Vaccination policy of the United States is the subset of U.S. federal health policy that deals with immunization against infectious disease. It is decided at various levels of government, including the individual states. This policy has been developed over the approximately two centuries since the invention of vaccination with the purpose of eradicating disease from the U.S. population, or creating a herd immunity. Policies intended to encourage vaccination impact numerous areas of law, including regulation of vaccine safety, funding of vaccination programs, vaccine mandates, adverse event reporting requirements, and compensation for injuries asserted to be associated with vaccination.

The Advisory Committee on Immunization Practices (ACIP) is responsible for making vaccine policies and recommendations for the vaccination schedule used in the United States. As of June 2025, after Secretary of Health and Human Services Robert F. Kennedy Jr. fired all 17 ACIP members and replaced them, the new members were either anti-vaccine activists or lacked expertise with vaccines. The resulting lack of trust in future changes to vaccine recommendations resulted in the creation of two interstate collaborations, the West Coast Health Alliance and Northeast Public Health Collaborative.

Regulation of vaccine safety The Food and Drug Administration (FDA) has the authority to enforce the safety of vaccines. The FDA requires that all new vaccines first be tested in laboratory settings and on animals,21 CFR 312.23(a)(8). and must then carry out a series of increasingly stringent tests in human subjects. Once vaccines are introduced to the market, the FDA regularly inspects their production facilities, tests their quality, and receives reports of adverse reactions.

In the 2012 court case Coalition for Mercury-Free Drugs v. Sebelius,671 F.3d 1275 (D.C. Cir. 2012). the U.S. Court of Appeals for the District of Columbia Circuit held that opponents of thimerosal-preserved vaccines lacked standing to challenge determinations by the Food and Drug Administration that the vaccines and their components were safe and effective. In the opinion, Judge Brett M. Kavanaugh (joined by Judith W. Rogers and Stephen F. Williams) therefore rejected the challenge on standing grounds. The court further found it irrelevant that thimerosal was included in some versions of mandated vaccines, because it was possible for those seeking to avoid the ingredient to receive thimerosal-free vaccines.

Vaccination schedule and mandates On January 5, 2026, Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. announced unprecedented reductions by HHS in the CDC childhood vaccine schedule, eliminating recommendations that all children be immunized for rotavirus, influenza, RSV, meningococcal disease, hepatitis A, and hepatitis B. The American Public Health Association (APHA) portrayed the Trump administration’s reduced vaccine recommendations as "public health malpractice at the highest level" in a January 5, 2026, public statement, pointing out that the dangerously opaque decision-making process at play was completely devoid of scientific backing. Numerous other organizations and medical experts followed suit, immediately condemning the decision as well, characterizing it as a political move lacking transparency and scientific legitimacy; many health practitioners thus plan to follow the vaccine schedule recommended by the American Academy of Pediatrics instead, which is far more rigorously supported by data. Furthermore, experts fully expect these changes would increase preventable illness, hospitalization, and deaths among youth—endangering not only children and adolescents, but medically vulnerable community members, too, should the questionable process used by HHS in revising the recommendations survive court challenges. One such challenge is the March 16, 2026, ruling in U.S. District Court on the lawsuit American Academy of Pediatrics et al. v. Kennedy et al., which has blocked the downgraded vaccine recommendations on the grounds that these reductions in the immunization schedule were "arbitrary and capricious"; in addition to the American Academy of Pediatrics, plaintiffs include: the American College of Physicians, the American Public Health Association, and the Infectious Diseases Society of America.

The Advisory Committee on Immunization Practices (ACIP) makes scientific recommendations which are generally followed by the federal government, state governments, and private health insurance companies, including making recommendations for the vaccination schedule used in the United States.

On June 23, 2025, Secretary of Health and Human Services Robert F. Kennedy Jr. fired all 17 ACIP members and—with one exception—appointed members who were either anti-vaccine activists or who lacked expertise with vaccines. The resulting lack of trust in future changes to vaccine recommendations resulted in the creation of two interstate collaborations, the West Coast Health Alliance and Northeast Public Health Collaborative. Also, in American Academy of Pediatrics et al. v. Kennedy et al., the court’s ruling imposed a stay on the ACIP appointments by Kennedy and invalidated any policy decisions those appointees have made since he purged the previous committee (formerly composed of immunization experts).

The American Academy of Pediatrics (AAP) advises physicians to respect the refusal of parents to vaccinate their child after adequate discussion, unless the child is put at significant risk of harm (e.g., during an epidemic, or after a deep and contaminated puncture wound). Under such circumstances, the AAP states that parental refusal of immunization constitutes a form of medical neglect and should be reported to state child protective services agencies.

All vaccines recommended by the U.S. government for its citizens are required for green card applicants. This requirement stirred controversy when it was applied to the HPV vaccine in July 2008 due to the cost of the vaccine. In addition, the other thirteen required vaccines prevent highly contagious diseases communicable through the respiratory route, while HPV is spread only through sexual contact. In November 2009, this requirement was canceled.

Though the federal guidelines do not require written consent in order to receive a vaccination, they do require doctors give the recipients or legal representatives a Vaccine Information Statement (VIS). Specific informed consent laws are made by the states. Several states allow minors to legally consent to vaccination over parental objections under the mature minor doctrine. Socioeconomic disparities have been found to hinder reasonable access to vaccinations in the U.S., and it has also been found that even where such status is not a factor, "racial ethnic minority adults are less likely than whites to receive preventive care including vaccination".

According to 2024 CDC Morbidity and Mortality Weekly Report report, fewer children born during the first two years of the COVID-19 pandemic received recommended vaccines compared to those born in the two years prior. Vaccine coverage for children born in 2020 and 2021 dropped by 1.3 to 7.8 percentage points, depending on the vaccine, compared to those born in 2018 and 2019.

School children History of school vaccination requirements The United States has a long history of school vaccination requirements. The first school vaccination requirement was enacted in the 1850s in Massachusetts to prevent the spread of smallpox. The school vaccination requirement was put in place after compulsory school attendance law caused a rapid increase in the number of children in public schools, increasing the risk of smallpox outbreaks. The early movement towards school vaccination laws began at the local level including counties, cities, and boards of education. By 1827, Boston had become the first city to mandate that all children entering public schools show proof of vaccination. In addition, in 1855 the Commonwealth of Massachusetts had established its own statewide vaccination requirements for all students entering school, this influenced other states to implement similar statewide vaccination laws in schools as seen in New York in 1862, Connecticut in 1872, Pennsylvania in 1895, and later the Midwest, South, and Western US. By 1963, 20 states had school vaccination laws.

These vaccination laws resulted in political debates throughout the United States as those opposed to vaccination sought to repeal local policies and state laws. An example of this political controversy occurred in 1893 in Chicago, where less than ten percent of the children were vaccinated despite the twelve year old state law. Resistance was seen at the local level of the school district as some local school boards and superintendents opposed the state vaccination laws, leading the state board health inspectors to examine vaccination policies in schools. Resistance proceeded during the mid-1900s and in 1977, a nationwide Childhood Immunization Initiative was developed with the goal of increasing vaccination rates among children to 90% by 1979. During the 2-year period of observation, the initiative reviewed the immunization records of more than 28 million children and vaccinated children who hadn't received the recommended vaccines.

In 1922, the constitutionality of childhood vaccination was examined in the Supreme Court case Zucht v. King.260 U.S. 174 (1922). The court ruled that a school could deny admission to children who failed to provide a certification of vaccination for the protection of the public health. In 1987, a measles epidemic occurred in Maricopa County, Arizona, and another court case, Maricopa County Health Department vs. Harmon, examined the arguments of an individual's right to education over the states need to protect against the spread of disease. The court found it prudent to take action to combat the spread of disease by denying un-vaccinated children a place in school until the risk for the spread of measles had passed. The Supreme Court has not since decided a vaccination mandate case, but noted in a subsequent case, Prince v. Massachusetts,321 U.S. 158 (1944). that the state had power over certain activities of children, including requiring that they be vaccinated. The court in Prince said:

California Senate Bill 277 (2015)

Until 2015, all states except Mississippi and West Virginia allowed children to opt out of vaccination requirements for religious or philosophical reasons. However, this changed after California removed personal and religious exemptions with the passage of California Senate Bill 277. This is the first time an immunization exemption was removed by a state legislature. The bill was prompted by the 2014 Disneyland measles outbreak and low levels of vaccination in pockets of California, with some schools having vaccination rates below 60%. Despite the bill receiving support by the California Medical Association, as well as by the American Academy of Pediatrics' California affiliate, opposition to the bill had been characterized as "possibly the most strident outpouring of political dissent in recent memory."

California's abolition of all non-medical exemptions for school entrance was upheld by the courts in 2018; a California appellate court rejected a dissident group's claims that the mandatory-vaccination law violated the right to due process, right to privacy, right to a public education, and right to free exercise of religion under the California Constitution.