Fri. Sep 30th, 2022

In his excellent Forefront article on legislative reforms to strengthen the Vaccines for Children (VFC) program, which is entering its third decade, Richard Hughes IV underscores the importance of updating the law to protect people of all ages. Another priority—one that can be addressed under existing law and without congressional action—is ensuring that as the science evolves, the program continues to ensure that children benefit from the full range of modern preventive therapies against transmissible, potentially deadly childhood disease.

The recommendations of the Advisory Committee on Immunization Practices (ACIP) set the nation’s immunization standards. The ACIP has already begun to align its recommendations to encompass not only traditional vaccines, which work by building protection over time, but also monoclonal antibodies (mAbs), which confer immediate protection against communicable disease. Both types of products confer immunity; as a result, the ACIP’s decision that newer immunization technologies fall within the scope of its charter authority is not only consistent with, but arguably required by, its 1964 founding mission—to advise the Surgeon General “regarding the most effective application in public health practice of specific preventive agents which may be applied in communicable disease control.”

The ACIP is now about to begin formal consideration of immunization recommendations for mAbs designed to prevent respiratory syncytial virus (RSV). A particularly vicious virus that strikes in infancy and early childhood, RSV can trigger serious illness in children; for infants, it can be life-threatening. RSV tends to be cyclical, striking from late fall through early spring and is the most common cause of deadly pneumonia and bronchitis in babies. Most children will experience RSV before they turn two, and RSV strikes millions of children worldwide.

Beyond causing widespread, costly sickness, RSV kills an estimated 500–1,000 children in the US annually. Death from RSV is an especially serious risk for premature babies and those younger than six months of age, children younger than two with chronic lung disease or congenital heart disease, children with weakened immune systems, and those with neuromuscular disorders, including children who experience difficulty swallowing or clearing mucus.

VFC’s Role In Protecting Children’s Health And Addressing The Challenges Facing Childhood Immunization

The VFC program is unique among US preventive health policies, a multifaceted health policy response aimed at creating a durable solution to a complex, related set of problems. The roots of VFC trace to a growing focus during the 1980s on the terrible health disparities attributable to broad health care system failures that especially confronted underserved communities disproportionately home to the nation’s poorest children and children of color. Much advocacy focused on the system failures caused by the lack of health insurance and the reforms that could be achieved through Medicaid eligibility expansion.

But experts and advocates also understood that multiple aspects of the health care system contributed to inequitable child health outcomes and that underserved children and the providers who served them were trying to navigate in a dysfunctional health care market that fell short even for something as basic as childhood immunization. Nationwide immunization rates cited by the Energy and Commerce Committee in the report accompanying the original measure establishing the VFC (H. Rept. 103-111, 1993 U.S.C.C.A.N.) were as low as 40 percent for certain childhood vaccines; in the poorest inner-city communities, rates were as low as 10 percent. Rates even among insured low-income children were deeply depressed.

Lack Of Coverage

Experts who studied the problem zeroed in on three issues driving the childhood immunization problem. First was lack of coverage: A total lack of coverage for millions of children, but insurance coverage (including coverage under state Medicaid programs) that fell short of the full-range of ACIP recommendations for others—immunizations, even in the case of established vaccines such as the measles vaccine, can be costly for poor families. Inevitably, low-income uninsured and underinsured children were at greatest risk for not being able to pay the cost of childhood immunization, and millions of families with preschool children, not yet eligible for free public health vaccination clinics as a school entry rule, simply went without. Pre-VFC data showed widespread outbreaks of preventable disease because of inability to pay for care.

Supply Shortage

The second barrier was supply shortage. Manufacturers viewed low immunization uptake as a disincentive to the production of a large, steady supply of vaccine and to the large-scale investment in costly technology needed to create vaccines. (Essentially, overcoming this basic market problem not only helped motivate VFC but also lay at the heart of the 2020 Operation Warp Speed, the Trump administration’s effort to speed the development and manufacture of COVID-19 vaccines.)

Accessibility Barriers

Third was the problem of accessibility. Even when vaccines existed, providers, especially underresourced clinics and physician practices serving low-income communities, failed to maintain a ready supply on-hand. This created a large number of missed opportunities to quickly immunize their patients. The high cost of vaccine management necessary to ensure a ready supply of vaccine, despite the fact that so few families were able to afford them, simply made no sense.

The VFC’s Structure

Addressing all three barriers became a priority for the Clinton administration and bipartisan congressional leadership. The brilliance of VFC was its visionary response to all three barriers. To create stable, durable financing, Congress moved childhood vaccine purchasing out of the annual discretionary appropriations process, where it had lived for decades alongside adult vaccines purchased pursuant to Section 317 of the Public Health Service Act. (Richard Hughes IV references this issue in his recommendation to expand VFC to include adults as well.) This fundamental shift in financing policy was a response to the reality that leaving vaccines, like other public health interventions, solely or predominantly to a discretionary appropriations mechanism inevitably erodes real-dollar value over time. Such a funding strategy limits the ability of public health responses to grow and strengthen over time in response to the massive demographic, health, social, technologic, and financial factors that drive health care spending.

In place of the old way of funding vaccines for children, lawmakers chose a path that would guarantee coverage, at full, ACIP-established levels, for nearly half of all children, including all Medicaid-eligible children and adolescents, children served by community health centers and rural health clinics, and American Indian and Alaskan Native children. VFC not only expanded immunization coverage but also required coverage to be at the evidence-based level identified by the ACIP in response to scientific advances, thus protecting children and their families from the arbitrary exclusions and limits that can affect even insurance as comprehensive as Medicaid. (Ultimately, the ACIP-established coverage standard would be adopted as the model for nearly all forms of health insurance under the Affordable Care Act’s universal vaccine coverage guarantee.)

To incentivize vaccine development, VFC empowered the HHS secretary to negotiate bulk purchasing agreements at discounted rates for both existing and newly emerging vaccines. Even as regulation of drug pricing continues to represent one of the nation’s most searing health care policy dilemmas, negotiated pricing has been a feature of VFC since the program’s enactment.

VFC also established a public-private partnership for the direct distribution, free of charge, of all listed vaccines. Distribution now reaches 86 percent of all practicing pediatricians and some 44,000 physicians practicing in more than 40,000 settings, from private office-based practices to community clinics. Manufacturers ship supplies to state health agencies that, working under broad government guidance, distribute the vaccines to individual providers. VFC also ensures reasonable administration fees and finances costs associated with state program operation.

Today, VFC is regarded as one of this nation’s most effective public health policy achievements. The program rests on stable funding, protecting it from the financial erosion that has affected so many other public health programs that rely on discretionary appropriations. VFC represents a remarkable effort that simultaneously and comprehensively deals with problems of supply and demand; operates with a high degree of efficiency for manufacturers, states, and providers; and guarantees coverage at an evidence-based standard of care, thus shielding childhood immunizations from the kinds of arbitrary coverage limits that exist in public and private insurance alike.

Moreover, VFC is effective. Since its enactment, VFC has lifted immunization rates across all children, significantly reducing financial and racial inequities in childhood immunization rates. Its successes have been measured not only in health care access but in health outcomes: Routine childhood immunization was estimated to prevent more than 3,000 cases of tetanus, 70 million cases of measles (including 8.9 million hospitalizations), and 500,000 deaths from diphtheria. These figures do not include health improvement estimates for influenza or hepatitis A. Net savings to insurers have been pegged at $295 billion, and societal savings from the reduced impact of preventable disease, at $1.3 trillion.

Building On VFC’s Successes To Strengthen Its Performance For Children

Nothing in federal law bars expanding VFC to include the new generation of preventive therapies represented by mAbs. To the contrary, the design of the statute supports that flexibility. Indeed, the ACIP already has recommended use of another agent that does not operate like a traditional vaccine, the hepatitis A immunoglobulin, as a supplementary therapy to the hepatitis A vaccine.

As noted, the original mission of the ACIP underscores that its authority does not stop at vaccines with a narrow mechanism of action per se but encompasses preventive therapy technology more generally. Furthermore, given the broad underlying purpose of VFC, as well as its proven cost-effectiveness, it would run counter to the program’s goals not to bring the power of VFC to bear on new preventive therapy technologies. The ACIP’s movement in this direction should be both applauded and encouraged.

As we continue to move slowly into the long recovery period following the worst worldwide pandemic in more than a century, the legislative reforms identified in the Hughes essay—expanding VFC to cover separately administered state CHIP programs, not only Medicaid, and adding an adult component to VFC—are compelling. Assuring that VFC continually reflects the best evidence as the science of prevention grows represents an equally important step, one that can be pursued now without legislative action.

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