Americans were asked to cover their mouths and noses for more than a year to protect themselves and others from COVID-19. Now, the mouth might be the surest path forward to save lives with oral antiviral pills becoming the next focus of the U.S. government’s response.
The U.S. government is pumping up to $3.2 billion into the antiviral program, the Department of Health and Human Services (HHS) said Thursday. The Biden administration wants the program, part of the American Rescue Plan, to have a longer-term impact to discover and create antivirals for other potential pandemic viruses.
Those who are unvaccinated or immunosuppressed remain vulnerable to the virus, and an oral pill would be critical to a “therapeutic arsenal” to complement the government’s vaccination campaign, said David Kessler, M.D., Biden’s chief science officer for the COVID-19 response, in a statement.
Flush with money, the program is expected to bring FDA-authorized antiviral medicines to the public within a year. There are 19 therapeutic agents currently prioritized for testing in clinical trials through a public-private partnership, the agency said.
Last week, the Biden administration procured about 1.7 million courses of Merck and Ridgeback Biotherapeutics’ investigational antiviral treatment molnupiravir, pending emergency use authorization or FDA approval. The ongoing phase 3 trial of the treatment, aimed at reducing the risk of hospitalization or death of patients at high risk for severe illness, is slated for final data in the fall.
Molnupiravir has not been approved by the FDA for treatment of other diseases, despite showing broad-spectrum activity against influenza, Ebola and Venezuelan equine encephalitis virus.
Atea Pharmaceuticals, with partner Roche, is working on a late-stage clinical trial of a “promising oral antiviral” for treating COVID-19. The first patient was dosed in the phase 3 global trial on April 29 to evaluate AT-527 in patients with mild or moderate COVID-19 in an outpatient setting. The advancement in the trial triggered a milestone payment of $50 million from Roche, which has exclusive commercial rights outside of the U.S.
Meanwhile, Pfizer has a phase 1 study for an oral antiviral, started in March, that has shown potent in vitro antiviral activity.
In addition to molnupiravir, the Biomedical Advanced Research and Development Authority (BARDA) is already funding therapeutics from Eli Lilly, Regeneron, AstraZeneca, Johnson & Johnson's Janssen pharmaceuticals unit, Genentech and others.
An antiviral pill for the virus behind COVID-19, the respiratory disease that has killed more than 600,000 Americans, has not yet reached the market. The U.S. government poured a far heftier sum into vaccines as part of the pandemic response, with an estimated $19.3 billion of federal funding as of March 2. The recipients were Pfizer-BioNTech, Moderna, Sanofi, GlaxoSmithKline, Johnson & Johnson and other vaccine developers, according to data from the Congressional Budget Office. The New York Times pegged the investment in drugs, by comparison, at less than half, $8.2 billion.
The shift toward an oral pill continues the U.S. government's goal of limiting the number of hospitalizations due to COVID-19.
“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 Anthony Fauci, M.D., President Joe Biden’s chief medical adviser, in a statement. Fauci has a track record of working on antivirals, with research that led to oral antivirals for HIV.
Many Americans received their vaccines at a pharmacy. Those corner drugstores could be the place they receive their oral antiviral treatments, too. So far, the only antiviral to gain full FDA approval, Gilead Sciences' remdesivir, doesn’t currently work as an oral pill and must be administered in a hospital setting.
The government's $3 billion-plus program, dubbed the Antiviral Program for Pandemics, tasks the National Institutes of Health (NIH) with bringing antiviral candidates to phase 2 clinical trials. More than $300 million is devoted toward research and lab support; $700 million is for development; and manufacturing and almost $1 billion will aid preclinical and clinical evaluation. HHS and NIH are collaborating on the program with the National Institute of Allergy and Infectious Diseases and BARDA.
Up to an additional $1.2 billion will fund the country’s preparedness for future viral threats through the Antiviral Drug Discovery Centers for Pathogens of Pandemic Concern.