HHS Letter to COVID-19 Vaccine Manufacturers

Thursday, July 13, 2023

Executive Summary:

  • HHS appreciates manufacturers’ partnership in COVID-19 vaccine development and distribution.
  • Transition to more traditional vaccine procurement, distribution, payment pathways is underway.
  • Manufacturers expected to prepare sufficient doses for 2023-2024 vaccination campaign.
  • HHS asks manufacturers to plan vaccine supply and regulatory submissions for FDA and CDC review by late September.
  • Updated vaccines should be priced reasonably, reflecting the benefits of U.S. government investment.
  • Companies are expected to work with CMS and other payors for payment information regarding updated vaccines.
  • HHS emphasizes the need for accurate, timely data for equitable vaccine access.
  • Announcement of “Bridge Access Program For COVID-19 Vaccines and Treatments” for adults without coverage.
  • CDC intends to purchase vaccines from manufacturers under the new program.

Unedited Press Release Text:

Letter to COVID-19 Vaccine Manufacturers

Dear COVID-19 Vaccine Manufacturers,

We are appreciative of your strong partnership over the last three years, which has seen the development, manufacture, and distribution of COVID-19 vaccines at a record pace. Your collaboration and dedication to this mission have enabled the U.S. Department of Health and Human Services (HHS) to deliver safe and effective medical countermeasures to the American public more efficiently and equitably than ever before. To put it simply, you have been an instrumental part of a vaccination campaign that has saved millions of lives.

The COVID-19 response remains a significant public health priority for the Biden-Harris Administration and HHS. Many people are still at risk of infection and re-infection, and millions are experiencing the longer-term effects of the virus, including seniors, immunocompromised people, and those with disabilities. The U.S. government remains committed to maximizing access to COVID-19 vaccines, treatments, and tests. The relationship with HHS and the manufacturers continues to evolve as the U.S. government moves into this next phase of our response, but your innovation and expertise will continue to be important to develop, manufacture, and help to ensure equitable access to lifesaving products going forward.

As you know, HHS is working to ensure a smooth transition of COVID-19 vaccines to more traditional pathways for procurement, distribution, and payment. After the transition, we expect that vaccines will remain available in the types of locations where the public currently receives them — including pharmacies, clinics, healthcare provider offices, health departments, and other points of care — to maximize access.

We also expect that vaccine manufacturers planning to offer updated COVID-19 vaccines are preparing an ample supply of doses for the 2023-2024 COVID-19 vaccination campaign that is sufficient to support wide and timely access to the vaccine. Further, we expect that vaccine manufacturers will remain ready to support potential surges in demand and evolving circumstances of COVID-19. Manufacturers are advised that they should plan the updated COVID-19 vaccine supply and regulatory submissions so that the Food and Drug Administration (FDA) can take regulatory action and the Centers for Disease Control and Prevention (CDC) can make recommendations on vaccination by the latter part of September.

As we approach this transition, we expect that companies will look to the example that the U.S. government has set in eliminating access hurdles for the American public. In just the past few years, the U.S. government has invested billions of dollars in research, development, and procurement for COVID-19 vaccines across multiple manufacturers. Moreover, federally-sponsored research has provided crucial insights that laid the groundwork for the development of COVID-19 vaccines over several decades. Updated COVID-19 vaccines entering the market this fall should be priced at a reasonable rate, reflective of the value that you have obtained through U.S. government investment. Price gouging behavior takes advantage of the trust the American people have placed in you through the COVID-19 response. In the coming weeks and months, we anticipate that you will work with the Centers for Medicare & Medicaid Services (CMS) and other payors to ensure that they have the required information to make payments for the updated vaccines this fall.

Accurate and timely data will also continue to be vital as we uphold our shared goal of facilitating equitable access to COVID-19 products. Throughout the pandemic response, HHS has used distribution and administration data to spotlight communities that have been left behind and enhance distribution efforts to maximize access. As ordering and distribution transitions to more traditional pathways, HHS asks you to find sustainable ways to enable continued visibility of the provider network and availability of vaccines. Your sharing of information with government partners is fundamental to maintaining our mutual commitment to equity.

Finally, as you know, HHS has announced the “Bridge Access Program For COVID-19 Vaccines and Treatments.” This program is intended to provide access to vaccines and treatments for adults without other sources of coverage. Part of the program is expected to provide support for the existing public sector vaccine safety net, using existing authority under Section 317 of the Public Health Service Act and decades of experience in similar efforts. Under this part of the program, similar to the Vaccines for Children Program, the CDC intends to purchase vaccines from the manufacturers. The second part of the program is designed to facilitate access to vaccines that manufacturers have previously committed to provide for uninsured adults, as well as those whose insurance does not fully cover COVID-19 vaccination. That part of the program will be supported via a partnership between the Federal government and pharmacies, and not with the manufacturers. However, HHS knows that this critical piece of the program can only function well with your support and provision of vaccines. Our teams have been in numerous conversations, and I hope you are as committed as we are to the success of this program. We will continue to provide you with details to facilitate your partnership on this program.

HHS looks forward to continuing to build our relationship and working closely with you in the coming weeks leading up to this transition in the fall. Thank you for your support.


Xavier Becerra


SOURCE: https://www.hhs.gov/about/news/2023/07/13/letter-covid-19-vaccine-manufacturers.html

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