(Another) New ACIP Charter, More HHS Reshuffling, and a Major New Outbreak Exposing Global Vulnerabilities

Welcome to our biweekly series in partnership with CIDRAP at the University of Minnesota. 

This will be the first time since we started this series that we don’t have a major update on the American Academy of Pediatrics (AAP) v Kennedy case. In our last issue, we mentioned we didn’t expect much movement on the litigation front for a while. Over the past two weeks, there have been routine procedural activities (scheduling orders). Also, a joint status report is due tomorrow.

Summer is nearly here, and the rhythm of vaccine policy is shifting with the season. Most state legislative sessions have wrapped up or are about to, so the flood of bills we’ve been tracking is slowing to a trickle. That doesn’t mean things are quiet, though. Federal leadership keeps reshuffling, the Advisory Committee on Immunization Practices (ACIP) charter is back (again), and the global picture is anything but calm. Let’s discuss…

The PDF version of today’s update is here. Read past installments here and today’s update on the Unbiased Science Substack here.

Take 2 on the ACIP Charter (Sort Of…)

On April 6th, the Department of Health and Human Services (HHS) published a revised ACIP charter that rewrote eligibility requirements, added vaccine-skeptical liaison organizations, and expanded the committee’s scope of revisiting existing vaccine recommendations (we covered these changes in depth in our April issue). These changes became the subject of legal scrutiny right away, since Judge Brian Murphy’s March 16th stay in the AAP v. Kennedy litigation remains active.

HHS has formally re-established ACIP’s charter (again)—the April 6th Federal Register notice was withdrawn, and replaced with a new charter signed by HHS Secretary Robert F. Kennedy Jr. on May 19th. The revised charter removed some of the “controversial” language from the April iteration. It no longer explicitly calls out mRNA vaccines as a focus for vaccine safety reviews (which was arguably a challenge on COVID-19 vaccines in not-so-subtle disguise). It also removed the specific requirements for a toxicologist, data scientist, and other disciplines, replacing the text with something a bit more flexible in requiring “a balanced range of scientific, clinical, and public health expertise.”

The flexibility piece is significant. As law professor Dorit Reiss, who has closely tracked this litigation, notes, the new language acknowledges the court’s injunction and that previous ACIP members likely wouldn’t have met the requirements anyway. However, the new language also remains vague enough that it doesn’t explicitly prevent Kennedy from trying again with new appointments. Under the newest charter language, Kennedy retains ultimate authority over ACIP membership, and there is no language specifying how often the committee should convene.

Of note, the June 24-26 ACIP meeting is still listed on the Centers for Disease Control and Prevention (CDC) website, despite the stay, which prohibits the committee from taking action. We’re keeping a close eye on this to see whether the meeting will still happen and, if it does, what it would and could look like.

More Personnel Shakeups

If you’ve been following our HHS org chart, it’s time for another update.

Dr. Katherine Szarama served less than three weeks as the acting director of the Center for Biologics Evaluation and Research (CBER), the U.S. Food and Drug Administration (FDA) division that oversees vaccine approvals. She had stepped into the role on May 1st following Vinay Prasad’s March departure. Karim Mikhail, a former pharmaceutical executive who joined the FDA in 2025 as a senior adviser, will now take that role. 

Dr. Tracy Beth Høeg is out as acting director of the Center for Drug Evaluation and Research (CDER). Per the New York Times, she says she was fired on May 15th after refusing to resign, and that she doesn’t know who ordered her removal. Her departure came just days after FDA Commissioner Marty Makary resigned as part of a broader leadership shake-up at the agency. Høeg was a key figure in the administration’s effort to revisit the childhood vaccine schedule, an effort Judge Murphy later blocked. Dr. Michael Davis, CDER’s previous deputy director, will now serve as acting director in her stead. 

Acting head of the National Institute of Health (NIH)’s National Institute of Allergy and Infectious Diseases (NIAID), Dr.Jeffery Taubenberger, has stepped down after serving in the role since April 2025. The exact timing of or reasoning for his departure remains unclear.

Finally, while Nicole Saphier awaits Senate confirmation to become the next U.S. surgeon general, HHS has appointed Stephanie Haridopolos as the interim surgeon general. 

State Round-Up

Despite the wave of Make America Healthy Again (MAHA)-backed legislation this legislative session aimed at weakening school vaccine requirements, most of those bills failed to become law. Lobbying efforts from groups like the AAP and American Families for Vaccines helped reverse the course of several of these bills. Legislative sessions in Alaska, Arizona, Illinois, Louisiana, Minnesota, Missouri, Oklahoma, and South Carolina have all ended since our last issue (or will end this week).

On May 19th, Iowa Governor Kim Reynolds signed SF 304, which will limit teenagers from receiving the human papillomavirus (HPV) or hepatitis B vaccines without parental permission. The law will take effect on July 1st. 

In Illinois, SB 3487 would amend the Hospital Licensing Act and require hospitals to identify and offer eligible patients influenza and pneumococcal vaccines in accordance with ACIP and the state public health director. The bill passed the House last week but is still awaiting the governor’s signature.

West Virginia remains one of only a handful of states without a religious exemption for school vaccination, and that’s being challenged in court. For full details on the briefs filed by the families and the governor, see our last issue. Otherwise, we’ll keep an eye on this; the school board’s reply brief is due on June 1st.

Finally, the solicitor general weighed in on a case about New York healthcare workers who were fired for refusing the COVID-19 vaccine on religious grounds. The Department of Justice argued that the Supreme Court shouldn’t take the case, a move that drew sharp criticism from supporters of the Trump administration, such as Aaron Siri, who felt betrayed by the decision.

Global Round-Up

After early success in animal models, scientists in Chile were close to moving a vaccine for the Andes hantavirus (the one in the news right now following the MV Hondius outbreak) to human testing, but they ran out of money.

This week, Gavi, the Vaccine Alliance, provided HHS with a formal timeline to phase out thimerosal-containing vaccines. It’s important to note that this transition was already in the works for reasons unrelated to the Trump administration’s recent decision to freeze $600 million in congressionally appropriated funding to the organization. It is unclear whether Kennedy will release the funds in response to the timeline.

The Ebola outbreak in the Democratic Republic of the Congo and neighboring countries continues to grow. Experts are weighing in on whether to use the existing Ebola vaccine (Ervebo) as cases increase. The World Health Organization (WHO) says the vaccine, which is unlikely to provide much cross-protection against the Bundibugyo virus that’s causing the current Ebola outbreak, should be administered only under a research protocol. Meanwhile, two Bundibugyo virus-specific vaccines are being prioritized for development.

Originally posted to Unbiased Science’s Instagram page.

A new piece in The Atlantictakes a broader look at how U.S. funding cuts and political pressure are affecting global relationships with multilateral health bodies, and the long-term implications for global vaccine infrastructure. It’s well worth your read, but suffice to say the ripple effects of these cuts extend far beyond U.S. borders.

What Else We’re Watching

• COVID-19 Vaccine Formulation: The Vaccines and Related Biologic Products Advisory Committee (VRBPAC) meets today to recommend which variant(s) the fall COVID-19 vaccine should include. The committee is considering XFG, which differs from the WHO’s guidance earlier this month recommending LP.8.1. However, the FDA’s briefing document acknowledges that either variant could be appropriate, so we’ll report back next time.
• Retracted Studies: Two prominently circulating vaccine-skeptical papers have been formally retracted: “Hepatitis B Vaccination of Male Neonates and Autism Diagnosis, NHIS 1997–2002” and “Vaccines and sudden infant death: An analysis of the Vaccine Adverse Event Reporting System (VAERS) database 1990–2019 and review of the medical literature.” Both have been frequently cited to support claims about vaccine safety that lack scientific evidence or consensus.
• COVID-19 Vaccine Injuries: Children’s Health Defense is actively recruiting plaintiffs for a potential lawsuit over COVID-19 vaccine injuries in children. This comes on the heels of a new report from the FDA stating that no pediatric deaths were definitively tied to COVID-19 vaccines. No new adverse event data have been published to spark this latest lawsuit, but we’re flagging it because this type of lawsuit can generate a lot of hype and headlines that will carry more weight than the ultimate legal outcome, and we want to get ahead of that.
• Insurance Coverage for Vaccines: AHIP (formerly America’s Health Insurance Plans) issued a statement this week confirming that member plans will continue to cover ACIP-recommended vaccines without cost-sharing through the end of 2027. This covers all pre-2025 ACIP vaccine recommendations (these are the recommendations in place right now while the AAP v Kennedy litigation continues). 

With many state legislatures adjourning and the AAP v Kennedy litigation slowly moving in the background, head over to Unbiased Science’s Substack to share your thoughts on which vaccine policy topic to dig into next!

Stay Curious,

Unbiased Science