Last week, the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) met for two days to discuss, among other topics, the hepatitis B vaccine. Specifically, the committee heard presentations on and discussed the initial dose of the vaccine, typically given to babies within the first 24 hours of life, before they even leave the hospital. Members of the committee were concerned that not enough was known about this product and its potential ultra-long-term effects, despite 30+ years of data showing the vaccine is both safe and effective. In fact, since ACIP universally recommended the vaccine for all babies (regardless of the hepatitis status of the parents), the annual hepatitis infection rate among infants has dropped by 99%.
This has long been considered a major achievement of public health. And yet, on Friday morning, the members of the committee voted to make a substantial change in the recommendation language. It’s now up to the Acting CDC Director on whether or not to accept the recommendation or listen to those urging him to reject it. For mothers whose status is either hepatitis B positive or unknown, the old recommendation remains: babies should receive their first dose of the vaccine within 24 hours of life and then 1 subsequent dose each at 2 months and 6-15 months. For mothers who are negative for hepatitis B, the ACIP no longer recommends this critical birth dose. Instead, they recommend that mothers, along with their health care providers, engage in shared clinical decision making that would allow the mother to opt for the birth dose or not (note: the mother always was, and continues to be, able to opt out of any and all vaccines). Additionally, the committee separately voted to urge parents to consult with their baby’s health care providers and inquire if they should get the baby’s blood levels tested for a proper immune response prior to vaccinating with doses 2 and 3. Studies have repeatedly shown that 3 doses is generally the appropriate level to ensure proper, long-term immune protection against the disease. On paper, these two changes don’t seem huge. In an ideal world, it seems like parents who want to vaccinate their baby at birth can continue to do so, and those that want to opt out can also make that choice.
So what’s the big deal? Like all federal policy, there is more to a seemingly simple change than meets the eye. First of all, it is important to note that representatives from both the Vaccines for Children (VFC) program and the Centers for Medicare & Medicaid Services (CMS) presented during the first day of the ACIP meeting. The bottomline takeaway is that since the new recommendation would include room for “shared clinical decision making,” the product would continue to be covered for those enrolled in VFC, Medicare, Medicaid or the Children’s Health Insurance Program (CHIP) at no cost, including nearly half of all children in the US. While the vaccine should remain covered for those that want it, access issues could begin to crop up. Providers are not required to opt into the VFC program, which has a long list of regulations that must be followed regarding vaccine ordering, storing and reimbursement. Small providers and those in rural communities might especially feel like providing the vaccine is too much of a financial risk and opt out of the VFC program, leaving low-income children unable to access the vaccine at no cost. This could further exacerbate disparities seen among vaccine uptake in rural communities vs. urban areas. If the local family doctor is unable or unwilling to participate in VFC, a Medicaid-enrolled child and their family will have to travel to the next closest provider that does participate in the program.
Beyond issues of access, this increased rhetoric on the safety and efficacy of a proven-safe vaccine has deepened distrust in vaccines overall among the vaccine skeptical. While no data was presented to show a safety signal or other reason for making this change at this time, the discussion contained a plethora of misinformation that is sure to cause confusion and ultimately sow distrust in vaccines as a whole. Additionally, the new recommendation for serologic testing after the first dose of the vaccine given to a child whose mother is hepatitis B negative will cause undue burden on health care providers, who are already swamped. All of these factors will clog the system, create mountains of work for providers, and ultimately lead to a greater rate of infection in infants. About 90% of infants with HBV infection will incur lifelong liver disease.
Looking forward, there continues to be reason for concern that the Department of Health and Human Services (HHS) will go after other safe, effective vaccines and related products, like the recently-announced study into the safety of the RSV monoclonal antibody shot. This comes days after President Trump released an official memo directing HHS Secretary Kennedy to expedite a review of the entire childhood vaccination schedule and align it with other “peer countries.”
While concern exists on the federal vaccine policy landscape, there is room for state advocates to try and help ease the burden on providers. The American Medical Association recently added new codes that allow providers to bill for time spent with a patient consulting on a vaccine that is ultimately not given in the same visit, also known as stand-alone immunization counseling. This allows for providers to be reimbursed by Medicaid and Medicare for the time it will take to engage in shared clinical decision making. Also, as a friendly reminder, ACIP is able to change their recommendations, but it is ultimately up to the state to change laws surrounding what vaccines are needed for children to enter into public school and other such requirements.
Editors Note: This topic is rapidly evolving and this blog should be treated as a point in time.