Former Surgeon General Jerome Adams: Prioritize new antivirals for Covid

The U.S. Covid-19 Public Health Emergency declaration may have ended, but the virus remains. Now is the moment to leverage the successes and challenges of fostering innovative Covid therapeutics to prepare for the future waves that we inevitably face from new variants.

On June 13, the House Energy and Commerce Committee’s Subcommittee on Health convened to discuss solutions to ensure preparedness for the next generation of public threats and hazards, including infectious diseases such as Covid-19. This was a critical discussion, particularly because seniors and immunocompromised patients remain susceptible to harm from Covid-19 and continue to have limited treatment options.

Many provisions within the Pandemic and All-Hazards Preparedness Act are set to expire in September, including support for two agencies that are integral to protecting vulnerable citizens from SARS-CoV-2 and other viruses: the Biomedical Advanced Research and Development Authority and the Administration for Strategic Preparedness and Response. Republicans and Democrats must continue discussions and find common ground to ensure appropriate medical countermeasures are in place in advance of the next public health emergency. More than most, I understand the challenges of navigating the politics of public health. However, we must prioritize and protect our most vulnerable by ensuring a ready supply of effective, safe, variant-resistant treatments.

A key example of an initiative that should not be allowed to fall short is Project NexGen, a $5 billion initiative launched by the current administration to expand the Covid-19 treatment toolbox with innovative vaccines and therapeutics. This multiagency initiative was launched to provide government support at key points through the development process — from clinical trials to Food and Drug Administration authorizations to ensuring commercial availability and equitable access to new treatments.

As a veteran of Project Warp Speed, which delivered Covid-19 vaccines in record time, I applaud this effort to marshal public and private sector resources and drive innovation.

However, the program’s currently stated funding priorities do not include the availability of the next generation of safe, effective oral antiviral medicines. Instead of supporting the acceleration of oral antivirals, some of which are already in late-stage clinical development, Project NextGen seems focused on technologies — such as more durable monoclonal antibodies — that many scientists feel are still years away.

In fact, monoclonal antibodies are the only treatments Project NextGen has expressed support for, despite their well-known challenges for Covid-19. The efficacy of monoclonal antibodies is dependent on specific targeting of currently circulating viral variants. As a result, most first-generation monoclonal antibodies no longer work, had their authorization rescinded by U.S. and global regulatory bodies, and have been pulled from the market.

As former White House Coronavirus Response Coordinator Deborah Birx has previously stated, we are one variant away from a wave that could evade all remaining treatments. No one I’ve spoken to in industry or in government believes a strategy that relies solely on new monoclonal antibodies will adequately prepare us for the new variants or viruses that will emerge.

In contrast, next-generation oral antivirals in development are variant neutral, with the potential to fill significant treatment gaps in the short-term and to ensure future, long-term preparedness. (Disclosure: I am on the board of Atea Pharmaceuticals, which has an oral antiviral for Covid in development.)

While the only currently approved oral antiviral, Paxlovid, works well for some, it has key limitations. These include contraindications for use with commonly prescribed medicines for people who are immune compromised, or who are at risk for worsening heart disease and stroke. In other words, those currently most at risk for harm from Covid-19 are also often most at risk of harm from taking the one approved and effective remaining outpatient treatment for Covid-19.

Covid-19 is the fourth leading cause of death in the U.S., after heart disease, cancer, and injury. We have the knowledge and the tools to change this, but not yet the will or the funding. Every day I hear from medical professionals nationwide who tell me they desperately need more therapeutic options. Their patients — including those in senior care facilities — need safe, effective oral treatments that can be easily administered and prevent disease progression.

That’s why in order to protect those at greatest risk of hospitalization and death, the Biden administration and Congress must prioritize new oral antivirals. They aren’t a “nice to have,” but a “must have.”

Support for manufacturing new oral antivirals that are in development would ensure an immediate supply at the time of an FDA authorization. That would be a cost-effective investment that could pay major dividends in reduced hospitalizations and deaths.

Without prioritizing more oral antiviral options for our treatment toolbox, we face the real possibility of reducing the gains we have made against Covid-19 and being ill-prepared for the next wave, and the next pandemic.

As conversations about legislation and funding for pandemic preparedness progress, I urge Congress and the Biden administration to take action. This is an issue of health equity. Making treatments available that can protect our seniors and those with disabilities now and in the future is surely something we can all agree on.

Jerome Adams, M.D., MPH, served as the 20th surgeon general of the United States and was a prior member of the President’s Coronavirus Task Force. He is currently presidential fellow and the executive director of health equity initiatives and distinguished professor of practice at Purdue University.