U.S. Department of Health & Human Services
Commercialization of COVID-19 Medical Countermeasures
Frequently Asked Questions
What is commercialization?
Commercialization is the transition of COVID-19 medical countermeasures, including vaccines, treatments, and test kits previously purchased by the U.S. Government (USG), to established pathways of procurement, distribution, and payment by both public and private payers.
Providing medical countermeasures in the commercial market is something that manufacturers, logistics companies, and payors do every day.
What is the timeline for commercialization?
While there are many considerations and timelines may shift based on the trajectory of the virus, we anticipate that the transition of vaccines to more traditional pathways for procurement, distribution, and payment will occur in early fall.
Some of those considerations include what will be authorized and recommended by FDA and CDC, and what will align with a strain change for potential variants.
Provided that one is authorized and recommended by FDA and CDC, we expect this transition will align with a possible strain change that accounts for any potential variants.
The treatments transition to commercial markets will vary by product and will likely occur for at least one product before the end of the year.
The USG is working on determining the exact dates for COVID-19 vaccines and therapeutics. We will share more information about timelines when we are able.
What is the impact of the end of the COVID-19 Public Health Emergency (PHE) on May 11 on access and costs to COVID-19 vaccines and treatments?
The PHE does not affect the transition of vaccines and treatments to commercial markets.
In February 2023, HHS Secretary Becerra renewed the PHE for one last 90-day period planned to end at the end of the day on May 11, 2023. This action is based on the most recent COVID-19 trends and is consistent with the Administration statement on January 30, 2023, that the PHE is planned to end at the end of the day on May 11.
In the past, HHS has committed to providing 60 days-notice in advance of ending the PHE. To foster a smooth transition, HHS has given 90 days-notice instead.
Even with the planned end of the PHE at the end of the day on May 11, on May 12, all vaccines and treatments purchased by the U.S. government will continue to be distributed and available for free to U.S. residents. The PHE itself does not affect the supply or distribution of our vaccines or treatments. It also does not affect FDA’s ability to authorize various products, including tests, treatments, or vaccines for emergency use.
How will commercialization change the accessibility of COVID-19 vaccines and treatments?
COVID-19 remains a significant public health priority for the Administration and for HHS. We know so many are still affected by COVID-19, particularly seniors and people with disabilities. We remain committed to maximizing availability of COVID-19 vaccines and treatments.
Our intention is that vaccines and treatments will remain available from all of the places U.S. residents currently receive them, whether it’s at their pharmacy or their health care provider.
Vaccines will remain free for most U.S. residents through the Vaccines for Children Program, Children’s Health Insurance Program, most commercial insurance, Medicare, and Medicaid programs.
Those with Medicare, Medicaid, and most private insurance will be able to access covered treatments, potentially with cost-sharing.
How will vaccines and treatments be available for the un- and underinsured?
CDC’s Vaccines for Children Program will provide coverage for uninsured children as it does for other routine vaccinations.
HHS is actively working with vaccine and treatment manufacturers to ensure that Patient Assistance Programs that provide free access to these products are easy to use and broadly accessible.
HHS continues to invest in health systems and programs that support vaccine access and outreach in underserved communities – such as Federally Qualified Health Centers, Rural Health Clinics, and state and local health departments. These networks can be leveraged for access to COVID-19 vaccines and therapeutics as well as other needed medicines.