When U.S. Health and Human Services Secretary Robert Kennedy, Jr. dismissed all members of the CDC’s Advisory Committee on Immunization Practices (ACIP), it allowed him to add any members he wanted who met the basic requirements to serve on the committee. He has already appointed eight new members, several of whom have a long record of anti-vaccine advocacy.
While it’s impossible to speculate what the full new panel will vote to do, it’s important to be ready for the possibility that they could remove vaccine recommendations from the current immunization schedule. Journalists need to help their audience understand the potential impacts of those actions. A lot of policy and law depends on ACIP recommendations. Make sure your audience knows about the most important downstream consequences of removing a vaccine from the recommended schedule.
A removed vaccine may not be covered by insurance or Medicaid
Removing a vaccine from the recommended immunization schedule may mean people will pay out of pocket for vaccines that were previously recommended and covered. The Affordable Care Act requires private insurance companies to pay for all federally recommended preventive care, including CDC-recommended vaccines. The ACA and the Inflation Reduction Act also require the Centers for Medicare and Medicaid Services (CMS) to pay for all recommended vaccines. If a vaccine is no longer formally recommended, there is no longer a legal requirement for insurance companies and CMS to cover the vaccine.
Historically, only a handful of vaccines have ever been removed from the schedule, and each was replaced with a different vaccine. The oral polio vaccine was removed when children began receiving the recommended, inactivated polio vaccine. The whole-cell diphtheria-tetanus-pertussis (DTP) vaccine was removed and replaced with the acellular DTaP and Tdap. And the rotavirus vaccine RotaShield was removed due to safety concerns, with two rotavirus vaccines added later.
But removing a vaccine without replacing it or without validated safety concerns is unprecedented, so there’s a lot of uncertainty around what will actually happen in terms of coverage. It’s possible insurance companies will continue to cover removed vaccines, or cover them for the rest of the year, because of the administrative costs of removing them from coverage. Or, their actuaries may determine it’s more cost-effective to cover vaccines and/or they may continue to cover them because the insurance company has a value-based payment contract or quality target arrangement with providers that requires them to cover the vaccines through the end of the contract.
TIP: Journalists should reach out to insurance companies to see if they can get clarity on this question.
Some vaccines, such as the meningitis B vaccine, are recommended by ACIP to undergo “shared clinical decision-making,” where a provider and patient discuss the vaccine’s risks and benefits and determine together whether the patient should get it. Insurance companies are supposed to cover vaccines whose administration is dependent upon shared clinical decision-making, but in reality, that may not always be the case. There have been reported instances of insurance denials for vaccines for which ACIP has recommended shared clinical decision-making, according to an immunization policy expert who spoke with me on background. This will be something to watch if a vaccine’s recommendation is “downgraded” from recommended to “shared clinical decision-making.”
A removed vaccine may no longer be covered by the Vaccines for Children program
This program, established in 1992, ensures access to all recommended vaccines for those who cannot otherwise afford them and/or lack health insurance. Children are eligible for VFC if they are on Medicaid, under- or uninsured, or American Indian or Alaskan Native. Approximately half of U.S. children are eligible for Vaccines for Children (which means removing VFC coverage could theoretically deny up to half of U.S. children access to a vaccine).
VFC is the reason that the U.S. was eventually able to eliminate measles. Until Vaccines for Children, many families could not afford vaccines, which created vulnerable hot spots of low immunization rates ripe for outbreaks. It’s unclear how removing a vaccine’s recommendation would affect VFC’s ability to cover that vaccine since, again, removing a recommendation without adding a new one is unprecedented. When the diphtheria-tetanus-pertussis vaccine and the oral polio vaccine were removed from the schedule, they were removed from the VFC program, according to Walter Orenstein, professor emeritus of medicine, pediatrics epidemiology and infectious diseases at Emory University. But the new vaccines that replaced them (DTaP, Tdap, and IPV) were added to Vaccines for Children.
When ACIP makes a recommendation for a vaccine, they also vote on whether to add that vaccine to VFC, a decision which does not require the CDC director’s approval to become official policy. So far, all vaccines that ACIP has voted to recommend or to recommend with “shared clinical decision-making” have then been approved for VFC coverage. If a vaccine’s existing recommendation is downgraded to shared clinical decision-making, then VFC should, in theory, still cover that vaccine, but it’s also possible, in theory, that ACIP could vote to remove it from VFC coverage.
A removed vaccine may not be covered under the Vaccine Injury Compensation Program
Compensation can be sought for any injury resulting from a recommended vaccine under the National Vaccine Injury Compensation Program (NVICP). (The only existing exception is the Covid-19 vaccine because Congress neglected to add it.) Although injury from a vaccine is extremely rare, it does occur, and Congress established a mechanism to compensate people with the National Childhood Vaccine Injury Act of 1986.
NVICP has a table of injuries that determines the amount paid out for a range of known injuries that can be caused by vaccines. If someone experiences that injury, they file a claim to NVICP and receive reimbursement. But that’s only if three things have occurred: the vaccine has been formally recommended by the CDC for children and/or during pregnancy; Congress has voted to add an excise tax to it to cover the cost of compensation; and the HHS Secretary formally recommends its addition to the NVICP program. Those conditions have been met for all vaccines recommended for children and pregnant people except the COVID-19 vaccines, again because Congress has not voted to add an excise tax to them.
If a vaccine is removed from the recommended immunization schedule, an injury that occurs as a result of its administration may no longer be automatically covered under NVICP. (Again: there’s uncertainty on what would happen since the move would be so unconventional.) If a vaccine is not covered under NVICP (or, in the case of COVID vaccines, under the Countermeasure Injury Compensation Program, since the vaccines were initially classified as a countermeasure while under Emergency Use Authorization status), the injured party would need to file a traditional lawsuit to seek compensation.
Removing recommended vaccines may affect some states’ school immunization requirements
All U.S. states require certain vaccines for children to attend public school. Each of those laws was determined by the state legislature, so they are not uniform, with some states requiring vaccines that others do not require. Some states tied their school immunization requirements to CDC recommendations while others’ laws specify required immunizations independent of CDC recommendations.
TIP: Local journalists should check their state laws to see how school immunization requirements are determined and whether changes to the CDC recommended schedule would affect school immunization requirements in their state.
Additional resources
- An open letter to Kennedy from Democrats on the Committee on Oversight and Government Reform regarding the ACIP dismissals
- This document is a compilation of official statements in response to the ACIP dismissals from dozens of national and state medical associations, vaccine advocacy groups, state immunization coalitions and other stakeholders. The AAP link is broken, but their statement is here.
- KFF’s fact sheet on federal advisory committees is rich with helpful links about ACIP.
- The text of the statute regarding ACIP’s role in making changes to vaccine recommendations.
- Comments from the Children’s Health Defense, the anti-vaccine advocacy group Kennedy founded, are here and here. Another anti-vaccine perspective is here. It may or may not be appropriate to include coverage of these anti-vaccine perspectives in a story, depending on what the story covers, but be conscientious of the risk of false balance with vaccine reporting.
- Vaccine Policy In Crisis: Secretary Kennedy Dismisses Entire Advisory Committee On Immunization Practices, in Health Affairs, by legal experts Richard Hughes IV and Sara Rosenbaum. Hughes, Rosenbaum and Dorit Reiss are excellent sources for vaccine policy questions.
