The Antiviral Program for Pandemics will be coordinated by the Department of Health and Human Services (HHS) and include sub-agencies such as the National Institutes of Health (NIH) and its National Institute of Allergy and Infectious Diseases (NIAID) as well as the Biomedical Advanced Research and Development Authority (BARDA). Activities will include kick-starting clinical trials and overseeing the manufacture of promising treatments.

Since the new administration took up work in late January, its pandemic control activities have focused heavily on vaccinations, and it has been accused by some of not devoting enough to treatments for the novel coronavirus. That said, a number of products developed by pharmaceutical majors once thought promising have not panned out, as observers note.

The budget for the new antivirals program provides $300 million for research and laboratory support, nearly $1 billion for preclinical and clinical evaluation, almost $700 million for development and manufacturing and $1 billion to form groups called Antiviral Drug Discovery Centers for Pathogens of Pandemic Concern and designed to accelerate the creation of antiviral drugs.

A particular emphasis will be on drugs that can be taken at home, avoiding costly hospitalizations and leading to fewer deaths, HHS said. "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,” Anthony Fauci, director of the NIAID and principal Covid-19 pandemic advisor to Biden, commented.

"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," Fauci said. Along with vaccinations, antiviral treatments would present an "extra line of defense against other, unexpected, emerging things like variants of concern,” he added.

Under the plan, NIH will be tasked with evaluating, prioritizing and advancing antiviral candidates to Phase 2 clinical trials, using current and expanded contract resources and the NIH’s own National Center for Advancing Translational Sciences laboratories to “de-risk” early stage development with sponsors and guide candidates along development paths.

 Working through a public-private partnership called ACTIV (Accelerating Covid-19 Therapeutics and Vaccines), to date 19 therapeutic agents are said to have been prioritized for testing in clinical trials for outpatients and inpatients. Having additional FDA-authorized antiviral medicines available within a year would be a major breakthrough in ongoing efforts to combat the virus and protect the public, HHS said.

Earlier this month, the Biden administration announced it would procure 1.7 million regimens of molnupiravir, an investigational antiviral treatment developed by US pharma giant Merck, if the US Food and Drug Administration grants an emergency use authorization (EUA). The price is put at around $1.2 billion. The drug developed in collaboration with Ridgeback Biotherapeutics and currently in Phase 3 trials is said to have shown promise for newly diagnosed, non-hospitalized Covid-19 patients.

Author: Dede Williams, Freelance Journalist