How government agencies influence vaccine policy
Fact checked by Derick Wilder
Although local health departments set vaccine requirements and schedules, the federal government plays a significant role in vaccine development, approval, and distribution. With Robert F. Kennedy, Jr. as secretary of the U.S. Department of Health and Human Services (HHS), that process may change.
Kennedy has been openly critical of vaccine mandates and vaccines, erroneously linking them to autism. “Kennedy is coming in hostile to science,” said Paul Offit, MD, a pediatrician at Children’s Hospital of Philadelphia and an expert on vaccines and immunology, in a December 2024 webinar for the Association of Health Care Journalists.
The Federal Advisory Committees Act requires transparency among the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) vaccination committees. Yet, Offit said, “Kennedy will constantly ask for transparency. He thinks things are being hidden. He is wrong.”
Within his first weeks as secretary, Kennedy canceled the Vaccines and Related Biological Products Advisory Committee (VRBPAC), which was supposed to meet in March to discuss flu strains for next season’s flu vaccine development. Officials notified meeting participants via email at the end of February, with no explanation for the cancellation, Offit reported to NBC News.
When the meeting was canceled, this season’s flu strains had killed 19,000 adults in the U.S. since October.
Who dictates vaccine policy?
Vaccine policy starts at the federal level in the U.S.
First, vaccines require approval from the FDA before the public can access them. Typically, the vaccine approval process is lengthy — 5 to 10 years on average, or longer — and involves three phases of clinical trials to assess whether the vaccine is safe and works well.
Phase I trials involve 20 to 100 healthy volunteers. Researchers are asking:
• Does this vaccine work?
• Are there any serious side effects?
• How is the size of the dose related to side effects?
Phase II continues to assess safety and immune response as well as side effects in several hundred volunteers.
Phase III clinical trials involve thousands of volunteers and are intended to assess safety and efficacy, identify common side effects, and compare outcomes in those who received the vaccine and those who received a placebo. The FDA can provide emergency use authorization, as happened during the Covid-19 pandemic, to bring needed vaccines to the public faster in emergency situations.
The VRBPAC also oversees the FDA’s research on vaccines and related biological products program, making recommendations to its commissioner. Only safe and effective vaccines whose benefits outweigh the risks receive a license, Offit, who is also a voting member on the VRBPAC, said in the healthcare journalists webinar.
Once a vaccine makes it through the FDA’s process, the CDC recommends when and how to use it via another committee, the Advisory Committee on Immunization Practices, or ACIP. This committee develops recommendations on the use of vaccines for Americans, and the CDC updates those recommendations in the immunization schedules for adults and children. These schedules are then distributed to medical practices throughout the country.
The main documents that dictate how the FDA’s committee on vaccines and the CDC’s immunization committees function must be renewed every two years. Part of the HHS secretary’s role is to renew those charters or opt to let the committees disband or lapse.
Illinois’ take on vaccines
In Illinois, with guidance from ACIP, the Illinois Department of Public Health (IDPH), works with local health departments throughout the state, deciding which vaccines are required and when. Vaccine mandates are mainly for children, though during the Covid-19 pandemic, many employers made Covid-19 vaccination mandatory for employment. The governor also issued an executive order requiring vaccinations for individuals working in settings with vulnerable populations, such as schools and hospitals.
Illinois’ State Administrative Code spells out rules for children’s health exams and vaccinations. To change the vaccine requirements in Illinois would require a recommendation by the State Board of Health, public hearings, and ultimately a change in the Administrative Code. Requirements last changed in 2017.
For example, Illinois doesn’t require many commonly administered vaccines for school attendance, including hepatitis A, flu, or Covid-19. Illinois law includes exemptions from school vaccination requirements for religious and medical reasons.
For Rachel Goodman, MD, a pediatrician with Pediatrust Elm Street Pediatrics in Winnetka, vaccines are a complicated topic. They’re expensive, though most patients never experience that side of them, she says.
The Vaccines for Children program, which is federally funded and state administered, automatically covers all vaccines that the CDC recommends for children under 18. The Affordable Care Act mandated that health plans cover these vaccines at no cost.
Goodman says she and her partners prioritize keeping kids up to date on their vaccines. “But we don’t want to offer something not covered. We have to balance innovation with what’s reimbursed. We don’t want patients to feel the burden of cost,” she says.
Opinions vs. reality
Hannah Van Gorp, of Chicago, has a toddler and an infant. “Recently our 2-month-old contracted RSV. Thankfully, I had received the RSV booster between 32 and 36 weeks of my pregnancy on the recommendation of my obstetrician,” she says. “My pediatrician said that my son’s case could have been a lot worse had I not been vaccinated.”
The RSV vaccine is now available for infants at 2 months, but Van Gorp’s son was too young when it came out.
While Van Gorp remains in the pro-vaccine majority, vaccination rates among children are declining, fueled by misinformation. And public opinion on vaccine requirements has been increasingly partisan, according to the nonprofit health research group KFF.
Those decisions are changing disease maps in the U.S. The World Health Organization declared measles eliminated from the U.S. in 2000. Now, though, Texas, New Mexico, and other states are battling outbreaks of the highly contagious, airborne virus. As of March, one child had died in Texas and 32 had been hospitalized.
The infection causes fever, cough, rash, and red eyes. Severe cases can lead to pneumonia, blindness, brain swelling, and death.
Van Gorp says she’s seen partisan discussions play out on social media and is fascinated when acquaintances openly discuss avoiding vaccinations for their children on social media. “I read that someone is saved every 10 seconds by vaccines. I’m fully trusting of what my pediatrician or OB-GYN recommends,” she says.
When politics outweigh science, there’s more than elections at risk. Human lives fall into jeopardy, too. According to the CDC, vaccinations during childhood prevent about 4 million deaths worldwide every year. This includes the prevention of more than 1 million deaths among children in the U.S. born in the past 30 years — one of public health’s most successful accomplishments.
Originally published in the Spring/Summer 2025 print issue.
Judith A. Weinstein, MPH, is a Chicago-based freelance writer and public health practitioner. She has been writing since she could hold a pen.
