State Policies Impact Access to New Immunization Products
July 12, 2024 | Maggie Davis, Kim Martin
Immunizations are a powerful public health tool, reducing the burden of disease among communities by preventing illness, disability, and death. Products that create immunity to disease provide tangible and intangible societal benefits. Broadly, immunization products prevent disease by bolstering a person’s immune system with protective antibodies, which fight infections. Vaccines are one type of immunization product that introduce a controlled disease threat; in turn, the body creates antibodies to fight off the infection. A different type of immunization products use monoclonal antibodies (mAbs) to provide immunity by introducing antibodies directly into the body rather than prompting the body to create them. While both vaccines and mAbs immunization products provide immunity, policies supporting vaccine access may not support mAbs immunization products because they are not, by definition, a “vaccine.”
In recent years, newer technologies are providing public health leaders more options to reduce disease burden in their communities. As these new products enter the market, state policymakers are considering legislation that could expand or limit access to new and emerging immunization products.
States Reassess Defining “Vaccines” to Expand Access to mAbs Immunization Products
In 2023, FDA approved the mAbs preventative product nirsevimab to prevent Respiratory Syncytial virus (RSV) in in neonates younger than eight months and some older babies. The Advisory Committee on Immunization Practices (ACIP) subsequently recommended nirsevimab to prevent RSV and included it in the federal Vaccines for Children (VFC) program. The VFC program requires coverage of vaccines recommended by the Advisory Committee on Immunization Practices (ACIP), defining “immunization” as “immunization against a vaccine-preventable disease” and “pediatric vaccines” as a product included in the ACIP-recommended list. While this recommended supported access to the new mAbs immunization product, several states encountered difficulties in accessing the product due because it did not meet their state definition of a “vaccine.”
At least 14 jurisdictions provide state-purchased immunizations for all or some recommended immunizations within the jurisdiction. These Universal Purchase (UP) programs support state efforts to provide essential vaccines to all children, but often have specific requirements and parameters in state law prescribing which products can be purchased through the program, including VFC purchases. In at least two states—New Hampshire and Washington—the state law governing the UP limits purchase to “vaccine” defined in state law as an FDA-approved live or attenuated vaccine—and does not include mAbs or other biologic products.
Both states introduced bills during the 2024 legislative session to address this inflexibility and enable their UP to include nirsevimab.
Washington introduced SB 5982 in January 2024, updating the definition of “vaccine” to include all FDA-approved immunizations and recommended by ACIP. This technical amendment to the law passed both chambers without amendment, with the Governor signing the change into law on March 13, 2024.
New Hampshire introduced SB 559 in December 2023, proposing to define “vaccine” as “any [FDA approved and ACIP recommended] immunization administered through vaccination.” Robust debate among legislators yielded an amended bill passed the New Hampshire Senate retaining the initial definition of “vaccine” and instead include “biological products” in the state UP.
Subsequent debate in the New Hampshire House of Representatives further refined the legislation to only permit the inclusion of “respiratory syncytial virus biological product” in the state UP. This version of the bill passed the legislature in May 2024 and currently awaits the Governor’s signature. Once the Governor signs the bill, New Hampshire’s UP program will be able to include nirsevimab or any subsequent biological product to prevent RSV whereas Washington’s new law broadly authorizes their program to purchase FDA approved immunization products that ACIP may recommend in the future.
Misinformation Fuels Policies that Limit Access to mRNA Immunization Products
Vaccine policy has taken an outsized role in legislative sessions in recent years, with ASTHO identifying at least 280 vaccine-related bills considered by state legislatures in 2024. Lawmakers are navigating evolving public sentiments, with many striving to balance constituent concerns with scientific evidence. However, misinformation about some newer immunization products creates a challenging environment. In addition to the new mAbs immunization product, there have been significant advancements in vaccine immunization products using mRNA technology.
Following the development of COVID-19 mRNA vaccines, shown to be safe and effective to prevent severe illness and death, there was significant misinformation spread about the technology (e.g., false-claims that mRNA vaccines alter the human genome) leading some people to reject mRNA technology. The spread of public health misinformation and disinformation can undermine public health, with the impacts of misinformation also seen in state legislative activity. Additionally, mRNA vaccine technology may protect animal health, with the National Association of State Departments of Agriculture adopting a policy amendment supporting access to USDA approved vaccines (including mRNA) in February 2024.
During the 2024 legislative sessions at least four states—Illinois (HB 4243), Kentucky (HB 163), Mississippi (HB 643 and HB 736) and Tennessee (HB 1894)—considered bills to either test donated blood for mRNA vaccine or label food products vaccinated with an mRNA product. Although most of these efforts failed, Tennessee HB 1894 was enacted May 1, 2024, requiring all food products that contain vaccine or vaccine material—defined as a substance intended to create antibodies and provide immunity against disease—to be classified as a drug and labeled accordingly.
Proponents of the legislation admitted that they were unaware of examples of vaccine-imbued foods sold in the state, with some proponents expressing extreme concern of mRNA technology in general, even suggesting outlawing mRNA technology entirely. Opponents of the bill noted that, although there have been research exploring alternative immunization administration techniques—including edible vaccines using plants—there is no indication of vaccines being included in the food supply.
ASTHO Supports Public Health Staff Navigate Legislative Sessions
In early 2024, ASTHO convened state public health leaders with experience navigating the legislative process. This meeting continued ASTHO’s successful virtual learning opportunities to increase confidence in immunization products, including both vaccines and mAbs immunization products. Through this peer learning opportunity, jurisdictions shared opportunities and challenges when developing policies to promote new immunization products, including improving access to mAbs immunization product nirsevimab and addressing misinformation about mRNA vaccine technology. Strategies discussed included proactive engagement, collaborative efforts, and a commitment to making decisions grounded in evidence. Additionally, maintaining open lines of communication with policymakers remains important, as do messages about the benefits of proposed policies.
Moving forward, policymakers and public health officials must continue to address emerging trends in vaccine policy and take advantage of opportunities to enhance public health by preventing vaccine-preventable diseases. ASTHO will continue supporting state leaders as they navigate this evolving policy landscape.