Disclaimer: this article is a simple summary of documented plans accessible on United States government-based multimedia resources. This article is not taking a political stance on the policies of the former or current US government administrations.
Politics aside, a new administration every 4 to 8 years in the United States White House often dictates a revamp, or an overhaul, of priorities and strategies for the United States. This year, these new priorities are aiming to further turn vaccines into vaccinations.
The Biden-Harris administration was sworn in on January 20, 2021. During the administration’s first three days in office, 30 executive orders were issued. Of those, 14 related to COVID-19, 5 related to immigration, 4 related to the economy, 3 related to equity, 2 related to the environment, 1 related to ethics, and 1 related to the census.
Of the 30 executive orders issued, a number had components that directly related to the new administration’s COVID-19 operational vaccination plans. The executive orders that directly relate to the vaccine production, distribution, and administration plans are as follows:
- Executive Order on Organizing and Mobilizing the United States Government to Provide a Unified and Effective Response to Combat COVID-19 and to Provide United States Leadership on Global Health and Security (Link)
- Executive Order on a Sustainable Public Health Supply Chain (Link)
- Executive Order on Ensuring a Data-Driven Response to COVID-19 and Future High-Consequence Public Health Threats (Link)
- Executive Order Ensuring an Equitable Pandemic Response and Recovery (Link)
- Memorandum to Extend Federal Support to Governors’ Use of the National Guard to Respond to COVID-19 and to Increase Reimbursement and Other Assistance Provided to States (Link)
In addition to these executive orders, the administration also released their comprehensive “National Strategy for the COVID-19 Response and Pandemic Preparedness” plan. Access the full 200-page PDF of the national strategy on WhiteHouse.gov.
This comprehensive plan is structured around 7 distinct overarching goals. Like mentioned above, this plan includes details for COVID-19 vaccinations, but it is not limited to COVID-19 vaccinations. However, the focus of this article is on the vaccination components of the plan.
Goal 1 is to “restore trust”. Goal 2 is to “mount an effective, safe, and equitable vaccination campaign”. Goal 3 is to “mitigate spread through expanding masking, testing, data, treatment, workforce, and clear public health standards”. Goal 4 is to “expand relief and exercise the Defense Production Act”. Goal 5 is to “safely reopen schools, businesses, and travel”. Goal 6 is to “advance equity, including across racial, ethnic and rural/urban lines”. Lastly, goal 7 focuses on advancing health science and being prepared for a hypothetical future public health threat.
In accordance with coinciding executive orders, the Biden-Harris administration’s vaccination plans most directly relate to goals 2, 4, and 6 described above.
The plans overall can be informally grouped into three buckets related to distribution and access, production, and education. Those buckets are expanded upon in detail below.
Vaccine Distribution & Access
Rather than being unique to individual states and territories, COVID-19 vaccine distribution and allocation is now gaining more of a federal sentiment.
One of the many recent executive orders in part established the White House COVID-19 Response Office to help coordinate uniform vaccination efforts across the entirety of the US government. It also restored the White House Directorate on Global Health Security and Biodefense that was previously dissolved. Of note, this White House COVID-19 Response Office will aim to establish channels for dialogue between governors, state public health officials, immunization managers, and local leaders for more proactive communications and rapid responses.
The duties of the White House COVID-19 Response Office, amongst other tasks, include coordinating a government-wide effort to produce, supply, and distribute personal protective equipment (PPE), vaccines, tests, and other supplies for the COVID-19 response while also coordinating efforts to reduce disparities in the response, care, and treatment of COVID-19.
Similarly, per the White House, “to meet the aggressive vaccination target of 100 million shots by the first 100 days, the federal government will work with states and the private sector to effectively execute an aggressive vaccination strategy, focusing on the immediate actions necessary to convert vaccines into vaccinations, including improving allocation, distribution, administration, tracking, and support to State, local, Tribal and territorial governments.”
To help do this, a variety of different strategies will be used. Most notably:
- Conducting an inventory of available vaccines, supplies, and PPE to assess current stock of supplies to help assess where the biggest needs currently are. This inventory will help drive decisions related to the Strategic National Stockpile (SNS), use of the Defense Production Act, budget requests, government investments, and supply distribution
- Purchasing COVID-19 vaccine doses for the U.S. population by leveraging contract authorities, including the Defense Production Act
- Deploying onsite federal government support to monitor contract manufacturing operations
- Purchasing additional FDA-authorized vaccines by the federal government
- Purchasing and allocating supplies that could cause bottlenecks, including glass vials, stoppers, syringes, needles, and the “fill and finish” capacity to package vaccines into vials
- Utilizing the pharmacy partnership model for long-term care facilities, help develop additional partnerships with pharmacies and other related groups to assist with mass vaccinations of individuals in congregate settings. This includes, but is not limited to, individuals residing in homeless service facilities and correctional/detention facilities
- Use federal resources to deploy thousands of federal staff, contractors, and volunteers to support state and local volunteer efforts. This will notably include resources from the US Public Health Commissioned Corps, US Department of Veterans Affairs, the Department of Defense (DOD), etc.
- Provide 100% reimbursement to states for the use of National Guard personnel
- Establish the White House COVID-19 Health Equity Task Force to help address health inequities related to the pandemic
- Support ongoing research for pediatric COVID-19 vaccine availability and the effectiveness of COVID-19 vaccines in mutating viral strains
- Support ongoing research and development of future safe and effective vaccine candidates. For example, current vaccine candidates at the forefront of being studied for potential approval are from Janssen (Johnson & Johnson), AstraZeneca, and Novavax. Additional vaccines in the supply chain would help with more vaccines being widely available
Using the strategies described above, the administration is planning on accelerating the pace of vaccination administration by encouraging state and local governments to move through the priority groups more quickly than previously planned.
To do this, there will be a reduction in federal hold back of doses. Because of this, there will be an updated priority to help ensure more people get first doses of vaccines rather than trying to ensure that highest priority groups get the 2 recommended doses before moving on to the next priority demographic.
With this updated priority in mind, the administration wants to immediately begin vaccinating essential frontline workers (educators, first responders, grocery store employees, individuals 65+) rather than simply healthcare workers and residents of long-term care facilities.
Even though this new strategy may draw a concern that vaccines may not be adequately available for 2nd doses, the administration is leaning on the utilization of the Defense Production Act to help ensure adequate vaccine supply.
A separate, but important, aspect of vaccination acceleration is the physical location to which people can get vaccinated. With more people being targeted for vaccination, more vaccination sites need to become available. Accordingly, federal resources and emergency contracting authorities will be utilized by the federal government to stand up new vaccination sites. The Department of Defense (DOD) will help staff these clinics with the Federal Emergency Management Agency (FEMA) helping with set-up and operations.
The federal government will also provide capital assets, such as land and buildings, for state use in community vaccination efforts and assistance sourcing, procuring, stockpiling, and shipping supplies directly to sites. It will additionally provide clinical and non-clinical staff needed to support or staff community vaccination centers. The federal government also plans to deploy mobile vaccination clinics to rural and hard-to-access locations. Other governmental agencies will also help with this effort (Department of Veterans Affairs, USDA staff, etc).
Federally Qualified Health Centers (FQHCs) serve more than 30 million patients every year and are described by the HRSA to be “community-based health care providers that receive funds from the HRSA Health Center Program to provide primary care services in underserved areas.” The federal government, via HRSA and the CDC, will help redirect resource allocation so FQHCs can receive additional vaccine supply. This is crucial for health equity and access concerns.
Additionally, in partnership with the federal government, grocery stores and pharmacies will be leaned on more heavily as predominant vaccination sites. This is important as nearly 90% of individuals within the United States live within 5 miles of a pharmacy.
While all of this is happening, the federal government will also aim to track national and state data on performance metrics such as COVID-19 cases, tests, vaccinations, hospital admissions, nursing home capacity, hospital bed capacity, supply chain shortages. The federal government will also help with interoperable data reporting from local and state governments to help ensure that common metrics will be collected, shared, and communicated in real-time so public health interventions can be made in a more timely manner. Accurate and advanced data collection is crucial for allowing a more opportune allocation of vaccines and vaccination supplies when and where they are most needed.
For more details regarding data tracking, reference the coinciding executive order.
Importantly, equity in the entire vaccination campaign is being stressed by the administration. Demographic data will be utilized to help identify communities hit hardest by the virus to better support vaccine access for those groups. This notably includes communities of color, immigrant communities, rural communities, and Tribal Nations. New vaccination sites being set up, mentioned previously, are using demographic data as one significant consideration when deciding where to set up new sites.
The new White House COVID-19 Health Equity Task Force will engage experts of health equity on a regular basis for recommendations for ongoing system enhancements. These recommendations will focus on the equitable allocation of resources, disbursement of pandemic relief funding and culturally-responsive communication, messaging, and sustained engagement of communities of color and other underserved populations.
For more context on the necessity of this task force, please reference Figure 1.
Figure 1. COVID-19’s Impact on Racial and Ethic Subgroups
For ongoing quality improvement for operational logistics, the COVID-19 Vaccinations Collaborative will be utilized.
Production Efforts
According to the administration’s plan, “timely vaccine production depends not only on sufficient supply of biological materials for the vaccine itself but also of appropriate equipment and materials for packaging the vaccine.” Thus, in brief, shortages of any of these materials can slow vaccine manufacturing and availability to the public.
The US plans to leverage contracting authorities, including using the Defense Production Act, to help strengthen the vaccination supply chain for raw materials and equipment and fill vaccination-related supply and distribution gaps. This will be done through purchase agreements, loans, and other similar mechanisms. The administration’s production support plan relies heavily on the utilization of the Defense Production Act to respond to shortfalls in PPE and the acceleration of COVID-19 vaccine manufacturing.
The federal government will also invest in additional vaccine manufacturing facilities and will do its part to help accelerate vaccine candidate development alongside pharmaceutical companies.
However, a proper vaccination campaign goes beyond simply vaccine availability. Adequate supplies also need to be available.
One of the aforementioned executive orders also directed the establishment of a Pandemic Supply Chain Resiliency Strategy. The Pandemic Supply Chain Resiliency Strategy will address onshoring production of COVID-19 and related pandemic and medical supplies, creating a manufacturing base in the United States that can fill the Strategic National Stockpile, helping to avoid a reliance on other countries for medicines and supplies, and allowing the speed and flexibility required to help produce needed supplies and medicines for ongoing COVID-19 outbreaks and future public health crises.
Public Education
The administration announced plans to create education materials in multiple languages to focus on topics such as vaccination information, vaccine hesitancy, masking, and testing. These efforts will span to both the public and private sectors. There is also a significant effort by the administration to strategize a fight against vaccine disinformation and misinformation.
Specifically, public health campaigns will encourage vaccination administration, provide accurate information about vaccines in general, and provide clear direction about how people can get vaccinated. This is all centric to the CDC’s Vaccinate with Confidence campaign.
There is also going to be a COVID-19 Vaccination Ambassadors Program created in the near future. This program will help to highlight stories and experiences of people who have received the COVID-19 vaccine to help communicate vaccine confidence. There will be a national program created and the CDC will also create a toolkit so local versions of the program can also be created.
However, all of this is simply the current tentative plan. For updates on how the situation progresses, it is crucial to stay up-to-date with Pharmacist Consult updates, CDC updates, and general news updates.
References:
- National Strategy for the COVID-19 Response and Pandemic Preparedness. WhiteHouse.gov. Published January 2021. Accessed 24 January 2021. Accessible via: https://www.whitehouse.gov/wp-content/uploads/2021/01/National-Strategy-for-the-COVID-19-Response-and-Pandemic-Preparedness.pdf
- Executive Order on Organizing and Mobilizing the United States Government to Provide a Unified and Effective Response to Combat COVID-19 and to Provide United States Leadership on Global Health and Security. WhiteHouse.gov. Published 20 January 2021. Accessed 24 January 2021. Accessible via: https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/20/executive-order-organizing-and-mobilizing-united-states-government-to-provide-unified-and-effective-response-to-combat-covid-19-and-to-provide-united-states-leadership-on-global-health-and-security/
- Executive Order on a Sustainable Public Health Supply Chain. WhiteHouse.gov. Published 21 January 2021. Accessed 25 January 2021. Accessible via: https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/21/executive-order-a-sustainable-public-health-supply-chain/
- Executive Order on Ensuring a Data-Driven Response to COVID-19 and Future High-Consequence Public Health Threats. WhiteHouse.gov. Published 21 January 2021. Accessed 24 January 2021. Accessible via: https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/21/executive-order-ensuring-a-data-driven-response-to-covid-19-and-future-high-consequence-public-health-threats/
- Executive Order on Ensuring an Equitable Pandemic Response and Recovery. WhiteHouse.gov. Published 21 January 2021. Accessed 25 January 2021. Accessible via: https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/21/extend-federal-support-to-governors-use-of-national-guard-to-respond-to-covid-19-and-to-increase-reimbursement-and-other-assistance-provided-to-states/
- Memorandum to Extend Federal Support to Governors’ Use of the National Guard to Respond to COVID-19 and to Increase Reimbursement and Other Assistance Provided to States. WhiteHouse.gov. Published 21 January 2021. Accessed 25 January 2021. Accessible via: https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/21/executive-order-ensuring-an-equitable-pandemic-response-and-recovery/
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