Analysis of the latest ACIP meeting at the CDC: Vaccines—and rigorous science—are increasingly under attack.
A close look at how the CDC’s vaccine advisory committee under RFK Jr. again changed high-stakes recommendations without solid evidence.
Friends, Yesterday and today, I watched many hours of the CDC’s meeting of the Advisory Committee on Immunization Practices (ACIP). In case you forgot, ACIP votes determine our national vaccine strategies. By law, vaccines recommended in its adopted resolutions must be covered by private insurance. (They also largely guide whether public programs will cover them.) Because the stakes are so high, Secretary Kennedy unilaterally fired every single expert on the committee this summer, replacing them with hand-picked replacements. Many of Secretary Kennedy’s new voting members understand neither the science nor the process by which this work is supposed to proceed—which I assume was the point.
Below are some thoughts from having jumped on the grenade to watch all of this for you. There are also incredibly good resources from The Evidence Collective, a group with which I am affiliated. They did a superb job covering FAQs from this meeting. If you’d like to read either the TEC “prebunk” (from before the meeting) or its debunk (from after), you can find those here:
Above all, thanks for caring about these issues! Please let me know if this was helpful. (I genuinely hope so, because many of these new voting members seem to be doing everything they can to break my brain.)
All right, let’s get to it…
The circus.
Neither folksy comments nor lip service to “respectful dialogues” render a circus into serious debate. The voting members are very proud of themselves for inviting dissenting viewpoints. The problem is that the debates we are now forced to endure are far closer to whether the Earth is round or flat than to genuinely contested areas of medical science. If it were the latter, I’d welcome it. Sadly, it is not.
Some lowlights…
Missing In Action: CDC experts.
No CDC scientist gave a presentation at the meeting. Some CDC subject matter experts were asked specific questions, and they performed well. But it is remarkable that CDC scientists have been sidelined by Secretary Kennedy’s incarnation of ACIP.
In Action: a slick lawyer ally of Secretary Kennedy.
Meanwhile, a lawyer who has made a living suing vaccine manufacturers lectured the committee for literal hours. I don’t know this definitively, but it certainly must have been the longest presentation any individual has ever given at an ACIP meeting. Unfortunately, it was full of mischaracterized data, often aimed at FDA approval of vaccines with well-established records of safety and effectiveness. While we’d expect this from RFK Jr. allies, what’s new is that someone like this was given an enormous platform to spread this garbage.
Of course, the large irony on “conflicts of interest” was not lost on observers with functioning brains. Secretary Kennedy fired all seventeen genuine experts from the committee this summer by claiming, despite evidence to the contrary, that the incumbent panelists had too many conflicts of interest. Now, the committee has to hear a lawyer who makes his living suing vaccine manufacturers pontificate for hours.
Aluminum-foil hat.
We heard two presentations that implied that aluminum exposure due to vaccines are problematic for kids. (Aluminum is added to stimulate immune responses from vaccines; the idea is that if we are going to vaccinate people, the shots should work.) That’s an anti-vaxxer talking point that has been roundly debunked, over and over. But Secretary Kennedy will not let it go (he had a public meltdown about a recent study that went against his beliefs) and I expect to see him weaponize terrible science on this to advance his anti-vaccine agenda, while ignoring mountains of high-quality data regarding their safety.
“Who am I? Why am I here?” The confusion would be funny, if it weren’t so serious.
Once again, the committee was plagued by procedural confusion. At times, the voting members did not know what was being voted on, nor the difference between the main vote and duplicate votes (that are legally necessary for the Vaccines For Children program). On a couple of occasions, the acting chair tried to duck out of responsibility by claiming that the committee does not make policy—that’s the CDC Director or HHS Secretary’s job! That was supremely disingenuous. The committee takes votes which the CDC Director (or Secretary) can either adopt or not. The added layer of review in the law was meant to protect the American public from rare instances when the leadership felt that the committee got something wrong and an intervention was needed. But make no mistake: ACIP makes national vaccine policy, unless higher-ups reject their recommendations—something which has happened, but infrequently. Meanwhile, that’s not true for the Vaccines For Children program. For that, the committee’s votes are binding, with or without the CDC Director’s or Secretary’s adoption. It would be nice if the voting members of the nation’s vaccine advisory committee knew the rules guiding their own work.
The votes. Bad news for children.
Let’s get to the votes—because this is where the national implications are.
VOTE 1
For infants born to HBsAg-negative women: ACIP recommends individual-based decision-making, in consultation with a health care provider, for parents deciding when or if to give the HBV vaccine, including the birth dose. Parents and health care providers should consider vaccine benefits, vaccine risks, and infection risks. For those not receiving the HBV birth dose, it is suggested that the initial dose is administered no earlier than 2 months of age.
VOTE 2
When evaluating the need for a subsequent HBV vaccine dose in children, parents should consult with health care providers to determine if a post-vaccination anti-HBs serology testing should be offered. Serology results should determine whether the established protective anti-HBs titer threshold of ≥10 mIU/mL has been achieved. The cost of this testing should be covered by insurance.
Both votes passed, although more narrowly than one might have expected. (It seems like a few of the new ACIP members are starting to realize that these votes are supposed to represent carefully vetted data. That led to some surprising “no” votes, but not enough to defeat the motions.)
Vote #1 analysis:
The fantasy is that infants of mothers who test negative for Hepatitis B do not need vaccination. Targeted approaches have been tried. They failed. A universal recommendation at birth, however, succeeded, leading to thousands of fewer cases. The problem is that not everyone gets tested. People without test results may think they are fine, but some are actually infected. Sometimes there are false negative results. Sometimes mothers (or other close-contacts of infants, such as family members) can accidentally transmit the virus to an infant, owing to exposure from cuts or insufficient hygiene. Depending on how common the virus is, an infant born to a mother who thinks that their infant won’t be exposed to the virus could be correct or could be tragically incorrect. The reason it matters is that the closer to birth you get (i.e., the younger the infant), the more likely that a Hepatitis B infection is to cause serious long-term effects—effects like liver disease, and eventually cancer or death.
All of this was justified on the grounds that there are “unknown harms” from the vaccine. Of course, decades of safety monitoring do not show that, but that didn’t stop RFK' Jr’s lackeys from invoking it as the reason to yank the CDC’s universal recommendation for a birth dose.
No good science was presented that justified the vote to remove the CDC’s prior universal birth dose recommendation. None. (RFK Jr.’s allies on the committee seem to conflate one mild side effect, fussiness, with another serious one, encephalitis. Reader, these are different. Meanwhile, randomized controlled trials show that the vaccines are safe and effective. Long-term surveillance ratifies that.
By the way, there are instances in which national de-escalation of a prior vaccine strategy might be warranted. We recently got new data showing that one dose of the HPV vaccine might be just as good as two. If that bears out, it could lead to an evidence-based change in our policies that would mean one less injection. Great!
But you don’t change vaccine recommendations that have likely saved thousands of lives in the US just because—and this is their literal justification—some advocacy groups are “concerned” about vaccine safety. You change this based on a rigorous assessment comparing benefits to risks. That did not happen at the CDC this week.
Make no mistake, this recommendation will decrease Hepatitis B vaccine uptake, which will lead to more infections, more disease, and eventually more death. The Trump administration owns this.
Vote #2 analysis:
There are two large problems with this vote. The first is purely procedural, as UC Law San Francisco’s Professor Dorit Reiss pointed out. ACIP does not have jurisdiction on questions related to antibody testing. ACIP makes recommendations about vaccine and immunization policy. So, the idea that parents should discuss whether multiple doses of the Hepatitis B vaccine series are really necessary based on antibody levels is out of left field. It’s like walking into an Arby’s and trying to order Chicken McNuggets or a Whopper. Wrong place.
Beyond that, though, the three-dose series was studied in clinical trials. The idea that a high-enough antibody level after one dose of the vaccine might negate the need for subsequent doses is a nice idea, but has not been verified as a safe and effective strategy. We can’t gamble on this. That’s what ACIP is now advocating, though.
So, even if ACIP was supposed to give a recommendation on whether Hepatitis B antibody levels should be used to guide an individually-tailored dose strategy, there’s absolutely no science to support it as a safe approach.
Actual experts are worried.
As above, genuine experts were excluded from the proceedings. Two experts I admire, Dr. Paul Offit and Dr. Peter Hotez, said publicly that they declined invitations to participate because to do so would be to lend credibility to the meeting. I’m of two minds here. Yes, I get their point. But, honestly, it would have been nice to hear some sanity in there.
Meanwhile, Dr. Debra Houry published a remarkable essay in Time entitled “I Left the CDC 100 Days Ago. My Worst Fears About the Agency Are Coming True.” The piece marks 100 days since her resignation as the Chief Medical Officer at the CDC.
Here are two excerpts, but I encourage you to read the entire piece.
“The December ACIP meeting this week hit an all-time low. The three presenters on the hepatitis B vaccine were not vaccine scientists, and two had authored a retracted paper about autism. Added to this, the Secretary’s ally, an anti-vaccine trial lawyer named Aaron Siri, who previously petitioned the FDA to revoke approval of the polio vaccine, was given a platform to present on the childhood vaccine schedule. We saw a preview of this in September, when the new ACIP focused on hypothetical risks of vaccines while minimizing established benefits and voted to narrow recommendations for the MMRV and COVID vaccines. The result has been less access to those vaccines for certain populations.”
….
“What we have witnessed at the CDC is not reform. It is the hollowing out of an institution Americans rely on in every emergency. The actions since late summer will leave the country less prepared for the next measles outbreak, foodborne illness cluster, maternal mortality crisis, or emerging pandemic. These changes are happening quietly, quickly, and with almost no oversight.”
—Dr. Debra Houry, MD, MPH.
That’s all for now. More soon from the frontlines of medicine and public health. Please share this work…or better yet…
If you have information about any of the unfolding stories we are following, please email me or find me on Signal at InsideMedicine.88.
Excellent follow-up to all the misinformation (or lies). Thanks. I would add that I like others, now refer to the Trump CDC or Trump FDA, or Trump Dept of Justice, etc. because that distinction is now really important in our dissemination of facts and information. This is not about politics or patisanship. This is about survival and the demise of our American Democracy and the solid institutions of Public Health and science we once could rely on.
I am so thankful for your experienced voice in all this chaos. I sometimes feel I’m living in a parallel universe with all the nonsense going on under RFK, JR’s direction. It is worse than I anticipated and the dismantling of our stellar public health system is a tragedy, at best. Thank you for keeping those of us who care about public health for everyone informed.