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Reflecting On The Future Of US Vaccine Programs

Doi: 10.1377/forefront.20230313.223470
A woman wearing a surgical mask receives a shot in the shoulder from two gloved hands.

The US government has been the sole purchaser of COVID-19 vaccines since they were authorized for emergency use by the Food and Drug Administration. This was a major departure from the customary public-private approach to vaccine programs wherein payers reimburse vaccines through health coverage and the federal government purchases vaccines for low-income children and some adults. Now, as that approach recedes, we are at a national inflection point in vaccine policy. There has been no “all of government” plan for the transition of the COVID-19 vaccine marketplace and no political acknowledgment of the need to continue prioritizing COVID-19 vaccination. Moreover, routine immunization rates have slowed throughout the pandemic as the threat and impact of respiratory pathogens has increased and we witness resurgence of previously well-suppressed diseases such as measles and polio.

As the federal government winds down its emergency response posture and conducts its post mortem, it has the opportunity and responsibility to seize the best aspects of the COVID-19 vaccination campaign, identify needed improvements to vaccine programs and infrastructure, and apply these learnings through reform of existing programs.

For Better And For Worse, COVID-19 Disrupted Vaccine Programs

The Centers for Disease Control and Prevention (CDC) has played an outsized role in responding to the pandemic and delivering vaccinations. The public health agency faced unprecedented whiplash, and sometimes overreactive backlash, throughout the pandemic and across two presidential administrations. This began in 2020 when the now former head of the National Center for Immunization and Respiratory Diseases, Nancy Messonnier, came under presidential fire when she gave her expert assessment of the toll COVID-19 could take on our country. I sat in the audience that day as she briefed the Advisory Committee on Immunization Practices (ACIP) on the approaching disease threat, and she was given a well-deserved standing ovation.

Then, no sooner had the agency announced its vaccination playbook to states in April 2020, when the Trump administration commandeered the response with Operation Warp-Speed (OWS). OWS in many ways exemplified a successful public-private partnership, but it did not immediately recognize the nation’s existing immunization infrastructure, stating it would “build the necessary plans and infrastructure for distributing” vaccines.

Eventually, the responsibility for managing the vaccine rollout found its way back to the CDC, but after significant debate within the administration about the level of resources that would be given to the CDC and states and how those funds would be used. It was in many ways an unusual vaccination campaign—the first in which the federal government purchased every vaccine and attempted to vaccinate every US citizen. This represented a departure, albeit a necessary one to secure supply, from the traditional public-private framework for vaccinating Americans.

The response also relied on unusual but ultimately successful approaches to distributing and delivering vaccines. For example, hospitals were leveraged in the first phase of vaccine distribution and delivery to reach health care workers and even broader communities. Pharmacists and other providers were allowed to go into long-term care facilities to vaccinate the elderly. Ultimately, the government stood up a brand-new Federal Retail Pharmacy Program (FRPP) that resulted in an unprecedented proportion of vaccine delivery in that setting relative to traditional medical settings.

The CDC should closely examine the successes and failures of the experimentation in these settings to understand how nontraditional or previously underused immunizers can be leveraged as providers going forward. For example, the CDC has not announced whether and how the FRPP will continue or be integrated into existing vaccine programs. It should do so. Moreover, the experience of any new provider types that were onboarded as vaccinators during the COVID-19 response should be evaluated to better understand how to expand the number and reach of vaccinating providers nationwide.

Rapid reporting of COVID-19 vaccine administration across all US jurisdictions, providing complete and timely data consistently on a national scale, was remarkable considering the existing patchwork of Immunization Information Systems across jurisdictions and correspondingly poor vaccine uptake data. By examining this patchwork and applying the COVID-19 reporting lessons of streamlining reporting and easing provider reporting burden, we can achieve greater, timelier insight into vaccine uptake and preparedness for disease outbreaks.

The Safety Net Must Be Rewoven

As the COVID-19 vaccine campaign recedes and is folded into the programs that orchestrate routinely administered vaccines, the CDC will continue to play an important, although evolving role in purchasing and delivering COVID-19 vaccines. This comes at a time when the agency is coming to terms publicly with its very mission and future leadership role in national public health matters. CDC programs are something akin to Scotch tape holding the pieces of vaccine infrastructure together, while, to borrow another metaphor, the national vaccine safety net suffers many holes.

The Vaccines for Children (VFC) program, which ensures that children in Medicaid or without health insurance have access to vaccines, took something of a backseat during pandemic vaccination efforts, as pediatric populations were among the last recommended to receive COVID-19 vaccines. Once COVID-19 vaccines are no longer available from the current federal supply, the CDC will begin to award manufacturer contracts for COVID-19 vaccines, and VFC providers will be able to order the vaccines through the VFC program. The VFC program recently received an increase in funding to $5.6 million for the current fiscal year, compared to a low point in FY21, when the program received just $3.8 million in funding. The CDC should consider modernizing the VFC program in several ways, including:

The CDC also administers a program under Section 317 of the Public Health Service Act that provides vaccine infrastructure funding to states and provides it with limited vaccine purchasing power for underserved populations. While not an entitlement like VFC, this enables the CDC to at least partially fill the uninsured gap and can hopefully be leveraged to ensure that every American has access to COVID-19 vaccines with no out-of-pocket costs. The Consolidated Appropriations Act of 2023 gave the program a boost compared to recent annual funding levels—$681.2 million in FY23 compared to $650.8 million in FY22. The CDC plans to use this increased funding to target hard-to-reach populations, including the vaccine-hesitant, minority groups, and other underserved populations based on socioeconomic status. The agency is expected to produce a “forward-looking plan” that develops tools to administer missed vaccine doses while improving health equity.

The Biden administration proposed in its FY23 budget, but Congress did not approve, the creation of a vaccine safety net or Vaccines for Adults program. Until Congress acts, it will be incumbent on the CDC to leverage the resources at its disposal, to sift through the successes and failures of the COVID-19 vaccination campaign, and forge ahead in its efforts to ensure that vaccines, COVID-19 and otherwise, remain accessible to every American. Section 317 can form the basis of incremental efforts toward creating a meaningful vaccine safety net. The purchase of vaccines for uninsured Americans is, however, insufficient to accomplish a meaningful safety net. Creating lasting infrastructure, building upon what became possible by virtue of COVID-19, is imperative. Moreover, the CDC should work with CMS and other stakeholders to further identify opportunities to unify and synchronize public and private immunization programs with comparable coverage and reimbursement, provider recognition, and incentives to immunize.

National Vaccine Policy Leadership Is Needed

There are many opportunities across the federal government to undertake much-needed vaccine policy leadership. One such opportunity would be to reverse the Trump administration’s decision to fold the National Vaccine Program Office (NVPO) into the Office of HIV/AIDS and Infectious Disease Policy. This vastly weakened the profile and influence of the office, as well as that of its affiliated National Vaccine Advisory Committee (NVAC). The NVAC, a body that once deliberated and made thoughtful vaccine policy recommendations, has essentially been reduced to a captive audience for presentations, and currently the responsibility for convening the committee falls to the communications director of the now defunct NVPO. This reduced status does not befit a sorely needed leadership entity that could provide a national vision for vaccine policy.

The Biden administration elevated the pandemic response arm of the Department of Health and Human Services, now called the Administration for Strategic Preparedness and Response, amid what turned out to be a successful effort to suppress Mpox with rapid vaccination of at-risk persons. It should further identify opportunities for national leadership on vaccine policy in a non-pandemic context as well as plan for future stockpiling, purchasing, and emergency distribution of vaccines in an outbreak context.

As the CDC undergoes its own reorganization efforts, it should evaluate its own leadership role and that of the ACIP in vaccine policy. These opportunities include:

Above all, the CDC can envision expanding its role beyond the narrow purposes of recommending and purchasing vaccine products to new possibilities to prevent disease. The federal government at-large can seize opportunities to provide a vision for vaccine policy that will take us beyond the pandemic response, restore vaccination rates and provide more equitable access to all vaccines in the future.

Author’s Note

Richard Hughes, IV was previously vice president of public policy at Moderna. He regularly advises vaccine and other biopharmaceutical manufacturers and other health-sector entities.