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COVID-19 Medical Countermeasures and the Commercial Marketplace

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Over the course of the pandemic, the federal government has played the central coordinating role in buying, distributing, and ensuring equitable access to COVID-19 vaccines, therapeutics, and tests. We have made significant progress as a country over the past 19 months in making these tools widely available and free to the American people.

Today, more than three in four Americans have received at least one COVID-19 vaccine shot; therapeutics are available within 5 miles of 90% of Americans; and testing is readily accessible. Daily COVID-19 deaths are down by nearly 90% since President Biden took office and severe illness is avoidable for most people as a result of the free vaccines and therapeutics we have procured and distributed quickly, efficiently and equitably. We are in a much better place than we were at the beginning of the Biden Administration.

While the federal government has been pleased to play this role, we have always known that we would not be in this business forever. We have always intended to transition this work to the commercial market and have been planning for that transition for some time now. Unfortunately, the timeline to make the transition has accelerated over the past six months without additional funds from Congress to support this work. We have been grateful for the bipartisan Congressional support of our response efforts, but it has been more than 530 days since we last received new funding for COVID-19 and without additional funds it will be difficult to continue procuring and distributing these countermeasures.

In fact, additional COVID-19 funding continues to be urgently needed for a range of critical response needs, including the development of next-generation vaccines, therapeutics, and tests.

In terms of commercialization planning, additional funding would allow for an orderly wind down of the federal government’s procurement and distribution programs to ensure that all have access to these needed interventions while the commercial market ramps up. And importantly, it would also allow us to more effectively ensure equitable distribution and coverage for the underinsured and uninsured. In the meantime, we continue to move forward with detailed commercialization planning, to ensure that we are prepared for all scenarios and to maximize access to vaccines and treatments for the American people. Our goal is to transition procurement and distribution of COVID-19 vaccines and therapeutics from a federally managed system to the commercial marketplace in a thoughtful, well-coordinated manner that leaves no one behind.

As part of this planning process, earlier today HHS convened more than 100 representatives from state and local government, health care providers and insurers, pharmaceutical companies and vaccine manufacturers, patient advocates, and more, to discuss the pathway to commercialization for both vaccines and therapeutics. During the meeting, we discussed our shared goals of transitioning these products in a way that ensures continued equitable access for all Americans and prepares us for whatever may come next with this virus that has been anything but predictable. A few key themes emerged from today’s meeting:

  • Vaccines: HHS has procured over 170 million updated COVID-19 boosters for a vaccination campaign this fall and winter, pending Food and Drug Administration authorization and action from the Centers for Disease Control and Prevention. As with previous vaccines, we will make these updated doses available for free to anyone who wants one. As early as January 2023, the Administration anticipates no longer having federal funds to purchase or distribute vaccines and will need to transition these activities to the commercial market, similar to seasonal flu or other commercially available vaccines.
  • Therapeutics: Earlier this month, we successfully transitioned Bebtelovimab, a monoclonal antibody treatment, to the commercial marketplace. We will use this experience to apply to future transitions of therapeutics. Based on current projections, we expect to run out of our remaining federal supply of the preventative treatment Evusheld as soon as early 2023, followed by the oral antiviral Lagevrio sometime in the first or second quarter of next year, and Paxlovid in mid-2023. As our federal supply of these treatments runs out, we expect to transition these products to the commercial market. 
  • Partnership: As we move to commercialization, it is absolutely critical for us to build on the strong partnerships we have established throughout the pandemic. HHS and other federal agencies stand ready to help our commercial partners succeed in providing these lifesaving products to the American people.

Today’s meeting was just one steppingstone on the path to full commercialization of COVID-19 countermeasures. We will continue to engage with our partners, honing our plans, and communicating key information to the American people as we move forward.


Category

Medical Countermeasures; Response and Recovery

Published

2022-08-30T16:54:00Z

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Dawn O’Connell, Assistant Secretary for Preparedness and Response

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Created at 8/30/2022 4:58 PM by ELIZABETH JARRETT
Last modified at 8/30/2022 4:59 PM by ELIZABETH JARRETT