An update–with commentary–on developments in federal vaccine policy. Published on Dec. 9, 2025.

A list that ranks the most significant changes to vaccination policy, with brief commentary from the editors. 

Following a process without integrity or credibility, the reconstituted Advisory Committee on Immunization Practices (ACIP) made recommendations without integrity or credibility. The question remains how long the nation will stand for an upending of science-based policy on vaccination. – Eds.

New and updated 

1. The reconstituted Advisory Committee on Immunization Practices overturns long-standing Hepatitis B vaccination recommendations  

ACIP, consisting of members hand-picked by Secretary Kennedy, met on Dec. 4 and 5. The main focus of the meeting was the reversal of longstanding recommendations for the hepatitis B vaccine.

For several decades, medical organizations, including the American Academy of Pediatrics, have recommended that all infants receive the vaccine at birth and additional doses during their first year of life. Since the early 1990s, infant immunization has virtually eliminated hepatitis B transmission in the United States, and there are no credible studies indicating serious safety concerns with the vaccine.

The committee's process for undoing this recommendation was bizarre and highly irregular. For example:

• Despite being asked repeatedly by liaison members, the acting ACIP Chair, Dr. Robert Malone, could not explain why ACIP was re-evaluating the birth dose recommendation. 

• CDC experts were not permitted to make formal presentations.

• Two of the presenters, neither of whom is a medical doctor or an epidemiologist, are co-authors on a study that purported to model the cost of the rising prevalence of autism. The study was retracted due to questions about the methodology and undisclosed conflicts of interest. 

To replace a recommendation for universal vaccination, the committee voted to recommend that, in the case of a negative hepatitis B test during pregnancy, parents should talk with their provider about “when and if” their child will receive the vaccine. (Those whose mothers have a positive test or no test at all are still recommended to be vaccinated at birth.) Independent analyses have concluded that this will result in an increased number of children infected with hepatitis B because some children will get infected in the interim. In addition, some negative tests will be false negatives, providing additional avenues for infection. And omitting the first dose at birth is likely to lead to overall lower levels of completed vaccination. 

The committee also voted to recommend a blood test after the first vaccination to determine whether there has been an appropriate antibody response; there is no evidence for this approach, which will further confuse the immunization schedule, will result in improved health outcomes. Furthermore, while the committee recommended that this test should be covered by insurance, ACIP has no authority over insurance coverage of testing. 

Terrible process, unjustifiable outcome. Children who contract chronic hepatitis B infection – for whom there is no effective cure – will bear the consequences. – SD

2. Reconstituted ACIP lays groundwork for additional changes to the vaccine schedule 

Other presentations to ACIP from well-known anti-vaccine activists—including a trial lawyer, Aaron Siri,  who sues vaccine companies and was given the podium for 1.5 hours—indicated the committee’s interest in making other changes to its recommendations around childhood vaccines. Aaron Siri’s presentation was wide-ranging and included a history of the immunization schedule, allegations about vaccine safety and lack of adequate testing, and criticisms of the Vaccine Injury Compensation program. Additionally, President Trump issued a memorandum directing HHS to revisit the childhood vaccine schedule with an implicit goal of reducing the number of vaccinations that children receive. Sec. Kennedy responded, “We’re on it.” (Refresher: During his confirmation process, the Secretary assured Senator Cassidy that he would not alter the pediatric vaccination schedule.)

This meeting—and those to come—are causing tremendous confusion about whether vaccinating infants is a good idea in the first place. This overall undermining of vaccine confidence appears to be a goal of the new administration. – SD

3. FDA plans new regulatory requirements for vaccines 

In a bizarre email to CBER staff sent the Friday after Thanksgiving, CBER director Vinay Prasad outlined new regulatory requirements for vaccines, including not using antibody studies as a basis for approving seasonal vaccinations, a standard practice for decades. The memo did not provide a specific timeline for draft guidance or any other policy document that would provide clarity. Twelve former FDA commissioners or acting commissioners published a response in the New England Journal of Medicine criticizing the memo, saying that it would "undermine the public interest” and “upend core policies governing vaccine development and updates.” Prasad invited those who disagreed with him to resign.

The Prasad memo was score-settling, vindictive, and arbitrary—not dispassionate, transparent, or thoughtful. The American people deserve better. – JS

4. FDA memo alleges 10 deaths related to the Covid vaccine  

In the same email to staff, Prasad also stated that FDA career staff had determined that covid vaccines have killed at least 10 children. 

Senator Bill Cassidy posted on X, “FDA has not published any data around the alleged deaths or explained the process they took to verify it. I’ve asked FDA for a full briefing on this. The American people deserve clarity. Withholding this critical information is not radical transparency and will worsen confusion and fear among patients and parents.”

Keep an eye out for the actual analysis of adverse events authored by FDA career staff, should the agency release one. If it differs in any way from the categorical assertion of causality in the Prasad memo, FDA will have a lot of explaining to do. – JR

5. CDC announces new deputy director

Ralph Abraham, the former Louisiana surgeon general, has been named deputy director at CDC. Dr. Abraham was the health official who ordered the Louisiana Health Department to stop vaccine promotion during the respiratory virus season, among other reasons because of his belief in the need to move away from a “one-size-fits-all” approach to medicine and that there are some vaccines that are “good for no one.” He also faced criticism for waiting for weeks before notifying the public of two infant deaths from pertussis. CDC currently has no permanent director.

After multiple appointments noted here, here, and here, it is clear that anti-vaccine sentiments are a job qualification for senior positions at HHS. – PL

6. CDC announces a new chair of ACIP

HHS announced that ACIP chair Dr. Martin Kuldorff was joining the Office of the Assistant Secretary for Planning and Evaluation as its Chief Science Officer. Dr. Kirk Milhoan, a pediatric cardiologist, will be the new ACIP chair. Dr. Milhoan, who missed much of the meeting due to travel, has falsely claimed that Covid vaccines cause cancer and miscarriages. 

Another example of how the promotion of anti-vaccine positions can lead to a leadership role at HHS.  – JR

Ongoing

1. Potential changes to the Vaccine Injury Compensation Program

Secretary Kennedy posted on X on Jul. 28 that he is working with the Attorney General to “fix” the Vaccine Injury Compensation Program (VICP), a longstanding effort that provides limited liability for vaccine manufacturers and administrators, thus reducing market barriers, as well as compensation for people who have been injured by vaccines.

He followed the post with an interview with Charlie Kirk, former Executive Director of Turning Point USA, but failed to articulate any concrete steps he and HHS are taking to address the issues he identified. This is on the heels of Sec. Kennedy bringing Drew Downing, a lawyer with experience suing vaccine manufacturers, into HHS to work on the VICP. HHS has never stated specifically what Downing was brought on to accomplish. It is clear that Sec. Kennedy does have levers with regard to liability exposure that could indeed impede access to vaccines.

(No change from the previous update.)

Changes to the VICP have the potential to dramatically reduce access to vaccines. This will remain on the list until we know more. – JR

2. HHS mismanages the measles response in the Southwest

As of Nov.18, there have been 1,753 confirmed cases of the disease, including 211 hospitalizations and three deaths; this is the largest number of cases in a single year in the US in 33 years. Growing numbers of cases in Utah and Arizona are cause for concern. 

The outbreak in West Texas has ended in part because the virus sickened so many people it ran out of susceptible people to infect. The number of communities where people are undervaccinated has grown, meaning there are increasing pockets of susceptibility to additional outbreaks of measles. 

During the response to the West Texas outbreak, Sec. Kennedy made a number of misstatements about the safety of the measles vaccine, endorsing unproven treatments, and preventing experts from briefing the public. HHS also cut grant funds for the states' measles responses.

In early November, Canada lost its measles-free status, and experts are concerned the US could be next. 

(No change from the previous update.)

This year we have seen three measles-related deaths, including two in children. The combination of reduced support for immunization efforts, false information about vaccines coming out of HHS leadership, and a growing number of under-vaccinated communities means that the risk of additional measles outbreaks this year is actually going up, not down. This item will stay on our list until the outbreak ends or the US loses its measles-free status. – SD

3. HHS moves $500 million to study older vaccine technology favored by two appointees

As noted in the New and Updated item 1 above, HHS has permanently pulled $500 million from contracts for next-generation vaccines and is using the funds to study a type of “whole-virus" vaccine technology championed by two political appointees. “Whole-virus” vaccines are 70 years old and thought by many scientists to be less effective and cause more adverse effects than newer technologies. 

(No change from the previous update.)

This item, described in more detail in previous updates of the Straight Shot, will stay on our list until we learn more about this enormous investment of federal resources. – JS

4. HHS and autism

On Apr. 10, Sec. Kennedy announced in a cabinet meeting that HHS has launched an effort to understand the causes of autism, with results expected in September. He has since amended that timeline, saying that there will be some information in September and “more definitive” information coming six months after that. On May 7, CMS and NIH announced that they will be sharing data in order to investigate the causes of autism. We're watching whether this effort will proceed in a scientifically rigorous manner, including whether it will attempt to point to vaccines as the cause of autism. 

Autism also came up at the press conference on Sep. 22. President Trump insinuated a link between autism and vaccines, saying, “And by the way, I think I can say that there are certain groups of people that don't take vaccines and don't take any pills that have no autism. That have no autism. Does that tell you something?”

The recent change to the CDC website on autism and vaccines (#1 in New and Updated above) now cites the ongoing autism work at HHS, suggesting that there is anticipation that the project will implicate vaccines.

We’ll keep this issue on the list as this project progresses – PL

5. New ACIP working group to target vaccine schedule 

On Oct. 8, the CDC posted the terms of reference for a new Child and Adolescent Immunization Schedule Workgroup as part of its ACIP. 

The workgroup will be evaluating a number of issues including timing and order of immunization and co-administration of vaccinations. The workgroup will also be examining the use of certain vaccine ingredients, including aluminum, which is used as an FDA-approved adjuvant (a compound that enhances immune responses) in a number of childhood vaccines, including vaccines DTaP, Hepatitis A and B, pneumococcus, and meningococcus. There are presently no alternatives to these formulations, so a restriction on them could produce shortages. 

In an interview, ACIP chair Robert Malone confirmed that the workgroup was planning to investigate aluminum. (See the Aug. 7 issue of The Straight Shot for an item on Sec. Kennedy challenging the validity of a study that found no association between aluminum and various neurodevelopmental conditions.)

See additional discussion on this in #2 (New and updated) above. 

It certainly sounds like the fix may be in for this Workgroup. The only question is how wide-ranging these changes will be in affecting access. We will keep this on the list until the workgroup reports out. – SD

6. Sec. Kennedy directs CDC to change its website on vaccines and autism

At the direction of Sec. Kennedy, CDC’s website on "autism and vaccines" was remade. The site now states that “The claim ‘vaccines do not cause autism’ is not an evidence-based claim because studies have not ruled out the possibility that infant vaccines cause autism.” The page then asserts that health agencies have not considered data suggesting vaccines might cause autism and selectively quotes from multiple reports without explaining their central finding that evidence does not support the claim that vaccines cause autism. 

The webpage includes a header that states that “Vaccines Do Not Cause Autism,” but an asterisk states that this header remains only because of an agreement that Sec. Kennedy made with Sen. Cassidy before Kennedy’s confirmation. 

In response to the changes to the website, the American Academy of Pediatrics, the American Academy of Family Physicians, and the American Medical Association joined with several dozen other medical and autism-related groups to object to the changes, stating that "Rather than devoting needed resources right now to support people with autism and their families in every community, our taxpayer-funded health agencies are using public resources to spread harmful rumors."

The CDC has long been a trusted source for information on a broad range of public health topics, including vaccines. Political interference with these communications undermines this trust. That such interference would take the form of a confusing set of messages about vaccine safety is likely to cause misunderstanding and harm. We will keep this item until the website is returned to credibility – Eds.

Archived this week

1. CDC posts agenda for December ACIP meeting 

We’ve previously covered the drama and chaos at the September meeting of the ACIP. A draft agenda has now been posted for the next ACIP meeting, scheduled for Dec. 4-5. 

Particular topics of note include: 

• Vaccine adjuvants (such as aluminum), which are used to stimulate an immune response. These well-studied and long-used components of several vaccines have come under fire from Sec. Kennedy and President Trump. As we’ve discussed before, their removal could significantly restrict access to vaccines in the United States because developing alternative vaccines that do not use aluminum would be an exceedingly expensive and lengthy endeavor.
• Birth dose of Hepatitis B vaccine. Somewhat unexpectedly, ACIP did not hold a vote on this topic at its last meeting. Anti-vaccine activists have sought to remove the birth dose of hepatitis B from the vaccine schedule, which would likely be a major setback in efforts to control the disease in the US because transmission from mother to infant during or shortly after birth is a common means of transmission. 

What is most remarkable about this agenda is what is not included. The US is grappling with deadly outbreaks of pertussis and measles and facing a potentially very challenging flu season, and yet, unlike in the past, when CDC staff routinely presented to the committee about ongoing outbreaks, ACIP members will not be hearing any real-world data about these infectious disease threats. – SD

2. HHS censors information about vaccinations from the Indian Health Service (IHS)

IHS leadership has flagged words including “vaccines” and “immunizations” as “risky,” requiring additional scrutiny in public-facing social media communications. These communications regarding vaccines have changed substantially over the last year. IHS has posted far fewer vaccine-related posts on Facebook this year as compared to last year. And the posts emphasize that immunization is a personal choice, de-emphasizing the health benefits of vaccination. 

What is happening at IHS is part of a broader shift in HHS communications relating to vaccines. For example, HHS shelved the CDC's campaign explaining that influenza vaccination changes illness from "wild to mild." This shift away from emphasizing the benefits of vaccination will discourage people from getting vaccines. – JR

3. Two recent FDA appointees upend vaccine safety 

After interviewing more than 20 current and former FDA staff, Stat Newsreported that Tracy Beth Hoeg, a Special Assistant to the Commissioner and Senior Clinical Science Advisor, and Vinay Prasad, FDA’s Senior Medical and Scientific Officer and Director or the Center for Biologics Evaluation and Research, are "quietly upending vaccine regulations," sidelining career scientists and working directly with contractors. Despite administration commitments to transparency, Stat reported that they have refused to let FDA scientists publish reviews of COVID-19 vaccine safety. One of these reviews, available on a preprint server, reviewed the experience of more than 7.5 million Medicare enrollees over age 65 who were vaccinated in 2023-2025. It found "no new safety signals" in this population. 

Other articles have flagged ongoing debates and disagreements between Secretary Kennedy and FDA Commissioner Makary over vaccine safety studies, which further indicates the turmoil at the agency. 

This administration has claimed to support "gold standard science" that is transparent, open to discussion, and tolerant of diverse viewpoints. The FDA's sidelining and silencing of vaccine safety scientists flatly contradicts these assurances. FDA has yet to discuss changes to vaccine safety processes and policies with its expert advisory committee. – JS