Dive Brief:
- The U.S. is betting on development of a pill for COVID-19, announcing on Thursday plans to invest more than $3 billion in the research, testing and manufacturing of antiviral treatments for the coronavirus and other viruses that may emerge in the future.
- The funding draws from the American Rescue Plan that President Joe Biden signed into law in March and will involve the National Institutes of Health as well as the Biomedical Advanced Research and Development Authority, both of which played key roles in the U.S.'s coronavirus vaccine program.
- In contrast to the remarkably rapid development of several safe and effective coronavirus vaccines, research into new antiviral drugs for COVID-19 has moved more slowly. Veklury, an antiviral from Gilead that won Food and Drug Administration approval last year, was repurposed from earlier study in hepatitis C and Ebola. Several antibody drugs are also available but must be intravenously infused, making them difficult to administer.
Dive Insight:
Widespread vaccination has dramatically lowered the number of cases, hospitalizations and deaths reported each day in the U.S. But even as some states near the point scientists believe could represent local herd immunity, many others are lagging behind.
About 30 states will likely fall short of the Biden administration's goal of having 70% of adults vaccinated by July 4, according to data compiled by The New York Times earlier this month. In some states where vaccine uptake is the slowest, reaching that goal might take six more months or even longer.
Vaccine protection from COVID-19 may also not be as great for people who are immunocompromised, or who only received one of two doses.
"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," said David Kessler, the former FDA commissioner who now is chief science officer for the Biden administration's COVID-19 efforts, in a statement.
The Biden administration plans to deploy more than $3 billion toward that goal, the bulk of which will be spent on clinical testing and subsequent manufacturing of antiviral candidates. The money will also fund creation of new centers aimed at discovering and developing new antiviral drugs, first for the coronavirus and then for other viruses of pandemic potential.
The NIH and BARDA, which will carry out this new effort, were closely involved in Operation Warp Speed, the Trump administration initiative that led to the successful development of several vaccines. But the two agencies were also working on development of treatments, too, and the NIH worked to test 19 experimental and existing drugs through a trial program called ACTIV.
Most of those drugs were antibodies, several of which are now in use for people infected with SARS-CoV-2 but not yet sick enough to need hospitalization.
The Biden administration hopes to have additional antiviral medicines "within a year," and is prioritizing oral pills that would be more convenient.
"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, director of the National Institute for Allergy and Infectious Diseases, in a statement.
The nearest-term hope for a COVID-19 pill is an experimental drug being developed by Merck & Co and Ridgeback Biotherapeutics called molnupiravir. Results from a Phase 3 trial testing the drug could come later this year and the U.S. recently agreed to pay $1.2 billion to preorder doses, should it succeed and win authorization.
Pfizer and partners Roche and Atea Pharmaceuticals are also in late-stage testing with COVID-19 antivirals.