Now that safe and effective vaccines are available, the challenge becomes turning vaccines into vaccinations. How do we distribute the vaccines and how do we prioritize who receives them?
These were the overarching questions considered at the Workshop on COVID-19 Vaccines: Distribution and Prioritization held virtually on January 8, 2021 under support of the DHS Office of University Programs. The workshop was co-organized by three DHS Centers of Excellence (COEs)—CCICADA led by Rutgers University, CEEZAD led by Kansas State University, and ADAC led by the University of Alaska.
The three-hour event included two keynote presentations and two panels that collectively considered:
- Supply chain issues such as cold chain requirements for storage and transportation;
- Partnerships needed between different parts of the government and cooperation between public and private entities;
- Vaccine prioritization and related workforce issues;
- Protection against counterfeit vaccines and other types of fraud; and
- Special challenges of getting vaccines to remote areas.
The first keynote emphasized coordination and partnership and was delivered by General Joseph Votel, CEO of Business Executives for National Security (BENS), a national, nonpartisan, nonprofit organization comprised of senior business leaders who volunteer their time and expertise to assist the US national security community. In the second keynote, Dr. Brian Strom, Chancellor of Rutgers Biomedical and Health Sciences and the Executive Vice President for Health Affairs at Rutgers, provided a broad overview of the highly dynamic state of vaccine rollout.
The first panel offered perspectives from people working in different aspects of vaccine development and distribution. Panelists were Dr. David Adinaro, Deputy Commissioner of Public Health Services in the New Jersey Department of Health, Dr. Kevin Ban, Chief Medical Officer at Walgreens, Karin Shanahan, Senior Vice President for Global Biologics and Sterile Operations at Merck, and Marion Whicker, Deputy Chief of Supply, Production and Distribution for Operation Warp Speed.
The second panel addressed some of the compounding challenges faced in vaccine distribution. These include criminal activity, reduced transport capacity because of grounded passenger flights, and getting vaccine to the nation’s most remote areas. Participating on the panel were Len DeCandia, Chief Procurement Officer at Johnson & Johnson, Brandon Fried, Executive Director of the Airforwarders Association, Reggie Jackson, Senior Manager for Supply Chain Security at Pfizer, Jere Miles of DHS Homeland Security Investigations, Ted Smith of the Alaska Native Tribal Health Consortium, and Shellie Martin of the Kodiak Area Native Association.
Controlling the pandemic rests on three key pillars: 1) public health interventions to reduce the spread of COVID-19; 2) rapid development of safe and effective vaccines and therapies; and 3) coordinated distribution of vaccines (and therapies) to where they are needed. The workshop largely focused on the third pillar and the multi-faceted challenges of vaccine distribution.
COORDINATION & COOPERATION
Gen. Votel’s keynote stressed the need for cooperation and transparency across levels of government and the private sector for smooth distribution of the materials, manpower, and supplies needed to get people vaccinated.
Votel described some of the findings and recommendations of a commission formed by BENS to review existing policies and procedures for pandemic response and to identify key areas for improvement, not just for the current pandemic but for future emergencies of a national scale. The BENS commission sought to define current and ideal states for managing a pandemic response and to identify existing gaps that need to be closed in order to mount an ideal response. Working groups within the commission conducted over 200 interviews with leaders across sectors, focusing a major portion of their effort on “surge and supply”—having the right materials and getting them to the right place at the right time.
The commission identified a series of overlapping gaps in our pandemic response, including:
- Weak command and control driven by a lack of infrastructure connecting critical stakeholders, leading to confusion over jurisdiction, priorities, responsibilities, and partnerships.
- Lack of sustained public-private engagement with very little wargaming, resulting in inadequate emergency preparedness.
- Limited supply chain visibility leading to confusion about availability of resources, supplies, and personnel.
With respect to the above points, other speakers offered specific examples. Panelist Karin Shanahan of Merck addressed the lack of supply chain visibility and noted, “With limited information, companies work to protect their patients, sometimes exacerbating shortages.” She said that when companies noticed delays and shortages at the start of the pandemic, they often expedited or increased orders, further straining the already-stressed supply chain. By the middle of 2020, there were complete shortages of some single-use components, syringes, and other key ingredients. “Ultimately, we were all trying to do the same thing—protect patients—but very quickly we were working against each other. How do we create the type of visibility that allows industry to holistically look at supply position?”
In his keynote, Dr. Brian Strom offered the example of vaccine shortages, in part worse because both federal and local agencies and even health systems are holding back doses for second shots. Whereas Shanahan illustrated shortages driven by lack of transparency, Strom’s example shows the link between shortages and weak command and control.
In a forthcoming report, the BENS commission describes key findings, summarizes gaps identified, and makes several specific recommendations to bridge these gaps. One such recommendation is to designate a leadership position within DHS to prioritize and oversee exercising and testing of emergency response plans.
Strom’s keynote offered an overview of the rapidly changing state of the pandemic, the vaccine pipeline, and vaccine distribution.
In describing the vaccine development for COVID-19, Strom said, “Vaccine development typically takes 73 months. It was done incredibly fast and incredibly well in Operation Warp Speed, getting the first vaccines in 14 months.”
Operation Warp Speed (OWS) is a partnership of the Department of Health and Human Services (HHS), Department of Defense (DoD), and other federal organizations to develop, manufacture, and deliver COVID-19 vaccines. Panelist Marion Whicker of OWS noted that delivering a vaccine in 14 months required that steps in the development process that would typically be done sequentially be done concurrently. Notably, this included beginning to manufacture vaccine doses while Phase 3 trials were ongoing—exposing a substantial financial risk borne by the federal government to expedite development. Panelist Len DeCandia of Johnson & Johnson cited additional examples of parallelizing the supply chain in anticipation of the vaccine. These include work done to expand capacity for producing critical elements like glass vials and even dry ice. There were also parallel efforts in planning for smart packaging to monitor temperature and enable tracking.
The Pfizer and Moderna vaccines that are now in use are highly effective, with efficacies of 94-95%. Nevertheless, they present supply chain issues, both because of cold storage requirements and the two-dose regimen. Other leading candidates for Emergency Use Authorization (EUA) and distribution in the US include a vaccine by AstraZeneca that is already in use in the UK, as well as one by Johnson & Johnson that is in late-stage clinical trials. Both are expected to come up for FDA EUA review in the next month. The J&J vaccine is a single-dose vaccine without the stringent cold chain requirements. These features will make it easier to distribute, especially to hard-to-reach places.
SOME BUMPS IN THE ROLLOUT
Vaccination against COVID-19 began in the US on December 14, 2020. By the time of the January 8th workshop, roughly 4.8 million people had been vaccinated—far short of the goal of 20 million by the start of 2021. (That goal was ultimately passed on January 23.)
In Strom’s words, “Lack of infrastructure and politics led to a varied and lengthy implementation period by federal, state, local governments.”
Public health in the US is highly decentralized. The CDC’s Advisory Committee on Immunization Practices (ACIP) provides advice and guidance to the Director of the CDC regarding use of vaccines and their prioritization. These recommendations are passed to the states and then left to the states to implement through county health departments. Unfortunately, these state and local agencies are ailing. As Strom put it, “The public health infrastructure has been gutted over the last decade, but especially in the last four years, and CDC has lost credibility over the last four years.” The lack of leadership and direction from the CDC has led to inadequate advanced preparation by the states and large differences in how vaccines are being rolled out. Again, quoting Strom, “Every state was starting from scratch, and every state has been doing it in a different way.” In New Jersey, the rate-limiting elements in the initial rollout were planning, logistics, and most of all, manpower.
In essence, the initial rollout revealed many of the gaps that Gen. Votel identified—weak command & control, lack of infrastructure, and inadequate planning—all compounded by overlap with the end-of-year holidays.
VACCINE ALLOCATION & PRIORITIZATION
During the time of limited supply in the initial rollout, prioritizing who receives the vaccine is perhaps the most visible and consequential decision. In December, CDC’s ACIP issued its first recommendations on prioritization. The recommendations weigh benefits and risks to different populations, feasibility of delivery, and adherence to ethical principles that include promoting justice and mitigating health inequalities. ACIP’s recommendations for Phase 1 were:
- Phase 1A: Healthcare workers and long-term care residents and staff.
- Phase 1B: Frontline essential workers, such as police and firefighters, and persons aged 75 or over.
- Phase 1C: Other essential workers, such as transportation workers, persons 65 or over, and those with increased medical risk.
Phase 2 would see expanded supply of vaccine accompanied by broader access to the general population.
These recommendations provide guidance to the states, but each state determines its own prioritizations, and they can vary greatly. For example, many counties in Florida opened vaccination to all people 65 and over, without further prioritization, even for medical workers. New Jersey, on the other hand, is adhering more closely to ACIP’s recommendations. Panelist David Adinaro of the NJ Department of Health described NJ’s process, which is prioritizing healthcare workers and long-term care residents in Phase 1A and moving to frontline essential workers to start Phase 1B (which was just underway at the time of the workshop).
Adinaro noted that, although there were some early glitches in the distribution process, things have gotten smoother. Still, he was concerned about assuring future delivery of vaccines to meet requests from vaccination sites.
Each week, the federal government allocates vaccine doses to 64 jurisdictions (primarily states and territories) and 5 federal entities proportionate to population. Operation Warp Speed is central to distributing them.
In addition to speeding up the vaccine development process, mentioned above, OWS is helping to bolster manufacturing capacity and to secure ancillary supplies, such as syringes and glass vials. It is also responsible for coordinating the distribution of the vaccines that are allocated to states and other entities.
Figure 4 illustrates the OWS distribution process described by Marion Whicker. The process relies on McKesson, a large commercial medical distributor, to serve as the central distributor of vaccines and ancillary kits to end use locations, such as hospitals and pharmacies, via commercial carriers, such as UPS and FedEx. The only exception is Pfizer, which sends directly to carriers for delivery to end use locations as shown.
Air transport is essential to distributing vaccine doses around the world. Panelist Brandon Fried of the Airforwarders Association cited figures from International Air Transport Association
quantifying the potential scale of the endeavor: delivering a single dose to over seven billion people would fill 8,000 747s. Even if half are delivered by land, it’s still a lot of air cargo. The supply chains for vaccine production and the need for ancillary supplies to support the vaccine campaign (syringes, etc.) would add to the volume of vaccine-related cargo.
Transporting COVID vaccines by air presents a number of challenges:
- The pandemic has reduced the cargo capacity available on commercial flights. Quoting Fried, “Shortly after the pandemic began, most passenger airlines parked their planes because of lack of demand. This resulted in loss of 50% of the world’s cargo capacity.” Passenger demand is coming back, but is still reduced. Some airlines are now using their fleet to fly cargo-only flights, or are flying cargo in unused seats. United Airlines flew over 10,000 such flights last month.
- Extra-cold storage requirements limit how much vaccine can be transported because of limits on how much dry ice can be carried on a flight.
- Vaccines are a high-value item, so the entire supply chain may be targeted for both cyber and physical attack.
PROTECTING THE PRODUCT
Panelist Reggie Jackson spoke about steps that Pfizer is taking to protect vaccine efficacy and prevent counterfeiting and fraud as the vaccines make their way from manufacturing to the ultimate recipients.
As mentioned previously, Pfizer ships its vaccines directly to points-of-use via UPS or FedEx. Doses are shipped in specially designed, temperature-controlled thermal shippers that use dry ice to ensure that the ultra-cold temperatures can be maintained for up to ten days unopened. Pfizer has security measures in place to determine the location of its vaccine shipments. If a shipment deviates from its pre-set route the Pfizer security team is notified immediately.
Secure shipping containers and direct distribution via trusted carriers protects the product enroute, but manufacturers also need to protect against counterfeiting and fraud. Jackson noted that the Pfizer vaccine is only available through dispensers such as state health agencies, hospitals, and pharmacies. It cannot be purchased online. Nevertheless, offers to sell the vaccine do appear online, and there is a Pfizer security team that works to find them and have them taken down.
Jackson also said that Pfizer has anti-counterfeiting features in place to make it difficult to manufacture a counterfeit product or label. After vaccines are used, Pfizer works to assure that vials are destroyed to prevent use of legitimate vials with counterfeit product.
Panelist Jere Miles of DHS Homeland Security Investigations said that a lot of pandemic-related fraud is cyber based. Early in the pandemic, there were sales of fraudulent cures for COVID-19. Later, this moved toward homeopathic remedies that claimed to provide unproven benefits. In both cases, purchasers would receive a product, albeit one with no proven benefit. More recently, scammers may sell a product for payment online with no intention of delivery. The resulting transaction is just an online payment, affording the “seller” little exposure to US law enforcement. These cyber criminals are able to quickly adapt their “business,” making it difficult for law enforcement to stay ahead of them. So, it’s good to remember Jackson’s warning, “This vaccine is not available online.”
THE LAST MILE
Once the vaccines are delivered to a provider, the final challenge lies in delivering shots to arms.
Whicker described OWS as taking a “whole of America” approach that leverages partnerships to combat the pandemic. Through one such partnership, CVS and Walgreens are administering vaccines to those in long-term care facilities, bringing the vaccine “the last mile”. Dr. Kevin Ban of Walgreens said the company is working closely with OWS, the CDC, and now the states to leverage the power of a respected pharmacy within the community to educate people about the pandemic, provide testing, and now administer the vaccine. Ban said, “While this vaccine is new, the model for delivery by Walgreens is not new. Walgreens has been building its vaccine program over the last ten years.”
Walgreens expects to have vaccination in most of its long-term care facilities completed by late February or early March 2021 and is laying plans for vaccination of the general population.
To vaccinate the general population, Adinaro said, “We need to get this vaccination close to where people live and work.” In NJ, this means vaccinating at locations that include a mix of county health facilities, “mega-sites,” hospitals, urgent care centers, physician’s offices, and retail pharmacies, as well as mobile sites to serve hard-to-reach, at-risk populations.
Panelists Ted Smith and Shellie Martin illustrated that closing the last mile is not so easy in remote areas of Alaska. Martin is a community health aide with the Kodiak Area Native Association (KANA) who travels between five remote villages in the Kodiak archipelago to provide primary health care and after-hours emergency services to their residents. In this role, she has helped to administer over 300 vaccine doses so far. But, getting the vaccines into arms is not so easy.
The villages that Martin serves have populations ranging from 25 to 220 and are accessible only by plane or boat…weather permitting. For the two weeks preceding the workshop, winged aircraft had been unable to reach the villages because of high winds, so Coast Guard helicopters flew in vaccines she administered to the native population (Figure 7). Non-native populations in these remote areas would need to travel to the city of Kodiak for vaccination.
The ultimate goal of a vaccination campaign for a highly transmissible disease like COVID-19 is to achieve herd immunity. Vaccination provides a path to herd immunity but requires high vaccination rates. That rate varies by disease—for measles it is 90%. It is too early to know what will be required for COVID-19, but past experience suggests that it will be upwards of 70%.
One obstacle to achieving herd immunity is vaccine hesitancy. Hesitancy arises, among other things, from concerns about safety and side effects, as well as a fundamental mistrust of the medical establishment and government, which in the case of COVID-19, has been exacerbated by politicization of the surrounding public health crisis.
Globally, the percentage of people expressing willingness to take the vaccine hovers around 70%, but varies widely by country (Figure 8). In the US, about two-thirds of the population—less than what is likely needed for herd immunity—express willingness to be vaccinated. Strom noted that this hesitancy is already apparent, “What we are finding, even among healthcare workers, is that there are a lot of people who are afraid to take the vaccine, particularly people in minority populations and the underprivileged who most need it.” Drs. Adinaro and Ban confirmed this hesitancy, but Ban also cited tremendous positive energy at vaccine clinics, which have been met with applause and even dancing.
Novel virus variants are another challenge to achieving herd immunity. As the virus evolves and mutates, particularly in the genomic areas targeted by the vaccine, it may reduce vaccine efficacy. Variant strains of the virus are already surging in the UK, South Africa, and Brazil. While there is optimism that the vaccines will work on most of these variants, the effect of the mutations on vaccine efficacy are still largely unknown.
Finally, we note that although the vaccine prevents severe cases of COVID-19, we do not yet know whether the vaccine prevents virus transmission. Public health interventions such as masking and social distancing will therefore remain important for controlling the disease, even after vaccination. Prematurely abandoning these measures will allow COVID-19 to maintain its foothold within the population.
As the workshop speakers emphasized, until we are all vaccinated, you should wear your mask, maintain social distancing, and wash your hands!