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We acknowledge the recommendation of the new ACIP. We now await the decision by the CDC on the path forward. We will have sufficient supply of Sanofi flu vaccine to support customer preference for this season.
08:07:11 LEVI: I think there’s a consensus that RSV is a serious illness that poses risks to babies, especially young babies, in their early stages of life, and particularly to vulnerable babies that have either some comorbidities and underlying conditions, or early preterm birth.
So, I think that we are all hopeful that these therapies are going to allow us to provide them better care and hopefully prevent serious hospitalizations and deaths.
That said, I think that we now have two products, one that is already approved, and one that we are about to approve, and I took the opportunity to look through what the clinical trials that were conducted on all of these products suggest, and I would like to share what I– share data that I found, and would be very happy to hear the reactions of our colleagues at the CDC, about what do they make out of that data in terms of safety concerns.
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08:13:17 LEVI: I would like to hear maybe from our colleagues at the CDC. Should we not be concerned that maybe there are some safety– potential safety signals?
Now, these are small numbers, so clearly you cannot establish a safety signal based on that, but should we be concerned? And when I consider the post-marketing analysis we’ve seen yesterday, which was, by the way, well done, very, very nice analysis, but focused on very specific adverse events and on a very short period of time after the immunization, and does not consider death.
So, I just I want to ask both my colleagues in the committee, but also the CDC colleagues here, should we, perhaps, be concerned that there are, side-by-side to the benefits, alongside the benefits, we also have some things that we should be concerned about.
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08:19:59 AMY (UNCLEAR), FDA: We did review all of these narratives very carefully, and we did not observe any trends or clusterings in causes of death, and nothing that seemed suggestive of a drug-related cause of death in any of these cases.
And similarly, as has been pointed out, this is a monoclonal antibody. And generally, this class is well-tolerated with limited toxicity.
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08:20:37 LEVI: I think I acknowledge the two-to-one ratio of the trials.
But I think that one trend I would like to ask you about is that you have here four trials, in all of them, the numbers of the deaths are going in one direction, so wouldn’t that be some kind of a trend that we need to think about?
Because I understand also, and I think we agreed, these trials are very small, they are not powered to actually detect a lot of signals, unless they are very, very strong.
But when you look on 4 different trials. And you see the same patterns, or similar patterns, weren’t you– doesn’t need to tell us something of two very similar products, right? So I’m just curious to hear your thoughts about this.
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08:21:48 AMY (UNCLEAR), FDA: Yes, it does. The numerical numbers go the wrong direction in these studies.
But if you look at the percentages here, I mean, it’s .3 versus 0.2%. I mean, we would not consider that to really be a difference in the death rate between the two arms. These are very small numbers, and so we did not find that to be any sort of meaningful trend or difference between arms.
And again, we put a lot of weight in our review of the narratives for these cases, and looking at potential biological plausibility in terms of the causes of death, and the receipt of clesrovimab.
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08:26:53 MEISSNER: These are all issues that were extensively discussed in our work group, which included over 60 members.
We went through the details very, very carefully. And, I think I appreciate Dr. Retsef’s careful review of the records. But the work group is comfortable with the results from the different clesrovimab trials.
I will say that– I will say that studies in high-risk infants, including preterm infants. That’s a very fragile group, and unexpected deaths unfortunately occur in both groups.
I don’t believe there was any evidence, as has been stated, that there was an imbalance or any pattern associated with adverse events, serious adverse events among the clesrovimab recipients.
I think that the work group was very comfortable making the recommendation that they did.
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08:32:21 LEVI: I’m a scientist, but I’m also a father of 6 kids, 6 children. And I think it’s also important to put yourself in the shoes of a parent.
So one of the things that makes me kind of beyond the science of the data, I was asking myself, what are– if I would be just a young parent for a baby and I had the amazing opportunity to be in that situation 6 times, and I know all the information, how would I think about this dilemma?
And I think if I had a baby that was born early, or had, God forbid, some underlying conditions, knowing the threat that RSV can pose to a baby like that, I would probably use these products to protect my child from this disease, because it could actually cause death to the baby.
On the other hand, if I was the father and, luckily, I was the father of a healthy child that was born on time, knowing all of this, I would be concerned to use that.
And I think that I understand that we’re trying to reduce the burden of hospitalizations, and these are all very important metrics, but I think we also need to ask ourselves, what a parent would say, given this data.
And I think that most parents that have a healthy baby would be concerned to use a new product against the disease that has turned out in the past to be quite tricky against immunization and vaccination.
I think they would be concerned, and as a father, I can feel that I would be concerned.
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08:50:38 LEVI: I vote no.
I just want to clarify that my objection is based on the fact that I don’t feel this is ready to be administered to all healthy babies.
I think we should take a more precautionary approach to this.
But I respect the discussion and the opinions of my colleagues.
I vote no.
+++ Pebsworth questions clesrovimab “given within the context of the current schedule”
08:34:26 PEBSWORTH: I would like to see, again, the safety and effectiveness outcomes data that are broken out by infant health status, especially gestational age. So I would just like to understand the difference between the health outcomes of very sick infants and healthy children.
The other comment I have is, do we have data on effectiveness, and particularly safety, when this product is given within the context of the current schedule.
Because depending on when the product is given, it could also be given with several vaccines, including hepatitis B, rotavirus, DTAP, Hib, pneumococcal, polio, COVID, and flu.
So, do we have information on simultaneous administration with these other products, as it relates to safety outcomes?
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08:44:47 MATT DALEY, VSD: The nirsevimab safety evidence that we presented yesterday was in 74,000 infants exposed to nirsevimab, and so then that’s roughly 20 times the size of the original clinical trial or more, and that’s in routine practice.
And so, as I summarized in the slides yesterday, 20% of the neonate cohort received same-day hepatitis B, and 84% of that older age group received simultaneous same-day vaccination with routine vaccines.
And so, essentially, the safety evidence that I presented yesterday, in particular for that group who were 37 days to less than 8 months of age, does represent safety with simultaneous vaccination.
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08:35:52 MEISSNER: First of all, and it’s a question of how far we want to go in this discussion. But remember, approximately, 80% of the children who are hospitalized for RSV, which is approximately 2-3% of the birth cohort, are perfectly healthy children who don’t have prematurity, who do not have congenital heart disease, chronic lung disease, these are infants who almost invariably become symptomatic with their RSV infection.
Approximately a third of RSV-infected children have lower respiratory tract infections, which necessitates visits to their pediatrician’s office, or to the emergency department, even if they’re not admitted.
So we cannot identify who among those 80% are the children who are going to experience severe lower respiratory tract disease.Clearly, there are factors. People are looking at that aggressively. But we cannot identify who is most likely to benefit from administration of clesrovimab or nirsevimab.
The second point is, death is very rare in the United States among infants due to RSV. There are probably fewer than 100 deaths a year in the United States due to RSV in very young children, and those are primarily occurring in children who have other comorbidities, which I just mentioned.
So, as people have noted, it would be nice if we could use death as an endpoint. But there aren’t many deaths, so it’s not possible to do that.
So the best primary endpoint that can be established is hospitalization rates. We can also look at rates of ICU admission, but the data is consistently demonstrating these vaccines, and they’re really not a vaccine, as we know, I think that’s why there’s confusion, these are monoclonal antibodies that are passively administered, they’re not a vaccine, it’s not an antigen which stimulates the host’s immune response.
So these– And then there’s the– we haven’t talked about maternal vaccination. If a woman decides that she does not want to receive an RSV vaccine, during gestation, between 32 and 36 weeks at the time of the year when it’s most beneficial, then the alternative is to administer monoclonal antibody to the infant at birth.
And I my response to Retsef, is that, Dr. Levi, I would, if I were your pediatrician, I would strongly recommend that your wife either receive the RSV vaccine, or monoclonal antibody at birth. There are are various issues that go into that decision-making process. But one or the other should be administered, or at least be available to every woman while she’s pregnant.
And I think that, we’ve come so far in the last few years in making these products available, and again, it’s really a result of the extraordinary investigations that Barney Graham has conducted on largely under NIH support, and his colleague, Jason McClellan, that we’ve gotten to this point with the monoclonal antibodies and the vaccines.
These are truly remarkable products. They are safe. And they’re effective. And I don’t think there’s any further data that need to be presented.
I think we’re in a position, the workgroup has spent an enormous amount of time, the FDA has spent an enormous effort looking at safety and efficacy, and it is simply not an issue here.
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09:44:48 UNCLEAR, SANOFI: The first thing I would like to point out is that these events were classified as unrelated to vaccination, all of these participants with suicidal ideation, they had a past medical history of mental health disorders. We did not specifically screen for mental health illnesses as part of the eligibility criteria in this study.
For the vast majority of these events, the investigators identified clear alternative triggers. And all of the SAEs that were observed in this study, we expect them to fall within the expected background rates for the respective age group. Currently, we don’t have any plans other than our standard post-marketing surveillance on safety events.
HIBBELN: Thank you for your answer.
What concerns me, then, is to whether or not there was a worsening of suicidal ideation in these patients, or whether it must be that you enrolled patients with suicidal ideation, into the trial, either it pre-existed or it was worsening.
And so, without a pre-screening, I’m not certain how you can be certain of these events being unrelated to the vaccine.
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09:49:30 MALONE: I have a specific question, and the intention here is to highlight a characteristic and address a concern that may be circulating in certain communities. I request Sanofi to address whether or not there are any fetal-derived products used in the manufacturing of Flublok.
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UNCLEAR, SANOFI: So they’re are none of those products–
MALONE: Thank you, that’s a key issue for certain communities in the United States that have religious concerns.
And, so I wanted to highlight that this product is free of human fetal tissue-derived material.
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09:57:43 MALONE: Some members of the scientific community have concern that they’re coming out of the COVID pandemic exposure to the virus, exposure to various countermeasures, there may be a pattern of a broad-based, energy, of some type that might contribute to increased severity of influenza disease.
I infer this is probably too early, but I encourage that the agency would be sensitive to that hypothesis, and provide us the data so that we can– that would either support or refute that hypothesis, that there is some, more broadly, population-based process going on, which might lead to more severe upper respiratory virus, clinical pressure.
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09:53:05 MALONE: Second, the 250 pediatric deaths, which is, let’s acknowledge, is a modest number fortunately, do we have a number needed to treat?
Regarding the endpoint of death in pediatric cohort?
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10:50:46 REDWOOD: Mercury is the third most toxic element on Earth, only behind polonium and plutonium. And it has no physiological role in the human body.
Thimerosal was grandfathered for use without adequate safety testing by the FDA. And it’s not generally recognized as being safe or effective by the FDA over-the-counter division since 1998.
There’s also evidence that thimerosal is not an effective preservative at vaccine levels. And that thimerosol can cross the placenta and blood-brain barriers and converts to inorganic mercury in the brain at higher levels than methylmercury.
Studies have identified infants with blood levels after exposure to thimerosol-containing vaccines that breach CDC guidelines for a case of mercury toxicity, mercury chemical poisoning.
Thimerosol is recognized as a developmental and reproductive toxicant and is listed as a chemical in the California Proposition 65 list since 1990. Unused doses of thimerosol preserved flu shots must be disposed of as a hazardous waste.
And tremendous progress has been made in removing thimerosal, but from data that I recently received, more than 60,000 pregnant women received thimerosol-containing flu vaccines through Medicaid and the 2019-2020 flu season.
We currently have enough bimerosol-free vaccines to recommend that all pregnant women, infants and children, receive only thimerosol-free vaccines. After a critical appraisal of this issue almost 25 years ago, the prestigious Institute of Medicine made this same recommendation.
Removing a known neurotoxin from being injected into our most vulnerable population is a good place to start with making America healthy again.
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10:53:09 KULLDORFF: We know that mercury is a toxin. We cannot completely avoid exposure to mercury. But it’s a cumulative issue, so we already have some exposure to mercury from other sources.
So, even if the amount available in the vaccine, maybe that amount is safe, but that’s not the amount we’re exposed to. We’re exposed to mercury from other sources, so it’s cumulative.
And there is a need. And if we care about public health, we should try to minimize exposure to mercury.
I know that FDA do not allow mercury, for example, in skin products. If that’s the only exposure you had, that would probably be safe. But we want to minimize the cumulative exposure.
So, the first argument not having mercury in the vaccines is that it is the cumulative exposure.
The second thing for seasonal influenza vaccines, there are alternatives, and in fact, most of the influenza vaccines given today, do not contain mercury or thimerasol. They are in single dose.
So, it’s very feasible, I think, uh, very feasible to not use thimerasol-containing vaccines for seasonal influenza, so we don’t really need it.
The third thing is that I’m not an expert on marketing. But, if we put mercury in a product, people are not gonna want to buy those products. If you put mercury in cereal, that’s not a good idea, because a lot of people won’t buy the cereal if they have mercury in it.
So, if we want to have confidence in vaccine, and we want to promote people taking vaccines, we should remove this mercury-containing preservatives from the seasonal influenza. So, those are my views on this matter. And I will now open up to other members of the committee to do comments or questions.
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10:58:14 MEISSNER: I’m not quite sure how to respond to this presentation.
This is an old issue, that has been addressed in the past. And, there are many aspects, I think, that we could discuss, but we don’t have time to go into it here.
I guess one of the most important to remember is that thimerasol is metabolized into ethyl mercury. And thiosalicylate. It’s not metabolized into methylmercury. Which is in fish and shellfish. Ethyl mercury is excreted much more quickly from the body, it is not associated with the high neurotoxicity that methylmercury is.
And as many experts, vaccine experts have said, including Paul Offit, all vaccines that are routinely recommended for young children in the United States are available in formulations that do not contain thimerosal as a preservative. This is also true for adolescents and adults, including pregnant women.
So of all the issues that I think we, ACIP needs to focus on, this is not a big issue. I will also hasten to add that thimerosol is included in most vaccines that are administered around the globe. And that is because single-dose vials are more expensive. And many countries cannot afford a single-dose vial.
Now, I realize ACIP is focused on the United States. But the recommendations that the ACIP makes are followed among many countries around the world. And removing thimerosol from all vaccines that are used in other countries, for example, is going to reduce access to these vaccines and will increase cost.
And, I think it’s important to note that no study has ever indicated any harm from thimerosol.
It’s been used in vaccines, as was noted by Ms. Redwood, since before World War II.
The decision by the FDA to remove thimerosol as much as possible is a very reasonable recommendation. But this recommendation was made not because there was any evidence of harm from thimerosol, it was made in an effort, as you said, Dr. Kuldorff, to reduce the total exposure to mercury in our environment.
That’s a reasonable objective. But you also have to consider what are the consequences of these sorts of recommendations. So. I– I’m not sure if we’re going to have a vote here or a wording.
But, I don’t think this is an issue.
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11:04:28 MEISSNER: The ACIP makes recommendations based on scientific evidence, as much as possible. And there is no scientific evidence that thimerosol has caused a problem.
And you are correct. There are several other preservatives that could be used. Benzethonium chloride, 2-phenoxyethanol, are alternatives, but they have not been studied to the same extent.
2-phenoxyethanol is, in fact, I believe that’s included in the polio vaccine.
But to make the industry jump through hoops for something for which there is no evidence of harm, I think, is an issue that needs further discussion.
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11:07:20 KULLDORFF: II think that’s an extremely important point. Let’s say a child is exposed to mercury from 10 different sources.
Each of them, those 10 sources might be small enough that that source in itself is not dangerous. But if you then put all 10 together, then it might be dangerous. So it’s a cumulative exposure.
So that means that if you did a study on every one of these 10, you would not find anything. But we know that mercury is a toxin. So the key thing is to minimize the total exposure, the cumulative exposure.
And we do that by removing the exposure in any way we can. And there are some exposures we can’t remove, but whatever we can remove would help reduce the total amount of exposure to mercury.
And we do know that mercury is a toxin, so that’s– I don’t think anybody’s is claiming that it’s not.
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11:10:35 TRACY BETH HOEG, FDA: The data that I’ve been provided, by CBER, and I thank them for their help, it looks like less than 5% between 4% and 5% in the 2024-2025 season of influenza doses were multi-dose thimerosol-containing vaccines, and so the remainder were single-dose preparations.
And moving forward, I want to confirm what Lyn stated, that next year, that for the next season, it does not look like we would be limited in terms of availability if we were to switch to only using the single dose preparations.
And again, I’ve had this confirmed by my CBER colleagues. And to my understanding that this is the only current vaccination on the childhood schedule that could– that children could potentially receive, or pregnant women, containing thimerosol.
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11:13:34 PHYLLIS ARTHUR, BIO: That was a CDC document on the thimerosal issue. I wondered if that could be reposted as well, to accompany Ms. Redwood’s presentation.
MALONE: My understanding is that article was not authorized by the Office of the Secretary, and has been removed consequent.
I’m sure that the Office of the Secretary will make note of your comment. And, direct the CDC as necessary.
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11:20:46 MOLLY HOWELL, AIM: I am wondering how this discussion will impact our pandemic preparedness.
My understanding is that multi-dose vials and potentially thimerosal would be used should there be a future influenza pandemic, and so I don’t know if federal partners can speak to how this would impact if we could no longer use thimerosol-containing vaccines, our pandemic preparedness.
My other question is, if there is a concern about thimerosol in vaccines, why is the FDA then not restricting the use of thimerosol in vaccines? Thanks.
KULLDORFF: So the vote today is for seasonal influenza vaccines, not for a pandemic, because there’s no such vaccines currently on the market, I think, so they’ll– the future meetings of ACIP and CDC will have to consider those things.
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11:19:38 JASON GOLDMAN, ACP: You know, this committee has always prided itself on openness, transparency, and review of data and evidence, so I am wondering if we will have an actual scientific presentation with peer-reviewed literature, strong evidence to actually discuss this issue, as many statements have been made here today without support of science or evidence, but merely opinion.
So, in fairness, will we be seeing, if necessary, even though the established data for decades really speaks to the safety and efficacy of thimerosol.
If necessary, will there be an actual CDC presentation done by staff scientists, physicians, and those who are subject matter experts with accurate peer-reviewed scientific data for the ability for the committee to review, or will we have layperson presentations only?
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11:21:55 KELLY GOODE, APHA: I would also like to, again, ask the question posed by Dr. Goldman about ACIP process and transparency, and seeing the evidence to recommendations, which includes the balance of benefits and harms, the values and preferences of affected populations, the resource implications, the equity considerations, and the feasibility of this question and vote before ACIP.
KULLDORFF: So we have had a presentation from Lyn Redwood, who is very knowledgeable about vaccines. This committee will always be open and receive comments from a variety of people. That’s part of us being transparent.
We had earlier comments today from– on other topics from the pharmaceutical companies, so we will– that’s the principle that we have, and I think it’s inappropriate to dismiss a presentation, just because the person does not have a PhD or an MD. There are a lot of knowledgeable people who we would like to hear from, and we want to hear from a variety of viewpoints.
And I think today’s discussion is a very good example that we have received input from a variety of people on this topic, and we will continue to do that as this committee moves forward at future meetings.
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11:33:42 KULLDORFF: So the first one is recommendations for influenza vaccination for the 2025-26 season.
ACIP reaffirms recommendation for routine annual influenza vaccination for all persons ages greater than 6 months, who do not have contradication.
The second draft vote, ACIP recommends children 18 years and younger receive seasonal influenza vaccine only in single-dose formulations that are free from thimerasol as a preservative.
Draft vote number three, ACIP recommends pregnant women receive seasonal influenza vaccine only in single-dose formulations that are free of the thimerasol as a preservative.
And draft vote number four, ACIP recommends that all adults receive seasonal influenza vaccines only in single-dose formulations that are free of thimerosol as a preservative.
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12:30:06 KULLDORFF: So ACIP, our committee is only advisory, it is the CDC who actually decides the recommendations.
And in a very unusual situation, because usually CDC do follow the ACIP recommendation, but in this case, they did just sort of an adjustment. So they say– the CDC said that either MMRV or MMR plus V may be administered at this age. But for the first dose in children aged 12 to 47, there’s a preference for MMR plus V.
Next slide, please.
So, in summary, there’s no known difference in the efficacy between these two options.
After the first dose for children ages 12 to 23, there’s very solid evidence, evidence-based evidence, that there are more febrile seizures after MMRV than after MMR plus V. About 1 per 2 to 3,000 doses.
After the second dose of these vaccines at age 4 to 6 years, there’s no excess risk for febrile seizure. Next slide, please.
So a proposed recommendation, we’re not going to vote on that this time, but possibly at the next meeting, could be, that as there exists a safer, equally effective alternative, the MMRV vaccine should not be administered to children under the age of 47 months.
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12:43:14 PEBSWORTH: I wanted to say that, my personal views on this, is that we should not be doing anything that restricts access to vaccines of any sort, especially those that are already approved by the FDA and that are already in the schedule.
My problem, and the reason I abstained for all of these votes, is because of the way the voting question was written.
In the world of survey research, you don’t ask two things in the same question. So, there’s buried in this is a recommendation that all adults receive seasonal influenza. And then the second part of it, in formulations that are free of thimerosol as a preservative.
Yes, I think we should not be using thimerosol as a preservative. But we didn’t get into any sort of a discussion about the first part of the question.
So, I just, in the future, when we’re asked to vote on something, if we could just vote on one thing at a time, that would be helpful.
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12:46:20 MEISSNER: I would like to comment on the decision by the American Academy of Pediatrics to boycott this meeting.
In the past, the AAP has been very helpful in generating recommendations. And, I think it’s somewhat childish for them not to appear.
It’s dialogue that leads to the best recommendations for the use of vaccines.
I mean, I’m led to think that they didn’t want to come because they didn’t want to have to support some of their decisions that are difficult to do.
But in the future, I strongly recommend the American Academy of Pediatrics to participate in these meetings, as they always have.
11:40:19 KENNEDY It puts the individual in charge of their own health.
I have a friend who – I have many friends who have worn glucose meters and have lost their diabetes diagnoses because of that.
Because they are able to buy – you might go an buy a yogurt and think this is healthy for me, and then you watch your glucose spike. And you think, oh I have to go to a different kind of yogurt.
I have a good friend who, because he was wearing a glucose meter, he saw that if he ate a dessert, his glucose would spike off the roof. If he ate a steak, or a piece of meat, protein and then ate the dessert, there was no glucose spike.
So you can start understanding your own health, understanding as you chew your food, the glucose meter is registering what it’s doing to your body.
That kind of information puts individuals in charge of their own health and it improves their understanding of what food is actually doing to their bodies and that is really critical.
10:06:13 KULLDORFF: Secretary Kennedy has given this committee a clear mandate to use evidence-based medicine when making vaccine recommendations. And that is what we will do.
Vaccines are not all good or bad. If you think that all vaccines are safe and effective and want them all, or if you think that all vaccines are dangerous and don’t want any of them, then you don’t have much use for us. You already know what you want.
But, if you wish to know which vaccines are suitable for you and your children, no matter what age it is, then we will provide you with evidence-based recommendations.
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10:14:15 KULLDORFF: I’m Martin Kuldorf, I have worked on vaccine safety for over 20 years. I have been very closely involved with the CDC’s vaccine safety data link, and the FDA sentinel initiative, helping developing their vaccine safety surveillance and monitoring program.
I used to be a professor of medicine at Harvard University, and at Harvard’s Brigham and Women’s Hospitals, until I was fired. I did not take the COVID vaccine, because I already had immunity, superior immunity, from having had COVID.
And I was astonished that universities threw away two and a half thousand years of knowledge about infection-acquired immunity, when they very unscientifically and unethically fire people for not having taken the COVID vaccine.
I used to serve on two work groups, under ACIP in the past. One was for the COVID-19 vaccine safety, but I was removed from that committee, because I objected to the pause of the J&J vaccines, there were reports of blood clots in young women, sort of made sense not to give them the vaccine, but I objected to the pause of older Americans because there was a shortage of vaccines, and people were dying.
So, I think that pause of the J&J vaccine was inappropriate, and actually, I think, some Americans died because of it, so in that case, I was I guess the most pro-vaccine person among vaccine scientists in this country, so it’s kind of a little bit ridiculous that then the media says that I am anti-vaccine.
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10:19:53 MALONE: My name is Robert Malone, I’m a Maryland licensed physician and scientist. I have been secret cleared by the U.S. Department of Defense, extensively vetted. I’ve now been through 3 months of vetting and training, regarding COI with HHS. I have no conflicts of interest.
Those potential– any potential conflicts of interest have been analyzed and vetted and declared lacking, both internally by HHS and specifically by CDC.
My relevant background is that I’ve been working in virology, immunology, molecular biology pathology since 1983, beginning in a laboratory focused on retroviruses and intimately involved in initial findings relating to what we now call HIV.
I’ve had done– I’ve worked in academia to associate professor, most recently at the Uniformed Services University of Health Sciences in DC. I’ve worked for the government at length, particularly with Defense Threat Reduction Agency and in the biodefense space, including the prime systems contractor, DynPort Vaccine Company, that had responsibility for virtually all DOD-related vaccines and threat mitigations for biowarfare agents.
I’ve worked for a rest global TB vaccine foundation and tuberculosis vaccine development, which is a Bill and Melinda– it was a Bill and Melinda Gates-funded non-governmental organization.
I’ve worked in industry and regulatory affairs, I’m an expert in clinical research, clinical regulatory affairs, project management, and contracting, with extensive government experience, particularly with Defense Threat Reduction Agency.
Regarding specifically vaccines, my experiences included influenza, seasonal, and pandemic vaccine development, including senior management position at Solvay Vaccines, managing a 300-plus million dollar contract for cell-based influenza.
I’ve been an invited speaker at the World Health Organization to lecture on novel influenza vaccine manufacturing technology. I have experience in HIV, anthrax, plague, tuberculosis and virtually all of the classical biodefense-related vaccine products that are currently in the pipeline.
My core competence, again is in virology, immunology, pathology. I taught pathology for many years in academia, molecular biology, and in particular, polynucleotide delivery.
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10:28:40 PEBSWORTH: My name is Vicki Pembsworth, and I’ve worked in the healthcare field now for about 45 years. I have doctoral degrees in nursing and in public health from the University of Michigan. My public health background is in health services organization and policy.
I previously served on the FDA’s VRBPAC committee for quite a few years. I also served on two committees at the National Vaccine Advisory Committee. I currently am a volunteer as the director of research at the nonprofit National Vaccine Information Center. I’m also the Pacific Region Director of the National Association of Catholic Nurses.
As it relates to conflicts of interest, I have been asked to read the following statement.
As required under the ACIP policies and procedures, I am also disclosing that I own stock in a healthcare sector fund that includes holdings relevant to the ACIP, including vaccine manufacturers. However, the amount of that stock holding is under the Office of Government Ethics Regulatory de minimis amount.
I understand that I, therefore, can fully participate in the ACIP meeting. Thank you very much. I look forward to being of service and working hard to improve policy-making decisions for vaccines.
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10:35:40 KULLDORFF: Some new work groups will also be established.
The number of vaccines that our children and adolescents receive today exceed what children in most other developed nations receive. And what most of us in this room received when we were children.
In addition to studying and evaluating individual vaccines, it is important to evaluate the cumulative effect of the recommended vaccine schedule.
This includes interaction effects between different vaccines, the total number of vaccines, cumulative amounts of vaccine ingredients, and the relative timing of different vaccines.
The Institute of Medicine, which is now the National Academy of Medicine, wrote an important report on these issues some years ago, arguing for more research on this topic. And it’s now time to evaluate that new research.
Towards that end, we will be establishing a work group that will look at the cumulative childhood vaccine schedule, as well as the adolescent schedule.
We will also be convening a new work group to look at vaccines that have not been subject to review in more than 7 years. This was supposed to be a regular practice of the ACIP, but it has not been done in a thorough and systematic way. We will change that.
We are learning more about vaccines over time, and to stay true to evidence-based medicine, we have a duty and responsibility to keep up to date with scientific research to make sure that the ACIP recommendations are optimal for both individuals and public health.
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10:37:23 KULLDORFF: Among other topics, this new vaccine group may look at the universally recommended hepatitis B vaccine at the day of birth.
Is it wise to administer a birth dose of hepatitis B vaccine to every newborn before leaving the hospital? That’s the question.
Unless the mother is hepatitis B positive, an argument could be made to delay the vaccine for this infection, which is primarily spread by sexual activity and intravenous drug use.
Vaccines are important for combating measles. For the first dose at age 12 to 15 months, a previous ACIP meeting recommended two alternative options equally. With either separate MMR and varicella vaccines, in two different needles, or the combined MMRV vaccine in one needle, even though the latter causes an excess number of fever and seizures.
Aware of this, most pediatricians administer separate MMR and varicella vaccines. And CDC has also expressed a preference for that.
To minimize vaccine adverse reactions, the ACIP may follow the lead of pediatricians and re-evaluate his earlier recommendation concerning MMRV for 1-year-old children.
This working group may also look at new research concerning the optimal timing of the MMR vaccine, to resolve religious objections that some parents have concerning the MMR vaccine being used here in the United States.
We could also look at other MMR vaccines, such as the one used in Japan.
While we may bring different perspectives on some issues, we look very much forward to working collaboratively with the current members of the existing work groups, as well as with scientists here at CDC.
We share the same goal: the improvement of public health. That can only be achieved through close collaboration, open discussions, and most importantly, with evidence-based medicine.
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11:56:50 MEISSNER: That answer. I would also– I guess it would also apply to the question of death due to SARS-CoV-2.
How many of the deaths of current people who had respiratory symptoms or other symptoms referral to a viral infection. And how many simply had a positive throat swab, because many hospitals have required a throat swab on anybody who’s admitted and then classified as SARS infection.
CHRISTOPHER TAYLOR, CDC: Yes, thank you, that’s an excellent question, and we actually have an ongoing analysis looking at deaths. We’re compiling the most recent years of death certificate data and it will be– we’re actually in the mid-stages of that now, and we hope to present it to ACIP when we have findings in the future.
One thing I would also note, too, about the COVID hospitalizations is one of the things that we knew early on in the pandemic was everyone being presented to a hospital was being screened for COVID. And we know that that is no longer necessarily the practice in most hospitals.
So what we have seen, at least preliminarily with the 21-22 and 22-23 data in our published COVID hospitalization paper is that the proportion of hospitalizations attributable to COVID has actually increased slightly over time, likely as a result of decreased screening.
So, the number of asymptomatic people being screened has decreased, so the people that are being tested for COVID-19 are more likely to be those that come in and have some sort of symptom of COVID-19-related illness.
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12:04:34 LEVI: My question is did we kind of scrutinize what are alternative explanations to the analysis that was conducted about the efficacy that might not point to an efficacy of the vaccine, but maybe to a different direction?
ADAM MACNEIL, CDC: If I think I’m following your question, it’s probably a question about how much we’ve been able to control for certain confounding variables?
LEVI: So, let me be more precise. So, the method that you’re currently using is comparing the relative fraction of people that are updated with their vaccinations between people that came and were tested positive versus people that came and tested negative.
And a possible scenario to conclude that the vaccine is effective, if they are overrepresentative in both scenarios, but just slightly less on the one in which they tested negative, in that case, you will assume that there are– that the vaccine is protective.
But the only thing– but an alternative explanation would be that the vaccine is actually making you more vulnerable for multiple viruses, including COVID, but maybe more so on other viruses than COVID, and the perception is that it’s effective.
And there are other scenarios, I think that there are other scenarios that you can take the same results that are presented and potentially think about alternative explanations that do not point out to vaccine efficacy, but maybe to vaccine lack of efficacy of deficiency, if I say.
ADAM MACNEIL, CDC: That’s one of the weaknesses with the test negative design.
LEVI: Yeah, so I just wanted to make it more precise, because some of the data here suggests that maybe, actually, that’s actually happening, because the rate of– it seems that the rate of people that are hospitalized with updated vaccination is actually higher than their relative proportion in the population, and that’s kind of should make you at least concerned about these options.
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RUTH LINK GELLES, CDC: The goal of a test-negative design is to use the controls to represent the vaccination coverage in the population that gave rise to the cases.
So one of the benefits of the test-negative design is that these are individuals who have the same symptoms as the cases, and sought testing and medical care at the same facilities as the cases. And so in that sense, these are population-based controls, even though it is a test-negative case control design.
And then I would add that the over– the representation of the controls of this case, these are not the general population in that they are elderly people who are hospitalized with acute respiratory illness, and therefore we would not expect them to have the same vaccination coverage as in the unhospitalized, likely healthier, general U.S. population.
They are really meant to be representative as much as possible of people who, if they had COVID, would have sought medical care or been hospitalized at the same location. And so for that reason, we think that the controls here are exactly what we would want to understand the relative impact of the vaccination.
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TRACY BETH HOEG, FDA: I share Dr. Kulldorff and Dr. Levi’s concerns about the potential for confounding, and I’m wondering, if the goal is to really have comparable groups with comparable symptoms, one that happens to test positive for COVID and one that doesn’t, why exclude the patients that test positive for influenza, and then those over 60 that test positive for RSV?
And, are we not concerned that these may be fundamentally different groups of people that are seeking medical care, but happen to test positive for COVID-19 versus something else, and it’s really difficult to say their symptoms are exactly comparable, and so just to get my point in, I think I share a lot of people on this panel’s desire to see randomized control trials to minimize these types of bias so we aren’t sitting here saying, wondering, are we being misled by these data?
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RUTH LINK GELLES, CDC: I would add to my previous answer that I think, if you include controls or cases that test positive for another vaccine-preventable disease, you are actually going to add bias to your study.
And there’s been quite a lot of published literature by Dahl et al and others showing that this would happen. And so for that reason, we dropped controls that would test– that tested positive for flu or RSV because the vaccine status is actually correlated.
And so if you had a positive control for influenza, they would be less likely to be influenza vaccinated, also would mean they’d be less likely to be COVID vaccinated, because we know that COVID and flu vaccine status are highly correlated.
We also do quite a lot of work with the study sites to make sure that the cases and controls have similar symptoms, and we have looked at a number of cases, and published looking at number of symptoms among cases and controls, severity of symptoms among cases and controls to ensure that our case and control populations are balanced in that respect.
As far as the question about clinical trials, I would actually defer that back to you all at FDA.
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ADAM MACNEIL, CDC: You know, and I would actually maybe weigh in on what other aspect of this with clinical trials, just realizing some of the real-world realities of the time and cost it takes to do clinical trials, and I think the test negative design has provided a robust way to, in a very timely manner, get real-world data.
I mean, to realistically say that, you know, this is June, and we’re looking at VE data from this last season is– the timing would not be possible from a temporal or a cost standpoint to be able to for CDC to be able to do randomized clinical trials with that.
So I think this is, for us, has served a robust way to be able to rapidly get real-world data very efficiently.
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13:22:44 PEBSWORTH: Thank you very much for this very enlightening presentation.
I am very concerned because, with uptake being as low as it is reported, and also that reports to VAERS are extremely high compared to other vaccines.
They are, the last time I looked, it was about 1.6 million reports that came in. I don’t know the extent to which underreporting is still an issue, for this vaccine, but there are published studies suggesting that under-reporting, about 10% of adverse events are actually reported.
So, that being the case, I think we need to be very careful and also have access to data that we probably wouldn’t ordinarily have. And that is, I’m very interested in learning more about what we now know through animal studies, the studies that we would typically have for preclinical trial data, the reproductive toxicity data, the various biodistribution studies.
I think this would maybe help to sort out some of the confusing information that we have.
Thank you very much.
SARAH MEYER, CDC I just wanted to respond to your concern about VAERS underreporting, and what I just wanted to share is that some of those reports suggesting vast under-reporting in VAERS are inclusive of things like sore arm, rash, things that people don’t normally report to VAERS.
So, I’m not sure about anyone here, but I never reported to VAERS when I had a sore arm last time for vaccination.
But CDC has conducted a number of studies that we have published in the literature that shows that for serious adverse events, the reporting rate to VAERS is much higher, so it’s up to 76% for anaphylaxis, depending on the vaccine, up to 64% for Guillain-Barre Syndrome, again, for, depending on the vaccine.
We’ve looked at this for interception following rotavirus vaccine, vaccine-associated polio, following polio vaccination. So, I think I just wanted to point out that for serious reports, we are confident that we get a majority of those reported to VAERS.
LEVI: First, this is very useful information.
I still think that there are, if I take the myocarditis example, I still think that we probably have– we can see, if we actually compare the rates based on VAERS versus the rates based on clinical diagnosis versus the rates based on actually testing the troponin levels of people before and after vaccination, we see underreporting, depending on the system you’re using, and VAERS is probably still under-reporting, maybe not to the extent of 10%.
And the other thing is that I think that, if I understand correctly, the data, we do see inverse some serious adverse events, and some actually new ones that are being reported at rates that are far exceeding other vaccines, even when you normalize to the number of doses, which suggests something, I think.
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14:15:34 CHRISTOPHER BRADEN, CDC
There’s a number of foodborne outbreaks that we’re detecting through a system called PulseNet, which uses whole genome sequencing to match isolates that likely have a common source.
We are looking at salmonella infections linked to pistachio cream right now, again, these are multi-state, and also to eggs.
Interestingly, we have a cluster of illnesses due to Botox injections. We’re working with Massachusetts to investigate this cluster of illnesses. These are injections that cause a systemic illness beyond the injection site.
It looks to be due to a unlicensed provider and an unlicensed facility that is providing Botox injections. We get heavily involved because CDC is the source of the botulinum antitoxin.
The antitoxin is stored in port health stations that CDC runs around the country, and we provide that for clinical care, and we do consultations on all of these types of illnesses in addition to the epidemiologic investigation.
And one other thing that I’ll just say that emphasizes the zoonosis aspect of our work is New World Screwworm which is making its way up from Central America into Mexico right now.
It is mainly an animal disease. It has led– the investigation is led by USDA, but we– there is a human component where New World Screwworm can cause a very nasty myiasis. That is basically an infestation of the maggots in skin, and so forth, and they eat the live tissue. So, that always is a little bit impressive.
We’re working with USDA on that. It is a threat right now to mostly animal agriculture, some human component in the United States as it makes its way up from Central America and Mexico.
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16:16:29 KULLDORFF: So there’s a little bit of a change in plan here.
Before we do the public comment, there’s a rule that we have to present the draft votes. Before we present the draft votes, there’s a rule we have to see here the updates and summary of the evidence to recommendation.
We will postpone the vote until tomorrow, so that will not happen today. But what we will do now is we will hear from Dr. Macneil and Dr. Peacock. And then we’ll present the draft vote, and we will have then the public comments after that.
And I’ve asked Dr. Macneil to do that as quickly as possible, and if there are any questions on this presentation, we will also do those tomorrow.
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16:50:38 ADAM MACNEIL, CDC: The first proposed recommendation: ACIP recommends infants aged less than 8 months born during or entering their first RSV season, who are not protected by maternal vaccination, receive one dose of clesrovimab.
GEORGINA PEACOCK, CDC: The proposed recommendation for the VFC resolution is to approve the updated Vaccines for Children, VFC resolution, for the prevention of RSV.
KULLDORFF: And do you have the text of that proposed resolution?
GEORGINA PEACOCK, CDC: I do, there’s a– there’s a slide set that I need to go through that shows updates to the VFC resolution update, is that after this?
So I’m going to now go through the updated VFC resolution update, and so what you’ll see first is, the changes to the currently approved VFC resolution language are going to be shown in orange font, and the existing language is shown in black font.
So the purpose of the resolution is to update the resolution to include an additional RSV long-acting monoclonal antibody.
The first component of the resolution addresses RSV maternal vaccine, and there are no changes to eligible groups.
There are no changes to the recommended schedule and intervals, however, the individual product name was replaced with a product group name, because now there are two products available.
There are no changes to the dosage, contraindications, or precautions.
The second component of the resolution has been retitled to refer to a product group name rather than an individual product name. The eligible groups are unchanged.
The list of children at increased risk for severe RSV disease is unchanged.
For the recommended schedule and intervals, information about nirsevimab is unchanged. However, a new row has been added to the table to reflect the clesrovimab, the newly licensed RSV long-acting monoclonal antibody.
As previously discussed and noted in this table, the product is not indicated for the second RSV season.
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14:11:57 DEMETRE DASKALAKIS, CDC: And so the first is the measles outbreak. As of today, um, CDC has reported 1,227 measles cases from 37 U.S. Jurisdictions in 2025. There have been 23 outbreaks reported in 2025, and 89% of the cases of measles have been associated with those outbreaks.
One specific outbreak really makes up the lion’s share of infections. This is the outbreak that is occurring in the Southwest, with Texas reporting 750 cases across 35 counties, and New Mexico reporting 81 total cases, primarily in the southwestern part.
There’s some really good indicators that we have hit a plateau. The cases are definitely decreasing, so as we are seeing fewer cases in the Southwest, we continue to see global introductions that come into the U.S, which thankfully to date have mainly been, like, short terminal chains of transmission, as opposed to more sustained transmission like we saw in the Southwest.
So, our overall risk to the U.S. population is low, but we continue to have vigilance around mobility as well as populations who may not be immune.
10:30:42 MARSHALL: The CDC’s done a great job at addressing communicable diseases, but there’s other diseases out there that I think are more of a pressing issue. How would you help address the CDC to address chronic disease?
MONAREZ: Thank you, and thank you again for taking the time to meet with me, um, the other week. So, part of the approach to organizational optimization will be to get CDC back to its core mission functions to prevent, detect, and respond to infectious diseases and emerging threats.
But what you highlighted are very important public health concerns and what I will do if I’m confirmed as a CDC director, is continue to support the secretary and to support these critical issues, and make sure that any of the activities that were supported under CDC in the previous models are successfully transitioned to other part of HHS, and as you said, there are critical work– there’s critical work to be done in preventing chronic diseases and addressing other issues like maternal mortality, and addressing issues, like neurodegenerative disorders.
And so, if I’m confirmed as CDC director, I will make sure that I’m laser-focused on the mission at hand at CDC, but also as supportive as I can be to the secretary’s goals in making America healthier again, and transitioning those other programs to other parts of the agency.
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10:21:47 PAUL: You were at OSTP, 2015 to 2016. Was any of the research between Ralph Baric and WIV, the Wuhan Institute of Virology, subject to the pause on gain-of-function during your period of time there?
MONAREZ: I don’t know the specific details of that, but all federally funded research that met the standards of gain-of-function should have been paused under that– that gain-of-function pause.
PAUL: Right, but several were granted exemptions. Are you aware of an exemption that was granted to the Wuhan research?
MONAREZ: I am not aware of that.
PAUL: Do you believe that the research that was being done over that period of time and subsequently was gain-of-function research?
MONAREZ: I haven’t had an opportunity to look at that research, but I share your concerns about gain of function research.
PAUL: There’s about 10 books written about it. I mean, we’ve been talking about it. 15 million people died, you’re going to be in charge of infectious disease, you know. You’d think you might have an opinion on, you know, where this came from and what happened.
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10:20:46 PAUL: Francis Collins infamously emailed Anthony Fauci and told him to take down three prominent scientists.
The implication was use whatever means, use the media, use reporters, but damage their reputations. One of these scientists is now the head of NIH, Jay Battacharya. Do you think that was an appropriate use of his office?
MONAREZ: So I’m not familiar with that particular encounter, but we need to make sure that we are open to letting–
PAUL: Is that an appropriate use of the office for Francis Collins to have emailed the head of NIH and say, take down scientists that he disagreed with?
MONAREZ: We need to make sure that we are open–
PAUL: It’s sort of a yes or no question. Is it an appropriate use of office? Because the question goes to you. Is it an appropriate use of the office to email other government scientists and say, take them down. Take down these people that are disagreeing with us and have a different opinion?
MONAREZ: It is not something I would do.
I welcome an open and honest debate and scientific discourse.
PAUL: Yeah. I’m disappointed that we don’t get a little better answer from that.
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10:25:28 SANDERS: The American Medical Association has adopted a policy that, quote, recognizes the substantial body of scientific evidence that has disproven a link between vaccines and autism, end quote.
The president of the American Academy of Pediatrics has stated that in the effort to undermine decades of research, finding no link between vaccines and autism, quote, poses a threat to the health of children and our nation, end of quote.
Do you agree with the American Medical Association that there is no scientific proven link between vaccines and autism?
MONAREZ: I have not seen a causal link between vaccines and autism.
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10:39:37 MURKOWSKI: Throughout his confirmation process, Secretary Kennedy made commitments to not take action that would discourage use or limit access to vaccines.
And so, when he made that decision recently to call for the removal of all those on the committee, the ACIP, it kind of called into question that commitment. it certainly did for me.
As you know, ACIP is kind of important. For those who are not as familiar, ACIP recommendations help the states determine which vaccines pharmacists can administer, and insurance companies use these recommendations as a guidance to determine coverage.
So, this is one of those committees that the general public isn’t really very familiar with, but the outcomes from this committee are important, and so the makeup of who is on that committee is equally important.
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10:42:21 MURKOWSKI: – more specific to my question, though, is there are seats that are still available on that committee. I think people would be looking to you for your guidance here to make sure that either there is no conflict of interest, or that the individuals themselves and what they bring to the table, what they bring to these very important, very technical considerations, are not going to cause further doubt about the credibility of the committee, because you and I talked about that.
MONAREZ: That’s right.
MURKOWSKI: There’s a lot of trust that needs to be rebuilt here. How do you do that?
MONAREZ: Well, first, I would welcome– these are not easy positions to fill. I mean, it takes a lot of time and commitment from some of these highly trained technical experts to want to participate.
And I would encourage them to participate. I would encourage them to raise their hand, and to offer their support to be considered for placement on the ACIP.
They need to have a depth and a breadth of technical experience to be able to understand immunological processes, to understand statistical analysis. And, as these– if someone feels that they are a good fit to be able to understand this complex information, and they want to volunteer, and they want to be considered. I welcome that.
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10:57:50 KIM: In February, I asked the secretary about this. He said that he was unaware and did not realize that the funding cuts that he was making, that was authorizing, were cutting staff from programs such as this.
I guess I just wanted to ask you, were you aware that programs like this would suffer, that this program would suffer from the staffing and budget cuts?
MONAREZ: I was not involved in that decision-making, and I am not aware of what has happened.
KIM: So can you explain to me who was involved in that decision-making?
So you were the acting director at that time in February. How did– did you have any input into the budget process?
MONAREZ: I’m not aware of any of those staffing changes that transpired during that period of time or the budget processes, this is a critical vital function that the CDC performs–
KIM: So in February, you showed up at work one day, and they told you that, you know, these are the cuts that are being made to your staff? Is that how it happened? Who told you that? Like, how did that unfold?
MONAREZ: I’m not familiar with the specific details that you’re talking about. I am happy to look into it and follow up with you.
KIM: So in February, when there are cuts to CDC staff, especially for the World Trade Center Health Program, do you recall how you were made aware of those cuts to the staff?
MONAREZ: I’m not– I am not aware of the specific details that you’re asking about.
I am happy to look into it and follow up with you if I am confirmed as the CDC director.
KIM: Yeah, look, I mean, I guess I raised this because, you said earlier that a lot of what you want to focus on is creating evidence-based, rapid decision-making. You want to make sure that your actions are being driven by the data, by the science.
Yet, some of the most important decisions while you were acting director seemed like they were made without your knowledge, without your inputs.
Did you agree with those cuts to the World Trade Center Health Program?
MONAREZ: The World Trade Center Health Program is very important to this country. It is very important that we continue to support it.
KIM: So you did not agree with the cuts?
MONAREZ: Again, I’m not aware of the specific details of what you’re asking about. I’m happy to look into it and follow up with you.
KIM: It’s just a little odd, because they cut the staff. Congress, in many ways, bipartisan way pushed back on this. And the staff were reinstated.
I just, I don’t understand what the decision-making process is, and I guess that’s something I wanted to get a sense of what type of role would you play in terms of standing up against some of these cuts. If you disagree with them, what voice would you have?
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11:10:40 MURRAY: And it’s not just the members that I’m concerned about. Secretary Kennedy is bringing anti-vaccine conspiracy theorist from his former organization into that crucial vaccine meeting.
Lyn Redwood, who’s from the Children’s Health Defense, is scheduled to give a presentation on thimerosol and vaccines. And to further RFK’s debunked claims that it causes autism, and she cited a study that does not exist. And after that was pointed out, CDC uploaded a new presentation.
But let me ask you, do you think it is acceptable for a known conspiracy theorist who cites made-up sources. To be presenting at CDC’s ACIP meeting and advising on vaccine recommendations?
MONAREZ: So I’m not familiar with the person you’ve identified. The ACIP is a public meeting and members of the public are in a position to be able to present what should be scientific and evidence-based information, and members of the ACIP should listen to that information and be able to evaluate the veracity of the data that is being discussed.
MURRAY: Well, the CDC director makes the decision on whether a vaccine should be recommended to the public, and does not have to follow recommendations. Passed by ACIP. What will you do if the committee votes to remove vaccines from the vaccine schedule or to not approve new ones in opposition to clear, established science.
MONAREZ: So if I’m confirmed as a CDC director, I will be an active listener and, and will be very interested in the discussions that take place at the ACIP meetings.
I will be looking at how the ACIP members are able to evaluate this complex scientific information and the statistical analysis that goes into the risk-benefit–
MURRAY: I appreciate that long answer there, but I have to say that many of us are very deeply concerned about the recommendations, because they impact millions of people, as I said but they also translate directly into which vaccines get covered by insurance. And which vaccines are then accessible to patients. Secretary Kennedy has spread really blatant disinformation about vaccines. And undermined the established science by pretending that families need to do their own research on vaccine safety.
Secretary Kennedy recently decided to revoke COVID vaccine recommendations for children and pregnant women, meaning that their insurance may now not cover the cost of their vaccines. Do you think leaving it up to the parents or the individual, if the choice they are left with is to spend hundreds of thousand dollars just to get one vaccine that was previously free, is the right way to go here?
MONAREZ: I think we need to make sure that we are providing transparent and clear, effective communications about the benefits and the risks associated with vaccines so parents can make informed decision-making for themselves, their children.
MURRAY: Well, it’s hard to know if it’s informed if you have ACIP members who are listening to somebody who’s a vaccine conspiracy theorist that has been debunked.
And I just want to make this clear, when ASIP pulls its recommendation or refuses to recommend an evidence-based vaccine. A lot more kids and a lot more families will not get vaccinated. They will not be able to afford it. And that is the reality.
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11:20:49 HASSAN: One critical role of the CDC director is to help protect children from lethal infectious diseases.
The CDC director can’t perform this critical role unless they are politically independent. Which means that you must be willing to disagree with political leaders based on scientific evidence.
So, is there anything that you disagree with Secretary Kennedy about?
MONAREZ: If I’m confirmed as CDC director, um, I look forward to having technical discussions with the secretary. He has said he values and prioritizes independent thinking and using science to drive decision making.
I am an independent thinker, and I am a scientist, and I will welcome the opportunity to share my opinions based on science and evidence with him as he makes some of these very difficult decisions.
HASSAN: Is there anything you disagree with him about?
MONAREZ: So, look, if I’m confirmed as a CDC director, I look forward to supporting the secretary, with science and evidence, and making sure that I am giving him the best information possible to help support some of these critical decisions that he’s making.
HASSAN: Well, let’s go to some specifics, then.
When you were acting director of the CDC, Secretary Kennedy stated, quote, it’s very, very difficult for measles to kill a healthy person, close quote.
Do you have any scientific concerns about Secretary Kennedy’s statement?
MONAREZ: So measles is an important public health threat, and we have to make sure that we are doing everything that we can to prevent and mitigate the spread–
HASSAN: Do you have any concerns about a statement? Didn’t a child die from measles while you were acting CDC director?
MONAREZ: See, measles can be lethal. So we know from historical data that in populations, unvaccinated populations, that 1 in 1,000–
HASSAN: Right, so, excuse me for interrupting, but I have limited time. So when the Secretary said it’s very, very difficult for measles to kill a healthy person no concerns from you about that?
MONAREZ: So look, we know that measles can be fatal in 1 in 1,000 individuals, and look, these are very critical issues that we need to be able to–
HASSAN: Right, which is why your being able to independently state in public that you differ with the secretary is a really, really important thing. And right now, you’re showing a real reluctance to do this.
What about when Secretary Kennedy said, again, while you were CDC acting director, that cod liver oil and vitamin A have, quote, 87% effectiveness, close quote for preventing death from measles.
Do you agree with that from a scientific perspective?
MONAREZ: So there are no FDA-approved antivirals or aligned treatments for the measles.
We do know that vitamin A has been approved by the WHO, and has been supported by the American Academy of Pediatrics, as an effective, supportive therapy to–
HASSAN: And so where’s the science that says it’s 87% effective?
MONAREZ: So, I’m not familiar with that quote, I’m not familiar with the specific statistic.
But if I am confirmed as a CDC director, I’m happy to look into it and follow up with you.
HASSAN: Well, for the record, and with a request for unanimous consent, Mr. Chair, I have a copy of an article from the New York Times entitled, ‘I feel like I’ve been lied to when a measles outbreak hits home’ from somebody who followed Secretary Kennedy’s kind of alternative treatment theories in Texas, whose family got very, very, very ill, almost died because of measles.
I am very concerned that a CDC nominee who says she wants to be independent and will apply science is so unwilling to speak publicly about scientific evidence that contradicts the secretary.
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11:34:54 BLUNT ROCHESTER: When we met, you told me during our meeting that you didn’t believe that the ACIP members had conflicts of interest. That was the justification for Secretary Kennedy firing all of them.
Do you, and members asked, do you disagree with him on anything, which you did not say you did or didn’t.
Do you agree with Secretary Kennedy’s decision to fire all 17 ACIP members on the basis of conflicts of interest?
MONAREZ: So, look, the American– restoring trust in public health is a critical priority for me, it’s a critical–
BLUNT ROCHESTER: Doctor, I would really just love an answer.
Do you agree with that?
MONAREZ: I agree that the secretary had to make a decision related to ensuring that the ACIP could be supportive of restoring public trust in decision making.
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11:37:45 CASSIDY: I am concerned, and the ACIP directly relates to you, of course, because the agenda will ultimately be approved by the CDC, by you, and you will help decide, are we building trust or not?
I will note that there are people who are critics of thimerosal who’ve been asked to testify. But no one speaking of the substantial evidence that in the amounts used in vaccines, thimerosal is safe.
You had nothing to do with that, but I will say, going forward if the ACIP hearing today is being used to sow distrust, I would ask, as you go forward, that you would make sure that there really was a balanced perspective.
And yes, someone can speak as a critic. But there should be someone who’s reviewing the overwhelming evidence of the safety of vaccines.
MONAREZ: Absolutely. This group, this ACIP, has a very vital role to play.
And it must make sure that it is using science and evidence to drive that decision-making.
CASSIDY: And I think part of the concern is that the people on the panel, although scientifically credentialed, no one has the experience with immunizations, the kind of already knowledge, to say, well, wait a second, the evidence that you’re presenting, there’s a lot more evidence to say it’s not true.
And so, again, that responsibility will fall upon you.
And I trust you to help fulfill President Trump’s vision of making America healthy again, which immunization is such an important part of.
MONAREZ: Yes.
…
11:40:21 CASSIDY: Any thoughts about the safety of mRNA vaccine in general?
MONAREZ: The FDA has, in the production of the COVID-19 vaccine, had approved the mRNA vaccines as safe, and had demonstrated efficacy associated with them.
CASSIDY: So you would not be prejudiced from the get-go against such a platform, such a vaccine built upon a platform, whether it’s for COVID, flu, for Lyme disease or anything else?
MONAREZ: That is why– I have no a prior prejudice against mRNA platform or any other approach that is being taken to develop vaccines, and that is why we have safety and efficacy standards that the FDA puts in place for any of these medical product trials to ensure that anything that is being developed, we can have the confidence that we can put it in ourselves and our children, our family members.
…
11:58:38 ALSOBROOKS: You’re a scientist, and I know that you believe– I want to just ask you whether you believe that fluoride, is it safe and effective when used appropriately?
MONAREZ: Fluoride is an important component to oral health, and there are various aspects of using fluoride to improve oral health, a direct application can be very valuable–
ALSOBROOKS: Valuable. So let me just say this, so I’m so glad to hear that, because the secretary has directed the CDC to stop recommending fluoridation in communities, I’m very concerned about this. I know you are one of my constituents, I’m very happy about that.
In your community has fluoridation, and so I just want to ask you a last question.
Do you believe that the water in Potomac, Maryland, for example, is safe for families? They have fluoridation there.
Is it safe for families, the water in Potomac, Maryland?
MONAREZ: I believe the water in Potomac, Maryland is safe.
10:37:07 KENNEDY: Well, first of all, very few of the studies that were being done by NIH were being done on chronic disease.
NIH should be telling us: what are seed oils doing to our children? What are– what is corn syrup doing to our children? What are food dyes doing to our children? What is the packaging and microplastics doing to our children? What are pesticides doing to our children?
None of those studies were being done. Studies that were being done by NIH and many– let me give you an example of the few that I cut.
There was a study, a $2.2 million study from Boston University, to study the effects of exogenous testosterone therapy on communication in gender-diverse speakers. We cut a $3 million study at the University of Pennsylvania. Studied anti-vaping social media campaigns targeted towards sexual gender minorities, teens between 13 and 18. We cut a million dollars from the University of Michigan to study sexual fluidity and longitudinal changes in alcohol misuse.
And that’s just an example of thousands of studies like that, that were doing nothing to improve American health.
…
10:41:55 KENNEDY: I don’t know anything about that Washington Post article. And I–
DEGETTE: No, do you know anything about the Defend the Spend initiative?
KENNEDY: About what?
DEGETTE: The defend the spend initiative that your agency has?
KENNEDY: No.
DEGETTE: You don’t know about it.
…
10:45:59 KENNEDY: The people who were subject to the reduction in force are on administrative leave, and they will remain on administrative leave until the injunction is lifted.
At that point, we will make decisions. And, you know, in some cases, we’ve– there have been gaps in our ability to perform our duties. I’ve brought people back.
I’ve brought 722 people back to CDC. I brought 220 people back to NIH, because we were not able to perform our job. And I brought 313 people back to NIOSH, for the World Trade Center, for the Cleveland office, and the Morgantown office. They were doing important work that we did not– that was critical.
But people have been terminated, our– people who are involved in administration. There are tremendous redundancies in my department.
…
10:56:15 KENNEDY: If I can take a minute just to respond to something that Congressman Pallone said. And I’ll address you, Congressman Pallone.
15 years ago, you and I met, you were at that time a champion for people who had suffered injuries from vaccines. You were very adamant about it, you were the leading member of Congress on that issue.
Since then you’ve accepted $2 million from pharmaceutical companies in contributions, more than any other member of this committee. And your enthusiasm for supporting the old ACIP committee, which was completely rife and pervasive with pharmaceutical conflicts, seems to be an outcome of those contributions.
DEGETTE: Mr. Chairman, point of order.
CHAIR: Point of order. The chair recognizes…
DEGETTE: Point of order, the gentleman is impugning the reputation of a member of Congress.
CHAIR: Can you state the point of order?
DEGETTE: He was impugning Mr. Pallone’s reputation.
PALLONE: Mr. Chairman, I didn’t hear it. Did the –
CHAIR: Well, you weren’t paying attention, that’s why.
PALLONE: Well, you know, it’s hard to pay attention here when we’re not getting any responses.
My understanding now is that the Secretary said something about me taking money from pharmaceuticals? Is that what he says?
DEGETTE: He– the Secretary implied that Mr. Pallone would not fight for vaccine victims because he took money from the pharmaceutical industry.
He needs to take back those words.
CHAIR: Here we go.
This, Mr. Secretary, this is a valid point of order, I’m told. So I’d ask you, if you would, please take back those words.
KENNEDY: They’re retracted.
…
11:21:03 BILIRAKIS: Can you speak further on the need for the national priority voucher program, and how HHS will broadly ensure U.S. leadership in innovative treatments, and that those treatments are developed here in America.
KENNEDY: We’re already– we’re using that program now extensively.
We’re very excited about it because it crashes through the red tape.
It may– it facilitates a very rapid approval of these drugs. We’ve already applied it to a number of new drugs, and it’s something that we’re going to, as I said, use extensively, so I appreciate your support on that.
…
11:23:28 KENNEDY: What you said was wrong. We’re not depriving anybody of choice.
If a pregnant woman wants the COVID-19 vaccine, she can get it. We’re no longer recommending it because there was no science supporting that recommendation. There’s study after study that shows adverse events.
One study, 27 adverse events, during pregnancy from that campaign.
KELLY: I’m going to interrupt you, because I need to reclaim my time.
KENNEDY: Another study shows an increase in miscarriage. There’s no safety data for it, so we’re not going to recommend–
KELLY: Not true, we have a–
KENNEDY: We don’t have safety–
KELLY: We have a pediatrician that is on this committee. Not true.
…
11:30:19 CRENSHAW: Another interest of mine, and we’ve had some legislative success as well in the past couple of years, is the use of psychedelics for assisted therapy for conditions like PTSD, depression, addiction.
What steps do you plan on taking to accelerate that domestic research, clinical trial access, and the safe deployment of these kind of therapies for trauma-related disorders.
KENNEDY: We are launching clinical trials now on that at FDA.
I think there are 11 clinical trials at the VA going on at this point.
I’m particularly for our service members, retired service members, it’s critically important that we make sure that the science on this is solid, and the preliminary results are very, very encouraging, and it’s something that we want to pursue.
Martin Makary has told me that we don’t want to wait 2 years to get this done. These are people who badly need some kind of therapy, nothing else is working for them. This line of therapeutics has tremendous advantage if given in a clinical setting. And we are working very hard to make sure that that happens within 12 months.
…
11:45:27 SCHRIER: Now, I know Senator Cassidy had concerns about your views on this, and so when he voted to confirm you as secretary of HHS on February 4th, he explained that decision by saying, on the Senate floor that, quote if confirmed, you will maintain the CDC’s Advisory Committee on Immunization Practices without changes.
But then 2 weeks ago, you fired all 17 experts on that very committee. Mr. Secretary, question for you. Did you lie to Senator Cassidy when you told him you would not change this panel of experts?
KENNEDY: I never made that agreement.
SCHRIER: So are you saying that Senator Cassidy lied when he was on the Senate floor, lied to the American people?
KENNEDY: I didn’t see that statement by Senator Cassidy. I’ve only heard it from you, but if he said that I agreed to it, it would be inaccurate.
I made an agreement with him– I made an agreement with him, and he and I have talked many times about that agreement.
SCHRIER: My time. I just want to tell you that for most of us sitting here right now, we believe Senator Cassidy more than we trust you when it comes to vaccinations, it sounds to me like you gave him the answer he needed to hear in order to get his confirmation vote, and then as soon as you were secretary, you turned around and did whatever you want.
You fired all 17 members.
KENNEDY: I’m complying with all the agreements I made with Senator Cassidy.
SCHRIER: Mr. Secretary. You’re now on the record. You lied to Senator Cassidy. You have lied to the American people, you have lied to parents about vaccines for 20 years, and I also want to be clear that I will lay all responsibility for every death from a vaccine-preventable illness at your feet.
…
11:48:34 KENNEDY: Absolutely. In fact, we’re about to launch one of the biggest advertising campaigns in HHS history to encourage Americans to use wearables.
It’s a way of people can take control over their own health. They can take responsibility. They can see, as you know, what food is doing to their glucose levels, their heart rates, and a number of other metrics as they eat it. And they can begin to make good judgments about their diet, about their physical activity, about the way that they live their lives.
So we think that wearables are a key to the MAHA agenda, making America healthy again, and we are going to – my vision is that every American is wearing a wearable within 4 years.
BALDERSON: Thank you, Mr. Secretary. Following up on my previous questions, what steps will you take? And you just said that you’re going to do a big announcement, next week, to access digital health tools to track, monitor, and improve their health, while also ensuring appropriate patient data privacy, security, and protections.
In dealing with some of that, I have had questions come up, when I’ve spoken to medical groups about wearables and the privacy. Do you have anything reassuring for that, or would that be part of the announcement?
KENNEDY: Well, as I said, we, you know, we’re gonna do a major advertising campaign encouraging Americans to wear wearables.
I’ve personally had friends who’ve utterly changed their lives just from wearing a glucose meter. And they’ve lost weight, they’ve lost their diabetes, diagnoses, and you see this happen again and again. It really has a miraculous impact on health in our country.
And, it’s 80 bucks a month. And, we’re exploring ways of making sure that those costs can be paid for.
It’s– the Ozempic is costing $1,300 a month. If you can achieve the same thing with an $80 wearable, it’s a lot better for the American people.
…
12:20:56 KENNEDY: And in answer to your first question. There’s a very, very exciting new drug out there called Journavx, which is a non-opioid, very effective non-opioid pain reliever, and we are doing everything we can across our department to promote access to that solution.
…
12:41:23 KENNEDY: Congressman, the first thing that we need to do. Is to recalibrate the dietary guidelines, and we’re– those are due in December. We got a 453-page document from the Biden administration, that was just the product of the same kind of industry control that put Froot Loops at the top of the food pyramid.
And we’re now going to give Americans a 4- or 5-page document that tells them what they should be looking for, particularly in their locality. And when we do that, it’s going to drive good food, it’s going to reduce the amount of processed food in our school lunch programs, in our military, in our hospitals, and other institutions.
And it’s going to drive good food. That’s going to create markets for good food all over the country, and that’s one of the ways we penetrate the food deserts.
There’s also two programs under Medicaid to make sure that people in food deserts, on Indian reservations and urban areas, etc, can get good food.
JAMES: We absolutely have to take care of the poorest of the poor. We need to make sure that folks who deserve it can have support from us.
KENNEDY: By the way, we’re going to be– we’re going to have the dietary guidelines out at least by August, so we’re going to be months early, and I’m working with Brooke Rollins on that.
…
12:57:14 CARTER: Lastly. I’d like to bring your attention to termination of HIV vaccine studies. These cuts make up $258 million. Secretary Kennedy, did you make the decision to terminate these studies?
KENNEDY: I didn’t personally make that decision, but I understand.
CARTER: You sanctioned them. How could you possibly justify such an action?
KENNEDY: We’ve been studying HIV– been promising an HIV vaccine since 1984. And every year, Congress pours money into it, and every year–
CARTER: Because they haven’t come up with– you cut the forward motion by getting rid of NIH dollars, that critically do research that save lives, and because it hasn’t happened yet–
KENNEDY: Show me one life–
CARTER: It’s my time, sir. I can show you a whole lot of lives if you’ve got a minute. I’m insulted that you would suggest that there aren’t lives that have been lost.
People are dying every day, sir
…
12:59:30 KENNEDY: As I said, we’ve got 27 HIV divisions. Some of those were cuts, some of the studies that were not– where we poured billions of dollars in, and they were yielding nothing, have been cut.
We’re looking for a real solution. And we’re looking to do evidence-based, gold standard science. And we’re going to do that, and we’re going to do it to take care of the most desperate, most vulnerable Americans, including people of HIV, and there has been no withdrawal of any of that commitment.
…
13:13:32 KENNEDY: A couple of the congresswomen have– congressmen and woman have, on the Democratic side, have raised issues about ACIP.
The ACIP committee that we fired, was a committee that was rife with conflicts of interest, with the pharmaceutical companies. They had committed multiple acts of malpractice, including allowing, now kids, when I was a kid, got 3 vaccines. Today, it gets 69 to 92 jabs of 19 vaccines before, between conception and when they’re 18 years old.
None of them have been safety tested, with the exception of the COVID vaccine. It’s the only one that had a pre-licensing safety trial. How can you mandate, which effectively is what they do, these products to healthy children, without knowing the risk profile?
So they know. They do efficacy studies, and they show that it cures– that it averts the disease. But they don’t do safety studies, and what we’re going to do, the new ACIP panel, which has great scientists on them, none of them are anti-vax.
The leading statistician alive in the world today, Martin Kulldorff, is the chair of that committee. The inventor of the mRNA vaccine, Robert Malone, is co-chairing the committee.
We have scientists, immunologists, toxicologists, every kind of medical discipline that you would want on that committee, and we’re going to have gold standard science now, and good recommendations.
Mehmet Oz, CMS [00:24:11]
I’m going to applaud the insurance companies for taking a very thoughtful, brave first step. That stated, I know that we’re going to have to keep watching what everyone’s doing carefully.
I want to be clear about that. In reality, if the insurers industry cannot address the needs of preauthorization by themselves, there are government opportunities to get involved.
They might not be as nimble, but they will be used if we’re forced to use them.
…
Robert F. Kennedy Jr., HHS [00:34:14]
During the transition last January, one of the people I was bringing on as a special government advisor was a long-term friend of mine called Jake Levine.
And I, I asked Jake, what, can you give me an agenda of the most important things that we can do very quickly, as soon as we get in there. And Jake called a professor at Harvard named David Cutler, a famous economist who spent an entire career studying the healthcare system and advising reforms.
And he asked, he posed that question to Dr. Cutler. He said, what is the single most important thing that we could do to improve the patient experience in this country? How we could do very, very quickly without regulations and without legislation?
And Dr. Cutler immediately said to him, you can convene the insurance companies and get them to voluntarily agree to end the scourge of preauthorization.
…
Robert F. Kennedy Jr., HHS [00:39:06]
In the past, the insurance industry has made commitments to prior authorization, but they have not kept them. And in this case, we think it’s very, very different because one, the number of patients covered by this is unprecedented.
As Dr Oz said, 257 million patients are covered by the group that we met with this morning. And while we were in that meeting, another company joined the group and we expect we’re going to have rolling enrollments, so we expect many other companies to also join.
The other difference is we have standards this time. We have deliverables. We have specificity on those deliverables. We have metrics. And we have deadlines. And we have oversight.
So, we’re all going to be, I’m very grateful to the insurance company for stepping up and the hospital systems for stepping up. We’re all very, very grateful to President Trump for his leadership and giving us the impetus to make this happen.
This has been something that we have been struggling with in this country for decades, two decades of presidents have promised to do this, and none of them have succeeded.
…
Chris Klomp, CMS [00:42:11]
Industry has pledged to provide metrics along several key dimensions, including numbers and percentages of code reductions requiring prior authorization, as well as adherence to defined standards around timeliness and transparency of that process, as well as adoption of electronic prior authorization standards that are being rolled out as part of the regular rulemaking process by CMS, both for medical procedures and for pharmaceutical procedures. Those should be available on the AHIP website. We intend to publish those as well, ourselves at CMS.
…
Mehmet Oz, CMS [00:48:06]
As high as the numbers that we quoted for the insurance executives that we just met with upstairs, you know, 257 million Americans, that’s not all the Americans. So we still have about 25% of Americans who are not, whose insurance companies are not represented in the meeting today. During the meeting, another one joined.
But, they’re not all there. And until they’re all there, we’re going to keep pushing and shoving. And even the people who are already in the room agree that there’s a possibility you may have to help nudge people, herd people, so you’ll make the right decisions in a timely fashion.
But what Secretary Kennedy outlined is really critical, if we addressed inter-operability challenges of the industry, it actually helps them do what they probably want to do already.
The beautiful thing about this preauthorization process is in discussions with these insurance executives in private, they all sort of want to do it. They just couldn’t do it that easily.
So using the ability of government and under President Trump’s leadership and Secretary Kennedy’s passionate desire to address this, we made it clear that we are going to do this one way or the other. We’re going to open doors to make it easier for you to do it yourselves, without us getting involved.
Please build the nimble industry friendly system that takes care of the American people. That’s the challenge. I mean, it doesn’t work the way that we intend, as was outlined earlier, we trust but verify.
…
Mehmet Oz, CMS [00:50:15]
This is a very fast moving process. We anticipate having in place rules that will protect patients, I shouldn’t say rules. The industry, having rules for themselves in place by the end of this calendar year. So seven months from now, you’re already going to be benefiting from these decisions, if you’re a patient.
We are confident that some companies will come along. Others might not. We have the ability through the rules process to enforce preauthorization, if necessary. It is a process that is necessarily limited by a series of steps that’s there to protect all Americans in this case. And unfortunately it’s going to slow down the implementation of prior authorization.
That stated I’m optimistic, hopeful that we don’t have to do that, but it’s always in our back pocket if we need it.
…
Chris Klomp, CMS [00:51:15]
We’d like to see meaningful reductions in code counts requiring prior authorization, including several of the obvious ones that we’ve talked about, vaginal delivery. Why is that a question mark in this day and age you’re shaking your head, I do too. I think most insurers do as well. There’s opportunity to eliminate that.
That’s actually not the set of metrics I think are most compelling and will be most felt by individual patients. It’s the faxes and the phone calls that providers experience, where they then experience uncertainty often at that moment as was talked about by Dr. Oz and Secretary Kennedy and Eric, when they feel the greatest level of uncertainty, but also a despondence and despair and desire for knowledge and certainty and action, and they can’t get it.
So I am most focused, I think we are most focused on the set of metrics related to the process.
One of the goals is that by 1/1/27, at least 80% of all prior authorization requirements will be adjudicated in real time at the point of care. That’s a meaningful change in behavior. You’re sitting with your provider, they’re telling you the test that they want to order or the treatment plan that they’d like to issue. They put it into their EMR, or their other software program through FHIR based standards that CMS is identified and promulgated throughout the system, and immediately let you know where you are.
And in the event that there isn’t an approval, you have a transparent, clear timeline that you can hold your insurance company accountable for so that you can gain clarity, and that doesn’t need to add to the burden of uncertainty.
Those are the metrics that we care about. That’s the patient experience. The beneficiary experience that we’re focused on.
…
Chris Klomp, CMS [00:53:01]
What percentage are we of real time, same day adjudication? Low single digits.
It’s a little bit complicated by– you have to break down medical versus pharmacy, but it’s low. And from a patient’s perspective, exceptionally low, more than 50% of all prior authorizations are still paper based using phones and faxes. So you can imagine the timeliness of that.
…
Mehmet Oz, CMS [00:53:36]
Secretary Kennedy alluded to that. There was another effort in 2023.
I think two things have changed.
I mean, there’s violence in the streets over these issues. This is not something that is a passively accepted reality anymore. Americans are upset about it. Secretary Kennedy made it very clear from the outset that we’re going to deal with this issue one way or the other. We have legislation pending that would come in as well to codify some of these changes.
But I think the major factor is the industry realizes that some of the things that are preauthorized just don’t make any sense. And they now believe that because we could actually create a interoperable digital system, a connectivity, with very agreed on standards, this actually could become a real time process, which takes a lot of money out of the system.
Demetre Daskalakis, CDC [00:53:42]
And on the ACIP meeting, the– I would watch that because I think that’s going to be really– I don’t think we, we know what that’s going to be like.
I’m optimistic because I provide through my center, all of the data and science that should inform discussion. And so I’m hoping that that information will be the kind of thing that will trigger like really good generative discussions.
But I do think it’s one to watch.
…
Demetre Daskalakis, CDC [01:00:44]
For COVID I think that’s where it’s gonna get a little interesting because of the framework that’s that the FDA is putting out from the regulatory perspective. So the way that their framework is written is if you’re over 65, slam dunk, get the COVID vaccine. If you’re between, I think there, it was like, if you’re six months to 64, you should get the COVID vaccine based on their framework. If you have underlying conditions and their list of underlying conditions is pretty extensive where about 90% of the American population have them.
And so I think where it’s getting interesting is the recommendation for me, I’m 51, I’m healthy. I don’t have the underlying risk factors, although I guess I sit on my couch and watch TV. So maybe I’m sedentary sometimes, maybe, but that is sort of the space where they’re looking to say, does there need to be more randomized control studies to figure out the effectiveness and safety of the vaccine?
So from the CDC perspective, the data that we have in the real world, our vaccine effectiveness data, really demonstrates that there is a role for the vaccine regardless of underlying medical condition. And so that’s going to be a really interesting conversation at the ACIP, because our vaccine effectiveness data really show that.
And there is, I think, some debate as to what they would define as sort of gold standard science in sort of achieving the goal of really understanding the effectiveness of COVID vaccine. It’s going to be a really interesting area for a few years, I think.
Here are the answers to your questions. They are attributable to a CDC Spokesperson:
Q1. Am I interpreting the figures correctly that there have been now 36 cases in people with two MMR doses?
Yes. Nationally, 36 cases occurred in people that had two documented doses of MMR vaccine.
Q2. How many of those received vaccine as post-exposure prophylaxis?
None of these individuals received MMR vaccine as post-exposure prophylaxis. The vaccination data on our website reflect a patient’s vaccination status at the time of their exposure to measles.
Q3. How many of the 36 cases have been in older adults or in young children?
Of the 36 cases, none were younger than 5 years old; 5 (14%) were ages 5-19 years; 30 (83%) were ages 20 years and older; and 1 (3%) had an unknown age.
Q4. Have any of the cases been hospitalized?
None of the measles cases hospitalized this year had documented evidence of receiving two doses of MMR vaccine. The MMR vaccine is the best way to protect against measles and its complications. Disease symptoms are generally milder in vaccinated people. People who are vaccinated are also less likely to spread the disease to other people. The decision to vaccinate is a personal one. People should consult with their healthcare provider to understand their options to get a vaccine and should be informed about the potential risks and benefits associated with vaccines.
Kyle Diamantas, FDA [00:13:00]
We also are excited to embark on an effort co-led with USDA, and on behalf of other government partners, to establish a consistent definition for ultra processed foods.
We expect to post a request for information on this issue by the end of this month.
…
Elizabeth Miller, FDA [00:24:43]
And of course the last few months have seen further changes to improve efficiency and operations. I can tell you with full confidence that we are ensuring medical foods, medical products, and foods are safe, effective, and accessible for Americans and their family. And this is our top priority.
I will also note that we’ve been operating under paradigms that are frequently part of a change of administration and as well as new priorities that are emerging. And we recognize that this has impacted our collaboration.
For example, I know our current travel restrictions have impacted contract audits that help your programs conform to regulatory program standards. And we’re working on an exception to the restriction affecting these audits.
I want to thank the states that have worked with our divisions to find creative solutions, to accomplish some audits like state inspectors and auditors traveling to where the FDA investigator was located, or the state inspector picking up our investigator to conduct the audit.
Our divisions will work with you to make a plan to meet all of your audit requirements.
…
Elizabeth Miller, FDA [00:28:05]
And all of you know we have faced challenges with the loss of some of our staff, and this is not new for the federal government and more specifically for our food inspectorate.
Our staffing levels have fluctuated over the years, and I know our state cha partners face similar hiring and retention challenges for highly qualified staff.
We’re exploring different ways to expand our operational staff. You may have seen the most recent investigator announcement that was specific to the food inspectorate program. Despite the hiring freeze, we were able to get a public safety exception.
…
Kyle Diamantas, FDA [00:55:46]
We’re in a little bit of a unique spot in the human foods program, given that we did go through a large scale reorganization in October of last year. That reorganization unified FDA’s previously fractured food work in portfolios and created the human foods program, but standing up the program did leave a number of gaps and unfilled positions. And of course, on top of this year’s departures and attrition, we do have some gaps there that we are working to catch up on and fill those positions as much as possible.
I am proud to say, we have made strides in ensuring our review work, our labs, our inspectors and our compliance teams have had very limited impact to date and are running full speed ahead. And we’re also pleased to be on a path to start filling some critical review hires, having just released a series of job announcements, less than 10 days ago. And we’re confident that that those will help us fill backfill those who have retired or moved on to other opportunities and specifically, we’re prioritizing filling critical roles among our food inspectorate, I’m sure Elizabeth will reference, as well as our inspectorate adjacent roles and reviewers to help support our postmarket chem safety initiatives.
So, we are hoping to post even more announcements in the very near future. So we’re really excited about the future on training hiring and retaining key staff.
Are you able to say if any of the 6 cases with 2+ doses were seniors or required hospitalization?
…
None of the six cases with 2+ doses were seniors or required hospitalization.
Regarding the 20 measles cases confirmed so far this year in people with 2+ doses of vaccine, are you able to clarify:
(1) Does this figure include people who received their second dose from PEP?
(2) How many older adults (65+) or children are included in this figure?
(3) Were any of the vaccinated 2+ doses cases hospitalized?…
Hi Alex,
Here are the answers to your questions:
No
All 20 are children 8 years old or younger.
None of them were hospitalized.
HHS stands by its decision to end funding for research that prioritized ideological agendas over scientific rigor and meaningful outcomes for the American people. Under the leadership of Secretary Kennedy and the Trump administration, HHS is committed to ensuring that taxpayer dollars support programs rooted in evidence-based practices and gold standard science – not driven by divisive DEI mandates or gender ideology.
HHS is exploring all legal options, including filing an appeal and moving to stay the order.
Natalie Thornburg, CDC [00:07:35]
If patterns of transmission and seasonality reflect what we’ve seen in recent years, we could expect a summer, fall wave.
Last year, if you look at the COVID data tracker, we started seeing an increase in positivity, right at the very end of June, July. I’m sorry. That’s right there. Very end of, well kind of started in May, June, and we saw a peak of up to almost 20% peak in August, and in the previous year, late June, July, and we saw a peak kind of in late August as well.
So we may in the coming weeks start to see an increase in COVID activity if it is like more recent years.
…
Natalie Thornburg, CDC [00:09:02]
If you’ll think way back when we originally developed Nowcast, we had one week reporting periods, data bins, and when we kind of saw our reduction in sequences about two, three years ago, we expanded our data bins to two weeks and we’re now expanding our data bins to four weeks.
And then we’ll plan on doing updates every four weeks thereafter.
…
Natalie Thornburg, CDC [00:10:27]
What is NB dot 8.1. Well, it has been circulating internationally for a couple of months. It was prevalent in other parts of the world, earlier this spring. And it does now seem to be increasing in proportionality in the United States.
If you look at our dendogram on the COVID data tracker, it kind of sits in an odd place it sits here. So it is a sub lineage of something called XDV.1. It looks like it’s quite different than everything else that’s been circulating since winter of 23, 24 has been JN.1.
But it’s actually very similar to these viruses. This is not accurately– this location in the dendogram does not accurately represent how different it is. It is XDV.1 is a recombination event between JN.1 and an XBB virus, which is why it’s sort of rooted upstream of JN.1, but it is very, very similar to XEC, which is the lineage that was most prevalent, sort of during that large peak in the fall of 2024.
Notably, it has two substitutions in the spike protein that are a little different. It’s got one at residue 435. We’re seeing that substitution pop up in several lineages. So that’s indicating that it’s got some sort of selective advantage. And then there’s a substitution at 478 in the spike protein, which is a little bit unique to NB.1.8.1.
Now there’s – there is a little bit of data, some laboratory data looking at sort of like cross neutralization of current lineages. And there’s no data that indicates that this virus is antigenically much very different than anything else that is currently circulating.
So everything else that’s circulating and has been circulating for about a year, year and a half are all descended from JN.1, which is the current vaccine strain, JN.1.
So this is, it does seem to have a little bit of a selective advantage, but it doesn’t seem to be dramatically different than anything else that has circulated in the past year and a half.
…
Natalie Thornburg, CDC [00:13:11]
So we like to have about 3,000 to accurately detect new emerging lineages and to use for Nowcast modeling. We like to have about 3,000.
In the most, I think the past two times we’ve done this analysis, we’ve only had about 500, so we are still not going to have the number that we like to have, but a thousand is much better than 500.
Now, notably we only use sequences that CDC generates, or that are tagged as baseline in public repositories.
There are a lot of sequences that are in there that aren’t tagged baseline. So we don’t know if they could be from outbreaks or something specific.
So we don’t use those in our analysis because we don’t know that they are representative of everything that is circulating in the community.
…
Natalie Thornburg, CDC [00:15:59]
We don’t have any data to indicate the symptoms are any different than any other lineage that has circulated previously.
…
Brian Wakeman, CDC [00:19:03]
There are 1,197 confirmed measles cases in 35 different jurisdictions with the largest outbreak centered in Texas, specifically west Texas.
Additional cases have been seeded from the outbreak in Texas, as well as related outbreaks in Mexico and Canada. Additionally, measles importation from international travel continues, especially as the busy summer of travel season ramps up.
…
Brian Wakeman, CDC [00:20:07]
As you can see the number of confirmed measles cases is significantly higher than 2023 and 2024. And we’re currently on pace to eclipse the 1,274 cases of measles that we saw in 2019, with a large outbreak concentrated in New York. And we’re also on pace to be the greatest number of measles cases since the early 90’s.
…
Brian Wakeman, CDC [00:24:36]
So these days, most U.S. measles cases are detected by PCR, typically performed on NP and OP swabs, but can also be detected in urine. PCR is most commonly done in public health laboratories, but can also be done in commercial laboratories.
Quick turnaround time for testing is crucial. Specimens are ideally collected within three days of rash onset for optimal sensitivity, but PCR can be positive up to 10 days after rash onset.
It’s best to collect specimens for RT-PCR as soon as possible after rash onset to optimize detection, proper specimen collection storage, and processing’s important to maintain the stability. RT-PCR has a much higher sensitivity and specificity than serology, as most people know, but false positives can occur, but it’s much less common.
…
Brian Wakeman, CDC [00:25:43]
We’ve been getting some questions about primer mismatch with some measles variants that in the past have shown a 3UC mutation. That mismatch is fixed by adding a reverse primary containing the mismatch at a 50 50 ratio.
…
Brian Wakeman, CDC [00:34:02]
There’s only been 14 of those variants detected in the U.S. since 2023 and none have been detected in 2025. There was a paper put out by the CDC, and you can email us at CDC measles lab at CDC dot gov, but the paper is Beck et al 2024, Eurosurveillance paper.
I’m grateful to have been part of such important and effective work that has provided decision-makers with real-time, high-quality, rigorous scientific evidence that have been used to track disease severity over time, tailor vaccine messaging to groups at highest risk for severe disease and provide critical inputs for vaccine cost- effectiveness analyses.
Of all the work we have accomplished, I am most proud of how COVID-NET and RSV-NET hospitalization data, presented at nearly every public ACIP meeting since 2020, have been critical drivers of COVID-19 and RSV vaccine policy in recent years. As an infectious disease physician dedicated to ensuring that decision-makers can develop evidence-based immunization strategies to protect individuals and communities from vaccine- preventable diseases, I deeply value the impact we have created together. I have complete confidence that RESP-NET will continue to be a critical resource and that the RESP-NET team - including CDC and our academic and state and local health partners - will continue to generate epidemiologic and clinical data of the highest quality. Unfortunately, I no longer have confidence that these data will be used objectively or evaluated with appropriate scientific rigor to make evidence-based vaccine policy decisions.
Martin Makary, FDA [01:29:26]
You want your body to be in a low inflammatory state. That means avoiding simple sugars over– complex sugars are slower to absorb, so they’re not as bad as the refined sugars, but generally speaking, you want a low carbohydrate load in your system. If you want go mega healthy and try keto, I think it takes a lot of discipline, but certainly any of those diets, be it south beach keto, low carb, you name it. Anything is gonna be better than the standard American diet or what we call SAD, the sad diet.
So any of those, those are all pro-health things. Avoid the processed foods, avoid things that are premade and you sort of pull out of a can or and cook, generally speaking, things that you can cook are going to be healthier than things that you can just buy and eat.
Be careful about pesticides, Roundup, there’s a report showing that it probably causes cancer. That’s what the report said. They got to be careful, of course, with lawyers, I can just tell you right off the bat, I avoid it all together.
Roundup is a weed killer and it’s on almost all these non-organic things that we eat: produce, fruit, vegetables, you name it. So a strawberry has been sprayed on average 15 times.
Question [01:30:54]
How do you avoid the pesticides?
Martin Makary, FDA [01:30:56]
So you want to buy organic produce when, especially when there’s the peel that you’re going to be consuming the peel when, when buying fish, you want to avoid fish that are farmed in closed environments because the heavy metals build up in the fish, fish can be very healthy, omega three fats are good. They balance out the omega three omega six imbalance that we have in our modern diet.
…
Martin Makary, FDA [01:32:21]
I don’t subscribe to the modern day phenomena of, produced by the food industry, that everyone has to eat a large breakfast in the morning. I don’t think we were made like that. I think, I don’t think our biome was designed for it.
I think that hunters and gatherers would get these large sums of food and then sort of eat large meals. And I think that’s why you’re seeing the micro and mini-fasting movement grow in the United States.
There was a small animal experiment that showed if you sort of segmentally fast, the animals that they could have a better longevity. So it created a lot of interest. Of course it wasn’t– it was kind of a sloppy study, but maybe there’s something to fasting.
If you think about how we were designed, how we sort of changed over time, did we really have food in four and five hour increments? All of our waking hours? No.
So these, when the food industry puts these things out like milk, right, we have to drink milk. Why are we drinking milk? Were we really meant to drink so much cows milk? Is that how– all right, this is messing up the human biome. And so I like either macadamia milk, I like almond milk or a mix of different types of milk.
I don’t love coconut milk that much, although anything with coconut is generally very healthy. You can put it on your skin, use it as suntan lotion, cook with it. It’s great. Anything coconut’s great.
The Defend the Spend initiative is a department-wide effort to ensure that taxpayer dollars are being used effectively, transparently, and in alignment with this administration. As part of this oversight, grant recipients may be asked to provide additional information, which is essential to preventing waste, fraud, and abuse. HHS is committed to working all grantees to resolve outstanding issues as quickly as possible while maintaining the highest standards of accountability.
HHS and CMS take the integrity of the Medicaid program and the protection of American taxpayer dollars extremely seriously. With respect to the recent data sharing between CMS and DHS, HHS acted entirely within its legal authority – and in full compliance with all applicable laws – to ensure that Medicaid benefits are reserved for individuals who are lawfully entitled to receive them.
This action is not unprecedented. What is unprecedented is the systemic neglect and policy failures under the Biden-Harris administration that opened the floodgates for illegal immigrants to exploit Medicaid – and forced hardworking Americans to foot the bill. In states like California, these failures are now on full display. While millions of Americans struggle to afford care, the state of California has aggressively expanded its taxpayer-funded health benefits to cover illegal immigrants – directly defying the intent of federal Medicaid law. California provides free, full-scope Medicaid coverage to low-income illegal immigrants, no questions asked. The Biden administration looked the other way and allowed federal funds to potentially flow into a system that is ripe for abuse.
The Biden administration not only failed to enforce the law—it actively created the conditions for abuse. Through rulemaking and policy guidance, it weakened state oversight, discouraged immigration verification, and tied the hands of CMS and state agencies alike. These deliberate choices have cost American taxpayers dearly and allowed benefits to be siphoned away from the vulnerable citizens they were designed to serve.
That ends now.
Under the leadership of Dr. Oz, CMS is aggressively cracking down on states that may be misusing federal Medicaid funds to subsidize care for illegal immigrants. This oversight effort – supported by lawful interagency data sharing with DHS – is focused on identifying waste, fraud, and systemic abuse. We are not only protecting taxpayer dollars – we are restoring credibility to one of America’s most vital programs. The American people deserve accountability. HHS is delivering it.
Secretary Kennedy is restoring public trust by reconstituting ACIP with highly credentialed doctors, scientists, and public health experts committed to evidence-based medicine, gold standard science, and common sense.
Unlike the old ACIP that had become little more than a rubber stamp for any vaccine, this group will go where the science takes them. They will demand definitive safety and efficacy data for any new vaccine recommendations. They will also review safety and efficacy data for the current vaccine schedule.
Before starting work on ACIP, the new members’ ethics agreements will be made public. Every ACIP member will be vetted in accordance with their ethics agreement before they are permitted to participate in each meeting agenda item.
The new ACIP members with experience serving on similar HHS expert panels include:
Martin Kulldorff, MD, PhD, served on the CDC’s Vaccine Safety Subgroup of ACIP and on the FDA’s Drug Safety and Risk Management Advisory Committee.
Cody Meissner, MD, served on both ACIP and the FDA’s Vaccines and Related Biological Products Advisory Committee.
Vicky Pebsworth, OP, PhD, RN, served on the FDA’s Vaccines and Related Biological Products Advisory Committee.
Michael A. Ross, MD, served on the CDC’s Advisory Committee for the Prevention of Breast and Cervical Cancer.Secretary Kennedy has replaced vaccine groupthink with a diversity of viewpoints on ACIP.
03;43;40 KENNEDY
We are not going to allow anybody with conflicts of interest on there.
I think, you know, and you had posted the criticism of my choice by Senator Cassidy and a claim that I had promised Senator Cassidy not to change the vaccine panels. That’s not true.
What I told Senator Cassidy is that I would allow him to put one of his candidates on which we are going to do.
Dr. Ross was an affiliate faculty member with the Virginia Commonwealth University School of Medicine’s Inova Campus from 2006 to 2021. Inova was a regional campus for the VCU School of Medicine at that time. That campus relationship ended in 2021, as did Dr. Ross’ faculty status with VCU.
He was a clinical professor and just simply stopped teaching medical students or residents.
Dr. Michael Ross has not held a faculty appointment at the George Washington University since 2017.
“Based on the HHS announcement Monday, we no longer meet the requirement of at least two ACIP voting members in attendance to convene the COVID-19 Work Group tomorrow. As such, we will send out a cancellation for the meeting shortly.
We will be in touch as we receive further guidance, particularly as it relates to the June ACIP meeting and future Work Group meetings. Thank you all for your patience and understanding.”
ACIP FAQ
What Authority Does the Secretary Have to Reform ACIP?
42 USC § 217a give the Secretary the authority to establish discretionary advisory committees, such as the Advisory Committee on Immunization Practices (ACIP). As a Federal Advisory Committee covered under the Federal Advisory Committee Act and its implementing regulations, “advisory committee members serve at the pleasure of the appointing or inviting authority. Membership terms are at the sole discretion of the appointing or inviting authority.” 41 C.F.R. § 120-3.130(a).
Why Did the Secretary Do This?
The American people elected President Trump to support a review of vaccine policy to improve public trust in vaccines. The Biden administration attempted to block a full scientific review of vaccines by appointing members on the ACIP at the Centers for Disease Control and Prevention (CDC) before President Trump assumed office. The previous administration tried to prevent membership changes until 2028. This action will restore regular order to the important vaccine committee. Secretary Kennedy is restoring transparency and gold standard science to ACIP.
How was the current ACIP Roster Appointed?
All the current ACIP members are Biden appointees. 13 were appointed and one term was extended in 2024, and three appointments were made in 2021. Several were appointed after the election in the “Midnight Hour” of the Biden administration.
Does This Affect Private Insurance Coverage, Medicaid, or the Vaccines for Children Program?
This decision does not affect insurance coverage or any program that relies on ACIP recommendations.
Does This Affect the Vaccine Schedules?
This decision does not affect the childhood vaccine schedule.
How Are New Members Being Selected?
New members will be selected through a rigorous examination of their scientific credentials and a comprehensive ethics review for potential conflicts of interest.
Will the June ACIP Meeting Still Go Forward?
The June ACIP meeting that was announced on Friday, June 6th will go forward as scheduled.
Is There Precedent for HHS Secretaries to Use their Authority to Make Changes to the Composition of this Panel?
What President Biden did to ACIP was truly unprecedented, including stacking the ACIP in the final year of a presidential term through “Midnight Hour” appointments. Increasing ACIP membership beyond the historical 15 or 16 members, was also unprecedented.
Secretary Kennedy is restoring the Committee to precedent and reconstituting ACIP into an objective scientific body, rather than a political forum
Does this Personnel Change Affect ACIP Procedures?
No.
Are the Terms of New Members Staggered or will there Need to be a Completely New Board After New Members Serve Their 4-Year Term?
The new members will be appointed with staggered two- to four-year terms to ensure that ACIP returns to regular order and retains institutional knowledge.
How Will HHS Ensure Balance of Views Being Represented When Filling All New Member Seats?
We will be appointing scientists, public health experts, and doctors to ensure balanced membership in terms of the points of view represented and the functions to be performed so that all vaccine recommendations are made without bias.
What Is the Role of the Secretary in the Member Nomination Selection Process in the Absence of a CDC Director?
The Secretary is vested with the authority to make these appointments in accordance with statutory authority under 42 USC 217a and regulatory authority found in 41 C.F.R. § 120-3.130(a).
Does this Announcement Affect the 31 Non-Voting Liaison Representatives from the American Academy of Family Physicians, American Academy of Pediatrics, et al?
Liaison membership is not affected.
Robert F. Kennedy Jr. [05:26:58]
In terms of changes to ACIP, this had been a long time coming.
More than two decades ago, Congress investigated ACIP, the government oversight committee found that, for example, that year, which was 2003, gave one example that 4 out of the 5 people who added the rotavirus vaccine to the schedule had direct financial interest in that vaccine. One of those individuals voted the rotavirus onto the vaccine and sold his rotavirus vaccine that he had in development for $186 million. He said he won the lottery.
That year, Congress says that 97% of the people on ACIP had undisclosed conflicts. So people have known about this for years.
You know, probably the worst example of malevolent malpractice has been adding all of these new products to this schedule without doing pre-licensing safety studies. In 1986, there were 11 vaccines on the schedule. Today, a compliant child must take between 69 and 92 vaccines to stay in school in some states. And not one of them has been safety tested in a pre licensing placebo controlled trial. And that is just malpractice.
So the people who are in charge of that are now gone, and we’re going to bring people onto the ACIP panel, not anti-vaxxers, who are bringing people on who are credentialed scientists, who are highly credentialed physicians, who are going to do evidence based medicine, who are going to be objective and who are going to follow the science and make critical public health determinations for our children based upon the best science.
BALDWIN 10:31:00
Dr. Bhattacharya, I’m struggling to find a reason why NIH would implement this forward funding policy. How is this proposal anything but intentionally sabotaging biomedical research?
BHATTACHARYA
So, Senator, a couple of things. So, one is, regarding funding for this year, Congress allocated the money. My job is to make sure that the money goes to excellent research projects. My intention is that we will spend–
BALDWIN
I’m asking about the forward funding proposal that disguises even deeper cuts in the NIH budget than the budget submission would suggest.
BHATTACHARYA
Yeah, so I just wanted to preface my answer to that, because you asked that also. But, as regarding forward funding, that’s a budget proposal. I mean, again, the–
BALDWIN
Well, you don’t deny that it reduces the amount that will be spent on biomedical research next year by an even deeper amount than the 18 billion dollars, 40% cut already.
BHATTACHARYA
Right, so the way the forward funding works, right now we have multi-year projects that we fund. And forward funding says we will allocate the money for those multi-year projects this year, rather than in the out years. In principle–
BALDWIN
And so, if it’s a four-year project, three of the years will sit in an escrow account and not be spent next year. Again, further diminishing the amount that will be spent on biomedical research.
BHATTACHARYA
I think, I mean– I think the thing is, in the long run, what it does is allow you to spend more money and have more flexibility for new research projects. That’s because what it says–
BALDWIN
That’s funny math.
BHATTACHARYA
I mean, it’s just the math. I mean, I’m an economist, also. What it does is it says, look, let’s allocate the money this year so that next year, the money isn’t tied up for– on previous years’ projects. That’s, in the long run.
I think, as I said, I’m happy to work with Congress and looking forward to working with Congress on this. This is a budget proposal, not a final thing.
I think if I had to start and redesign the system again from the start, allowing more flexibility as new scientific opportunities come up with the forward funding model makes– allows that to happen, actually, more than the current model where large fractions of the NIH budget are tied up with old projects.
So I think that– but as the transition in, it really matters how we do it, and so I’m absolutely really glad to work with Congress on that, to make sure that there’s no disruptions.
…
10:41:49 DURBIN
When you look at specific schools, of course, I’m concerned about Illinois. We have great research there.
Northwestern University has not received a penny for NIH grants in 11 weeks. 1,359 NIH awards to Northwestern have been frozen or terminated, halting $81 million in research to date.
I could go through some of the specifics of this research. But it includes $9 million in clinical trials for brain cancer, colon cancer, breast cancer, childhood cancer. How are you able to reconcile these budget decisions, with the reality of research and what it means to alleviate suffering, and more importantly, they give people hope, if research is underway, you at least have the hope that maybe there’ll be a cure, maybe in the lifetime of someone I love.
How can you walk away from that?
BHATTACHARYA
It was my intention not to walk away from that. I mean, I think that–
DURBIN
But the budget speaks for itself. You cut $18 billion in research.
BHATTACHARYA
Senator, the budget is a collaboration between Congress and the administration. So, you know, I look forward to talking about the advances that NIH researchers have made.
I mean, I think the transition has been a very bumpy time, and I don’t mean to, like, downplay that, but there have been opportunities for reform for how the biomedical research enterprise works.
I think the decisions about Northwestern happened before I got into office, but– let me just say that–
DURBIN
The buck stops in your office.
BHATTACHARYA
I know it does, so let me just say that–
DURBIN
Don’t blame another person.
BHATTACHARYA
I’m not blaming anybody.
DURBIN
We’re asking you, and you’re in charge.
BHATTACHARYA
Senator, I agree with that. So let me just say that I think that the way that the universities operated during the pandemic wasn’t always– didn’t always make it easy for scientists to–to do their work. I can tell you that personally, from being a professor. And I think, some of the—
…
DURBIN
But eliminating grants, eliminating research, how can that solve the problem?
BHATTACHARYA
So, I think that I’m very hopeful that a resolution can be made with the universities where those decisions have been– those grants have been paused.
I’ve worked very hard to make sure, for instance, at Harvard, we didn’t pause grants, for instance, to the medical centers, because there were clinical trials going on.
But I think that this is– I’m very hopeful that these universities where these pauses have happened will come to terms so that we can move forward with the agenda that I think you and I both share.
…
BHATTACHARYA 11:15:38
Senator, can I just address the HIV? Because I am absolutely committed to the– in 2019, President Trump issued a challenge for us to eliminate the threat of HIV in this country. And we’ve had a 22% reduction in HIV transmission since then.
We now have the technological tools to do that. And I’ve been working on developing a program to actually implement this vision, so we can use—
MURRAY
But you did terminate the HIV research at Fred Hutch that, again, was on the cusp of a treatment for 6,000 patients nationwide. You did do that.
BHATTACHARYA
I’d have to get back to you on that.
MURRAY
You did do that.
BHATTACHARYA
Senator, I mean, I think we actually have now the chance, with existing technologies, lenacapavir and other technologies, to actually address—
MURRAY
I’m delighted to hear that, but I’m just telling you what clinical trials have been terminated. And I’m asking you this because we have to write an appropriations bill.
…
SHAHEEN 11:26:32
We had this conversation, as you pointed out, and that’s why it was so puzzling to me to see what the budget proposes in terms of slashing the funding for NIDDK.
So help me understand why that is and how that’s going to improve our research into diabetes?
BHATTACHARYA
Senator, I think the budget is a negotiation, a collaboration between the administration and Congress, and you’ll have your say.
I think for my job is to make sure that the funds that you all appropriate to me make—are– go to advancing and meeting the health needs of the American people.
I think that that’s– that’s a productive thing. I’m hearing from basically everybody that the NIH is a valued – is really valued in Congress, and I find that gratifying.
I value the NIH, and so you know, I don’t– the administration, President Trump has committed the that the U.S. be the leading nation in biomedicine in the 21st century, and I entirely support that goal.
SHAHEEN
Well, I do too, but it’s hard to understand how we’re going to get there when the budget slashes funding, particularly in critical areas of research.
…
BHATTACHARYA 11:32:56
Senator, I’ve established a process for appeals for those grant terminations and decisions. And hundreds of people have appealed.
It won’t take 18 months. It’ll take weeks to get through those appeals. We’ve reversed many of them.
I mean, I didn’t take this job to terminate grants. I took this job to make sure that we do the research that advances the health needs of the American people
SCHATZ
Okay, so give me, like, a time frame for processing all of them.
BHATTACHARYA
I mean, it’s hard to promise a specific timeframe, but it won’t take– it won’t be years, it’ll be weeks.
I mean, I spent the last couple of weeks– last few weeks, I think it was, like, a month ago, we set up the appeals process.
And they’ve been working through those numbers, those grant applications.
SCHATZ
Can we agree that we shouldn’t do it that way again?
BHATTACHARYA
I mean, I—
SCHATZ
I know you have to survive in this administration, but can we agree that this is not the most helpful way to do things?
BHATTACHARYA
I mean, I think a lot of those decisions were made before I got in.
Per the June 9, 2025 directive from the Secretary of the U.S. Department of Health and Human Services, this email serves as formal notice of your immediate termination as a member of the Advisory Committee on Immunization Practices (ACIP). We appreciate your prior service and commitment
QUESTION 03:34:45
Do you believe that some vaccines save lives?
BHATTACHARYA 03:34:53
Yes. Many vaccines save lives.
QUESTION 03:34:56
Do you believe that some vaccines that are given to children save lives?
BHATTACHARYA 03:35:01
Yes.
QUESTION 03:35:02
Do you believe that some vaccines are known to be harmful and yet still given?
BHATTACHARYA 03:35:07
Let me, let me say a specific one.
I think the COVID vaccine for children, in particular, I don’t think is net beneficial for kids
QUESTION 03:35:14
Not– but you said not net beneficial? Does that mean it’s harmful?
BHATTACHARYA 03:35:19
Net harmful.
QUESTION 03:35:20
You believe that the COVID vaccine is net harmful–
BHATTACHARYA 03:35:23
For– especially for young men.
QUESTION 03:35:25
Can you define the age cutoff there?
BHATTACHARYA 03:35:27
We can argue about this. Like there’s a scientific– but I think it’s pretty clear that, I don’t know, somewhere between age 12 and 30 or something for boys and men, young men, the COVID vaccine is probably net harmful.
Again, with full boys who have no other underlying conditions and all that, there’s–
QUESTION 03:35:46
Not obese, no heart condition–
BHATTACHARYA 03:35:48
Well, I mean, even obese, you have to like, look at the numbers.
I mean, I there’s lots of debates and fights over this in scientific literature. So I hesitate to like actually give you a specific age threshold, but I think just as a general matter, there exist groups for whom the COVID vaccine was net harmful, specifically young men.
QUESTION 03:36:05
Do you think there’s any reason to think that the adjuvants that essentially what the vaccines are suspended in, not the vaccines themselves, are potentially harmful? I’ve heard this. I don’t– I am personally not aware of any strong evidence for it.
BHATTACHARYA 03:36:21
I think these are one, these are the kind of things that ought to be investigated, but it’s very difficult to investigate just because of the sort of like political aura around vaccines, where if you ask, if you are– if you really do investigate it and find something, that’s the public health authorities don’t like, you’re going to have trouble.
I think there– I don’t know the answer to that question, from a scientific point of view.
…
BHATTACHARYA 04:08:57
I think that there’s good evidence on the MMR vaccine that, of failing to find a link with autism.
There’s, and I don’t know the full extent of this literature, so I shouldn’t comment too much, but I’ve – when I’ve looked I haven’t seen quite the same level of evidence for some of the other vaccines failing– just haven’t that again, they just haven’t looked.
As a general matter, I think it’s an unlikely, just from a biological point of view, unlikely to be the main reason why autism– the rise in autism, which is now well documented that you talked about, has occurred.
So to me, the question then is thinking about autism, you’re asking, and you want to tell parents, answer for parents, well, what does cause what does, has led to the rise in the prevalence of autism?
The honest answer is, I don’t know, you focused on what’re focused now in this conversation on just one potential cause, vaccines. To me, it’s unlikely that they are the reason for the rise in the cause of autism. But there are many other potential hypotheses for the rise in the prevalence of autism that I’ve seen, so alterations, the gut microbiome I’ve seen.
…
BHATTACHARYA 04:11:44
Unless you understand the etiology, it might be different etiology for kids in different parts of the spectrum, then you’re never gonna have good answers, both for prevention and also for therapies.
So it’s that question that Bobby Kennedy’s asked me to answer or try to get an answer. And that President Trump has asked to get an answer and I think it’s appropriate because if you ask me what is, I mean, we just talked about vaccines as a potential cause I think it’s unlikely to be the cause, but you can see my mind is open, for depending on the levels of evidence I’ve seen.
Now, this is not my area, right. Just, I should say this, like I’m saying this as someone who’s now like tried to wade into it some just to get a sense of it. But, as I’ve waited into it, it’s very, very clear that there is not a scientific question, a consensus answering the question of what causes the rise in autism or what is the etiology of autism.
…
BHATTACHARYA 04:15:33
So what I’ve done is I’ve organized an initiative inside the NIH to address this question of the etiology of autism.
QUESTION:
Not limited to vaccines?
BHATTACHARYA
No, wide ranging, it includes basic science work. It includes epidemiological work, it’ll include environmental exposure work, includes all – and we’ll bring together data sets that will make available to the researchers. We will have a competition among scientists, just like the normal NIH way with peer review panels, to ask who should get the awards.
We’ll have a dozen or more scientific teams asking the question, what is the etiology of autism. We’ll have that, I think that normally it takes a year or longer to set up a thing like this. We’ll, by September, we’ll have like an open competition for these scientific projects.
And, you can’t rush science, but hoping within a relatively short period of time, who knows how long exactly depends on how science works. We’ll have a much better understanding of the etiology of autism than we have at this current moment.
…
BHATTACHARYA 04:16:49
On vaccines, can I say one thing?
Now, I don’t want to—as the NIH director, I don’t want to put my thumb on the scale on any part of these potential etiologies, right. As I already said, I’m not particularly an expert in this area.
And so even if I were to put my thumb on the scale, would be from, not from the point of view of expertise, it would just be the point of view of, like, I just happened to read the literature and I was impressed by X, Y, or Z.
But if I were to put my thumb on the scale, I think it would make it more difficult, A for scientists to ask the question, honestly, because they want to impress the NIH director or something and then B for the public to trust the result at the end.
I want an open-minded– So this is why like I—I was asked, well, if you don’t believe that vaccine, these vaccines cause autism, why would you allow that people to ask that as a part of the research agenda? And my answer is that a lot of people, especially in the public, but that, and even some scientists who disagree with me and I want them to have their say, I want an honest conversation.
I think that if you have an honest evaluation, you’re not going find that that vaccines are the primary reason for the cause of the rise autism you’re going to be, it’s going to be something much more fundamental and complicated, but I don’t want the results to be disbelieved because I put my thumb on the scale.
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BHATTACHARYA 04:18:25
The other thing about the initiative, it’s very important to understand we’re working with autistic parents, we’re working with the autism community, right?
It’s—a lot of times scientists, when they study things, we put ourselves above and we like, it’s like, we’re like examining amoeba or something on a slide. When you do population research, you have to work with the communities that you actually trying to help. And that’s exactly the spirit of this.
We’re going to work with communities of autistic kids and parents. And we’re going to apply rigorous research methods with control groups and just the normal of sort of like high quality, the term of art nowadays is gold standard science, like we’re going to try apply gold standard science to this and subject it to the same kind of replicability standards I want all science subject to.
From: Buzzelli, Matthew J (Matt) (CDC/IOD)
Sent: Monday, June 9, 2025 9:34 AM
To: CDC Senior Leadership
Subject: All Staff MeetingAll,
The upcoming CDC All-Staff meeting will be rescheduled to a later date. While we had intended to share several important leadership updates this week, these matters remain under review and are still in progress. We believe it will be more effective to convene once the planned updates are finalized.
We recognize that many staff have been preparing for the meeting and that there was strong interest and anticipation across the organization. We appreciate these efforts and know they will contribute meaningfully when the all-staff takes place.
A revised date will be announced in the near future. Please feel free to communicate this update with your staff as appropriate.
Regards,
Matt Buzzelli
Chief of Staff
Centers for Disease Control and Prevention
The FDA remains fully capable of fulfilling its public health mission to protect the safety of the American people. Under Commissioner Makary’s leadership, the agency continues to meet its inspection obligations, ensuring that all facilities are reviewed within mandated timeframes.
Question [00:11:13]
At a governmental level, where do you think we start with this? Because it’s hard. You can’t make seed oils illegal, you know. Is it education? Is it–
Robert F. Kennedy Jr. [00:11:21]
I think it’s a combination of things. Some of the really bad stuff we’re going to withdraw the– we’re going to revoke the approvals of, for example, dyes, the petroleum based dyes.
There’s other components and ingredients in our food that we’re– we’re going to give people a choice. If you want to eat them, you can eat them, but you want to know what you’re doing to yourself.
Question [00:11:45]
So some labeling?
Robert F. Kennedy Jr. [00:11:46]
It’s going to be probably labeling, but also just really good science so that people know, and people can, mothers can walk in the grocery store and use an app to tell them what can I be– what I ought be feeding our kids.
And we’re going to use technology. We’re going to use and encourage use of glucose meters, wearables.
Things that can tell you, as you eat in real time, here’s what’s happening to my glucose, here’s what’s happening to my insulin resistance, and give what the power to make everybody the CEO of their own health. So that Americans can take control of their health.
Steven Abrams, Panelist [10:12:53]
There are some basic things like iron, calcium and phosphorus that have a tremendous need to be updating and harmonize as best possible with European and Codex, which are World Health Organization standards.
Our standards for these nutrients in many cases are quite different. And just to give you an example, the iron in infant formula in the United States is much higher than it is allowed to even be in Europe. And the current science supports the European perspective.
So it’s a chance for us to take a look at every nutrient, not just the seed oils and say, do we need to set our limits? Where do we need to look at what needs to be done? And can we harmonize so that the world sees formula in one way and families, as they’re trying to say, well, I want to buy a formula that’s made in Europe can understand that the formulas made in the United States meet those same standards for them.
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Marty Makary, FDA [10:03:16]
We really want to learn from you. We desperately need to innovate in this space and that means regulatory innovation.
So we want to hear your ideas unprompted, unfiltered, tell us exactly what you think needs to be done to improve the health of babies and children in the United States and worldwide through the regulatory authorities that we have.
And I mean that sincerely as moms want to see more options for formula, they want to see formula options without seed oils. They want to see formula options without corn syrup. They want to see formula options without added sugar, and some of those are already on the market.
And in other spaces, we, as a regulatory body can help facilitate some of that innovation.
There’s been almost no change to the monograph for baby formula since 1998, with the exception of adding selenium.
Now, in my view, the field of medical science does not stay stagnant for 26 years in any space. And it’s hard to believe that is the only sort of enlightened moment that we’ve had in understanding how best to nourish children.
There are people who are concerned about the heavy metal levels in formula. And I think for foremost to this entire conversation, we have to acknowledge that we all want the same thing.
There are no malicious actors and we have to see the best in everybody, and this should not be a us versus them with any stakeholder group or any innovator developer or company out there.
This is an expert forum to ask how can we think collectively about what’s best for some of the most vulnerable in our nation.
Gandhi once said that the true measure of any society can be found in how it treats its most vulnerable members, our seniors and our children.
And so, we look forward to your ideas. We are going to take them very seriously.
This is not a horse and pony show where you get to say what you think. And then we ignore it and say that we had a forum. This is a true listening session.
And so we are going to take your ideas and go back to our subject matter experts and the terrific career scientists at the FDA who have been working on this and our policy staff and ask, what can we do differently?
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Tom Brenna, Panelist [10:20:29]
So now I get onto the topic of seed oils. Well, seed oils are one sort of oil. There’s two other kinds of oils, fruit oils and let’s say cows milk fat, and you can maybe think of other ones, but those are the major ones.
And the thing I want to – the one point that I want to make scientifically here is that it’s not just about some problem with seed oils. They’re– it’s not all seed oils are the same.
So in this study, rhesus monkeys, pregnant rhesus monkeys were fed formulas that had all of their fat that came from either soybean oil or from safflower oil, both seed oils on the hit parade these days.
And, so when the infants were born, they were weaned to those essentially formulas where that was the only source of fat and what they measured was visual acuity.
Now visual acuity in humans or primates or pretty much any other mammal is a measure of brain development, not just retinal development. And what you find is that with safflower oil, which is very omega-3 deficient, much less, much slower development of visual acuity, and that’s the lower line there, and I don’t really have a pointer, but if you get to the end there’s a red circle, and that corresponds on the eye chart to about a 2100, on our familiar scale where 2020 is normal vision. But in soybean oil, which has some omega 3, it’s got the plant one, but it has some omega 3. They have a vision at 12 weeks of age of 2050, so much, much better.
And, as it turns out, if you give these same animals a source of omega 3’s, EPA and DHA, so fish oil, classic fish oil, when they get a little bit older, let’s say starting at about a year, the ones that on the lower curve don’t recover. So you’ve gotta get this right early on. That’s another salient point we have to make.
So it’s not just about seed oils, it’s about what we replaced them with. Something like 60 or 70% of the edible oils in the United States are seed oils. And so if we shut it off tomorrow, domestic seed oil, I should say. So, there are things we can do to make it better. There’s no question about that.
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Michael Goran, Panelist [11:05:06]
The FDA regulates these older regulations that we’re talking about, they only regulate the amount of carbohydrate, not the type of carbohydrate. So during the last 20 or 30 years, there’s been all kinds of different types of carbohydrates introduced into infant formula. And in fact, now today, the majority of infant formula sold in the U.S. is made with non lactose sugars, such as sucrose, which is ordinary table sugar. But most of the non lactose formulas are in fact made with corn syrup solids, which is a glucose polymer, meaning it’s a big molecule of glucose, sugars joint together, in one big polymer. So there’s no, there’s no galactose there. So it’s a very different type of sugar, it is handled quite differently in the body.
And, this I think has occurred through a series of concerning situations, mostly due to misunderstanding by the public, as well as advertising and marketing claims, based on the concept of lactose intolerance in babies. So these are often sold as gentle formulas or marketed towards fussy babies, but actually this– the fact is that almost all full term babies can digest lactose, which is the only carbohydrate energy source in breast milk.
Now, in addition, um, emerging research just quite recently, probably in the last five or 10 years is beginning to show that these non lactose carbohydrates in formula are linked to a number of different outcomes, including alteration of the infant microbiome, which is the colonization of gut of microbes in the gut changes and taste and food preference because these glucose polymers from corn syrup are much sweeter than lactose and also a study that we published a couple of years ago in collaboration with WIC, so it was a very large population, showing an increased risk of obesity in children who were fed formula made with corn syrup versus traditional formula made with lactoses.
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Michael Goran, Panelist [11:10:02]
I think there should be consideration just like the EU is doing to determine an allowable level of glucose polymers that that would be okay to deal with, to deal with as a, and or a required level of lactose should be determined.
It’s very hard for consumers to know, other than looking at the ingredient list on the back of the product, whether either lactose or milk sugar would be listed as an ingredient or something like corn syrup, it would be listed as the ingredient. There’s no other labeling law.
I think there should be consideration if there is lactose intolerance. I don’t know why there was a decision made to go straight to corn syrup to resolve that issue. That’s not what adults with lactose intolerance would do. So there should– could be a consideration to break apart the lactose into the residual sugars of glucose and galactose, as probably a healthier issue than using corn syrup.
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Steven Abrams, Panelist [11:16:17]
There are a lot of issues involved in this regulation. So for example, labeling approaches and legalities are different in Europe than they are in the United States about average versus minimum content. So I think that we can’t just take European or EFSA guidelines and just turn them into the U.S., and that’s why the FDA is here, but I think the FDA does need to reach out the content experts people in– I mean, we have people about fat. We have people involved in carbohydrates. We have people involved in minerals, people involved in oligosaccharides. And I think each of those are kind of their own scientific groups and interacting with established groups, which include groups like American Society for Nutrition, American Academy of Pediatrics is helpful. But I think ultimately there are topic experts that are going to be need to be reached out to it. We can’t– I think there’s a lot to be gained from trying to harmonize as much as possible with European guidelines. I think that would be tremendously valuable for everyone, but there are differences in how we regulate formulas and how we label them and that need to be addressed in doing that.
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Tim Sentongo, Panelist [11:27:21]
We do have pretty compelling data that shows that excess protein is a big contributor to rapid weight gain because the infant formulas have the same caloric density. The different components are matched differently. Some fats are blended, some carbohydrates have corn starch syrup, others are lactose. But the big differences at that time between breast milk and infant formula is breast milk has about 1.4 grams of protein per a hundred calories. Whereas standard infant formulas have more than that. And the guidelines give a ranges higher as 4.5 grams of protein per a hundred calories.
So you can just see that that excess protein intake, clearly programs – has something to do with the programming of how children grow in the first couple of years of life. And if you follow these children, you realize that if you’re over– if you’re very big in the first three years of your life, you’ll likely be bigger overweight during your preschool years during your school age years. And if you enter adolescence as being overweight, that probability of turning that around is gets less and less and less again with all the additional environmental things that in our diets and that we choose to make, that programming continues.
So clearly the protein data I think is compelling enough. I think the Europeans, I think have had, I think they have more tighter. They have a narrow range of proteins that they recommend. And that’s also one of the reasons I believe why cows milk, which has a much high protein content is really discouraged in infants.
Of course at another age is encouraged, but even in a controlled amount, because you take too much of it, ultra protein, those kids really get very overweight.
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Steven Abrams, Panelist [11:35:50]
So the FDA over decades has created an immense and overwhelming process to make sure that that formula is safe and it’s been extremely effective, but the formula shortage has pointed out that there are times when we needed to bring in formulas that did not go through the full FDA process. Many of which had safely been used overseas for many, many years with excellent testing done using overseas guidance.
So I think there is the opportunity for us to take a look and that’s what the NASEM panel did and say, how do we make sure that we maintain that absolute level of excellence of FDA review of formula, but also add certain types of flexibility. Do we really need six visits? Do we really need for the growth studies? Do we really need to not enroll anyone who is not only on formula by two weeks of age, all sorts of very strict kind of rules that may be flexible as we bring upon new sources of protein, different types of energy and those sorts of things.
And that’s what the FDA I think can really take a look at with the scientific world and take a look at what the European experience has been.
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Andrea Gilbaugh, Panelist [11:42:16]
So formula companies marketing is part of the confusion. It confuses healthcare professionals, it confuses families. So if there are limitations on the marketing that they were allowed to do, I think education would be easier for healthcare professionals.
They say some really dramatic things like designed to reduce crying in 24 hours. So if that’s on a can of formula and you’re thinking, okay, well I’m breastfeeding, but if this is designed to reduce crying in 24 hours, maybe I should try this because my baby keeps crying.
Another thing that they’ve said is just what your baby needs and nothing they don’t. So I think there’s a lot of misleading in the labeling and we need to look at that.
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Tom Brenna, Panelist [11:48:44]
I think we can get on with the business of updating our regulations for fatty acids, and get with the rest of the world. And maybe, if we do it right, we might be able to get ahead of the rest of the world, while we’re at it, that’s the first thing. And those would be the underlying fatty acids.
And the second thing is, if we have a chance to have a detailed discussion, and as the commissioner said, not just walking out of here and saying, gee, we did something, but actually getting together and discussing it, we can do something about the seed oil story, which doesn’t mean, I don’t think getting rid of all seed oils, but giving moms and dads options, which I think is what the point was.
There are currently insufficient historic data to predict whether norovirus GII.17 will remain the dominant genotype and lead to an earlier onset of the norovirus season later this year. In the United States, GII.17 has only circulated at low levels and has never been the dominant norovirus strain. Following the surge of GII.17 strains in Asia and parts of Europe in 2014, the GII.4 Sydney variant re-emerged as the dominant genotype by 2016 with no reports of seasonality change. At this time, there is no clear evidence linking the GII.17 genotype to changes in norovirus seasonality. We will continue to monitor norovirus outbreaks through CaliciNet and will report any early activity or emerging trends through our website https://www.cdc.gov/norovirus/php/reporting/calicinet-data.html.
08 27 26 MAKARY: Moms want more options for baby formula.
They want baby formula options with no corn syrup, no seed oils. They want baby formula options with no added sugar.
And we’ve seen no innovation in the baby formula space since 1998, with the exception of simply adding selenium.
The research has moved and we have now had great learnings in the medical field, but the regulatory obstacles have not allowed companies to really innovate. So we’re going to look at all of it.
We’re going to look at heavy metals in baby formulas, on the– in the supply chain, you know there was a shortage in the last administration, so we’re going to get ahead of it and deliver for moms what they want, which is more options for baby formula.
QUESTION: Yeah, when my daughter was an infant, I relied on this, and I just trusted– she had some tummy issues, and so I had to get this one particular formula. But I didn’t know what was in it, I just listened to the doctors.
Do we have seed oils, do we have heavy metals in our formulas?
MAKARY: Yes, seed oil– it is almost impossible to find baby formula without seed oils and seed oils are not a naturally occurring substance.
You know, in the history of mankind, they did not press seeds and extract the oils and then add a chemical solvent to it, and then bleach it, just to increase the shelf life.
And generally it is– they’re believed to be pro-inflammatory. We don’t want babies with general body inflammation. 40% of our nation’s kids have a chronic condition. Many of those are tied to inflammation and insulin resistance.
Moms want more options and we’re going to deliver.
Checking in to see if you can confirm if it is accurate that FDA Commissioner Makary wrote a letter to Sen Hawley committing to a review of mifepristone. Can you clarify what the review will examine and when it will begin?
On background to an HHS spox: Secretary Kennedy asked Commissioner Makary to review the latest data on mifepristone. Commissioner Makary will ensure gold standard science is used while incorporating practical, common-sense considerations to its regulatory processes.
Sarah Gebauer, FDA [00:38:07]
Now that we’ve issued the final rule to update the criteria for the claim, we are continuing our efforts on developing a healthy symbol, and this would be a visual way that manufacturers could demonstrate that their product meets the healthy criteria.
And we’ve conducted consumer research on a potential healthy symbol to help us understand what would really be helpful to consumers. And you can see some symbols that were tested in the middle of the slide. And symbols can be particularly helpful, for example, for people who are less familiar with nutrition information, by having that visual to let consumers know that a product qualifies for the claim.
Finally, we will be working with manufacturers to support implementation of the claim. We see opportunities for using the healthy claim beyond the label and using creative ways to leverage the healthy claim. And we are eager to work with interested groups to support the use of the healthy claim, so that it’s really as impactful and helpful as possible to consumers.
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Sarah Gebauer, FDA [00:48:27]
So as mentioned in the presentation, we have been working on developing a healthy symbol. The symbol would be a standardized graphic, and I showed some examples on the slide that manufacturers could use to show that their products meet the healthy criteria. And so it can really be sort of as that quick visual.
We have conducted two rounds of focus groups and also an experimental study of– related to a healthy symbol, to really learn what would be the most useful for consumers. And we don’t have a specific timeline to share at this point, but again, we are continuing to work on the healthy symbol work.
Robin McKinnon, FDA [00:49:10]
Maybe I can just add on there, Sarah, as well. We know that, because I was involved in some of the early work on the healthy symbol, and we found that people– they were hesitant to engage, especially manufacturers, on the symbol until they had seen the updated criteria.
So now it’s kind of a natural progression, if you like, to have finalized the updated criteria and then to be turning a focus to the– towards the symbol.