substance use block grant programs.

The Community Mental Health Services Block Grant Program and Substance Abuse Prevention and Treatment Block Grant Program will disperse $1.5 billion each to states and territories, with the latter also awarding money to a tribe. This follows the March announcement of supplemental funding of nearly $2.5 billion for these programs.

The Substance Abuse and Mental Health Services Administration, an operating division of HHS, has expedited federal funding to grantees to help communities grappling with mental health and substance use needs during the COVID-19 pandemic.

In March, Fitch Ratings said the ARP contains a number of measures that would subtly improve the revenue profile and reduce cost pressures for nonprofit hospitals. In contrast to the Coronavirus Aid, Relief and Economic Security Act, which allocated funds directly to hospitals based on size and COVID-19 caseload numbers, the ARP only provides direct aid to rural providers.

But it will help support hospital patient revenues by reducing the number of those who are uninsured, which is a credit positive for hospitals.

ON THE RECORD

"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."

"With the president's leadership, this administration has vaccinated millions of people," said Dr. David Kessler, chief science officer for the Biden Administration's COVID-19 Response. "Even with very effective vaccines, some people may remain vulnerable to the virus, including people who are immunosuppressed or who are unvaccinated.

"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."
 

Twitter: @JELagasse
Email the writer: jeff.lagasse@himssmedia.com