Letter to Deborah Birx, Coronavirus Task Force Coordinator, and Alex Azar, Secretary of Health and Human Services - Lawmakers call on Trump administration to release its vaccine-distribution plan

Letter

Dear Dr. Birx and Secretary Azar:
On July 21, 2020, the Committee held an oversight hearing on the efforts underway to
develop a safe and effective vaccine against the coronavirus disease of 2019 (COVID-19).
Congress has provided billions of dollars to support the unprecedented pursuit of a COVID-19
vaccine and we applaud the progress that has been made to date through public-private
partnerships. We continue to root for collective success in finding a COVID-19 vaccine that is
both safe and effective, that will be a crucial tool in helping restore the nation's health and
economy.
As the pursuit for a safe and effective COVID-19 vaccine proceeds, however, we are
concerned that the Trump Administration has yet to finalize and release a national COVID-19
vaccine plan. Alarmingly, in the absence of a comprehensive plan, the Administration appears to
be making decisions without the critical input of public health partners or consideration for the
existing infrastructure the nation has long relied upon for the allocation, distribution, and
tracking of vaccines. While the Administration has awarded billions of dollars for the
development and manufacturing of COVID-19 vaccines, Congress, key public health
stakeholders, and the American people have yet to be informed about how the Administration
intends to ensure the equitable distribution of a vaccine once it is available.
On May 21, 2020, we wrote to the Trump Administration's White House Coronavirus
Task Force regarding the urgent need for a comprehensive national COVID-19 vaccine plan that
extends beyond research and development--including manufacturing, distribution, education,
and patient cost considerations.1
In our letter, we requested critical information about the Administration's vaccine planning efforts and sought a copy of the plan itself. More than two months later, we have yet to receive a response. According to testimony from senior
Administration officials before this Committee on June 23, and before the Senate Committee on
Appropriations on July 2, such a plan is still under development more than six months into the
COVID-19 pandemic.3

Despite the lack of a comprehensive plan, the White House and the Operation Warp
Speed (OWS) initiative appear to be advancing decisions that will impact future COVID-19
vaccine distribution efforts. In an interview on May 14, 2020, President Trump indicated that the
U.S. military would be mobilized to distribute a COVID-19 vaccine once it was available.4

More recently, reportedly at the initial request from Dr. Francis Collins, Director of the National
Institutes of Health--followed later by a formal request from Dr. Collins and Dr. Robert
Redfield, Director of the Centers for Disease Control and Prevention (CDC)--the National
Academies of Sciences, Engineering, and Medicine (NASEM) convened a new committee to
develop "a framework for equitable allocation of vaccine for the novel coronavirus."5

While we value the input of NASEM, these ongoing efforts do not appear to fully
incorporate CDC, the Advisory Committee on Immunization Practices (ACIP), and state,
territorial, tribal, and local health departments, all of which have played critical roles in planning
and implementing existing vaccine programs and prior outbreak responses. The nation's current
immunization system, for example, relies on ACIP, which is convened by CDC, comprised of
medical and public health experts, and charged with developing recommendations on the use of
vaccines in the United States.6
According to ACIP Chairman Dr. José Romero, however, the
Administration has yet to provide clarity as to ACIP's role or any assurance that the prioritization

guidelines it develops will contribute to the national COVID-19 vaccine plan
And, in a presentation to ACIP on OWS, Administration officials reportedly asked ACIP members to bear
with the "lack of ability to provide a lot of specifics about what we're doing."
Additionally, as of July 22, 2020, Claire Hannan, the Executive Director of the
Association of Immunization Managers (AIM)--a 21-year-old-organization representing the
leadership of CDC-funded programs across 64 states and territories working together to improve
immunization coverage in the United States--had not heard from OWS.
In addition to her
concerns regarding "how distribution will be carried out" and "the lack of planning with state
and local public health agencies," she stated that AIM members had "received no assurance that
existing vaccine allocation, distribution, and tracking systems will be used."10
The Administration's apparent lack of engagement with these key stakeholders is deeply
troubling. Experts agree that CDC and public health partners will be vital to the successful
execution of a future COVID-19 vaccine program. In a recent report, for instance, Johns
Hopkins University researchers spoke to the importance of these public health partners 'roles in
the distribution of vaccines in prior pandemics.11
The researchers also noted that the U.S.
Department of Defense (DOD) appears to be taking over CDC's role with respect to the
distribution of COVID-19 vaccines, cautioning that this may undermine public confidence in any
eventual COVID-19 vaccine.12
If true, in addition to threatening public trust in a future COVID19 vaccine, distribution efforts by DOD may also risk duplicating or undermining existing public
health partners and infrastructure with longstanding experience in supporting the distribution,
allocation, and tracking of vaccines.
Finally, some vaccine company executives have also emphasized the importance of
partnering with these public health experts to ensure equitable distribution of a future COVID-19
vaccine. In testimony before the Committee, for example, Dr. Julie Gerberding, Executive Vice
President and Chief Patient Officer of Merck--and a former CDC Director--stated, "we cannot
possibly do this without the CDC and the frontline of our state and local health departments."13
Public health leaders and the existing immunization infrastructure will be vital to the
development and implementation of a national COVID-19 vaccine plan. Unfortunately, the
Administration's apparent failure to engage these stakeholders, its continued secrecy surrounding
OWS, and its ad hoc announcements in lieu of a comprehensive national plan perpetuates
confusion and further threatens public trust in a future COVID-19 vaccine.
Given the concerns above, we reiterate our request for a staff briefing on the full scope of
OWS and responses to our May 21 letter, as well as responses to the following by August 19,
2020.
1. When will the Administration publicly release its national COVID-19 vaccine plan?
2. Will the Administration include public health experts and partners, including CDC career
staff, and state, territorial, tribal, and local health officials, including state immunization
program leadership, in the development of its COVID-19 vaccine plan? If so, when?
3. What will be DOD's role with regard to the distribution of a future COVID-19 vaccine?
Will DOD coordinate with CDC and state, territorial, tribal, and local health officials to
utilize existing immunization program distribution centers and processes?
4. What is the role of the newly charged NASEM committee and its relationship with ACIP
and their respective guidance recommendations for populations to prioritize for future
COVID-19 vaccination?
Thank you for your attention to this matter. If you have any questions, and to schedule
the requested briefing, please contact Jesseca Boyer and Kevin Barstow of the Majority staff at
(202) 225-2927

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