Full text
U.S. Department of Health and Human Services
Office of Inspector General
Early Challenges Highlight
Areas for Improvement in
COVID-19 Vaccination
Programs
Ann Maxwell
Deputy Inspector General for
Evaluation and Inspections
January 2023, OEI-04-21-00190
U.S. Department of Health and Human Services
Office of Inspector General
Report in Brief
January 2023, OEI-04-21-00190
Early Challenges Highlight Areas for
Improvement in COVID-19 Vaccination
Programs
Why OIG Did This Review
Vaccines help reduce disease-related
illnesses, hospitalizations, and
deaths. The Centers for Disease
Control and Prevention (CDC) assists
and funds State and local
immunization programs—to which
we refer as awardees—to support
vaccine programs that immunize
individuals in their jurisdictions
against vaccine-preventable diseases
(e.g., measles and influenza). CDC’s
COVID-19 vaccination program is an
extension of these efforts. As
vaccine supply increased in March
2021—during the early stages of
COVID-19 vaccination programs—
awardees faced challenges in
meeting their goals of immunizing
the U.S. population amid an ongoing
pandemic.
As CDC makes ongoing program
improvements, it can be assisted by
understanding the challenges that
awardees experienced with the
COVID-19 vaccination program and
the mitigation strategies they took.
This understanding can also help
CDC enhance routine immunization
programs and better prepare for
vaccination programs for future
pandemics.
How OIG Did This Review
The Office of Inspector General (OIG)
collected data on the challenges and
mitigation strategies that 56 State
and large metropolitan area
awardees reported in March 2021.
We also interviewed CDC officials,
officials from other Department of
Health and Human Services (HHS)
agencies, and other Federal officials,
and we reviewed written responses
and documentation across HHS. To
sup port ongoing vaccination efforts,
OIG shared preliminary analysis with
CDC in late March and early April
2021.
Key Takeaway
State and local immunization
programs distributing COVID -19
vaccines faced numerous challenges,
including (1) achieving logistical
efficiency, (2) obtaining complete
vaccine data from providers,
(3) combating vaccine hesitancy with
public health messaging, and
(4) overseeing vaccine providers.
What OIG Found
In the early stages of their
COVID-19 vaccination
programs, awardees
consistently reported
challenges that affected their
ability to administer COVID-19
vaccines efficiently and
equitably. Specifically,
awardees reported logistical
challenges that impacted
efficiency, including large
minimum order sizes for vaccines, requirements for ultra-cold storage,
and insufficient ancillary supplies. Additionally, awardees reported
challenges in obtaining complete, timely, and accurate vaccine data from
both Federal program and jurisdictional providers, which affected their
ability to determine community needs efficiently and equitably. Finally,
awardees also reported wanting more Federal government support for
public health messaging and for their oversight of providers.
For each type of challenge, awardees also reported using a variety of
strategies to mitigate the challenge. For example, awardees reported
breaking down large minimum order sizes to improve vaccine access.
Awardees also reported having less experienced providers shadow each
other to improve provider understanding of data systems.
What OIG Recommends and How the Agency Responded
COVID-19 vaccination efforts are ongoing, and CDC continues to take
steps to address many awardee challenges. However, areas for
improving the efficiency and equity of the vaccination program remain.
Specifically, we recommend that CDC update its plans for mass
vaccination programs with strategies that address awardee-reported
logistical challenges and strengthen reporting of vaccine allocation data
and administration data. In addition, we recommend that CDC clarify
roles and responsibilities within HHS for vaccine public health messaging
during a pandemic. Finally, we recommend that CDC work with awardees
to enhance current and future capabilities for provider training and
oversight. CDC concurred with all four recommendations.
TABLE OF CONTENTS
BACKGROUND................................................................................................................................................ 1
FINDINGS........................................................................................................................................................11
Awardees reported logistical challenges that affected their ability to administer vaccines equitably
and efficiently...........................................................................................................................................................................11
Awardees reported that data challenges affected their ability to allocate and distribute vaccines
equitably and efficiently.......................................................................................................................................................14
Awardees reported challenges with public health messaging to combat vaccine hesitancy....................19
Awardees reported lacking resources to sufficiently oversee COVID-19 vaccination program providers
.......................................................................................................................................................................................................20
CONCLUSION AND RECOMMENDATIONS.......................................................................................... 23
Update its plans for mass vaccination programs with strategies that address awardee-reported
logistical challenges...............................................................................................................................................................24
Strengthen reporting of vaccine allocation data and administration data.......................................................25
Clarify roles and responsibilities within HHS for vaccine public health messaging during a pandemic…
.......................................................................................................................................................................................................26
Work with awardees to enhance current and future capabilities for provider training and oversight...26
AGENCY COMMENTS AND OIG RESPONSE ........................................................................................ 28
APPENDIX..................................................................................................................................................... 30
Appendix A: Storage and Handling Requirements for COVID-19 Vaccines in March 2021.......................30
Appendix B: State and Federal Data Systems ..............................................................................................................31
Appendix C: More Details on Awardee-Reported Challenges and Mitigation Strategies...........................32
Appendix D: Agency Comments .......................................................................................................................................34
ACKNOWLEDGMENTS AND CONTACT ................................................................................................ 39
Acknowledgments..................................................................................................................................................................39
Contact........................................................................................................................................................................................39
ABOUT THE OFFICE OF INSPECTOR GENERAL.................................................................................... 40
ENDNOTES ....................................................................................................................................................41
BACKGROUND
OBJECTIVES
1. To describe awardee-reported challenges in the early stages of their
COVID-19 vaccination programs.
2. To describe awardee-reported mitigation strategies for addressing
challenges in the early stages of their COVID-19 vaccination programs.
Rationale
The Department of Health and Human Services (HHS) plays a critical role in the
distribution and administration of routine and pandemic vaccines to the public.1 The
Centers for Disease Control and Prevention (CDC) provided funding to 64 State, local
and territorial immunization programs (hereinafter referred to as “awardees”) through
its Immunization and Vaccines for Children Cooperative Agreement.2 Through this
cooperative agreement, CDC provided $350 million on average each year between
fiscal years (FYs) 2017 and 2021 for awardees to plan for and oversee routine
vaccination programs.3 Additionally, HHS and CDC have developed various pandemic
vaccination planning guides, such as the 2005 HHS Pandemic Influenza Plan, which
also provide guidance to awardees. 4
The COVID-19 vaccination program is a joint Federal, State and local initiative to
provide safe and effective COVID-19 vaccines to the public.5 To ensure wide access to
COVID-19 vaccines, the Federal government uses multiple programs to get vaccines
into communities, including both directly through the awardee, and through
providers participating in Federal programs (i.e., programs run by the Federal
government rather than by awardees).6 Therefore, providers may receive COVID-19
vaccines through an awardee, a Federal program, or a combination of both.
CDC assisted awardees in developing and implementing plans that built upon existing
routine immunization program efforts and past pandemic planning.7 Moreover, CDC
has provided $7.2 billion in COVID-19 supplemental funding to awardees between
FY 2020 and FY 2021. As a result, Federal, State, and local personnel have carried out
one of the largest mass vaccination efforts in U.S. history to combat the COVID-19
pandemic.8 This included enrolling many providers who do not routinely administer
vaccines (hereinafter referred to as “nontraditional providers”), in addition to
traditional vaccine providers, to meet the demand for the COVID-19 vaccines. As of
October 2022, CDC reported that approximately 68 percent of the U.S. population
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(i.e., adults and children) had received at least two doses of Moderna or Pfizer
vaccines or one dose of Johnson & Johnson.
Stakeholders reported several initial challenges when vaccine distribution and
administration began in late 2020. These included limited vaccine supply; vaccine
hesitancy; and storage and handling requirements.9 Stakeholders acknowledged that
some of these initial challenges would likely evolve, or new challenges would emerge,
as vaccine supply increased.
This report provides a national view of challenges that 56 awardees reported
experiencing in the early stages of their vaccination program, as well as any mitigation
strategies implemented to address those challenges. To improve COVID-19
vaccination programs while they were ongoing, we issued preliminary, nonpublic
analysis of reported challenges to CDC in late March and early April 2021. This
preliminary analysis allowed CDC to address awardee challenges in a time-sensitive
manner. This report builds upon that preliminary analysis, by using additional data
and qualitative analysis, and includes formal recommendations to improve COVID-19
and future vaccination programs.
COVID-19 vaccination program logistics
In the COVID-19 Vaccination Program Interim Operation Guidance, CDC outlines
various sections related to vaccination program logistics, including vaccine allocation;
vaccine packaging; vaccine distribution; vaccine storage, handling, and administration;
and critical populations.10
During our data collection, the Countermeasures Acceleration Group (CAG), a joint
HHS and Department of Defense (DoD) effort, led the logistics associated with the
development, manufacturing of COVID-19 vaccines, and distribution of those vaccines
to awardees and their communities.11 In March 2022, HHS replaced CAG with a
permanent office, called the HHS Coordination Operations and Response Element (H
CORE), within the Administration for Strategic Preparedness and Response (ASPR).12,
13, 14
Vaccine allocation
Vaccines generally enter communities in one of two ways. A push model “pushes”
vaccines into communities on the basis of a pre-determined vaccine allocation.
Within a push model, an entity, such as the Federal government, determines vaccine
allocations, or the number of vaccines doses made available, and manufacturers
package and distribute vaccines. A pull model is typically used for routine
vaccinations.15 Within a pull model, there is not an entity allocating vaccines, as
manufacturers package and distribute vaccines to providers on the basis of the
number of vaccines doses that the provider requests.16
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Since the COVID-19 vaccination program began, and as of May 2022, COVID-19
vaccines have entered communities using a push model. When we collected data in
March 2021, CAG was responsible for allocating vaccines.17, 18 As of March 2022,
H-Core had taken over this responsibility.
Vaccine packaging
COVID-19 vaccine manufacturers determine how to package and determine minimum
order sizes for vaccines. Minimum order sizes are the smallest number of vaccine
doses that the manufacturer sends within each order. See Exhibit 1 for each
COVID-19 vaccine’s minimum order size during the time period for which we
collected data (i.e., March 2021).
Exhibit 1: Minimum order sizes for COVID-19 vaccines in March 2021.
Vaccine
Minimum Order Size
Pfizer
1170 doses*
Moderna
100 doses
Johnson & Johnson
100 doses
Source: OIG analysis of CDC documentation, 2022.
* Initially, Pfizer orders contained 975 doses of vaccines. However, it was later determined that providers can obtain
an extra dose out of each vial with a certain syringe, which increased the quantity of doses from 975 to 1170.
As of this report’s release, the Pfizer vaccine was the only vaccine for which the
minimum order size had changed, from 1170 doses to 300 doses.
Vaccine distribution
Using the number of vaccines doses they are allocated and the manufacturer-
determined minimum order size, awardees manage and distribute vaccines to the
providers enrolled in their jurisdiction using one of two methods.19 Awardees have
manufacturers ship vaccines to either (1) enrolled providers directly or (2) a central
depot or warehouse where awardees repackage vaccines into smaller shipment sizes
using their own resources.20
CDC notes several things to consider when establishing a depot or warehouse to
break down vaccine shipments. CDC recommends that, when possible, vaccines be
shipped directly from the manufacturer to the location where they will be
administered.21 This approach follows the vaccine manufacturer’s quality system and
minimizes opportunities for breaks in the temperature-controlled supply chain (i.e.,
cold chain), which could compromise the vaccine and cause the vaccine to be less
effective.22 However, repackaging vaccine shipments, rather than shipping vaccines
directly to some providers who may not need a full minimum order amount, reduces
the potential for vaccine waste by sending only the quantity that providers need. In
addition, this helps ensure vaccine access for areas with smaller needs (e.g., smaller
provider offices and mobile vaccination clinics). While this targeted approach ensures
access for smaller providers (i.e., increases equitable access), repackaging vaccine
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shipments also may decrease the distribution throughput, as it would add time to get
vaccines to providers (i.e., delay patient access to the vaccine).
Vaccine storage, handling, and administration
Vaccine storage and handling requirements for each COVID-19 vaccine varied from
refrigerated (36oF to 46oF) to frozen (-13oF to 5oF) to ultra-cold (-112oF to -76oF).
Maintaining each vaccine within its required temperature range is important to
maximize the potential potency and viability of the vaccine. Storing vaccines at
freezing temperatures requires a standard pharmaceutical freezer, while storing
vaccines at ultra-cold temperatures requires additional equipment that most
providers typically do not have. See Appendix A for additional information on the
specific storage and handling requirements for each COVID-19 vaccine when we
collected data from awardees.
To administer the COVID-19 vaccine, providers need ancillary supplies, which are
shipped in kits with the vaccines. These kits include needles, low dead-volume
syringes, alcohol pads, vaccination cards, needle information cards, and personal
protective equipment for providers.23, 24 Each ancillary kit included enough supplies
to administer the number of doses in each minimum order size, with overage to allow
for breakage and loss.25
Critical population prioritization
Initially, CDC recommended in its playbook that awardees ensure that populations in
their jurisdiction that are at higher risk for COVID-19 illness or death have priority
access to vaccines.26 In December 2020, CDC published its Advisory Committee on
Immunization Practices (ACIP) recommendations for allocation of COVID-19
vaccines.27 This recommendation included prioritizing COVID-19 vaccines for health
care personnel to protect these workers and keep health care facilities operating.28 In
addition, CDC recommended prioritizing other vulnerable populations, such as
residents in long-term care facilities; populations over the age of 65; populations with
underlying medical conditions; and essential worker groups, some of which have high
proportions of some racial and ethnic minority populations.29 Awardees used these
CDC recommendations and established their own priority groups with some
variations.30, 31, 32
Vaccine data reporting
Given the multiple programs through which providers can obtain COVID-19 vaccines,
data on where vaccines are distributed (i.e., vaccine allocation data) and the people
receiving those vaccines (i.e., vaccine administration data) are important for ensuring
an efficient and equitable vaccine campaign. Vaccine allocation data is important for
vaccine access planning, while vaccine administration data is important for monitoring
vaccine uptake.
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Vaccine allocation data
The Federal government provides awardees with projections of the expected number
of COVID-19 vaccines that will be allocated to them (i.e., allocation data). Awardees
access allocation data through Tiberius, which is a system developed for the
COVID-19 vaccine campaign. Allocation data are used by awardees, particularly when
vaccine supply is limited, to plan distribution of allocated doses to providers.
Vaccine administration data
Each awardee has an immunization information system (IIS) that is used by its
providers to report vaccine administration data. CDC requires that COVID-19 vaccine
providers receiving vaccines through an awardee report data into awardee IISs for
each dose administered. The data must be entered into the provider’s system of
record within 24 hours and reported to the jurisdiction’s IIS within 72 hours.33 The
required data include the vaccine recipient’s date of birth, address, race, and ethnicity,
as well as vaccine administration date, location, and manufacturer.34 Awardees then
upload the data from their IISs into CDC’s immunization system, according to State
and local laws.
While CDC encourages Federal program providers to report vaccine administration
data to awardee IISs, some of these providers do not have the technological
infrastructure and/or a data-sharing agreement to do so.35 As a result, some of these
Federal program providers submit vaccine administration data to CDC directly.
See Appendix B for more information on various immunization data systems used to
collect and report COVID-19 vaccination data.
Vaccine public health messaging
Vaccine public health messaging is essential for building the public’s confidence in
vaccines, as highlighted in prior pandemic vaccine planning and routine vaccination
programs.36 Prior pandemic planning outlines steps for the Federal government and
awardees to take to develop and disseminate public health messaging regarding
vaccine safety and the benefits of being vaccinated.37
Educating the public and providing a clear, consistent message regarding vaccination
is a joint Federal, State, and local effort. For routine vaccines, outbreaks, and other
emergencies, CDC’s primary role is developing and sharing core messages that reflect
the latest science so that, in turn, health departments, clinical partners, and
communities can hone those messages to reach the communities they serve.38 CDC
also assists awardees in strategies to combat vaccine hesitancy. In 2019, CDC
developed a Vaccinate with Confidence strategy to build trust in populations that may
be hesitant to receive routine vaccines.39
CDC also develops health messaging materials including frequently asked questions,
flyers, testimonial videos, fact sheets, and social media posts regarding routine
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immunizations. CDC tailors these materials to health care providers; State and local
health departments; and the general public to enhance their applicability. CDC may
also coordinate with nonprofits and/or professional organizations to develop public
health messaging materials, such as public service announcements, social media
campaigns, or radio ads, to encourage the public to get vaccinated.40 Finally, CDC
also provides resources to State and local health departments and health care
providers to assist vaccine providers in developing their own public health messaging
materials.41
In its COVID-19 Vaccine Playbook, CDC provides guidance to awardees on developing
specific COVID-19 vaccine public health messaging. This includes creating messaging
that encourages people to receive the COVID-19 vaccine, educates the public on the
COVID-19 vaccine development process, and addresses COVID-19 vaccine
misinformation.42 CDC guidance states that COVID-19 public health messaging
should be inclusive and consider the culture of the target audience.43 Additionally,
CDC recommends that awardees consider tailoring messaging for specific critical,
high-risk populations.44 Awardees have discretion on how public health messaging is
shared, such as through print, radio, social media or television.45
Vaccine manufacturers also created vaccine-specific fact sheets for vaccine recipients
to help ensure that patients understand any potential risks associated with the
vaccine.46 Vaccine manufacturers translated these fact sheets into multiple languages
and posted them online for the public.47 COVID-19 vaccine providers are responsible
for disseminating these fact sheets to individuals receiving the vaccine.48
Vaccination program training and oversight
Training and oversight of providers administering vaccines are critical aspects of both
routine and pandemic vaccination programs to ensure compliance with program
requirements. Adherence to program requirements is necessary to ensure vaccines
are properly distributed, stored, and handled and are administered equitably and
efficiently. Failure to adhere to program requirements may contribute to lower overall
vaccination coverage and may cause individuals to lose confidence in vaccines and
providers.
Provider training
CDC requires awardees to train its enrolled providers to ensure that they understand
the COVID-19 vaccination program requirements.49 Training is especially important
to ensure the success of the vaccination program. CDC provides educational
resources to awardees, but awardees may develop their own materials.50 CDC notes
that awardees should determine the most efficient method for training delivery (e.g.,
online videos, webinars, or in-person instruction) and tracking the completion of
those trainings.51
CDC expects awardees to train all of its providers on several topics, including:
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•
storing and handling COVID-19 vaccines,
•
administering COVID-19 vaccines with appropriate ancillary supplies,
•
reporting COVID-19 vaccine administration into the IIS, and
•
providing COVID-19 vaccine fact sheets to vaccine recipients.52
Awardees may also leverage resources from CDC and other external sources to train
providers. For example, vaccine manufacturers developed training resources that
awardees may use to train providers on vaccine storage and handling.53
Provider oversight
CDC primarily relies on awardee-led site visits to ensure that providers adhere to
program requirements. For COVID-19 vaccine providers, CDC requires awardees to
conduct site visits each year for a fixed number of vaccination sites based on the
population of the jurisdiction (i.e., 25, 50, 70, or 100 site visits).54 Awardees with fewer
than 25 enrolled providers are required to conduct site visits for all enrolled
providers.55 CDC recommends that awardees prioritize site visits on the basis of the
number of vaccines administered and the amount of inventory onsite. CDC also
requires that awardees conduct site visits for all depot or warehouse locations where
vaccines are redistributed.56
Currently, COVID-19 vaccine provider site visits are only a one-time requirement
(rather than an annual requirement).57, 58 CDC requires that awardees conduct either
in-person or virtual site visits, with in-person being the preferred method.59
Site visits involve reviewing and assessing COVID-19 provider operations with the
following goals, as outlined in CDC’s playbook:
•
Assessing provider adherence to program requirements;
•
Identifying and addressing areas in which providers are doing well and areas
needing additional follow-up;
•
Identifying and addressing provider educational needs to help providers meet
program requirements;
•
Ensuring that vaccine recipients are receiving properly managed and viable
vaccine;60 and
•
Ensuring that vaccines are distributed equitably and according to State and
local priorities.61
Awardees may, but are not required to, implement other oversight mechanisms, such
as data quality checks.
As of October 2021, awardees were also required to conduct site visits for some
provider types enrolled in Federal programs.62
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Related work
OIG has conducted several prior studies on pandemic vaccine preparedness. In a
series of reports from 2009, OIG found gaps in awardees’ influenza vaccine
distribution plans, as well as medical surge planning.63 OIG made recommendations
to both CDC and ASPR, all of which have been implemented since 2014.64
OIG has a companion report that provides a deeper analysis of the challenges that
awardees reported experiencing with Federal program provider vaccination data.65 In
this review, OIG found that awardees did not receive comprehensive data for more
than 250 million COVID-19 vaccine doses administered by Federal agencies and retail
pharmacies that partnered with the Federal government. OIG recommended that
CDC (1) work with State and local immunization programs and pharmacy partners, to
improve data gaps and timeliness challenges and (2) provide educational outreach to
ensure State and local immunization programs are aware of existing tools to address
campaign needs. This report complements the information highlighted in this review,
as we describe similar challenges that awardees reported to us at a higher level.
The Government Accountability Office (GAO) also reviewed the COVID-19 vaccination
program in several recent reports. GAO found that vaccine companies had limited
manufacturing capacity, challenging their ability to scale up COVID-19 vaccine
production.66 GAO also found that HHS’s use of multiple vaccination programs
improved high-risk populations’ access to the COVID-19 vaccine, but cited
coordination challenges.67 Finally, GAO also released a report examining the
transition from CAG to HHS’s H-CORE.68 At the time of this report’s release, all of
GAO’s recommendations from these reports remain unimplemented.
Methodology
Scope
This evaluation was designed to describe awardee-reported challenges and mitigation
strategies in the early stages of their COVID-19 vaccination programs. To do so, we
collected and analyzed qualitative data from a variety of stakeholders, including 56
State and large metropolitan area awardees. The term “awardees” refers to 56 State
and large metropolitan immunization programs included in our data collection.69, 70
We collected data from awardees between March 12 and 24, 2021, which we refer to
as the early stages of the COVID-19 vaccination program because vaccines were not
widely available at this time.
Data sources and collection
We collected qualitative data from awardees, as well as from officials within HHS,
including CDC and CAG, and other Federal agencies. We acquired these data via
surveys, interviews, and submitted documentation.
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Awardee data. We conducted email surveys or phone interviews with all 56
awardees to understand their challenges and any mitigation strategies they
implemented to address the challenges.71, 72 To do so, we first asked awardees to
report the top three challenges they were facing in the early stages of their COVID-19
vaccination programs. Then, to ensure that we were capturing a comprehensive
picture of all challenges, we asked awardees questions about whether they were
experiencing challenges in six specific COVID-19 vaccination program-related areas.
We asked awardees whether they were experiencing challenges in each area and, if
so, to describe the challenges. The six areas were (1) provider enrollment; (2)
establishing and distributing public messaging; (3) addressing disparities and
inequities; (4) vaccine allocation, ordering, distribution, and inventory management;
(5) administering the vaccine; and (6) Federal vaccine data systems.73 We also asked
awardees to describe any other COVID-19 vaccination program-related challenges.
Finally, we asked awardees to identify ways in which the Federal government could
help awardees address these challenges, as well as mitigation strategies awardees
implemented on their own to address them.
HHS and other Federal agency data. We conducted two interviews with CDC and
CAG in May 2021. The purpose of these interviews was to obtain CDC and CAG
perspectives on the challenges that awardees reported, including any actions CDC or
CAG had taken or planned to take to address the reported challenges. We also
received additional written responses and documentation from CDC to clarify their
actions and plans in May 2022. The documentation we received contained both
internal and publicly available information related to both routine and COVID-19
vaccine programs.
Data analysis
We compiled and reviewed all the qualitative data to determine thematic challenges.
Most awardees (i.e., more than 43 of the 56) reported challenges in each of the six
specific targeted areas. However, some awardees reported challenges that applied to
more than one of the six areas and some awardees reported challenges that did not
align with our six areas. As such, we synthesized the data into meaningful themes
about programmatic issues but do not provide quantitative counts in the report. See
Appendix C for the raw counts of how many awardees reported challenges and
associated mitigation strategies in the six specific COVID-19 vaccination
program-related areas.
In determining which themes to report on, we focused on those themes that met two
criteria: (1) the issue was currently challenging COVID-19 vaccination efforts, would
challenge future pandemic vaccination efforts, or both; and (2) awardees alone could
not implement potential solutions.
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Limitations
Wherever possible, we compared interview and written responses to facts we could
determine from our review of publicly available information, as well as other
documentation provided by awardees, CDC, and CAG.
Standards
We conducted this study in accordance with the Quality Standards for Inspection and
Evaluation issued by the Council of the Inspectors General on Integrity and Efficiency.
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FINDINGS
Awardees reported logistical challenges that affected their
ability to administer vaccines equitably and efficiently
In March 2021 (i.e., the early stages of COVID-19 vaccination programs), awardees
reported logistical challenges, such as large minimum order sizes for vaccines;
requirements for ultra-cold vaccine storage; and insufficient ancillary supplies.
Awardees reported that challenges in these areas hindered their ability to vaccinate
their communities equitably and efficiently. For example, large minimum order sizes
for vaccines and requirements for ultra-cold storage limited the ability of some
smaller and rural providers to receive, store, and administer COVID-19 vaccines.
Awardees reported that these providers were critical to ensuring equitable vaccine
access and increasing vaccination rates within their jurisdictions. Further, awardees
reported that some providers did not always have sufficient ancillary supplies when
administering vaccines, which hindered efficiency and increased the potential for
vaccine waste.
Awardees reported that large minimum order sizes and ultra-cold
storage requirements hindered equitable and efficient vaccine
distribution
The Pfizer vaccine—which was the first COVID-19 vaccine to be authorized for use —
initially had a minimum order size that was about 10 times greater than that for the
other 2 vaccines.74 Further, while FDA authorized less restrictive temperature
requirements in certain circumstances by early February 2021, the Pfizer vaccine still
required ultra-cold storage if the vaccines were not used in 2 weeks. Therefore, if a
provider received Pfizer vaccines and did not have ultra-cold storage, the provider
had to use all 1,170 doses in 2 weeks to avoid wasting vaccines.
In March 2021, awardees reported that the Pfizer vaccine’s large minimum order size
and requirements for ultra-cold storage were particularly challenging for some
providers. Awardees reported challenges in distributing the Pfizer vaccine to
providers that did not have the ability to use all doses in a minimum order within the
required timeframe or did not have the equipment to store the doses for longer
periods of time. As a result, awardees reported that some providers and subsequently
the populations they served had limited vaccine access.75 For example, one awardee
reported, “Many of our providers who serve the most vulnerable populations cannot
manage large quantities of vaccines…. These are the providers that these populations
trust.”
However, in March 2021, vaccine availability was limited, and vaccine access and
uptake of those limited vaccines was a priority. As a result, awardees reported
spending significant resources to either procure additional equipment for ultra-cold
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-
-
-
I -'D-
,
' --
storage that was not always readily available and/or breaking down and redistributing
Pfizer vaccine orders into smaller quantities to improve vaccine access and reduce the
potential for vaccine waste.
AWARDEE REPORTED MITIGATION STRATEGY: We are a
small State. Not every provider can use Pfizer. We end up
as a warehouse receiving shipments and break them apart.
We are doing about 50 customized deliveries daily.
AWARDEE REPORTED CHALLENGE: Ultra cold storage is a
challenge in rural areas with smaller providers due to the
need for special storage equipment.
More specifically, awardees reported breaking down the large vaccine orders into
smaller quantities at a central warehouse or depot and then distributing these smaller
amounts to providers in their jurisdictions. Using this method, awardees ensured that
more providers received vaccines that they could use in the required timeframe
without having to procure additional equipment for ultra-cold storage or waste
vaccines. See Exhibit 2 below for the cold chain management steps for COVID-19
vaccination programs and the additional step that some awardees had to take to
ensure vaccine access for providers who could not store or administer the large
minimum order sizes during the required timeframe.
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ine
manufacturing
·····························►
Manufacturer
responsibility
Awardees had to break down
large shipments of vaccines
before distributing to
providers, which increased
the possibility of breaking the
cold chain
Awar-dee
responsib i I ity
Vaccine
distribution
Vaccine arrival
at provider
facility
Vaccine storage
and handling at
provider facility
Vaccine
administration
·····························►
........................................................................................................
Manufacturer/
distributor
responsibility
Pr-ovider
responsibility
Exhibit 2: Due to large minimum order sizes, awardees reported adding a
step to the standard cold chain management process to improve COVID-19
vaccine access.
Source: OIG adapted this graphic from CDC’s Vaccine Storage and Handling Toolkit. Accessed at
https://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit.pdf on August 6, 2021.
While breaking down large minimum orders sizes mitigated some equity challenges,
awardees also reported concerns with this approach. Awardees reported that adding
another step to the cold chain increased risk to vaccine potency and of vaccine
spoilage. Awardees also reported challenges with the amount of staffing and
transportation resources required for this additional step. As of October 2021, CDC
required that awardees conduct site visits for all depots and warehouses.76 The
purpose of these site visits was to ensure that providers understood the COVID-19
vaccination program requirements and were adhering to such requirements, such as
ensuring the proper handling of the vaccine.
In May 2021, CDC and CAG reported to OIG that they were working with COVID-19
vaccine manufacturers to make smaller minimum order sizes available. This resulted
in a limited inventory of 450 minimum order size shipments of the Pfizer vaccine in
Summer 2021 only. CDC reported to OIG in written responses that as of December
2021, the Pfizer vaccine was available in 300 dose minimum order size for adults, and
100 dose minimum order size for pediatrics.
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Awardees reported that providers did not have sufficient ancillary
supplies to efficiently administer vaccines
Awardees also reported that the contents of their ancillary supply kits were not
sufficient for efficient vaccine administration. Awardees reported that providers
needed more low dead-volume syringes to maximize the number of doses they could
administer from each vial. Awardees also reported that their providers needed
additional needles, more generally. Explaining the need for additional needles,
including variety of needles, one awardee specifically reported that “the standard
needles in the ancillary kits are often too large for elderly [and] frail populations.”77
Not having sufficient ancillary supplies limit a provider’s ability to administer vaccines,
even if the doses themselves are available.
CDC reported to OIG that ancillary supply kits contained 5-percent overage for
training needs, breakage, and errors. CDC further reported that it independently
reviewed awardee claims of insufficient ancillary supplies and determined that
awardees not having enough needles was primarily due to the large number of
nontraditional providers, which resulted in more needle breakage and errors. In
follow-up interviews, CAG also reported that the supply chain could not support
providing additional supplies beyond the overage already supplied when we collected
data in 2021.
In May 2022, CDC reported to OIG that CDC had received feedback that insufficient
ancillary supplies had become less pervasive a challenge as more individuals had been
vaccinated, thereby decreasing demand. However, CDC did not report identifying
and/or implementing a solution for future pandemic vaccination efforts, for which
many nontraditional providers may be needed.
Awardees reported that data challenges affected their ability to
allocate and distribute vaccines equitably and efficiently
Awardees described challenges in obtaining complete, timely, and accurate data in
the following areas: (1) doses allocated to and administered by their own providers;
(2) doses allocated to and administered by providers enrolled in Federal programs;
and (3) demographic information (e.g., race and ethnicity) across all providers. Not
having complete, timely, and accurate vaccine allocation and administration data
hindered awardees’ ability to vaccinate their communities equitably and efficiently, as
it challenged awardees’ ability to plan and prioritize vaccine distribution, particularly
for vulnerable and underserved populations. One awardee reported,
Having that data, visibility, and data support really matters when steering the
State in the right direction. Having all that visibility on all those moving
components is important particularly as we shift away from those that show up at
the door [to be vaccinated] to those that are truly the most vulnerable and we
have to go to them [to get them vaccinated].
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Awardees reported completeness, accuracy and timeliness
challenges with allocation and administration data for their
enrolled providers
Awardees reported experiencing challenges in obtaining vaccine allocation data from
the Federal government and obtaining vaccine administration data from their
providers, which hindered awardees’ ability to ensure equitable and efficient
vaccination among their various communities. These challenges included gaps in
both the timeliness and accuracy of allocation data visible to awardees, as well as
gaps in the timeliness and completeness of administration data that awardees
received from their providers.78
Provider allocation data. In March 2021, awardees reported challenges in obtaining
accurate vaccine allocation data from the Federal government.79 Awardees noted that
they could see allocation projections 3 weeks in advance, which was a helpful
improvement from prior projections they received. However, awardees still reported
inaccuracies with the data, as sometimes they received less, and sometimes they
received more, vaccine doses than expected. Both scenarios made it difficult to plan
how and where to distribute vaccines to providers. Specifically, awardees expressed
that the number of doses shipped directly to them changed substantially from week
to week and often did not match their previously advised allocations for which they
had planned. One awardee reported, “CDC told us that we could have 3 weeks of
visibility. With that we get 3 weeks of static allocation numbers. But the day before
[the vaccines are scheduled to arrive], they tell us the allocation must change, which
still doesn’t give us the ability to plan ahead.”
AWARDEE REPORTED MITIGATION STRATEGY: [Our
jurisdiction] uses GIS maps to generate heat maps displaying
vaccine allocation as it relates to the prioritized zip codes
identified by [us]. Collectively, these strategic tools allow [us] to
assess situational awareness as it relates to vaccine allocation.
AWARDEE REPORTED CHALLENGE: There s dramatic variation
in the number of doses we could receive. We are trying to plan
for as little as 3,600 doses and as many as 50,000 with not much
turnaround time.
Having accurate and timely allocation data is important with regard to prioritizing
vulnerable and underserved populations and providers, such as those in rural areas.
For example, awardees often used complex algorithms that considered certain equity
measures (e.g., CDC’s social vulnerability index and demographic information) when
determining where to distribute doses.80 However, when the number of vaccine doses
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received was different from the allocation projections, awardees had to move quickly
to figure out how and where to distribute the new number of vaccine doses. This was
challenging when awardees received fewer vaccine doses than previously projected. It
was also challenging when awardees received more vaccine doses than expected.
Awardees reported downstream challenges with locating providers who could fill
vaccine appointments and administer these doses efficiently. As one awardee
reported,
The problem is that the [allocation] projection changes. We are using a central
scheduler to register patients and set up appointments. So, when you
[have]…less than a week’s notice [that] we get an additional 8,000 vaccines, that is
an additional 8,000 more appointments that have to be built out and new
providers need to be identified to do that.
Administration data from jurisdictional providers. Awardees reported challenges
obtaining timely and complete vaccine administration data from their providers. These
data are critical for understanding where gaps in vaccination coverage exist.
Awardees attributed this data challenge to having limited resources to sufficiently
train providers on how to use their data systems, including how to input data in the
various data systems in a timely and accurate way. Specifically, these awardees
reported that training providers to use data systems, including IISs, was particularly
challenging and burdensome when some providers had minimal to no prior vaccine
experience.
AWARDEE REPORTED MITIGATION STRATEGY: We are
exploring strategies like a buddy system or shadowing to
mitigate incongruent information and experience.
AWARDEE REPORTED CHALLENGE: We do not have the
bandwidth to provide coaching and technical assistance to
1,200 providers.
Awardees also attributed their challenges in receiving and reporting vaccine
administration data to technological infrastructure limitations at the provider and
State levels. These challenges were further exacerbated by the large volumes of
COVID-19 vaccine administration data needing to be reported in a short time period.
For example, some providers were unable to use specific data exchanges, such as
Health Level 7, due to their electronic health record systems being outdated or not
compatible.81 Having these exchanges allows data to automatically flow between
provider electronic health records and jurisdictional immunization systems (i.e., IISs).
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•
Without these connections, providers had to upload vaccine administration data
manually into jurisdictional immunization systems, which was resource-intensive and
caused delays in uploading data.
Awardees reported not having visibility into Federal program
provider allocation and administration data
In March 2021, awardees also reported not having data on how many doses Federal
program providers were being allocated. Awardees further reported that gaps in
allocation data hindered their planning efficiencies because without knowing how
many vaccines were going to which providers, awardees reported not having a full
picture on their jurisdiction’s vaccine campaign. Further, planning inefficiencies could
lead to vaccine waste.
AWARDEE REPORTED MITIGATION STRATEGY: We have some
visibility going, mostly with the pharmacies. We have weekly
check ins with Rite Aid, Walmart, Walgreens, CVS.
AWARDEE REPORTED CHALLENGE: We do not know how
much supply is in our State and what is given out. There are
providers getting vaccines from us and from Health Resources &
Services Administration (HRSA). We get total number of doses
administered, but we do not know [what supply the doses came
from], which makes data reporting messy.
In May 2021, CDC and CAG reported in a joint interview that they were aware of this
challenge but that no improvements had been made to allow awardees visibility into
allocation data from Federal program providers. In May 2022, CDC subsequently
reported that awardees now have access to this information.
In addition to challenges with allocation data, awardees reported challenges with
vaccine administration data. While awardees reported being able to see aggregate
vaccine administration data from Federal program providers, awardees reported not
having access to individual-level vaccine administration data. One awardee reported,
Getting access to the Federal doses administered is important. We can’t
understand what proportion has been covered because we only see what is going
into our IIS. The rest of the data is going into the CDC Clearinghouse, but we
don’t have the ability to query that and to get that data.
Some awardees specifically attributed this challenge to delays in implementing full
functionality of the IZ Gateway, which is one technology solution for administration
data sharing between awardees and Federal program providers. In 2020, prior to any
COVID-19 vaccines being distributed and administered, CDC reported that its goal
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was to have all IISs onboarded onto the IZ Gateway by September 30, 2020.82
However, in March 2021, one awardee reported that even if connected to the IZ
Gateway, it still could not query data to meet its needs for obtaining individual-level
vaccine administration data from all Federal program providers.
In May 2021, CDC and CAG reported in a joint interview that they were aware of this
challenge. As an interim solution, CDC and CAG reported they actively encouraged
Federal program providers to report administration data into awardee IISs, which
would enhance visibility for awardees into administration data from providers enrolled
in Federal programs. In May 2022, CDC further reported that it continues working to
address legal and technological infrastructure challenges to allow for data sharing
between Federal program providers and awardees. CDC also reported that it is
working on policy agreements to onboard more parties to the IZ gateway, as well as
enabling interoperability when there may be different data standards by jurisdictions.
Awardees reported challenges obtaining and reporting
comprehensive race and ethnicity data for vaccine recipients
Awardees reported challenges obtaining comprehensive demographic data, such as
race and ethnicity, on individuals receiving a COVID-19 vaccine.83 Awardees reported
that gaps in this data hindered their efforts to identify and address inequities in
vaccine distribution and administration. Awardees attributed challenges in this area
to a hesitancy to report personally identifiable information and some States not
having standards for collecting demographic information.
AWARDEE REPORTED MITIGATION STRATEGY: For providers that
don't collect race or ethnicity, we are matching with other databases
to see if we can backfill any of that [vaccine data]
AWARDEE REPORTED CHALLENGE: With regards to race, ethnicity,
and inequity, it comes down to data. If you can t prove it, it didn t
happen. Having consistent data that is collected across thousands of
providers in one state can be a challenge.
Despite initial challenges in collecting demographic data, improvements have been
made in the number of States including race and ethnicity data within their reported
vaccination rates since we collected data in March 2021. According to the Kaiser
Family Foundation, in January 2021, only 17 States reported race and ethnicity data
for vaccination rates, while as of July 2022, this had increased to 41 States and
Washington, D.C.84
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In addition to challenges collecting race and ethnicity data, one awardee reported
technological limitations in the data reporting systems did not allow awardees to
make changes to demographic data if they collected it after uploading the
information into CDC’s systems. CDC reported to OIG that as of July 2021, awardees
have the ability to manually edit, and re-upload previously submitted records. CDC
reported that awardees also have the ability to use an automated upload solution
rather than manually editing and re-uploading their vaccine administration data.
However, CDC reported that not all awardees had elected to implement this solution
yet due to time constraints at the jurisdictional level requiring prioritization of
resources.
Awardees reported challenges with public health messaging to
combat vaccine hesitancy
In March 2021, awardees reported challenges with public health messaging to combat
vaccine hesitancy. Awardees reported wanting more Federal government support in
two areas: (1) a unified public health message and (2) adaptable public health
messaging materials.85 A unified public health message is critical to building trust with
the public and ensuring that individuals receive the same information regarding the
vaccine regardless of where they live or who delivers the message. Adaptable public
health messaging materials ensure consistency in messaging, while also allowing
awardees to tailor the message to their jurisdiction’s populations. Combating vaccine
hesitancy and building vaccine confidence with unified and adaptable public health
messaging may make communities more willing to receive the COVID-19 vaccine.
AWARDEE REPORTED MITIGATION STRATEGY: [We are] using
community health workers to educate and promote vaccine
knowledge and to develop and air targeted media messaging to
those same racial/ethnic groups and communities after assessing
their attitudes and beliefs about the vaccine.
AWARDEE REPORTED CHALLENGE: The importance of a
national, public media campaign cannot be overlooked. States
may have funding for smaller campaigns but something
comprehensive and overarching that will reach most Americans
will be important to sustain interest and demand for the vaccine.
Awardees reported various reasons for wanting more Federal government support for
public health messaging. These reasons included having limited funding to develop
public messaging campaigns themselves; wanting to reach a greater audience in
vaccine messaging; wanting to minimize duplication of efforts when developing
materials; and wanting to decrease variation across jurisdictions in the framing and
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content of messages. For example, one awardee discussed the need for the public to
hear the same message from all partners, including the Federal government. One
awardee reported,
I’d like to see some generic public service announcements being created so that
States can use the same messaging. I know the messages will need to be tailored
to different areas and populations, but I think the Vaccines for Children program
has sent public service announcements that we use and publicize so that
messaging is consistent across the nation.
CDC reported several ways in which it was taking steps to mitigate awardee-reported
public health messaging challenges. For example, CDC reported that it developed
several “plug-and-play” public health messaging resources that health departments
can use for their jurisdictional-specific public health messaging campaigns, including
a communication toolkit that is available in 33 languages.86 CDC also reported
developing social media posts and other advertisements to promote the COVID-19
vaccine program. In addition, CDC reported building a website for health care
providers to compile various materials for easy access and dissemination. CDC also
creates and disseminates reports on vaccine confidence to provide awardees and
other partners with information on the public’s questions regarding the vaccine as
well as on misinformation that may be prevalent in communities. These reports aim
to help awardees and partners develop materials to combat vaccine hesitancy. Finally,
CDC reported providing public messaging technical assistance to awardees on a daily
basis through regional coordinators and project officers.
Finally, CDC also reported that the COVID-19 vaccine public health messaging
strategy did not follow the standard approach used for routine vaccination, outbreaks,
and other emergencies. Rather, HHS’s Assistant Secretary for Public Affairs (ASPA),
not CDC, is the lead for COVID-19 vaccine messaging. While CDC reported not
having its own national public health messaging campaign for the COVID-19
vaccination program, CDC noted that it was engaging with and supporting ASPA’s
“We Can Do This” national, public health messaging campaign as a technical
advisor.87 The “We Can Do This” campaign launched in April 2021, which was after we
collected data from awardees.
Awardees reported lacking resources to sufficiently oversee
COVID-19 vaccination program providers
In March 2021, awardees reported having limited resources, such as personnel and
equipment, to conduct provider site visits. Between December 1, 2020, and
December 31, 2021, awardees and CDC conducted 5,495 site visits (5,399 and 96
respectively) at both mass and non-mass vaccination sites.88, 89 However, less than 3
percent (i.e., 149 of 5,495) of these site visits occurred between December 1, 2020,
and May 31, 2021. This is concerning because by the end of May, nearly 50 percent
of the U.S. population had received at least one dose of a COVID-19 vaccine.90, 91 Of
further concern is that during these site visits, both awardees and CDC found
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deficiencies that pose vulnerabilities to patient health. These deficiencies included
lacking a temperature monitoring device to monitor vaccine storage units and
noncompliance with training requirements for vaccination staff who manage or
administer the COVID-19 vaccine.92
AWARDEE REPORTED MITIGATION STRATEGY: “We are trying
to partner with the State Pharmacy Board that already does
compliance visits.
AWARDEE REPORTED CHALLENGE: With the inclusion of the
site visit requirement for COVID 19 vaccine providers and the
increasing number of enrolled COVID 19 vaccine providers, more
site visits are going to need to be completed....it poses a staffing
challenge to meet all of the site visit requirements.
Site visits are an important tool for ensuring that patients are not at risk of receiving
vaccines that are spoiled or compromised due to improper storage, handling, and
administration (e.g., not being held within the required temperature ranges). During
site visits, CDC found that half (48 of 96) of providers did not adhere to storage and
handling requirements. Vaccines that are not maintained within their required
temperature storage ranges may be less potent and effective and may not provide
maximum protection to vaccine recipients. Moreover, patients may lose confidence in
vaccines and their providers if the vaccines are less effective than reported.
CDC requires awardees to conduct site visits for a fixed number of providers. CDC
reported establishing a fixed number because awardees did not have the resources to
conduct site visits for all enrolled providers. CDC also reported using a fixed number
because the number of providers administering COVID-19 vaccines changed over
time, as some vaccination sites were only temporary. However, a fixed numbered
approach poses vulnerabilities in that at least hundreds of COVID-19 vaccine
providers were not subject to site visits at a time when much of the U.S. population
was receiving vaccines. For example, in March 2021, Delaware reported having over
400 enrolled COVID-19 vaccine providers. According to CDC’s requirement based on
the jurisdiction’s population, Delaware was required to visit only 25 providers in 2021,
which means that over 375 providers were not required to have a site visit.
Moreover, site visits also serve an educational purpose for some providers (i.e., these
providers may not know if they are or are not adhering to vaccination program
requirements), and when site visits do not happen, that educational opportunity is
lost. While awardees recognized the importance of site visits and meeting CDC’s
minimum requirements, awardees also reported challenges acquiring the staffing
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resources necessary to conduct provider site visits to all enrolled providers in a timely
manner.
In addition to challenges conducting provider site visits, awardees reported not being
able to obtain a sufficient number of digital data loggers. Proper monitoring of
provider adherence to the temperature requirements helps ensure that vaccines are
viable for administration to the public. These devices also allow for remote
monitoring of the storage temperatures of vaccines by awardees, which is another
valuable safeguard.
This challenge generally applied to nontraditional vaccine providers, as they may not
have needed these devices prior to this vaccine campaign. As a result of the 5,399
site visits awardees conducted between December 1, 2020, and December 31, 2021,
awardees issued 441 citations for a lack of digital data loggers for vaccine transport
and/or storage unit monitoring.93 This challenge was magnified by worldwide supply
shortages of digital data loggers, which resulted in the use of less accurate
temperature monitoring devices. During the supply shortage, CDC allowed awardees
to use minimum/maximum or traditional digital thermometers as an alternative until
digital data logger supply issues were resolved.
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CONCLUSION AND RECOMMENDATIONS
CDC has long funded State, Territory, and large metropolitan area immunization
programs to support vaccine programs that immunize individuals in their jurisdictions
against vaccine-preventable diseases (e.g., measles and influenza). The COVID-19
vaccination program is an extension of these efforts with a goal to immunize the U.S.
population amid an ongoing pandemic. The COVID-19 vaccination program is one of
the largest mass vaccination efforts in recent U.S. history. In late 2020, awardees, in
coordination with Federal partners, began preparing to stand up COVID-19
vaccination programs, with the first vaccines being administered in December 2020.
By mid-March 2021, COVID-19 vaccine supply and demand continued to increase,
and challenges implementing these vaccination programs continued to change and
evolve.
We found that during the early stages of the COVID-19 vaccination program (i.e.,
March 2021), awardees were experiencing challenges administering COVID-19
vaccines efficiently and equitably due to multiple factors. Specifically, awardees
reported challenges with vaccine logistics, such as large minimum order sizes for
vaccines, requirements for ultra-cold storage, and insufficient ancillary supplies.
Additionally, awardees reported challenges in obtaining complete, timely, and
accurate vaccine allocation and administration data from both their providers and
Federal program providers, which impacted their ability to efficiently determine
community needs. Further, awardees reported challenges in obtaining
comprehensive race and ethnicity information on doses administered, which impacted
their ability to monitor equitable distribution. Finally, awardees reported wanting
more Federal government support for public health messaging and provider
oversight.
To improve COVID-19 vaccination programs while they were ongoing, we issued
preliminary, non-public analysis of reported challenges to CDC in late March and early
April 2021. This preliminary analysis allowed CDC to address awardee challenges in a
time-sensitive manner. This report builds upon that preliminary analysis, by using
additional data and qualitative analysis, and includes formal recommendations to
improve COVID-19 and future vaccination programs.
Understanding awardee-reported challenges with the COVID-19 vaccination program,
as well as the mitigation strategies awardees took, can assist CDC in ongoing program
improvements. It can also assist CDC with improving routine immunization programs,
as well as with preparing for future pandemic vaccination programs.
To continue to drive vaccination program improvement, we recommend that CDC:
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Update its plans for mass vaccination programs with strategies
that address awardee-reported logistical challenges
CDC should update its plans for mass vaccination programs with strategies that
address awardee-reported challenges with vaccine minimum order sizes and ancillary
supply kits. We offer ways in which CDC can continue to drive improvement for the
ongoing COVID-19 vaccination campaign, and drive improvement for future
pandemic vaccination efforts.
Vaccine minimum order sizes and vaccine storage requirements. To address
ongoing COVID-19 vaccine challenges, while noting the reductions made to the Pfizer
vaccine’s minimum order size, CDC should first determine whether these reductions
are sufficient to address awardee-reported challenges. If awardees still report
challenges with the Pfizer vaccine’s minimum order size, CDC should coordinate with
the Biomedical Advanced Research and Development Authority (BARDA) to determine
the feasibility of solutions that will address awardee challenges. As of this report’s
release, COVID-19 vaccines are not packaged in a similar way to routine vaccinations
(i.e., customizable order sizes and/or pre-filled syringes). Ensuring that providers can
obtain the number of vaccine doses that they need for their jurisdiction’s population
in a timeframe that does not require the procurement of additional storage
equipment will help address challenges with vaccine access and waste.
To address future pandemic vaccination efforts, CDC should update mass vaccination
planning to include guidance that advises BARDA on vaccine manufacturer contract
parameters for packaging quantities of vaccines.94 This guidance should advise on
how vaccine storage requirements intersect with vaccine minimum order sizes, as well
as changes needed in these parameters as the pandemic evolves. For example, while
large minimum order sizes may be efficient early in a mass vaccination effort, smaller
order sizes may make vaccine distribution more efficient and equitable later in a mass
vaccination effort.
As a part of updating mass vaccination planning, CDC should also consider including
guidance on the establishment of centralized, Federal depots to break down large
order sizes into smaller ones to reduce the burden on awardee resources. CDC
reported that it would need to consider the following risks when considering this
option: (1) compromised vaccine quality/effectiveness, as the breakdown activity may
be difficult to accomplish manually at ultracold temperatures; (2) increased risk for the
U.S. Government as removing vaccine from the manufacturer’s quality system shifts
responsibility for this complex process to the U.S. Government; and (3) a significant
decrease in distribution throughput. It is worth noting that these risks also apply to
awardees setting up their own depots for breaking down vaccines. Therefore, CDC
should consider providing guidance to awardees on how they can conduct this risk
benefit analysis for breaking down vaccines themselves.
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Ancillary supply kits. While challenges with COVID-19 vaccine ancillary supply kit
contents have subsided, CDC should use lessons learned from this effort to update
future planning that includes:
(1) determining the projected ancillary supply kit needs during future mass
vaccination efforts and
(2) determining ways to ensure sufficient overages of these supplies that accounts for
potential global supply chain shortages.
For example, CDC could work with ASPR to determine whether, and in what quantity,
items that were challenging for awardees to obtain (e.g., needles in a variety of sizes
and low dead-volume needles) should be included in the Strategic National Stockpile.
CDC could also consider supplementing awardee provider training with its own
training to help reduce provider error and thus the need for additional supplies.
Strengthen reporting of vaccine allocation data and
administration data
CDC should strengthen reporting of vaccine allocation data and administration data
in two ways:
Improve vaccine allocation data accuracy. CDC should work with relevant partners
(e.g., vaccine manufacturers) to determine why awardees are receiving inaccurate
projections of their expected vaccine shipments and take steps to address this issue.
We recognize that these projections are of less importance now that the COVID-19
vaccination effort is well underway and ample vaccine supply exists. However, there is
value in understanding that the need to ensure that this challenge does not occur
during any future mass vaccination campaigns when vaccine supply may be initially
limited.
Develop strategies to improve vaccine administration data. CDC should define
and communicate data quality standards for providers and require that awardees
develop an approach to provide routine data quality feedback to all providers for IIS
reporting. This will allow awardees to more consistently check the quality of the data
reported to their IISs. This can, in turn improve the completeness and accuracy of the
vaccine data.
Further, OIG has a companion work in this area regarding improvements needed for
vaccine administration data submitted by providers enrolled in Federal programs. In
that report, OIG recommends that CDC (1) work with State and local immunization
programs and pharmacy partners, to improve data gaps and timeliness challenges
and (2) provide educational outreach to ensure that State and local immunization
programs are aware of existing tools to address campaign needs. This report’s
findings also support those OIG recommendations.
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Conclusion and Recommendations | 25
In addition to supporting those recommendations, this report makes one additional
recommendation regarding strategies to improve vaccine administration data more
broadly. CDC should also continue to work with awardees on the collection of
complete and accurate race and ethnicity data. This will allow jurisdictions to have
better visibility on the extent to which disparities exist in vaccination rates and
subsequently allocate resources towards improving vaccination rates in those
populations.
In implementing these recommendations, CDC could consider requiring that
awardees ensure that their vaccine administration data systems and processes can be
scalable during an emergency. Doing so will decrease the time to operationalize
systems and processes during an emergency, as involved parties will already have an
understanding of the underlying systems and processes in place and how to scale
them as needed.
To the extent that any new data systems are created, or existing data systems are
modified for vaccine allocation and administration data during ongoing and future
vaccine campaigns, CDC should ensure that these recommendations are still
addressed, as appropriate.
Clarify roles and responsibilities within HHS for vaccine public
health messaging during a pandemic
CDC should clarify agency roles and responsibilities within HHS (including, at a
minimum, ASPA, ASPR, and FDA) for vaccine public health messaging during a
pandemic. In doing so, CDC should use lessons learned from the COVID-19 response,
including the awardee-reported challenges outlined in this report. Doing so will help
take steps towards a more unified, national message, and will limit the delays in
making vaccine public health messaging materials available nationwide and to the
awardees, in particular.
Work with awardees to enhance current and future capabilities
for provider training and oversight
Training and oversight of providers administering vaccines are critical aspects of mass
vaccination programs to ensure compliance with program requirements. However,
conducting provider training and site visits are resource-intensive activities, especially
when hundreds of new, and often inexperienced, providers are enrolled to help
facilitate a mass vaccination effort. As a result, CDC should identify ways to support
awardees in training and overseeing providers both during the current COVID-19
vaccination campaign, and in future mass vaccination efforts. These could include:
Establishing and maintaining a pandemic-ready vaccine provider roster. CDC
should work with awardees to establish a plan for expedited provider training during
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Conclusion and Recommendations | 26
a pandemic when more inexperienced, nontraditional providers may need to be
leveraged. This could include annual, abbreviated training so that a “pandemic
ready” roster of nontraditional providers is available. Such a plan would ensure that a
group of nontraditional providers are sufficiently trained on items such as, awardee
data systems and vaccine administration techniques, prior to the start of a mass
vaccination campaign, thereby reducing the burden on awardee resources during a
critical time. It also could mitigate awardee-enrolled provider vaccine administration
data challenges.
Implementing a risk-based approach for conducting provider site visits. CDC
could consider requiring that awardees use a risk-based approach to determine the
priority and frequency of provider site visits. For example, awardees may consider
whether the provider is experienced or inexperienced; prior site visits results; how
many vaccines the provider is administering; and what type of technology the
provider has (e.g., digital data loggers) to remotely monitor adherence to program
requirements.
Providing supplemental Federal resources for conducting provider oversight. In
addition to the resources that CDC provided early in the COVID-19 vaccination effort,
CDC could continue to provide Federal personnel to assist with conducting provider
site visits. In addition, CDC could work with ASPR to ensure that temperature
monitoring devices, such as data digital loggers, are available to awardees and
providers through the Strategic National Stockpile or ancillary supply kits.
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Conclusion and Recommendations | 27
AGENCY COMMENTS AND OIG RESPONSE
CDC concurred with all four of OIG’s recommendations.
CDC concurred with our first recommendation, to update CDC plans for mass
vaccination programs with strategies that address awardee-reported logistical
challenges. While CDC agreed with some of our suggestions for implementation, it
disagreed with others. CDC agreed with our suggestion that future vaccine contract
requirements should provide for multiple vaccine presentations, including a large
presentation for mass vaccination clinics and a smaller presentation(s) appropriate for
other health care settings. CDC also agreed with our suggested methods to address
vaccine ancillary supply kit challenges. However, CDC disagreed with OIG’s
suggestion that, as a part of updating its planning, CDC consider including guidance
on the establishment of centralized, Federal depots to break down large order sizes
into smaller ones. CDC stated that there are numerous risks involved with the Federal
government setting up its own depots, which OIG acknowledges in its suggestion.
Further, CDC stated that implementing OIG suggestion’s that future contract
requirements allow for multiple presentation sizes of vaccines reduces the need for
centralized depots to break down larger presentations, as well as reduces the risks to
the Federal government. OIG agrees that updating CDC planning to include guidance
on how future vaccine contracts should allow for multiple presentation sizes of
vaccine will address the root cause of this issue. However, there are no guarantees
that a vaccine contract will unfold exactly as expected during an emergency response.
Therefore, OIG believes that it would be beneficial for CDC to prepare for multiple
possibilities, including the possibility that centralized Federal depots will be needed to
break down vaccines during future pandemics. Further, this guidance could focus on
assisting awardees who may need to set up their own centralized depots, as they did
during the COVID-19 response.
CDC concurred with our second recommendation, to strengthen reporting of vaccine
allocation data and administration data. CDC stated it will continue to work with
relevant partners to improve projections of expected vaccine shipments and continue
to improve data quality standards for reporting.
CDC concurred with our third recommendation, to clarify roles and responsibilities
within HHS for vaccine public health messaging during a pandemic. CDC suggested
further agency-specific and HHS-wide communication hot washes, to include
representatives from State and local public health stakeholders.
CDC concurred with our fourth recommendation, to work with awardees to enhance
current and future capabilities for provider training and oversight. CDC had concerns
with the suggestions that OIG offered to support vaccination provider training and
oversight. OIG’s goal with this recommendation is to ensure providers have the
training and oversight needed to ensure vaccines are stored, handled, and
administered properly. Beyond the suggestions OIG offered, CDC should identify
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Agency Comments and OIG Response | 28
practical and effective ways to support and address awardee-reported challenges with
provider training and oversight.
For the full text of CDC’s comments, see Appendix D. We also addressed all of CDC’s
technical comments.
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Agency Comments and OIG Response | 29
APPENDIX
Appendix A: Storage and Handling Requirements for COVID-19
Vaccines in March 2021
Each COVID-19 vaccine authorized for use in the United States has specific storage
and handling requirements to ensure viability and potency of the vaccine. These
requirements include ensuring cold chain conditions, using digital data loggers to
check temperatures, monitoring storage unit temperatures, monitoring vaccine
expiration dates, and preserving records for vaccines.95, 96 See Exhibit 3 for the
COVID-19 vaccine storage requirements for the time during which we collected data
from awardees (i.e., between March 12 and 24, 2021). The COVID-19 vaccine storage
requirements have been updated since March 2021, when we collected data.
Exhibit 3: COVID-19 vaccines had varying storage and handling requirements
during our data collection.
Vaccine
Storage and Handling Requirements
Pfizer-BioNTech
This vaccine may be stored in an ultra-cold freezer
(requirements in effect
between -112oF and -76oF until ready to thaw. Before mixing
March 3, 2021, through
with adjuvant, this vaccine can be stored in freezer (i.e., between
May 21, 2021)97
-13oF and 5oF) for up to 2 weeks or in a refrigerator (i.e., between
36oF and 46oF) for up to 5 days. Once the vaccine is mixed with
the adjuvant, the vaccine may be stored at room temperature
(i.e., between 35 oF and 77 oF) and subsequently used within 6
hours. Mixed vaccines may not be returned to freezer storage.
Moderna
(requirements in effect
December 20, 2020,
through April 23, 2021)98
This vaccine does not require use of an ultra-cold freezer. This
vaccine may be stored in a freezer between -13°F and 5°F. This
vaccine must be thawed before using. Once thawed, this vaccine
can be stored in the refrigerator between 36oF and 46oF for up to
30 days. Unpunctured vials may be stored at room temperature
(i.e., between 46.4°F and 77°F) for up to 12 hours.
Johnson & Johnson
This vaccine is not frozen. This vaccine is stored in a refrigerator
(requirements in effect
between 35.6°F and 46.4°F until expiration date. If vials are
March 5, 2021, through
punctured, the vaccine they contain must be used within 6 hours.
April 12, 2021)99
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Appendix A | 30
Appendix B: State and Federal Data Systems
COVID-19 vaccine administration data flows from the provider to the national-level
through several different State and Federal data systems, including the following:
•
Immunization Information System (IIS): a confidential, population-based
database that records all vaccine doses administered by participating health
care providers to persons residing within a specific geographical location.100
Awardees manage the IIS and enroll their providers into it. Providers must
report data elements to an IIS within 24 hours of a vaccine being
administered.101
•
IZ Gateway: a gateway that enables exchange between IISs, other provider
systems and Immunization (IZ) Data Lake.102 Federal program providers or
other non-IIS-connected entities may submit administration data directly to
the IZ Gateway. CDC is currently in the process of setting up this data
exchange, which is not yet operational.
•
IZ Data Clearinghouse: a cloud-hosted data repository that receives,
deduplicates, and redacts COVID-19 vaccine administration data for the IZ
Data Lake. This data is patient record-level and identifiable. Federal program
providers or other non-IIS-connected entities may submit administration data
directly to the clearinghouse if they do not report to the State IIS. Until the IZ
Gateway is stood up, awardees upload IIS file extracts to the clearinghouse
manually.
•
IZ Data Lake: a cloud-hosted data repository to receive, store, manage, and
analyze a limited dataset for COVID-19 vaccine data, including administration,
ordering, inventory, and allocation data. This data is record-level and
redacted. No personal health information is stored in this dataset.
•
Tiberius: an HHS platform that visualizes administration data, among other
data points, from the IZ Data Lake.
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Appendix B | 31
Appendix C: More Details on Awardee-Reported Challenges and
Mitigation Strategies
Below is data regarding how many awardees reported challenges in one of the six
broad areas that we asked them about, as well as mitigation strategies that awardees
reported using to address challenges in those six areas. These six areas include: (1)
provider enrollment; (2) establishing and distributing public messaging; (3) addressing
disparities and inequities; (4) vaccine allocation, ordering, distribution, and inventory
management; (5) administering the vaccine; and (6) Federal vaccine data systems.
These challenges and mitigation strategies are self-reported. Further, OIG did not
independently assess the accuracy or effectiveness of these strategies in addressing
awardee challenges.
Exhibit 4: Most awardees reported experiencing challenges in all six areas.
Challenge Area
Awardee
Count (N=56)
Addressing disparities and inequities
53
Vaccine allocation, ordering, distribution, and inventory
management
52
Establishing and distributing public messaging
50
Federal vaccine data systems
49
Administering the vaccine
48
Provider enrollment
43
Source. OIG analysis of awardee interview and survey data, 2022.
Exhibit 5: Awardees reported using a variety of mitigation strategies to
address challenges in all six areas.
Challenge Area
Awardee-Reported Example Mitigation Strategies
Provider
enrollment
•
Holding “office hours” for providers to be a ready
source of assistance, information, and troubleshooting
for enrolled providers
•
Partnering with pharmacy boards and the National
Guard to onboard providers
Establishing and
distributing public
messaging
•
Conducting a massive door-to-door campaign to
promote the benefits and accessibility of the vaccine
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Appendix C | 32
Challenge Area
Awardee-Reported Example Mitigation Strategies
•
Administering a survey to assess what are the issues
related to vaccine hesitancy and how the jurisdiction
can educate the public on those issues
•
Partnering with community-based organizations and
faith-based organizations to conduct vaccine outreach
Addressing
•
Sending out letters to individuals in priority groups that
disparities and
have not yet been identified as vaccinated in State
inequities
vaccine registry systems
•
Creating teams to deploy to underserved communities
to ensure vaccine access
•
Targeting the Johnson & Johnson vaccine to at-risk
communities who might be difficult to locate for a
second dose
Vaccine allocation,
•
Updating training for new providers on inventory
ordering,
management
distribution, and
inventory
•
Centralizing vaccine scheduling systems to increase
management
visibility in vaccine supply, uptake, and allocation
Administering the
•
Purchasing ultra-cold freezers for regional hubs before
vaccine
distribution
•
Formation of “strike teams” that are ready to
administer vaccines at mass vaccination sites
•
Holding weekly stakeholder calls to discuss issues, such
as ancillary kits and maximizing use of syringes
Federal vaccine
•
Updating State IISs to include validation steps to
data systems
improve completeness and accuracy of reported
vaccine data
•
Using the National Guard for data entry
•
Creating a Memorandum of Understanding in order to
share data with other jurisdictions
Source: OIG analysis of awardee interview and survey data, 2022.
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Appendix C | 33
Appendix D: Agency Comments
Following this page are the official comments from CDC.
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Appendix D | 34
Centers for Disease Control and Prevention (CDC)’s planned actions in response to the Office of
the Inspector General’s (OIG) draft report, “Early Challenges Highlight Areas of Improvement in
COVID-19 Vaccination Programs, OEI-04-21-00190” (the Report)
CDC appreciates OIG’s ongoing work on the Report and agrees with the need to continue to support
awardees in provider training and oversight. CDC will build upon the framework established for
provider-ready training resources. Having tools and references developed for the current response allows
for adjustments for the future. CDC will continue to encourage awardees to maintain a roster of trained
vaccination providers for rapid assistance to the extent feasible and disseminate available funding to
awardees to enhance their ability to properly hire and train staff, purchase supplies, and train providers.
CDC is currently reviewing and updating its immunization program field staff structure and recruitment
processes to ensure awardees and staff are more adequately supported in the future. As recommended,
CDC can work with Administration for Strategic Preparedness and Response (ASPR) to ensure
temperature-monitoring devices are available through the Strategic National Stockpile or ancillary
supply kits.
OIG Recommendation 1:
CDC should update its plans for mass vaccination programs with strategies that address awardee-
reported challenges with vaccine minimum order sizes and ancillary supply kits. We offer ways in which
CDC can continue to drive improvement for the ongoing COVID-19 vaccination campaign, as well as
drive improvement for future pandemic vaccination efforts:
• Vaccine minimum order sizes and vaccine storage requirements
• Ancillary supply kits
CDC Response:
OIG has two recommendations regarding vaccine minimum order size and storage requirements:
• To address future pandemic vaccination efforts, CDC should update mass vaccination
planning to include guidance that advises Biomedical Advanced Research and Development
Authority (BARDA) on vaccine manufacturer contract parameters for packaging quantities
of vaccines.93
• As a part of updating mass vaccination planning, CDC should consider including guidance
on the establishment of centralized, federal depots to breakdown large order sizes into
smaller ones to reduce the burden on awardee resources.
CDC concurs with the first recommendation about updating guidance/collaborating with BARDA
around COVID-19 vaccine contract requirements. Specifically, those requirements should provide for
multiple vaccine presentations, including a large presentation that is appropriate for mass vaccination
clinics and a smaller presentation(s) appropriate for provider sites, health departments, pharmacies, etc.,
as vaccine administration options that are complementary to mass vaccination clinics. Having more than
one sized presentation available reduces the burden on awardees by decreasing the redistribution
required. Finalizing the details of these requirements must consider the inherent trade-offs between
larger presentations and manufacturing throughput (i.e., larger presentations, such as Pfizer’s 1170 dose
presentation allow vaccine to be produced more quickly, which is especially important in the early
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Appendix D | 35
weeks and months of a vaccine response.) In addition, the COVID-19 vaccine contract requirements
about vaccine presentations should include a time component: (1) initially, the majority of vaccine shall
be provided as a large presentation and a small proportion of vaccine shall be provided in the smaller
presentation(s), and (2) at a specified point in time, the proportion of vaccine to be provided as a large
presentation decreases and the proportion of vaccine to be provided as a smaller presentation increases.
CDC does not concur with the recommendation to consider the establishment of centralized, federal
depots to breakdown large order sizes into smaller ones. There are numerous risks involved with the
second recommendation (provided by CDC in prior feedback to OIG). Further, implementation of the
first OIG recommendation (updating COVID-19 vaccine contract requirements to include multiple
presentation sizes of vaccine) reduces the need to break down larger presentations and allows the
government to avoid the risks associated with the second recommendation related to minimum order
size. Implementing the first OIG recommendation in this section allows government to require the
appropriate combination of vaccine large and smaller presentations rather than purchasing vaccine in
only a single, large presentation and then implementing (and paying for) a separate mechanism to
convert a large presentation into smaller ones.
CDC concurs with the recommendation to use lessons learned from the COVID-19 vaccine ancillary
supply kit challenges. CDC has and will continue to use the lessons learned from this response to update
planning efforts.
OIG Recommendation 2:
CDC should strengthen reporting of vaccine allocation data and administration data in two ways:
o Improve vaccine allocation data accuracy
o Develop strategies to improve vaccine administration data
CDC Response:
CDC concurs with the recommendation to strengthen reporting of vaccine allocation data and
administration data in two ways: improve vaccine allocation data accuracy and develop strategies to
improve vaccine administration data. CDC has and will continue to work with relevant partners to
improve projections of expected vaccine shipments, and CDC has and will continue to improve data
quality standards for reporting.
OIG Recommendation 3:
CDC should clarify agency roles and responsibilities within the Department of Health and Human
Services (HHS) (which includes, at a minimum; Office of the Assistant Secretary for Public Affairs
[ASPA], ASPR, and the Food and Drug Administration [FDA]) for vaccine public health messaging
during a pandemic. In doing so, CDC should use lessons learned from the COVID-19 response,
including the awardee-reported challenges outlined in this report.
CDC Response:
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Appendix D | 36
CDC concurs with the recommendation to clarify HHS-wide agency roles and responsibilities and for
setting public communication and outreach priorities and implementing activities.
• CDC recommends further agency-specific (CDC, ASPA, ASPR, FDA, etc.) and HHS-wide
communication hot washes that include representatives from organizations that represent state
and local public health stakeholders such as the National Public Health Information Coalition,
the Association of Immunization Managers, the Association of State and Territorial Health
Officials, and the National Association of City and County Health Officials.
• While reported as a mitigation strategy, CDC recommended and actively supported the use of
community health workers, vaccine ambassadors, and other trusted community leaders and
messengers as the foundation of any successful vaccine confidence, communication, or media
strategy. CDC recommends and is supporting strengthening local, state, and federal capacity to
evaluate and strengthen and community health worker, vaccine ambassador, and other trusted
community leader and messenger activities to reinforce vaccine confidence and education,
combat misinformation, support public health community pandemic recovery, and prepare for
future emergencies.
OIG Recommendation 4:
CDC should identify ways to support awardees in training and overseeing providers both during the
current COVID-19 vaccination campaign, as well future mass vaccination efforts. These could include
establishing and maintaining a pandemic-ready vaccine provider roster, implementing a risk-based
approach for conducting provider site visits, and providing supplemental federal resources for
conducting provider oversight.
CDC Response:
CDC concurs with the recommendation to identify ways to support awardees in vaccination provider
training and oversight; however, the specific examples listed have been implemented or may not be a
practical solution.
1. Establishing and maintaining a pandemic-ready vaccine provider roster is an activity that
awardees have been asked to do in preparedness planning for many years. The frequent change
in ownership or organizational structure to healthcare provider organizations as well as the rapid
turnover of healthcare provider staff makes this extremely difficult, if not impossible, to achieve
on a large scale. Within only months, a provider’s vaccine coordinator (position generally
responsible for vaccine ordering, storage, and handling, etc.) and back-up staff can completely
change, resulting in the need for full training for the organization again. Additionally, much of
the training is centered around the specific vaccine storage, handling, and administration
requirements by product and can only occur when products to be used have been authorized and
that information along with each product’s specifications can be made publicly available. CDC
developed and provided numerous training materials and resources posted to the CDC website
that providers could use for self- and staff-training purposes.
The limitations with training influence the ability to have oversight (i.e., compliance site visit
materials) ready early on. During site visits, providers are assessed to ensure they are adhering to
the storage, handling, and administration requirements for each specific product. With COVID
19 vaccine, getting vaccine out and administered as quickly as possible was the primary focus
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Appendix D | 37
and one that required “all hands on deck.” Once vaccine was distributed, then some resources
were freed so that efforts could be devoted to beginning oversight activities.
2. A risk-based approach to site visits was implemented in that awardees were instructed to
prioritize providers who were administering the greatest number of vaccine doses. CDC’s intent
with this approach was to assess providers whose vaccination practices were impacting the
greatest portion of the population. CDC agrees that the proportion of required number of visits to
enrolled providers was less than ideal, but the staffing challenges described in this report at all
levels (federal, state, local) posed a major barrier to increasing the number or frequency. This
also contributed to the reasoning behind prioritizing those providers impacting the greatest
number of vaccine recipients. CDC could have instructed that awardees perform more visits than
defined (and some did), but many would have not been able to do so due to lack of available
staff. Even awardee staff who routinely conducted Vaccines For Children visits were pulled to
perform other response-related roles that were just as critical.
CDC agrees experienced providers would theoretically be able to perform more readily, but
vaccine administration, storage, and handling requirements for some COVID-19 vaccine
products were vastly different than other vaccines providers routinely administered.
CDC allows allow virtual visits and, in fact, suspended all in-person visits for a period. Once
local travel restrictions were lifted and staff were considered to not be at risk due to local virus
transmission, in-person visits were prioritized so that all aspects of the provider operations could
be better observed. Screen sharing provided limited viewing ability of all that was happening
within a provider location. (NOTE: There were Health Insurance Portability and Accountability
Act concerns around photos/streaming of vaccine administration in progress.)
3. Supplemental federal resources were made available for conducting provider oversight.
Approximately $3 billion in supplemental funding was made available to jurisdictions, and
required activities included implementation of site visits, purchase of supplies (e.g., digital data
loggers to monitor vaccine storage temperatures, appropriate storage equipment), provider
training, and many others. CDC allowed jurisdictions to fund contractors or local health
department staff to perform site visits, and many jurisdictions took advantage of such an
arrangement. Through the CDC Foundation, CDC funded additional field staff to be placed in
jurisdictions; jurisdictions were allowed to request staff to perform site visits through this
mechanism. Additionally, ~70 CDC field staff were already embedded in state/local
immunization programs that could be used to perform site visits. For added support, CDC held
trainings that were recorded and posted online and regular office hours for jurisdiction site visit
reviewers.
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Appendix D | 38
ACKNOWLEDGMENTS AND CONTACT
Acknowledgments
Lauren Buss served as the team leader for this study, and Rebekah Schwartz served as
the lead analyst. Others in the Office of Evaluation and Inspections who conducted
the study include Margaret Dore and Alicia Stevens. Office of Evaluation and
Inspections headquarters staff who provided support include Jennifer Gist, Althea
Hosein, and Christine Moritz.
We would also like to acknowledge the contributions of other Office of Inspector
General staff, including Victoria Coxon, Kaliane Davidson, Adam Freeman, Samantha
Handel-Meyer, Jonathan Jones, Kayla Phelps, Kelsey Ridenour, Lucio Verani, and
Brianna Weldon.
This report was prepared under the direction of Dwayne Grant, Regional Inspector
General for Evaluation and Inspections in the Atlanta regional office, and Evan
Godfrey, Deputy Regional Inspector General and Jaime Stewart, Assistant Regional
Inspector General.
Contact
To obtain additional information concerning this report, contact the Office of Public
Affairs at Public.Affairs@oig.hhs.gov. OIG reports and other information can be found
on the OIG website at oig.hhs.gov.
Office of Inspector General
U.S. Department of Health and Human Services
330 Independence Avenue, SW
Washington, DC 20201
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Acknowledgments and Contact | 39
ABOUT THE OFFICE OF INSPECTOR GENERAL
The mission of the Office of Inspector General (OIG), as mandated by Public Law
95-452, as amended, is to protect the integrity of the Department of Health and
Human Services (HHS) programs, as well as the health and welfare of beneficiaries
served by those programs. This statutory mission is carried out through a nationwide
network of audits, investigations, and inspections conducted by the following
operating components:
The Office of Audit Services (OAS) provides auditing services for HHS,
either by conducting audits with its own audit resources or by overseeing audit work
done by others. Audits examine the performance of HHS programs and/or its
grantees and contractors in carrying out their respective responsibilities and are
intended to provide independent assessments of HHS programs and operations.
These audits help reduce waste, abuse, and mismanagement and promote economy
and efficiency throughout HHS.
The Office of Evaluation and Inspections (OEI) conducts national
evaluations to provide HHS, Congress, and the public with timely, useful, and reliable
information on significant issues. These evaluations focus on preventing fraud, waste,
or abuse and promoting economy, efficiency, and effectiveness of departmental
programs. To promote impact, OEI reports also present practical recommendations
for improving program operations.
The Office of Investigations (OI) conducts criminal, civil, and administrative
investigations of fraud and misconduct related to HHS programs, operations, and
beneficiaries. With investigators working in all 50 States and the District of Columbia,
OI utilizes its resources by actively coordinating with the Department of Justice and
other Federal, State, and local law enforcement authorities. The investigative efforts
of OI often lead to criminal convictions, administrative sanctions, and/or civil
monetary penalties.
The Office of Counsel to the Inspector General (OCIG) provides
general legal services to OIG, rendering advice and opinions on HHS programs and
operations and providing all legal support for OIG’s internal operations. OCIG
represents OIG in all civil and administrative fraud and abuse cases involving HHS
programs, including False Claims Act, program exclusion, and civil monetary penalty
cases. In connection with these cases, OCIG also negotiates and monitors corporate
integrity agreements. OCIG renders advisory opinions, issues compliance program
guidance, publishes fraud alerts, and provides other guidance to the health care
industry concerning the anti-kickback statute and other OIG enforcement authorities.
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About OIG | 40
ENDNOTES
1 Routine immunizations refer to vaccines that are distributed and administered annually to certain individuals (normally
children) to prevent against disease such as Hepatitis B, Measles, and Chickenpox, among others.
2 These awardees include the 50 States, the District of Columbia, five large metropolitan areas (i.e., Chicago, Houston, New
York City, Philadelphia, San Antonio), and eight Territories (i.e., American Samoa, Guam, Marshall Islands, Micronesia,
Northern Marianas, Palau, Puerto Rico, and the Virgin Islands).
3 This average amount does not include supplemental funding provided for COVID-19 activities. CDC has provided an
additional $7.2 billion in COVID-19 supplemental response funding through its Immunization and Vaccines for Children
Cooperative Agreement between Fiscal Years 2020 and 2021.
4 For example, see: HHS, Pandemic Influenza Plan, November 2005. Accessed at
https://www.cdc.gov/flu/pdf/professionals/hhspandemicinfluenzaplan.pdf on January 26, 2022.
5 CDC, COVID-19 Vaccination Program Interim Operational Guidance, October 2020, p. 5. Accessed at
https://www.cdc.gov/vaccines/imz-managers/downloads/COVID-19-Vaccination-Program-Interim_Playbook.pdf on February
11, 2022.
6 COVID-19 vaccines enter communities through Federal programs that include partnerships with retail pharmacies,
Department of Defense (DoD), Indian Health Services (IHS), Health Resources and Services Administration (HRSA), Bureau of
Prisons (BoP), and the Department of Veteran Affairs. These Federal programs target specific vulnerable, higher-risk
populations, such as long-term care residents, people experiencing homelessness, incarcerated populations, and
communities of color. CDC, COVID-19 Vaccination Program Interim Operational Guidance, October 2020, p. 25-26. Accessed
at https://www.cdc.gov/vaccines/imz-managers/downloads/COVID-19-Vaccination-Program-Interim_Playbook.pdf on August
16, 2022.
7 CDC, COVID-19 Vaccination Program Interim Operational Guidance, October 2020, p. 5. Accessed at
https://www.cdc.gov/vaccines/imz-managers/downloads/COVID-19-Vaccination-Program-Interim_Playbook.pdf on February
11, 2022. CDC, Interim Jurisdiction COVID-19 Vaccination Playbook Draft Executive Summaries, last updated on August 11,
2022. Accessed at https://www.cdc.gov/vaccines/covid-19/covid19-vaccination-guidance.html#playbook-draft-summaries on
August 26, 2022.
8 Gross, J., Five Past Vaccine Drives and How They Worked, New York Times, January 25, 2021. Accessed at
https://www.nytimes.com/2021/01/25/science/mass-vaccine-drives.html on February 11, 2022.
9 We identified these challenges through discussions with relevant stakeholders (e.g., the Association of State and Territorial
Health Officials and the National Association of County and City Health Officials) and a review of CDC guidance documents,
White House strategy documents, and media articles on initial vaccine efforts.
10 Vaccine allocations are covered in Section 5 and 7; vaccine packaging and distribution are covered in Section 7; vaccine
storage, handling and administration are covered in Section 7 and Section 8; and critical populations are covered in Section 4.
CDC, COVID-19 Vaccination Program Interim Operational Guidance, October 2020. Accessed at
https://www.cdc.gov/vaccines/imz-managers/downloads/Covid-19-Vaccination-Program-Interim_Playbook.pdf on August 26,
2022.
11 CAG was formerly known as Operation Warp Speed.
12 ASPR was formerly known as the Office of the Assistant Secretary for Preparedness and Response.
13 On December 31, 2021, after we collected data from awardees, CAG was dissolved and transitioned fully to an HHS effort.
In March 2022, HHS established H-CORE to build off CAG and Operation Warp Speed efforts. The White House, Press
Briefing by White House and HHS Public Health Officials, March 2, 2022. Accessed at https://www.whitehouse.gov/briefing
room/press-briefings/2022/03/02/press-briefing-by-white-house-and-hhs-public-health-officials-march-2-2022/ on May 18,
2022.
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Endnotes | 41
14 In January 2022, the Government Accountability Office (GAO) released a report examining that transition, as part of its
ongoing obligation to monitor the Federal government’s pandemic response. GAO, HHS and DOD Transitioned Vaccine
Responsibilities to HHS, but Need to Address Outstanding Issues, January 2022. Accessed at https://www.gao.gov/assets/gao
22-104453.pdf on March 29, 2022.
15 CDC encourages manufacturers and distributors to use a strategy in which partial shipments are used to allow as many
providers as possible to begin vaccination activities early in the vaccination season. Further, CDC recommends using
manufacturer-filled syringes for large influenza vaccination clinics. CDC, Frequently Asked Questions on Vaccine Supply, last
updated October 18, 2021. Accessed at https://www.cdc.gov/flu/prevent/vaxdistribution.htm on January 27, 2022. CDC,
Seasonal Influenza Vaccine Dosage and Administration, last updated November 16, 2020. Accessed at
https://www.cdc.gov/flu/about/qa/vaxadmin.htm on January 27, 2022.
16 Huang, Hsin-Chan et al., “Equalizing access to pandemic influenza vaccines through optimal allocation to public health
distribution points,” August 30, 2017. Accessed at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5576642/ on March 9,
2022.
17 CAG determined these allocations using population size in each jurisdiction. Allocations changed over time based on
recommendations for critical populations, vaccine production and availability, and overall jurisdictional population. CDC,
COVID-19 Vaccination Program Interim Operational Guidance, October 29, 2020, p. 29.
18 Haung, P., Government To Allocate Vaccine to States based on Population, not Risk, November 2020. Accessed from
https://www.npr.org/2020/11/25/939002641/government-to-allocate-vaccine-to-states-based-on-population-not-risk on
December 21, 2021.
19 Awardees recruited providers to administer the COVID-19 vaccine. As part of this process, providers who agree to
administer the COVID-19 vaccine, enroll into their awardee’s COVID-19 vaccination program. These providers must adhere to
the CDC COVID-19 Vaccination Program Provider Agreement. CDC, COVID-19 Vaccination Program Interim Operational
Guidance, October 2020, p. 21. Accessed at https://www.cdc.gov/vaccines/imz-managers/downloads/COVID-19-Vaccination
Program-Interim_Playbook.pdf on February 11, 2022.
20 CDC, COVID-19 Vaccination Program Interim Operational Guidance, October 2020, p. 31. Accessed at
https://www.cdc.gov/vaccines/imz-managers/downloads/COVID-19-Vaccination-Program-Interim_Playbook.pdf on February
11, 2022.
21 Ibid.
22 A cold chain includes all vaccine-related equipment and procedures. The cold chain begins with the cold storage unit at
the manufacturing plant, extends to the transport and delivery of the vaccine and correct storage at the provider facility, and
ends with administration of the vaccine to the patient. CDC, Vaccine Storage and Handling Toolkit, September 2021, p. 5.
Accessed at https://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit.pdf on February 11, 2022.
23 Additionally, because the Pfizer vaccine must be mixed before use, its ancillary supply kit also includes a mixing kit. CDC,
COVID-19 Vaccination Program Interim Operational Guidance, October 29, 2020, p. 30.
24 A low dead-volume syringe is a specific type of syringe that is able to reduce what is known as “dead volume”—the
amount of fluid remaining within in the syringe after an injection is completed. This allows providers to maximize the number
of doses from one vial, as a low dead-volume syringe can withdraw six doses out of a vial, rather than five. Pfizer, Information
about Low Dead-Volume Syringes and/or Needles, 2021. Accessed at
https://www2.gnb.ca/content/dam/gnb/Departments/eco-bce/Promo/covid-19/ldv-info-pfizer-biontech-vaccine.pdf on
March 3, 2022.
25 ASPR, COVID Vaccine Ancillary Supply and Mixing Kits, August 9, 2021. Accessed at
https://www.phe.gov/about/sns/COVID/Pages/covid19-ancillary-supplies-mixing-kits.aspx on March 4, 2022.
26 CDC, COVID-19 Vaccination Program Interim Operational Guidance, October 2020, p. 29. Accessed at
https://www.cdc.gov/vaccines/imz-managers/downloads/COVID-19-Vaccination-Program-Interim_Playbook.pdf on February
11, 2022.
27 To ensure equitable distribution of the vaccine, CDC worked with various partners, including ACIP and the National
Institutes of Health and the National Academies of Sciences, Engineering, and Medicine, to recommend how awardees
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Endnotes | 42
distribute the vaccination to reach critical populations. CDC, The Advisory Committee on Immunization Practices’ Updated
Interim Recommendation for Allocation of COVID-19 Vaccine — United States, December 2020, December 31, 2020. Accessed
at https://www.cdc.gov/mmwr/volumes/69/wr/mm695152e2.htm on February 11, 2022
28 Ibid.
29 Ibid.
30 Kaiser Family Foundation, State COVID-19 Vaccine Priority Populations, April 19, 2021. Accessed at
https://web.archive.org/web/20210129160408/https://www.kff.org/other/state-indicator/state-covid-19-vaccine-priority
populations/?currentTimeframe=0&sortModel=%7B%22colId%22:%22Location%22,%22sort%22:%22asc%22%7D on
February 11, 2022.
31 In May 2021, all individuals aged 16 years and older became eligible to receive the COVID-19 vaccine. The White House,
Fact Sheet: President Biden to Announce All Americans to be Eligible for Vaccinations by May 1, Puts the Nation on a Path to
Get Closer to Normal by July 4th, March 11, 2021. Accessed at https://www.whitehouse.gov/briefing-room/statements
releases/2021/03/11/fact-sheet-president-biden-to-announce-all-americans-to-be-eligible-for-vaccinations-by-may-1-puts
the-nation-on-a-path-to-get-closer-to-normal-by-july-4th/ on February 15, 2022.
32 In late October 2021, all children and adults aged 5 and older became eligible to receive the COVID-19 vaccine. FDA
authorized the Pfizer COVID-19 vaccine for emergency use in children 5-11 years old on October 29, 2021. For children 12
15 years old, FDA authorized the Pfizer vaccine on May 10, 2021. FDA, Coronavirus (COVID-19) Update: FDA Authorizes
Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Adolescents in Another Important Action in Fight Against Pandemic,
May 10,2021. Accessed at https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda
authorizes-pfizer-biontech-covid-19-vaccine-emergency-use on February 15, 2022. FDA, FDA Authorizes Pfizer-BioNTech
COVID-19 Vaccine for Emergency Use in Children 5 through 11 Years of Age, October 29, 2021. Accessed at
https://www.fda.gov/news-events/press-announcements/fda-authorizes-pfizer-biontech-covid-19-vaccine-emergency-use
children-5-through-11-years-age on February 15, 2022.
33 CDC, CDC COVID-19 Vaccination Program Provider Agreement, September 14, 2020. Accessed at
https://scdhec.gov/sites/default/files/media/document/COVID19
Vaccination_Program_Provider_Agreement_and_Profile_Form.pdf on September 23, 2022; CDC, COVID-19 Vaccination
Program Interim Operational Guidance Jurisdiction Operation, October 29, 2020, p. 35; CDC, Immunization Information System
Data Requirement Form, December 11, 2020. Accessed at https://www.cdc.gov/vaccines/covid-19/reporting/downloads/IIS
data-requirement-form.pdf on September 23, 2022.
34 CDC, COVID-19 Vaccination Program Interim Operational Guidance, October 2020, p. 64. Accessed at
https://www.cdc.gov/vaccines/imz-managers/downloads/COVID-19-Vaccination-Program-Interim_Playbook.pdf on February
11, 2022.
35 CDC written and verbal responses to OIG questions in February 2022.
36 HHS, Pandemic Influenza Plan, November 2005, p. 280. Accessed at
https://www.cdc.gov/flu/pdf/professionals/hhspandemicinfluenzaplan.pdf on January 26, 2022.
37 HHS agencies should develop and distribute communication materials for awardees to use during pandemic vaccination
efforts, as outlined in prior pandemic planning. Prior planning states that Federal government, including HHS, should
coordinate with awardees to disseminate consistent public health messages to the wider public. In addition, awardees should
tailor those messages to local populations. HHS, Pandemic Influenza Plan, November 2005, Supplement 10, p. S10-1 through
S10-21. Accessed at https://www.cdc.gov/flu/pdf/professionals/hhspandemicinfluenzaplan.pdf on January 26, 2022.
38 CDC, VFC Parents Brief Answers to Common Questions, June 17, 2020. Accessed at
https://www.cdc.gov/vaccines/programs/vfc/parents/qa-flyer.html on February 15, 2022. CDC, Educational Resources and
CMEs for Healthcare Professionals, July 13, 2020. Accessed at https://www.cdc.gov/vaccines/events/niam/hcp/educational
resources.html#maternal-vaccination on February 15, 2022. CDC, Growing Up with Vaccines: What Should Parents Know?, July
2018. Accessed at https://www.cdc.gov/vaccines/growing/images/global/CDC-Growing-Up-with-Vaccines.pdf on February
15, 2022. CDC, CDC Digital Media Toolkit: 2021-22 Flu Season, December 20, 2021. Accessed at
https://www.cdc.gov/flu/resource-center/toolkit/index.htm on February 15, 2022. CDC, What Vaccines are Recommended for
You, November 21, 2019. Accessed at https://www.cdc.gov/vaccines/adults/rec-vac/index.html on February 15, 2022. CDC,
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Endnotes | 43
Vaccines at 4 to 6 Years, February 25, 2020. Accessed at https://www.cdc.gov/vaccines/parents/by-age/years-4-6.html on
February 15, 2022.
39 CDC, Vaccinate with Confidence, 2019. Accessed at https://www.cdc.gov/vaccines/partners/downloads/Vaccinate
Confidently-2019.pdf on March 22, 2022.
40 CDC, VFC Awareness and Promotional Materials, August 31, 2012. Accessed at
https://www.cdc.gov/vaccines/programs/vfc/awardees/awareness.html on February 15, 2022; Ad Council, COVID-19 Vaccine
Education Initiative. Accessed at https://www.adcouncil.org/covid-vaccine on February 15, 2022; GAO, HHS Agencies’ Planned
Reviews of Vaccine Distribution and Communication Efforts Should Include Stakeholder Perspectives, November 2021.
Accessed at https://www.gao.gov/assets/gao-22-104457.pdf on February 15, 2022. (pg. 36/68); Ad Council, CDC, AMA, and
Ad Council Urge Flu Vaccinations to Reduce Flu Hospitalizations Amid COVID-19 Concerns, October 12, 2021. Accessed at
https://www.adcouncil.org/press-releases/cdc-ama-and-ad-council-urge-flu-vaccinations-to-reduce-flu-hospitalizations
amid-covid-19-concerns on February 15, 2022; Ad Council, No Time For Flu. Accessed at
https://www.adcouncil.org/asset/no-time-for-flu/203306523 on February 15, 2022; NACCHO, Community Health. Accessed
at, https://www.naccho.org/programs/community-health on February 15, 2022.
41 CDC, How to Tailor COVID-19 Vaccine Information to Your Specific Audience, November 3, 2021. Accessed at
https://www.cdc.gov/vaccines/covid-19/hcp/tailoring-information.html on February 15, 2022.
42 CDC, COVID-19 Vaccination Program Interim Operational Guidance, October 29, 2020, p. 43.
43 Ibid.
44 Ibid., p. 42.
45 Ibid., p. 44.
46 Ibid., p. 46.
47 FDA, Multilingual COVID-19 Resources, January 31, 2022. Accessed at https://www.fda.gov/emergency-preparedness-and
response/coronavirus-disease-2019-covid-19/multilingual-covid-19-resources on February 11, 2022.
48 CDC, COVID-19 Vaccination Program Interim Operational Guidance, October 29, 2020, p. 46.
49 Ibid., p. 23.
50 Ibid.
51 Ibid.
52 Additional topics include ordering vaccine, managing, and reporting vaccine inventory, reporting vaccine wastage and
spoilage, reporting adverse events, and submitting facility information and reports. CDC, COVID-19 Vaccination Program
Interim Operational Guidance Jurisdiction Operation, October 29, 2020, p. 23.
53 CDC, U.S. COVID-19 Vaccine Product Information, May 26, 2022. Accessed at https://www.cdc.gov/vaccines/covid-19/info
by-product/index.html on February 15, 2022.
54 CDC, COVID-19 Provider Oversight FAQ, v.1, June 24, 2021.
55 Ibid.
56 CDC, CDC COVID-19 Vaccination Program: Provider Oversight and Quality Assurance, October 12, 2021, p. 6
57 CDC, COVID-19 Provider Oversight FAQ, v.1, June 24, 2021.
58 In contrast, CDC requires awardees to conduct site visits of routine vaccine providers every 24 months. CDC, Vaccines for
Children Program vs. CDC COVID-19 Vaccination Program, December 7, 2021. Accessed at
https://www.cdc.gov/vaccines/covid-19/vfc-vs-covid19-vax-programs.html on February 15, 2022.
59 CDC, COVID-19 Vaccination Program Interim Playbook for Jurisdictions Operations Annex, January 2021, p. 23. Accessed at
https://www.cdc.gov/vaccines/covid-19/downloads/COVID-19-vaccination-program-playbook-annex.pdf on February 15,
2022.
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Endnotes | 44
60 As a part of this, CDC requires that every vaccine storage unit have a temperature monitoring device. CDC recommends
providers use digital data loggers, a specific type of temperature monitoring device, as these devices provide the most
accurate measure of vaccine storage temperatures while detecting the length of time during any temperature excursion.
CDC, Vaccine Storage and Handling Toolkit, September 2021, p. 10.
61 CDC, COVID-19 Vaccination Program Interim Playbook for Jurisdictions Operations Annex, January 2021, p. 23.
62 As of October 2021, awardees are required to conduct site visits of 10 percent of provider locations of selected Federal-
channel partner organizations within the jurisdiction (i.e., dialysis centers, HRSA federally qualified health centers, IHS
facilities, HHS facilities, and BoP facilities. Awardees are not required to conduct sites visits of providers enrolled through
DoD, Veterans Health Administration, Department of State, or the Federal Retail Pharmacy Program, as these programs
conduct site visits internally. CDC, CDC COVID-19 Vaccination Program: Provider Oversight and Quality Assurance, October
12, 2021, p. 1-2.
63 OIG, Local Pandemic Influenza Preparedness: Vaccine and Antiviral Drug Distribution and Dispensing, September 2009.
Accessed at https://oig.hhs.gov/oei/reports/oei-04-08-00260.pdf on July 28, 2022. OIG, State and Local Pandemic Influenza
Preparedness: Medical Surge, September 2009. Accessed at https://oig.hhs.gov/oei/reports/oei-02-08-00210.pdf on July 28,
2022.
64 Ibid.
65 HHS OIG, Challenges With Vaccination Data Hinder State and Local Immunization Program Efforts To Combat COVID-19,
OEI-05-22-00010, January 2023.
66 GAO, Accelerated COVID-19 Vaccine Development Status and Efforts to Address Manufacturing Challenges, February 2021.
Accessed at https://www.gao.gov/assets/gao-21-319.pdf on July 28, 2022.
67 GAO, HHS Agencies’ Planned Reviews of Vaccine Distribution and Communication Efforts Should Include Stakeholder
Perspectives, November 2021. Accessed at https://www.gao.gov/assets/gao-22-104457.pdf on July 28, 2022.
68 GAO, HHS and DOD Transitioned Vaccine Responsibilities to HHS, but Need to Address Outstanding Issues, January 2022.
Accessed at https://www.gao.gov/assets/gao-22-104453.pdf on March 29, 2022.
69 These six large metropolitan areas included Chicago, District of Columbia, Houston, Philadelphia, New York City, and San
Antonio.
70 We did not include U.S. territories (i.e., American Samoa, Guam, Marshall Islands, Micronesia, Northern Marianas, Palau,
Puerto Rico, and the Virgin Islands) in this review, given their different infrastructure and relatively low number of allocated
vaccines in March 2021.
71 We gave awardees the option to respond to our questions either via email or phone. Both email surveys and phone
interviews contained the same questions.
72 We received contact information from CDC for each awardee and made initial contact with awardees through these
individuals. We conducted surveys and interviews with one or more immunization program official, which sometimes
included the initial contact person CDC provided. The immunization program officials who completed our surveys or
interviews were typically Immunization Program Managers, Immunization Program Directors, or Immunization Program
Branch Chiefs within the awardees’ public health departments.
73 We selected these broad areas based on our review of CDC’s COVID-19 Vaccine Playbook, as well as challenges reported in
the media and by stakeholders prior to when we collected data.
74 FDA, FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine,
December 11, 2020. Accessed at https://www.fda.gov/news-events/press-announcements/fda-takes-key-action-fight
against-covid-19-issuing-emergency-use-authorization-first-covid-19 on April 20, 2022.
75 Awardees reported having manufacturers send the large minimum orders primarily to sites that had a predictably large
demand, such as metropolitan hospitals and mass vaccination sites with high volumes of people seeking vaccinations. This
approach used standard cold chain management processes and fewer awardee resources. However, this presented
challenges in ensuring vaccine access to populations who did not live near or were uncomfortable being vaccinated at these
types of locations.
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Endnotes | 45
76 CDC, CDC COVID-19 Vaccination Program: Provider Oversight and Quality Assurance, October 12, 2021, p. 6.
77 CDC recommends different needle sizes based on individuals’ age and the site of injection. CDC, Vaccine Administration:
Needle Gauge and Length, August 4, 2020. Accessed at https://www.cdc.gov/vaccines/hcp/admin/downloads/vaccine
administration-needle-length.pdf on March 29, 2022.
78 Tiberius provides awardees access to vaccine allocation data (i.e., the number of doses allotted to their jurisdiction). See
Appendix B for more information on State and Federal data systems.
79 Prior GAO reports found that State health officials reported lacking visibility into how many doses would be allocated to
them and challenges in reporting vaccine administration data to CDC. GAO, Efforts to Increase Vaccine Availability and
Perspectives on Initial Implementation, GAO-21-443, https://www.gao.gov/assets/gao-21-443.pdf. Accessed on July 22, 2022.
80 Zylla, E., Bernard, S., & Lukanen, E, Ensuring Equity: State Strategies for Monitoring COVID-19 Vaccination Rates by Race and
Other Priority Populations, June 3, 2021. Accessed at https://www.shvs.org/ensuring-equity-state-strategies-for-monitoring
covid-19-vaccination-rates-by-race-and-other-priority-populations/ on February 15, 2022.
81 Health Level 7 is a set of standards for the transfer of clinical or administrative data between software applications used by
various health care providers. Health Level 7 allows providers to send data to their State’s IIS from their electronic health
record system. This saves time as providers do not have to enter data into two different data systems. The standards are
produced by Health Level Seven International, an international standards organization. (Reference to “level 7” does not
indicate that there are other levels not described here; rather, it reflects the name of the company that developed the
standards.) CDC, Implementation Guide for Immunization Messaging, October 1, 2014. Accessed at
https://www.cdc.gov/vaccines/programs/iis/technical-guidance/downloads/hl7guide-1-5-2014-11.pdf on March 3, 2022.
82 HHS Office of the Chief Technology Officer, The Immunization Gateway, August 11, 2020. Accessed at
https://repository.immregistries.org/files/resources/5f3478b27ffc4/iz_gateway_aira_august_2020_final.pdf on May 24, 2022.
83 HHS reported to GAO that COVID-19 vaccine administration data was missing race and ethnicity data for almost half of
vaccine recipients from December 2020 to March 2021. GAO, Sustained Federal Action Is Crucial as Pandemic Enters Its
Second Year, GAO-21-387. Accessed at https://www.gao.gov/assets/gao-21-387.pdf on July 22, 2022. In another report
released in February 2022, GAO also found Federal vaccination programs lacked completed race and ethnicity data for
vaccination administration. GAO, Federal Efforts to Provide Vaccines to Racial and Ethnic Groups, GAO-22-105079. Accessed
at https://www.gao.gov/assets/gao-22-105079.pdf on July 22, 2022.
84 Kaiser Family Foundation, Early State Vaccination Data Raise Warning Flags for Racial Equity, January 21, 2021. Accessed at
https://www.kff.org/policy-watch/early-state-vaccination-data-raise-warning-flags-racial-equity/ on July 14, 2022. Kaiser
Family Foundation, Latest Data on COVID-19 Vaccinations by Race/Ethnicity, July 14, 2022. Accessed at
https://www.kff.org/coronavirus-covid-19/issue-brief/latest-data-on-covid-19-vaccinations-by-race
ethnicity/#endnote_link_538361-2 on August 30, 2022. Kaiser analyzed State COVID-19 vaccine dashboards to conduct this
analysis. Therefore, the remaining four States may still collect race and ethnicity data but do not report it on national
dashboards. Further, this analysis does not include an assessment of the accuracy nor completeness of this data.
85 GAO found that despite CDC developing COVID-19 vaccine communication toolkits, State and local health officials
reported a lack of availability of communication materials early in the COVID-19 vaccination program. GAO, HHS Agencies’
Planned Reviews of Vaccine Distribution and Communication Efforts Should Include Stakeholder Perspectives, GAO-22-104457.
Accessed at https://www.gao.gov/assets/gao-22-104457.pdf on July 22, 2022.
86 As part of these toolkits, CDC included a vaccine fact sheet with information on vaccine safety and efficacy to promote
vaccine uptake. CDC, Communication Toolkit, August 17, 2021. Accessed at
https://www.cdc.gov/immigrantrefugeehealth/resources/communication-toolkit.html on February 15, 2022.
87 CDC reported that the “We Can Do This” campaign includes formative research, creative development, partnership
engagement, media buying, earned media, and ongoing research and evaluation.
88 We analyzed documentation provided by CDC and found that billing practices was the most common deficiency that
awardees identified during their provider site visits. Thirty-six percent of providers (1960 of 5,399) were noncompliant with
vaccine documentation, data reporting and/or vaccine recipient communication.
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89 We analyzed documentation provided by CDC and found that CDC conducted site visits only between December 1, 2020,
and May 31, 2021. During site visits, CDC found that over half (54 of 96) providers did not adhere to vaccination procedures,
such as vaccine preparation, administration, and adverse events reporting. Further, half (48 of 96) of providers did not adhere
to storage and handling requirements.
90 CDC, COVID Data Tracker Weekly Review, May 28, 2021. Accessed at https://www.cdc.gov/coronavirus/2019-ncov/covid
data/covidview/past-reports/05282021.html on August 2, 2022.
91 Between December 1, 2020, and December 1, 2021, awardees identified 22 percent of providers (i.e., 1191) as
noncompliant with storage and handling requirements sitewide.
92 After our review period, in one awardee’s jurisdiction, hundreds of vaccines were spoiled due to a mishandling of vaccines
which led to the vaccines to be stored at the incorrect temperature. Deville, T., Cohn, M. & Miller, H, Whistleblower alleges
Maryland health officials failed to alert hundreds of patients of potentially spoiled vaccines, December 29, 2021. Accessed at
https://www.baltimoresun.com/coronavirus/bs-md-truecare-whistleblower-20211229-5sof2rxtnvfpji4lks3pumiqd4
story.html?utm_source=&utm_medium=email&utm_campaign=45830 on February 15, 2022.
93 We analyzed documentation provided by CDC and found that CDC did not provide granular data regarding citations in this
area for site visits that it conducted. However, CDC did report that 48 (of 96) site visits were noncompliant with storage and
handling per unit requirements, which includes “having a temperature monitoring device located on the storage unit at all
time,”, among other things.
94 CDC reported to the OIG that the Biomedical Advanced Research and Development Authority (BARDA) is a key partner in
coordinating with vaccine manufacturers. BARDA provides an integrated, systematic approach to the development of
necessary vaccines and other tools for public health emergencies, including pandemics and emerging infectious diseases. For
COVID-19, BARDA funded six COVID-19 vaccine candidates, which includes obligating funds to research and development,
increased manufacturing capacity, and advanced purchases of the final vaccine. ASPR, Biomedical Advanced Research and
Development Authority. Accessed at https://aspr.hhs.gov/AboutASPR/ProgramOffices/BARDA/Pages/default.aspx on August
26, 2022. CRS, Operation Warp Speed Contracts for COVID-19 Vaccines and Ancillary Vaccination Materials, updated March 1,
2021. Accessed at https://crsreports.congress.gov/product/pdf/IN/IN11560 on August 26, 2022.
95 Cold chain conditions refer to the temperature that a vaccine must be controlled at during various stages of distribution
and administration to ensure the viability of the vaccine. CDC, Vaccine Storage and Handling Toolkit, March 4, 2021, p. 5.
Accessed at https://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/index.html on August 24, 2022.
96 Digital data loggers are a temperature monitoring device used to monitor and record the temperature of a vaccine storage
unit on a continuous basis. CDC, Vaccine Storage and Handling, last reviewed August 18, 2021. Accessed at
https://www.cdc.gov/vaccines/pubs/pinkbook/vac-storage.html on August 26, 2022.
97 CDC, Pfizer-BioNTech COVID-19 Vaccine Storage and Handling Summary, March 3, 2021
98 CDC, Moderna COVID-19 Vaccine Preparation and Administration Summary, March 15, 2021; CDC, Moderna COVID-19
Storage and Handling Summary, December 20, 2020
99 CDC, Janssen COVID-19 Vaccine (Johnson & Johnson) Storage and Handling Summary, March 5, 2021.
100 CDC, Data Use and Sharing Agreement to Support the United States Government’s COVID-19 Emergency Response, p. 3.
Accessed at https://www.cdc.gov/vaccines/covid-19/reporting/downloads/vaccine-administration-data-agreement.pdf on
March 30, 2022.
101 These elements include date and location administered, recipient name, recipient date of birth, certain recipient
demographic information, such as race, ethnicity and sex, and type of vaccine administered. CDC, COVID-19 Vaccination
Program Interim Operational Guidance, October 2020, Appendix D, p. 63.
102 Awardees are not required but are encouraged to use the IZ Gateway upon it being available. CDC, Data Use and Sharing
Agreement to Support the United States Government’s COVID-19 Emergency Response, p. 8. Accessed at
https://www.cdc.gov/vaccines/covid-19/reporting/downloads/vaccine-administration-data-agreement.pdf on March 30, 2022.
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