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A federal vaccine panel will meet this week for the second time since it was remade by Health and Human Services Secretary Robert F. Kennedy Jr.. Typically a routine affair to update vaccine schedules and issue new recommendations, the committee’s meeting this Thursday and Friday could be particularly consequential for U.S. immunization policy.
Known as the Advisory Committee on Immunization Practices, the panel will meet amid a leadership crisis at the Centers for Disease Control and Prevention and rising alarm among physicians that Kennedy will sharply curtail vaccine access.
Already, Kennedy has overhauled ACIP, firing the 17 prior members of the panel and appointing seven hand-selected advisers in their place. At their first meeting, in June, the new panelists questioned use of COVID-19 vaccines and voted to remove a controversial, but little-used, vaccine preservative from flu shots.
Kennedy’s actions have sparked backlash. The ousted ACIP members have called for creation of an alternative to their former committee, warning of damage to U.S. vaccine policy. Medical groups are pushing back against the CDC and setting their own childhood vaccine recommendations, as several states move forward with plans to decouple their vaccine guidance from the federal schedule. A number of Democratic lawmakers have now called for Kennedy’s resignation, as have hundreds of HHS staff.
Ahead of the meeting on Sept. 18 and 19, here’s what to know:
What’s on the agenda?
A draft agenda released Friday shows this week’s ACIP meeting will focus on vaccines for hepatitis B, COVID, and measles, mumps, rubella and varicella.
Details for each discussion indicate that committee members will hear about seizures following vaccination with the “MMRV” shot, and about use of the hepatitis B vaccine at birth. The panel will vote on recommendations for both immunizations.
All of Friday is set aside for discussion of COVID shots, which have become a flash point in Kennedy’s efforts to upend current vaccine policy. According to The Washington Post,the Trump Administration plans to link the deaths of 25 children to COVID vaccination, potentially as evidence supporting restrictions in access.
In recent statements, COVID vaccine manufacturers Moderna and Pfizer affirmed the safety of their shots. Moderna noted that it’s not aware of any deaths in the last year or new information from past years, while Pfizer detailed the comparative risk of heart inflammation called myocarditis related to its vaccine versus from other causes, like COVID disease itself.
ACIP agendas provide a framework for committee discussion. They reflect months of preparatory work by dozens of CDC staff and scientists, who sift through emerging epidemiological and clinical data to outline vaccine benefits, risks and use.
In the usual course of business, CDC staff, company representatives or other experts provide presentations on vaccines set for discussion.
So who’s on ACIP now?
In June, Kennedy replaced the 17 previously vetted and confirmed ACIP members with eight new advisers he chose, citing unsubstantiated conflicts of interest. One of the eight later decided against participating. Among the seven now serving are vaccine skeptics and physicians whose specialties are in fields other than immunology and epidemiology.
One, MIT business professor and mRNA vaccine critic Retsef Levi, was recently named to lead a revamped COVID working group and will lead several discussions Friday, per the draft agenda.
Ahead of this week’s meeting, Kennedy has apparently been pushing to add more panelists to the smaller-than-usual roster.
Physician Jeremy Faust, in his Substack publication Inside Medicine, reported Sept. 3 on seven potential new members, including individuals whose backgrounds are atypical for ACIP.
It’s not clear how those individuals were vetted, or whether they have even been officially nominated to the panel.
Last Tuesday, however, the Independent Medical Alliance, a nonprofit supporting Kennedy, congratulated senior fellow Kirk Milhoan for his appointment to ACIP. Milhoan is a pediatric cardiologist and pastor who founded a Christian medical mission organization in 2001.
State officials and legislators in Hawaii previously called for an investigation of Milhoan for spreading misinformation about using hydroxychloroquine and ivermectin to treat COVID. He has advocated against use of the COVID vaccines in children, citing cardiac safety concerns related to the shot that data show are very rare.
Milhoan’s biography on the Independent Medical Alliance’s website says he is “dedicated to treating patients affected by acute SARS-CoV-2 infections, Long Covid, and vaccine-related cardiovascular toxicity due to the spike protein.” Many vaccine skeptics and activists have focused on the coronavirus spike protein, which vaccines train the body’s immune system to recognize, but they argue is inherently toxic.
Hilary Blackburn, another individual reportedly under consideration for nomination to ACIP, is a pharmacist and director of medication access and affordability at Ascension, the Catholic health system, according to LinkedIn. She is also listed as the previous Director of Pharmaceutical Services and chief pharmacy officer at Dispensary of Hope, an organization that redistributes medications to low-income individuals.
Others on the reported list either have backgrounds outside of epidemiology, or have been critical of past vaccine policy.
Evelyn Griffin is an obstetrician-gynecologist based in Baton Rouge, Louisiana. According to STAT News, she has transitioned to “lifestyle and root-cause medicine,” and has publicly supported abortion restrictions in Louisiana.
Catherine Stein is an infectious disease epidemiology professor at Case Western Reserve University School of Medicine, whose research focuses on genetic and environmental susceptibility to tuberculosis. Stein called for an end to vaccine mandates at universities in 2022 and was a proponent of a bill that would prohibit vaccine mandates.
Raymond Pollak is a family medicine physician and transplant specialist based in Illinois. In 1999, Pollak served as a whistle-blower in a suit against the University of Illinois Hospital for allegedly admitting patients for liver transplants when they were not medically necessary.
John Gaitanis, a pediatric neurologist at Hasbro Children’s Hospital, told The Washington Post he declined to serve on the committee, while Joseph Fraiman, an emergency physician, told STAT he would not be a voting member.
What impact could ACIP’s recommendations have?
Committee votes to change vaccine recommendations could affect who is eligible to receive a shot, as well as whether insurance will provide coverage.
Public and private insurers are required to cover vaccines recommended by ACIP. Should the committee narrow or remove prior recommendations, insurers may choose to no longer provide coverage, even if other medical associations provide a differing recommendation.
Earlier this year, Kennedy said the COVID vaccine would no longer be recommended for healthy children and pregnant women. The Food and Drug Administration, meanwhile, approved COVID boosters only for adults aged 65 years and older or people with underlying health conditions that put them at higher risk of severe disease.
Several reports have highlighted the challenges people are now facing in their attempts to get a COVID vaccine, despite Kennedy and FDA commissioner Marty Makary saying otherwise.
Access to COVID shots could become even more difficult if the ACIP narrows its recommendation further.
Changes to recommendations for other vaccines could have a similar impact, and potentially affect the Vaccines for Children’s program, which provides vaccines at no cost to low-income families. The draft agenda sets out planned votes related to the program and shots for measles and hepatitis B.
Who will sign off on the recommendations?
Usually, the CDC director is responsible for signing off on ACIP’s recommendations. However, there is no confirmed director of the agency after Kennedy ousted the recently appointed Susan Monarez for allegedly not preapproving recommendations ahead of ACIP’s meeting. Monarez will testify in front of the Senate Health, Education, Labor, and Pensions committee Wednesday to discuss her dismissal.
Without a confirmed director, interim director Jim O’Neill could endorse ACIP’s guidelines. O’Neill, an ally of investor Peter Thiel, was named by Kennedy to serve on an acting basis after his confirmation by the Senate in June to another HHS post.
O’Neill criticized the CDC during the pandemic, but during his Senate hearing, he told lawmakers he is “pro-vaccine.”
How does ACIP’s votes affect states’ plans?
During Kennedy’s short time as HHS secretary, he has narrowed access to COVID shots and touted vaccine misinformation, while regularly criticizing the CDC as a corrupt agency in need of overhaul.
Kennedy’s attacks have given cover for actions elsewhere. Recently, the state of Florida announced it would remove vaccine mandates, including for school children. Florida is the first state to implement such a policy, but other states could follow.
West Virginia, which has strict vaccine mandates, is currently in a political battle over religious exemptions against vaccination. Republican Gov. Patrick Morrisey demanded exemptions for parents who cite religious beliefs, with Kennedy’s support.
“At [HHS] we will enforce conscience protections and defend every family’s right to make informed health decisions,” Kennedy wrote on X.
A handful of states have taken an oppositional approach, including Colorado, Illinois, Maryland, Massachusetts, Minnesota, New Jersey, New York, Pennsylvania and Virginia, which have filed bills or executive orders to ensure access to vaccines, regardless of what federal guidelines are adopted. Other states are standing firm on vaccine mandates, meanwhile.
However, earlier this month HHS said state awards of the Vaccines for Children Program “must respect state religious and conscience exemptions from vaccine mandates.”
