As the Advisory Committee on Immunization Practices (ACIP) meeting moved into its second afternoon, members turned their focus to the childhood vaccine schedule, although no votes were planned or cast.
ACIP makes vaccination recommendations to the Centers for Disease Control and Prevention (CDC), including those for different age-groups and disease risk status, as well as on US immunization schedules for children, adolescents, and adults. The CDC director has ultimate discretion whether to approve ACIP’s advice, and physicians can make their own decisions about whether to comply, but ACIP recommendations have historically affected vaccine insurance coverage.
The first presenter, Aaron Siri, JD, spoke about the childhood and adolescent vaccination schedule. Siri is an ally of Health and Human Services Secretary Robert F. Kennedy Jr. and has worked with Kennedy on vaccine-related lawsuits.
His inclusion as a presenter was denounced by experts, including US Sen. Bill Cassidy, MD (R-La.), who posted yesterday on X (formerly Twitter): “Aaron Siri is a trial attorney who makes his living suing vaccine manufacturers. He is presenting as if an expert on childhood vaccines. The ACIP is totally discredited. They are not protecting children.”
Siri’s presentation focused on what he described as a lack of placebo-controlled trials in determining vaccine safety, a lack of large-scale studies (saying most studies were “underpowered”), and the short timeframe between licensure and recommendation.
Siri also blamed the 1986 National Childhood Vaccine Injury Act, which grants immunity to vaccine manufacturers from lawsuits related to adverse side effects for leading to a lack of oversight.
He also encouraged the committee to depoliticize vaccines. “The only way you depoliticize vaccines is you need to take them out of politics… you have to end the mandate. Mandates make vaccines political.”
When Siri concluded his presentation, Robert Malone, MD, a vaccinologist at Louisiana State University who led the two-day meeting, was directed to address the question of why Mr. Siri had been asked to speak and whether other voices and points of view were solicited to participate in the discussion.
ACIP Executive Secretary Mina Zadeh, who replaced veteran committee meeting coordinator Melinda Wharton when secretary Kennedy fired all previous ACIP members in June, noted that Peter Jay Hotez, MD, PhD, the Director of the Center for Vaccine Development at Texas Children's Hospital, and Paul Offit, MD, an infectious disease specialist at Children’s Hospital of Philadelphia, had been invited to speak but both declined. She did not address why Siri was chosen to speak.
‘Terrible, terrible distortion’ of facts
H. Cody Meissner, MD, retired chief of pediatric infectious diseases at Tufts Medical Center, pushed back forcefully against Siri’s arguments. “You live in this country, so you're entitled to the same First Amendment rights that we all are. But what you have said is a terrible, terrible distortion of all the facts.”
Meisner questioned why Siri had shown a slide showing the number of vaccines administered in the United States. “What was your point? I mean, that is a phenomenal accomplishment. That's why we have the lowest rates of infectious disease in the United States, because we have the highest uptake of vaccines. And if vaccine uptake goes down, we're going to see an increase of these diseases, such as with hepatitis B, which I think is going to happen now.”
Meisner also pointed out that Siri confused causation and association. “Remember, there are tens of thousands of vaccines that are administered every day, and just because there's an adverse event that occurs around the time of vaccine administration, it doesn't mean there is any causal association, and you're jumping to the conclusion.”
Siri also likely gets paid “very handsomely” to represent his clients, noted Meisner. In his rebuttal, Siri said, “in terms of being paid handsomely, I will assure you that this is not a very lucrative endeavor.” KFF Health News reports that Informed Consent Action Network (ICAN), an anti-vaccination group, paid Siri’s law firm $6 million dollars in 2023.
“The fact that you have an attorney who sues people for money for a living talking about how bad vaccines are is pretty amazing,” Yvonne Maldonado, MD, Taube Endowed Professor of Global Health and Infectious Diseases at Stanford University, told CIDRAP News.
“Number two, most of what he said was misinformation, disinformation, and information taken out of context and not from a subject matter expert,” she added. “He's not a physician, not a public health officer, not an immunologist or a vaccinologist. His job is to be a lawyer and advocate for his clients, and that is an incredibly biased standpoint.”
The shocking degree of bias at the CDC and among current ACIP members is Cassidy’s fault, says Maldonado. In February, Cassidy’s tie-breaking vote advanced Kennedy’s nomination to be HHS secretary from the Senate Finance Committee to a vote on the Senate floor.
Just because there's an adverse event that occurs around the time of vaccine administration, it doesn't mean there is any causal association, and you're jumping to the conclusion.
“I put all the blame squarely on his shoulders,” Maldonado says. “And now he's turned around and said this is a bad thing and that the ACIP is not to be trusted and [he] specifically called out this attorney [Siri]—I think, now, we understand how actions have consequences.”
US vs Danish vaccine schedule
Following Siri’s presentation, Tracy Beth Hoeg, MD, PhD, newly appointed acting director of the Center for Drug Evaluation and Research (CDER), presented on the US versus Danish vaccine schedule.
A physician and epidemiologist who practiced physical and interventional spine and sports medicine before joining the FDA as Senior Advisor for Clinical Sciences in the Office of the Commissioner and the Center for Biologics Evaluation and Research (CBER), Hoeg noted that the risk of getting hepatitis B in the United States is the same as the risk of getting hepatitis B in Denmark and compared the amount of aluminum exposure in children in both countries (with notably lower amounts in Denmark).
She went on to talk about what we owe our children, including the absence of an overmedicalized childhood, less focus on medical products, more focus on healthy living, and decreases in overdiagnosis and overtreatment.
She raised questions about the “safe” bolus dose of parenteral aluminum in infancy and invoked the Soviet Lysenko tragedy in encouraging recommendations based “on data and not politics.” She praised the level of transparency and public education in Denmark, where, she said, they are more open about acknowledging unknowns and promptly reversing decisions when new evidence comes out.
She said that hepatitis B rates are the same in the United States as in Denmark, though Denmark doesn’t recommend the hepatitis B birth dose vaccine.
For her to say that the risk of hepatitis B in the US is the same as the risk in Denmark, because the rates are the same, is wrong.
Making meaningful comparisons between the United States and Danish public health systems is challenging, notes Maldonado. “We’re not comparing apples to oranges, we're comparing kumquats to melons,” she says. “Denmark has a unified health care system for 6 million people, and they keep track of records of people from birth to death, and we have none of that,” she said.
“And I think in order for her to say that the risk of hepatitis B in the US is the same as the risk in Denmark, because the rates are the same, is wrong,” she added. “The risk is not the same. We have higher risk because our patients have less access to health care. So the risk of acquiring disease, given the lack of access and other determinants of health is, I believe, higher.”
ACIP members generally praised Hoeg’s presentation and the Danish approach, even as they eschewed the idea of mandates. Maldonado points out the hypocrisy in their statements. “Guess what? I don't think any of these people would want to live in Denmark because that's a socialist country, and we don't want that in the US, even though we benefit from socialist-type principles already.”
Proposed work group on aluminum adjuvants
The afternoon session also featured a discussion on the use of aluminum adjuvants in vaccines and whether their use merits ACIP attention or the formation of a working group.
Adjuvants, chemicals used in some vaccines to improve response to the vaccines' active ingredient, make it possible to reduce the dose of antigen, which triggers an immune response, in a vaccine without dampening the immune response. In this way, they enable the production of many more doses.
But, although the CDC website states that “adjuvants have been used safely in vaccines for decades,” some providers question whether infants receive too much aluminum under the current vaccine schedule, especially given their immature kidneys and blood-brain barrier.
Only one set of adjuvants, aluminum salts or alum is licensed in the United States and is used in vaccines such as those against shingles, hepatitis B, human papillomavirus (HPV), and flu, but no adjuvanted flu vaccine is licensed in this country.
“I think that there, there is evidence that stimulation of the immune system in utero or early, early childhood can interact with the neurodevelopment,” said member Retsef Levi, PhD, a professor of operations management at the MIT Sloan School of Management.
“I think that was mentioned in one of the previous presentations that non-live vaccines seem to have non-specific effects, namely those that are not corresponding to the target virus, that are typically negative, versus live vaccines that seem to have non-specific effects that are positive,” he added.
Member Kirk Milhoan, MD, PhD, medical director of For Hearts and Souls Free Medical Clinic, deemed early vaccine studies lacking in rigorous review of long-term safety and said he anticipates developing a work group that will ask about “what it is going to take to see whether we aluminum is causing a role in the adverse reactions along in a chronic that we're seeing in children,” he said.
Joseph Hibbeln, MD, a psychiatrist and neuroscientist and former chief of the Section on Nutritional Neurosciences at the National Institutes of Health, said, “I think that there are certainly valid hypotheses aluminum impacting the immune system, that can cross into the brain and potentially cause adverse neurodevelopmental or psychiatric effects. I think that it is both useful and important to develop the basic mechanistic hypotheses and then look at the human data.”
Work group unlikely to be productive, member says
But Meissner reminded fellow members that “trials that obviously have demonstrated there's no association between vaccines and the development of autism.” He also said that a working group on aluminum adjuvants was unlikely to be productive, given the considerable attention and study already given to the matter.
Maldonado concurred, citing a paper she co-wrote and published this week in Pediatrics, which reviewed 800 studies, commenting on 400. “Aluminum is the third most common element on the planet,” she said. “Aluminum is in everything that we eat or drink.” She also noted that aluminum concentrations in vaccines are much smaller than those in food or drink.
They didn't know certain key facts.
“Why are we wasting our time talking about a very low-yield possibility when the Danish government author just published a study a few years ago documenting that hey found no association with aluminum salts on the rates of autism?” she asked.
Offit, who also co-invented a rotavirus vaccine, characterized the meeting to CIDRAP News as “a sad day for America's children. You have a clearly poorly informed group making recommendations for the nation's health. They didn't know certain key facts.”
