WASHINGTON, D.C. – U.S. Senator Gary Peters (D-MI), Ranking Member of the Homeland Security and Governmental Affairs Committee, is pressing Secretary of Health and Human Services Alex Azar and Acting Secretary of Defense Christopher Miller for information on their preparations to meet the enormous challenge of coordinating the wide distribution of Coronavirus vaccines to Michiganders and all Americans once cleared by the Food and Drug Administration (FDA).
“I write to ensure our nation is prepared to engage in the largest vaccine campaign in U.S. history to safely, effectively, and equitably distribute millions of COVID-19 vaccines to Americans, when authorized for emergency use by the Food and Drug Administration With over a quarter of a million American lives already lost from this virus, we cannot afford avoidable missteps or unnecessary delay,” wrote Peters.
Peters continued: “In addition, political pressure on scientific agencies like the Food and Drug Administration and Centers for Disease Control and Prevention have shaken public confidence in the federal government’s response efforts, including vaccinations. Clear and consistent communication and public engagement will be essential for a successful vaccination campaign.”
In the letter, Peters raised the alarm on recent reports that state and local governments lack the necessary resources to equitably distribute Coronavirus vaccines and that political pressure at our nation’s public health agencies have eroded public confidence in vaccines. Peters also pressed Secretaries Azar and Miller to provide details on steps they are taking to ensure that vaccines will be readily available to all who want one.
As Ranking Member of the Homeland Security and Governmental Affairs Committee, Peters has called on the Administration to ensure the Coronavirus vaccine process is rooted in science and transparency and that its distribution is efficient, swift and equitable. Last month, he released a report highlighting shortcomings in the Trump Administration’s vaccine distribution plans and providing recommendations to ensure that vaccines will be safe, effective, trusted by the public, free, and widely available to every community. He pressed the Trump Administration to take swift action to ensure the U.S. has enough syringes and needles needed to quickly immunize millions of Americans once Coronavirus vaccines are authorized for distribution. He also introduced legislation to address shortages of medical supplies and personal protective equipment by encouraging domestic production.
Text of the letter is copied below and available here.
The Honorable Alex M. Azar II The Honorable Christopher Miller
Secretary Acting Secretary
U.S. Department of Health and Human Services U.S. Department of Defense
200 Independence Ave., SW 1000 Defense Pentagon
Washington, D.C. 20201 Washington, D.C. 20301
Dear Secretary Azar and Acting Secretary Miller:
The promising developments in vaccine candidates bring us one step closer to curtailing what has become uncontrolled spread of COVID-19. Widespread availability of COVID-19 vaccines will be critical to overcoming this pandemic, but the distribution of these vaccines presents a herculean logistical challenge that must be met with seamless federal and state coordination and planning. This is a task that requires a whole of government response. I write to ensure our nation is prepared to engage in the largest vaccine campaign in U.S. history to safely, effectively, and equitably distribute millions of COVID-19 vaccines to Americans, when authorized for emergency use by the Food and Drug Administration (FDA). With over a quarter of a million American lives already lost from this virus, we cannot afford avoidable missteps or unnecessary delay.
The COVID-19 pandemic has exacerbated many vulnerabilities in our nation’s medical supply chain. While the federal government has made significant investments to expand domestic manufacturing capacity and supply of needles, syringes, and glass vials, concerns remain regarding the availability of critical ancillary supplies needed to safely distribute and administer COVID-19 vaccines, such as personal protective equipment (PPE). Last month, the Government Accountability Office (GAO) identified limited manufacturing capacity and potential disruptions in supply chains as challenges to the distribution of COVID-19 vaccines. Recent supply chain disruptions will reportedly impact expected worldwide vaccine shipments from one developer by half – from 100 million doses to 50 million by the end of this year. According to one report, HHS has indicated these disruptions should not impact expected U.S. supply this month. Although Operation Warp Speed has emphasized the need for visibility into both vaccines and ancillary supplies, this information must be consistently shared with states and public health departments to improve coordination, garner trust, and set expectations. We learned early in the pandemic that transparency is essential for coordinated and successful supply distribution, and the same principles apply to the nation’s vaccination efforts.
Our states also face significant challenges in this effort, including the complex logistics of vaccine delivery and public hesitancy surrounding COVID-19 vaccines. Of the three vaccine candidates that have released preliminary or full data as of this letter, one vaccine must be stored on dry ice at ultra-cold temperatures with strict handling instructions, while another must be kept frozen. Further, none of the vaccines are interchangeable, making traceability – knowing which individual received what vaccine – of critical importance. In addition, political pressure on scientific agencies like the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) have shaken public confidence in the federal government’s response efforts, including vaccinations. Clear and consistent communication and public engagement will be essential for a successful vaccination campaign. To build public trust and actively combat misinformation and disinformation about COVID-19 vaccines, this Administration must provide transparent and nonpartisan information to the American people.
Another concern is the impending costs of this effort. Without sufficient federal funding, states’ ability to rollout their vaccine distribution plans will be restricted. Although the CARES Act and the Coronavirus Preparedness and Response Supplemental Appropriations Act made funding available for the development and purchase of COVID-19 vaccines, additional funding is critically needed. Reports indicate that states need anywhere from $6 billion to $8.4 billion for vaccine distribution. Concerns remain that without sufficient funding, states will be hamstrung in effectively implementing their vaccine distribution campaigns, regardless of even the most meticulous planning efforts.
I ask that your agencies do everything possible to ensure a seamless transition focused on safe, effective, and equitable vaccine distribution preparedness. To ensure the swift and safe distribution of eventual COVID-19 vaccines, I request responses to the following questions as soon as possible, but no later than December 14, 2020.
1. To ensure sufficient uptake, any vaccine must be trusted by the public.
a. What specific steps has the Administration taken to increase public confidence in a vaccine, including specific public education campaigns and resources?
b. What support, if any, has the Administration provided to states and other jurisdictions in the development of such campaigns and community engagement efforts? How is the Administration working to build trust in communities of color that have been disproportionately affected by this virus?
2. How will the Administration ensure transparency and equity in its vaccine distribution and allocation process?
a. What specific factor(s) is the Administration using to determine vaccine allocation to jurisdictions
b. How, if at all, does the Administration anticipate this allocation criteria will change as vaccine availability increases? Does the Administration plan to ship vaccines outside the U.S.?
c. How does the Administration define a hot spot and what methodology is used to make this determination? Will hot spots play a role in allocating vaccines to states? If so, why?
3. How is the Administration working to actively combat misinformation and disinformation surrounding vaccines and secure the COVID-19 vaccine infrastructure from potential cyberattacks?
4. Given the country’s continued shortages of vital PPE, what measures are your agencies taking to ensure a sufficient amount of PPE is available for health care workers to safely treat the rising number of COVID-19 patients and administer eventual COVID-19 vaccines?
a. According to a recent GAO report, states have reported concerns about having enough supplies needed to administer vaccines, such as needles. In addition to the federal government’s previous investments in expanding manufacturing capacity for vaccine supplies, please describe HHS’s plan to mitigate shortages.
b. How will the federal government ensure coordination of vaccine shipments with the appropriate ancillary supply kits?
5. How are Operation Warp Speed, the Department of Defense (DOD), CDC, and any other relevant agencies working with the incoming Biden Administration to ensure they are prepared to oversee widespread vaccine distribution?
a. What support is needed from Congress to ensure a unified transition between Administrations?
6. Please explain in detail how the federal government plans to continue supporting state public health departments in executing their vaccine distribution plans once FDA issues emergency use authorization(s).
a. Will the federal government’s support change as states move through the phased priority groups?
7. A successful vaccine distribution campaign will require a number of effective, up-to-date information technology systems, both existing and newly developed, to track vaccine distribution, administration, and other information. While data systems appear to be in place at both the state and federal levels, their seamless and secure operation is critical.
a. Please explain any shortfalls and anticipated challenges with current technology systems that will be used in vaccine distribution, the status of each system (existing or in development), and what steps have been taken to ensure each system is working as intended.
b. The CDC has stated that each state should have an immunization information system that is up to date and capable of storing and submitting certain information to the CDC. What steps has the Administration taken, if any, to support states and other jurisdictions in the development, update, and maintenance of these systems?
8. How is the FDA ensuring that vaccine manufacturing facilities (including packaging and ancillary supply facilities) are in compliance with Current Good Manufacturing Practice (CGMPs) regulations and that the vaccines and supplies manufactured at those sites are safe?
9. Please provide an accounting of any funds being used to support vaccine distribution, including accounting, monies expended, obligated, and any unobligated funds that could be used to support states’ vaccine distribution efforts.
Thank you for your prompt attention to this matter.