The Advisory Council of Immunization Practices (ACIP) meets tomorrow and many experts fear it will vote to  remove or delay recommendations for the hepatitis B vaccine. This action would be the latest in a string of vaccine policy reversals by the Trump Administration and Secretary of Health and Human Services (HHS) Robert F. Kennedy Jr. The country’s vaccine framework, once streamlined, is shattering in real-time. These monumental changes to federal policy filter all the way down to states, local pharmacies, and the vaccines that children receive.

Vaccines keep the nation’s children and communities healthy. Vaccines saved more than one million lives among the 117 million children born in the United States between 1994 and 2023 — that’s more than a million children who will be able to play with their friends, develop in school, and grow into adults. According to a recent global study, over the last 50 years, vaccines have saved the lives of more than 146 million children under the age of 5. In 2024, the study notes, a child younger than 10 who was vaccinated was 40% more likely to survive to their next birthday than a child who wasn’t. 

It’s also worth noting that the American people largely disagree with the changes made to federal vaccine policy under Secretary Kennedy, with just 1-in-4 Americans believing that the Trump Administration’s changes are based in science. Suddenly reversing course on decades of proven science and successful public health strategies isn’t the way any administration should operate. We are seeing in real time what happens when independent experts are unduly fired and censored by political actors.

The Food and Drug Administration (FDA), under control of the HHS secretary, evaluates and approves vaccines to be sold in the United States. Through a process that on average takes several years, the FDA oversees clinical trials of vaccines for both safety and effectiveness. The agency can also revoke approvals and emergency authorizations for vaccines and require additional testing, which the FDA has done for the COVID-19 vaccines.

Once a vaccine has been proven safe and effective, the Centers for Disease Control and Prevention (CDC) issues its immunization recommendations. For vaccines intended for children, this would mean including the vaccine in the childhood immunization schedule, which details what vaccines children should receive and at what age. These recommendations are informed by the Advisory Council of Immunization Practices (ACIP), an intentionally independent panel of experts that periodically reviews new vaccines and vaccine studies and recommends any needed adjustments to the CDC. If the CDC director accepts these recommendations they become official CDC policy. However, the CDC director and HHS secretary have the authority to reject these recommendations and can disregard ACIP’s findings — or fire the panel members and replace them with people more aligned with their policies, as Secretary Kennedy did earlier this year.   

Vaccines in the United States are free for eligible children under the Vaccines for Children (VFC) program, or are fully covered by private insurance. However, VFC only covers vaccines that are recommended by ACIP and the CDC, and insurance companies likewise usually only cover vaccines that are recommended. So once the CDC/ACIP stops recommending a vaccine, it is no longer guaranteed to be free for children or covered by insurance. In addition, doctors and pediatricians are no longer able to get the vaccine through the VFC program. Parents who still want their child vaccinated would have to go to a local pharmacy and pay for it out of pocket, a cost that in the case of the COVID-19 vaccine could go to $140 per shot.

But if the FDA additionally revokes a vaccine’s approval or doesn’t approve it for children, pharmacies are unlikely to carry it, or to even be able to buy it. 

So when CDC/ACIP no longer recommend a vaccine it becomes much, much harder and more expensive to receive that vaccine, even though it was free and easily available the day before. If the FDA also takes action on a given vaccine, even if temporarily, it’s essentially impossible to receive that vaccine. This is exactly what has happened with the COVID-19 boosters, which families are struggling to get for themselves and their children ahead of winter, when respiratory illnesses are likely to spread.

During his Senate hearing last week, Secretary Kennedy repeatedly claimed that “anyone can get a vaccine that wants it.” This is false. Because of the Secretary’s actions at CDC and FDA, vaccines will now be far more expensive for families — if they are available at all.

Going forward, if vaccines are approved by the FDA but not recommended by the CDC, only children whose families can afford them and obtain a prescription from a doctor will be vaccinated, further exacerbating the economic disparities in the U.S. health care system. These changes also undermine the nation’s health as a whole. Because the only way to keep a population truly protected from vaccine-preventable diseases is to make sure everyone in the community is protected.

What is happening at the federal level?

The CDC, ACIP, and the FDA have made it nearly impossible for children to get a COVID-19 booster. When ACIP meets again this week, many observers expect the panel to discuss the hepatitis B vaccine. Sen. Bill Cassidy, a doctor who serves as chair of the Health, Education, Labor, and Pension committee, has staunchly defended the hepatitis B vaccine, explaining that it is necessary for all babies to receive at birth because not all mothers are screened for hepatitis B while pregnant. The hepatitis B vaccine was first recommended by the CDC in 1991 and has been a critical safety net against a disease that is 100 times more infectious than HIV, has no cure, and causes liver cancer in 25% of infected people. Babies who receive the hepatitis B vaccine are also three times more likely to receive other recommended vaccines on time. The hepatitis B vaccine allows babies to live free of a deadly, incurable disease and keeps communities safe by preventing the spread of hepatitis B. 

There are currently 29 vaccines on the childhood immunization schedule, all of which keep kids protected and healthy. The Trump Administration’s appetite for overturning vaccine policy is especially troubling given the onset of respiratory disease season, a time when children are especially vulnerable to flu, COVID-19, and respiratory syncytial virus (RSV).

Figure 1. Data for 2022-2023, 2023-2024, and 2024-2025 respiratory seasons are from RESP-NET. Experts believe it is most likely that the combined peak hospitalization rate for COVID-19, influenza, and RSV during the 2025-2026 season will be similar to that of last season (within 20% of the 2024-2025 peak), represented by the blue band on the plot. SOURCE: Centers for Disease Control and Prevention

State Actions

In response to these changes at the federal level, states have taken a number of different approaches. Florida made headlines by promising to end all of its school vaccine mandates. These mandates are enshrined in state law, but Gov. Ron DeSantis plans to seek legislative approval to remove them. School vaccine mandates have been proven effective and necessary to protect the health of all Americans — not just students — from vaccine-preventable diseases. Having so many children, teachers, and parents in the same place is a recipe for a disease outbreak, experts say, if not enough of them are protected. Experts are most worried about measles, mumps, and pertussis, three highly infectious diseases that spread quickly and can be life-threatening for school-age children. Florida already has among the lowest vaccination rates in the country and revoking vaccine mandates will only make that worse.

In contrast, several states are trying to decouple their vaccine policy from the federal government, some on their own and others together. California, Hawaii, Oregon and Washington state have formed the West Coast Vaccine Alliance, which will issue its own vaccine recommendations and guidance. Other states plan to alter their state laws to automatically recognize vaccine schedules produced by non-federal agencies, such as the American Academy of Pediatrics. These approaches, however, may set a dangerous precedent, allowing states that are critical of vaccines to base their vaccine recommendations on untrustworthy entities or to uncritically accept the Administration’s shrinking vaccine schedule.

Public health does not work on an individual basis. It only works if a society moves as a unit to protect its most vulnerable members. Infections do not care about state lines, so while the West Coast Vaccine Alliance’s actions may help protect some people, it cannot guard against harm that may come from states like Florida that have eliminated or sidelined vaccines. People and infections travel, as the COVID-19 pandemic made clear. One state’s low vaccination rates threaten the health of its neighbors and the rest of the country with preventable illnesses.

These alliances also cannot completely recreate the federal vaccine infrastructure on their own. In addition to reviews and approvals, the federal government also plays a large logistical role in getting vaccines to market. For instance, vaccines are often stored in federal warehouses with advanced systems to cool and protect them, shipped across the country in secure and temperature-controlled containers and vehicles, and finally delivered to pediatricians’ offices. 

These movements are choreographed and planned months in advance according to data and modeling studies that predict how much vaccine each locality needs for a given disease. The Administration’s gutting of vaccine policy means that this entire system — which relied on federal equipment, federal experts, federal facilities, and most importantly, federal dollars — will vanish. States that want to keep protecting children from vaccine-preventable diseases aren’t starting from square one, they’re already months behind.

What to watch

Secretary Kennedy recently added 5 new members to ACIP, some of whom are known for their public anti-vaccine views during the COVID-19 pandemic. When the panel begins meeting tomorrow, experts will be watching to see whether any other vaccines are culled from the immunization list, especially the hepatitis B vaccine. 

A country that vaccinates its children is a happier, healthier country. It’s a country where kids spend more time at school and playing with their friends and less time sick with preventable illnesses. And the United States can only be that country with independent federal agencies free from political influence, a federal vaccine infrastructure that makes vaccines free and available, and a public that works together to protect each other.