Just Monday, CDC Acting Director Jim O’Neill approved the recommendations made over two weeks earlier by the Advisory Committee on Immunization Practices (ACIP). This in itself is extraordinary, since ACIP recommendations are usually approved by the CDC Director within 24-48 hours, giving them teeth. These, you probably remember, are the same ACIP recommendations that purportedly led to the firing of Susan Monarez from the CDC Directorship, because she wasn’t willing to give RFK Jr. a blanket commitment to rubber stamp whatever he managed to get ACIP to recommend. Jim O’Neill did approve them, but he took awhile to do it, which was a bit mystifying.
What were these recommendations, anyway, and why was it so contentious?
Well first, if you’re reading this update I’m pretty sure you already know that before the ACIP met in June, RFK Jr. summarily fired all its members and began installing his own hand-picks who largely agreed with his perspectives on vaccines. But this time around it got a lot more wild.
The new ACIP crew
Just days ahead of the meeting, RFK Jr. added five new members to ACIP, bringing the numbers up to 12. (For context, he fired 17 people in June and added only eight before the prior meeting, one of which withdrew at the last minute over conflict of interest.) Who did he add?
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Kirk Milhoan, a pediatric cardiologist. In the HHS press release they noted he “holds a PhD in the mechanisms of myocardial inflammation,” which, well, isn’t a thing. His PhD was actually in Physiology and Pharmacology (though he did study myocardial inflammation), so the fact that HHS would frame it that way pretty much shows their cards with this appointment. He authored two papers on the COVID vaccine, one of which called for pulling the mRNA vaccines from the market due to claims that they cause more cases of myocarditis than COVID-19 infection itself, which is not aligned with a large amount of other evidence, including CDC’s own tweet from 2023 (the page the tweet links to has since been updated to reframe, but here is an archived version from 2023). He is also in trouble with the Hawaii Medical Board for pushing hydroxychloroquine and ivermectin as COVID treatments after health officials had already advised against them.
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Catherine Stein, an infectious disease epidemiologist. She’s a PhD scientist with a focus on TB (a disease for which there is no routinely used vaccine in the US). At least she is an epidemiologist with a lot of publications relevant to the things the ACIP discusses. Notably, she’s given testimony supporting a bill in Ohio that would prohibit vaccine mandates, railing against Ohio’s use of mask mandates and various closures early in the pandemic.
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Hillary Blackburn, a pharmacist without any apparent expertise or knowledge about vaccines.
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Evelyn Griffin, an OB-GYN who now works in “lifestyle and root-cause medicine.” She also doesn’t seem to have any expertise related to vaccines.
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Raymond Pollack, a physician with expertise in transplant biology, but again no evident vaccine-related expertise.
And let’s not start sleeping on existing ACIP member Robert Malone, who took to X after former CDC Director Monarez’s Senate testimony, suggesting she was lying with, ”The CIA trains people how to lie and manipulate others. That is a fact. Has she been trained to lie by our intelligence community?” He’s also written a book (which RFK Jr. endorsed, right above Tucker Carlson) where he alleged that the Department of Defense, the FBI, and the CIA work with a “censorship industrial complex” to give the government “reality-bending information control capabilities.”
These are the best and the most qualified people RFK Jr. was able to find to be on his ACIP. Good thing we got rid of all those experts to avoid conflict of interest.
2 days of wild times
So what happens when you have a bunch of people who don’t seem very qualified, and aren’t very familiar with either the content or the process of the Big Important Meeting they’ve been selected to participate in? If you guessed that chaos ensues, gold star for you!
If you don’t know, the usual process for ACIP is to announce what will be on the agenda weeks (sometimes months) before a meeting, then assign working groups for each of the relevant issues, staffing those working groups with CDC scientists who have expertise in these areas, and having them carefully study the available research and make well-vetted presentations to the full committee to help inform their discussions and ultimate votes. If the ACIP members don’t fully understand the science and feel confident in their ability to make a science-based decision that will benefit the health of the vast majority of Americans, they (used to) delay the vote and decide to study and deliberate more first. Since, you know, these decisions have a huge impact on Americans’ ability to access certain vaccines. Protecting their health and safety is paramount, and these questions are often very difficult, with many factors to balance.
But instead of that, this time scientists from CDC’s vaccine center were “completely shut out” of the preparations. The specific resolutions that would be debated were not posted in advance of the meeting, and presentations—not delivered by CDC scientists—included papers that had not gone through peer review and not been vetted to ensure they were scientifically sound and based on actual evidence.
At the end of day one, the panel was preparing to vote on a resolution related to the use of the MMRV (measles, mumps, rubella, and varicella combination) vaccine for children under 4. The wording and meaning of the resolution were unclear to the members. At one point new ACIP member Hillary Blackburn asked whether the voting language could be amended. But then someone pointed out that the amendment she was requesting would make the new recommendation the exact same as the existing recommendation—and since a “yes” vote on the new recommendation was designed to overturn the existing recommendation, that meant they should leave the wording as-is and she should just vote “no.” (She did vote no, but was only one of 3 no votes. The resolution passed 8-3, restricting use of the MMRV vaccine for children under 4.)
But then there was a new resolution, to decide whether to include the MMRV vaccine in the Vaccines for Children (VFC) program. Obviously it would be bizarre to say the vaccine shouldn’t be available to kids under 4 (as the prior vote did) and then say it should be included in the VFC program, obligating that program to cover the cost of the MMRV vaccine for kids under 4. But this was the vote. At one point, ACIP member Cody Meissner admitted he didn’t understand what they were being asked to vote for, and what a yes vs. no vote even meant on the issue. Others seemed to agree; they were also confused. Chair Martin Kulldorff then tried to explain the difference between a yes or no vote. Apparently it wasn’t enough, because the committee indeed voted 8-1 (with three abstaining because they were so confused) that yes, the VFC program should cover the MMRV vaccine for children under 4. Despite voting that those same children shouldn’t be given that same vaccine, just moments ago. As soon as the vote finished, one of the members was caught on a hot mic saying he didn’t know what he had just voted for. That’s always a comforting sign.
When Chair Kulldorff opened day 2 of the meeting the next morning, he noted “We are rookies” (no kidding) and then they had a re-vote of the VFC MMRV vote from the day before, to clear up the conflict. He blamed it on the fact that this was the first or second ACIP meeting ever for all but one member. (Cody Meissner was an ACIP member from 2008-2012 before his recent re-appointment.) But let’s be clear. It’s not because this was their first meeting. It’s because this meeting was rushed, convoluted, and not properly prepared, which had never been a problem before RFK Jr. took over and molded it exactly to his vision.
Oh, and on Friday morning, another hot mic caught somebody saying “you’re an idiot” while a fellow ACIP member, Retsef Levi, was speaking. Good times.
The recommendations and what they mean for you
Confused about what happened in the end and how it will affect you? You wouldn’t be alone in that. I would sum it up quickly as “it’s not as bad as many of us feared.”
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MMRV: The shot that combines measles, mumps, rubella, and varicella (chicken pox) vaccination is no longer recommended to be given to children under 4 years of age (the first vaccine in the series, usually given around 12 months) and it will no longer be paid for by government insurance. In the end, this doesn’t amount to much of a change. There has been a known (very small, but noticeable) increased risk of febrile seizures for young children receiving this combination vaccine compared with those receiving the MMR and varicella vaccines separately (note: the risk of febrile seizure from the MMR vaccine itself is 0.03% during the first dose; with the MMRV vaccine it is 0.04%. This is compared to a risk of 2-5% for viral infections that the vaccines are intended to present…so in any case it’s much better to take the risk from the vaccine than from being unvaccinated and potentially getting the live virus). As a result of this increased risk, for a long time the CDC has recommended that separate vaccines be used for this first dose. (The increased risk disappears by the second dose, given age 4-6.) The change now is that sometimes pediatricians and parents would discuss and decide that fewer visits to the doctor (for example for people with poor healthcare coverage, or who live very far away from a pediatrician) or fewer injections into their kid were worth the very small increased risk of seizures, and just do the single shot. With this recommendation, that choice has been removed.
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Hepatitis B: On the first day of the meeting they delayed the expected vote to the next day, because they ran out of time. Then on the second day, they didn’t have the vote, in part because there was so much disagreement among members. What does this mean? No changes for now. What were they debating? Moving the first dose of the hepatitis B vaccine from birth to 30 days old. Maybe you take your medical advice from Trump, and therefore you believe that hepatitis B is sexually transmitted and “there’s no reason” to give a newborn baby hepatitis B [vaccine]. PLEASE DO NOT TAKE MEDICAL ADVICE FROM DONALD TRUMP. HE DOESN’T KNOW WHAT HE’S TALKING ABOUT. The reality is that there is a LOT of reason to give a newborn baby the hepatitis B vaccine while they’re still in the hospital.
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First, it’s not (only) sexually transmitted. Up to 60% of people in the US are unaware they have hepatitis B, and the virus spreads very easily through tiny amounts of blood, even blood that is dried and not visible by the human eye. This means that babies can easily contract hepatitis B from a family member who doesn’t even know they have it. The universal birth dose of this vaccine was recommended in 1991. Before that time, about 18,000 children under the age of 10 in the US were infected with hepatitis B every year, and half of those were infected at birth. Today there are fewer than 20 cases reported to CDC each year. Twenty! Do we really want to go back to those 1980s statistics?
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Second, 9 in 10 infants who get hepatitis B become chronically infected (compared to 1 in 10 adults)—this means they don’t clear the infection and it sticks around, causing problems for their liver. About 25% of children who are chronically infected eventually die from liver disease as a result of their hepatitis B, which still has no cure. That’s 1 in 4 chronically infected kids! So unlike what Trump suggests, it’s very important to vaccine kids against this disease when they’re still very young.
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Third, nearly every newborn in the US is in a hospital when they’re born. If that’s where these vaccines are universally administered, almost every infant will receive this protection. But about one third of infants in the US miss their one-month check-up (the pediatrician visit to which the ACIP was considering moving the recommended first dose). That’s one third of infants who would go unprotected, and may not end up vaccinated until much later—maybe too late.
For now, those newborns will keep benefitting from hepatitis B vaccination while they’re still receiving care in the hospital. But part of the decision to postpone the vote was that some members thought delaying the first dose to 30 days of age wasn’t enough of a delay. So we’ll see what happens from here.
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COVID-19: ACIP came extremely close to recommending that people must have a prescription to receive the COVID-19 vaccine, which would have severely limited access. This is what many (including me) thought would happen. Instead, they had a 6-6 deadlock, broken by Chair Kulldorff’s “no” vote to break the tie, and our access was maintained. The new recommendation is that the vaccine is still recommended for everyone over 6 months, but the decision should be made by a patient in partnership with their clinician. Interestingly, this goes further than the recent FDA licensing (only people age 65+ years or those at high risk), which means the CDC is recommending “off-label” use for a lot of people. The ACIP discussion surrounding this vote was bonkers, and by that I mostly mean not grounded in science. The team at Your Local Epidemiologist tallied more than 50 falsehoods spread during that debate. Regardless, the members voted in a way that means your health insurance should still pay for a COVID-19 vaccine, if you want to get one. Whether your insurance is Medicaid, CHIP, Medicare, or a private insurance plan, it should be no cost to you. (The one exception may be people who have employer plans that are self-insured and covered by ERISA, which can’t be forced to follow these guidelines.) In all 50 states, you should be able to get a COVID-19 vaccine from a pharmacist. BUT, because COVID-19 vaccines may be off-label for you (given the FDA license), in many states you may still need a prescription. As of two weeks ago, that included Utah, Nevada, West Virginia, Louisiana, Georgia, and Florida. But a lot of states are taking steps to protect access.
OK, well now you’re caught up on ACIP and the state of vaccines. At least for now. We’re still on a wild ride!