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  
Why OIG Did This Review   Early Challenges  Highlight Areas for  
Vaccines help reduce disease-related  
Improvement in  COVID-19 Vaccination  
illnesses, hospitalizations,  and  
deaths.   The Centers for Disease  Programs  
Control and Prevention (CDC)  assists  
and funds State and local   What OIG Found  
immunization programsto which  Key Takeaway   In  the early stages  of  their  
we refer as  awardeesto support  
COVID-19 vaccination  
State and local immunization  
vaccine programs  that immunize  
programs, awardees  
programs distributing COVID- 19 
individuals in their  jurisdictions  
consistently  reported  
vaccines faced  numerous challenges, 
against vaccine-preventable diseases  
challenges  that affected  their  
including (1)  achieving  logistical  
(e.g., measles and influenza).  CDCs  
ability to  administer COVID-19 
efficiency, (2) obtaining  complete 
COVID-19 vaccination program  is an  
vaccines  efficiently and  
vaccine data from providers,  
extension of these efforts.  As  
equitably.  Specifically,  
(3)  combating  vaccine hesitancy with  
vaccine supply increased in  March  
awardees reported logistical  
public health messaging, and  
2021during the  early stages of  
challenges that impacted  
(4)  overseeing vaccine providers.  
COVID-19 vaccination programs 
efficiency, including  large 
awardees faced challenges in  
minimum order sizes for vaccines, requirements for  ultra-cold storage,  
meeting their goals of immunizing  
and insufficient  ancillary supplies.  Additionally, awardees reported  
the U.S. population amid an ongoing  
challenges in obtaining  complete,  timely, and accurate vaccine data  from  
pandemic.    
both Federal program and jurisdictional providers, which affected their  
As CDC makes ongoing program   ability to  determine  community needs efficiently  and equitably.  Finally,  
improvements, it can be assisted  by  awardees also reported wanting more Federal  government support for  
understanding the  challenges that   public health messaging  and  for their oversight of providers.     
awardees experienced with  the 
For each type of challenge,  awardees also reported using a variety of  
COVID-19 vaccination program  and  
strategies to mitigate  the  challenge.   For example,  awardees reported  
the mitigation strategies  they  took.  
breaking down large minimum order sizes  to improve vaccine access.  
This understanding can also help  
Awardees also reported  having less experienced providers shadow each  
CDC enhance  routine immunization  
other to  improve  provider understanding of data systems. 
programs and better  prepare  for  
vaccination programs for future  
What OIG Recommends and How the Agency Responded  
pandemics.  
COVID-19 vaccination  efforts are ongoing, and  CDC continues to take  
How OIG Did This Review   steps to  address  many  awardee challenges.  However,  areas for  
The Office of Inspector General (OIG)   improving the  efficiency and equity of  the vaccination  program remain.  
collected data on  the challenges and   Specifically, we recommend that CDC update its  plans for mass  
mitigation strategies  that  56  State   vaccination programs  with  strategies that address  awardee-reported  
and large metropolitan area  logistical challenges  and  strengthen  reporting of vaccine allocation data  
awardees reported in March 2021.    and administration data.  In addition, we recommend  that  CDC clarify  
We also interviewed CDC officials,   roles and responsibilities  within HHS  for  vaccine public  health messaging  
officials from other Department of  during a pandemic.  Finally, we recommend that CDC  work with awardees  
Health and Human Services (HHS)  to  enhance  current and future  capabilities for  provider training and  
agencies, and other Federal officials,   oversight.   CDC concurred  with all four recommendations.   
and we reviewed written responses  
and documentation across  HHS.  To  
support ongoing vaccination efforts, 
 
OIG shared preliminary analysis with  
CDC  in late March and  early April  
2021.    
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 vaccines 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 reports 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 manufacturers 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 providers system of  
record  within 24 hours  and reported to the jurisdictions IIS  within 72 hours.33   The 
required data  include the  vaccine recipients 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  CDCs 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 publics 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,  CDCs 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  CDCs  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 HHSs  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  HHSs  H-CORE.68   At the time of this reports release, all of  
GAOs 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 vaccinewhich 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  vaccines  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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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 CHALLENGE:  Ultra- cold storage is a  
challenge in rural areas  with smaller providers due to the 
need for special storage equipment.  
-'DI  -
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.  
 
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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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.  
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 iI i ty 
Vaccine arrival  Vaccine storage 
ine  Vaccine  Vaccine 
at provider  and handling at 
manufacturing  distribution  administration 
facility  provider facility 
........................................................................................................ 
   
Manufacturer  Manufacturer/  Pr-ovider 
responsibility  distributor  responsibility 
responsibility 
Source:  OIG adapted this graphic from CDCs 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  providers 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 doesnt give us the ability to plan ahead.     
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.  
-'DI  -
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.  
 
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., CDCs 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 weeks 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 CHALLENGE:  We do not have the 
bandwidth to provide coaching and technical assistance to  
1,200 providers.  
-DI .'-
AWARDEE- REPORTED MITIGATION  STRATEGY: We are 
-
,  - '  exploring strategies like a buddy system or shadowing to  
mitigate incongruent information and experience.   
 
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 jurisdictions vaccine campaign.   Further, planning inefficiencies could  
lead to vaccine waste.    
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.  
  
-'0I  -
AWARDEE -REPORTED MITIGATION STRATEGY: We have some 
-
visibility going, mostly with  the pharmacies. We have weekly  
,  ' 
check -ins with Rite Aid, Walmart, Walgreens, CVS.  
 
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 cant  
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 
dont 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 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.  
-'0I  -
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]  
 
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 CDCs 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 jurisdictions 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 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.  
-DI  '-
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.  
 
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,   
Id 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 publics 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, HHSs  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 ASPAs  
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 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.  
-D'-
I 
AWARDEE -REPORTED MITIGATION  STRATEGY: We are trying  
-
,  ..  '  to partner with the State Pharmacy Board that already  does  
compliance visits.   
 
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 CDCs requirement  based on 
the jurisdictions 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 CDCs  
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  
vaccines 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 vaccines 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 reports  
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 jurisdictions 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 manufacturers 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 reports 
findings  also support those OIG  recommendations.  
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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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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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AGENCY  COMMENTS AND OIG  RESPONSE  
CDC  concurred  with all four of OIGs 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 OIGs 
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  suggestions  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.   OIGs 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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practical and effective ways  to support  and address  awardee-reported challenges with  
provider training and oversight.  
For the full text of CDCs  comments, see Appendix D.  We also  addressed  all  of  CDCs 
technical comments.   
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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     This vaccine does not require use of an ultra-cold freezer.  This  
(requirements in effect   vaccine may be stored in a freezer  between -13F and 5F.  This  
December 20,  2020,   vaccine must be thawed  before using.  Once thawed, this  vaccine 
through April 23,  2021)98   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 46.4F and  77F) for  up to 12 hours.  
Johnson &  Johnson  This vaccine is not frozen.  This vaccine is stored in a refrigerator  
(requirements in effect   between 35.6F and 46.4F 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 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  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   52   
management   
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      Holding office  hours for providers to be a ready  
enrollment   source of assistance, information, and troubleshooting  
for  enrolled providers  
   Partnering  with pharmacy boards and  the  National 
Guard to onboard providers  
Establishing and      Conducting a massive  door-to-door campaign  to  
distributing public   promote  the benefits and accessibility of the vaccine  
messaging  
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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 
   Centralizing vaccine scheduling systems to increase 
inventory  
visibility in vaccine supply,  uptake,  and allocation  
management  
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 D: Agency Comments  
Following this  page are the official comments  from  CDC.  
   
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OEI-04-21-00190   Appendix D |  34     
Centers  for Disease Control and Prevention (CDC)s  planned actions in  response to the Office of  
the Inspector Generals (OIG) draft report, Early Challenges  Highlight Areas of Improvement in  
COVID-19 Vaccination Programs, OEI-04-21-00190  (the Report)  
 
CDC appreciates  OIGs  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 Pfizers 1170 dose  
presentation allow vaccine to be produced more quickly, which is especially important in the early 
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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:  
   Improve vaccine allocation data accuracy  
o
   Develop strategies to improve vaccine administration data  
o
 
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:  
Early Challenges Highlight Areas for Improvement in COVID-19 Vaccination Programs  
OEI-04-21-00190   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 providers  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 products 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  
Early Challenges Highlight Areas for Improvement in COVID-19 Vaccination Programs  
OEI-04-21-00190   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. CDCs  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.    
 
 
 
   
Early Challenges Highlight Areas for Improvement in COVID-19 Vaccination Programs  
OEI-04-21-00190   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  
 
Early Challenges Highlight Areas for Improvement in COVID-19 Vaccination Programs   
OEI-04-21-00190   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 OIGs 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. 
Early Challenges Highlight Areas for Improvement in COVID-19 Vaccination Programs   
OEI-04-21-00190   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.  
 
Early Challenges Highlight Areas for Improvement in COVID-19 Vaccination Programs   
OEI-04-21-00190   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 governments  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 awardees 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 volumethe  
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  
 
Early Challenges Highlight Areas for Improvement in COVID-19 Vaccination Programs   
OEI-04-21-00190   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,  
 
Early Challenges Highlight Areas for Improvement in COVID-19 Vaccination Programs   
OEI-04-21-00190   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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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 CDCs 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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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 States 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 awardees 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 Governments 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 Governments 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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