After last month’s controversial meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP), new committee chairman Kirk Milhoan, M.D., Ph.D., appeared on the podcast “Why Should I Trust You?” to answer exactly that, providing a glimpse into the vaccine viewpoint that could drive future ACIP decisions.
Milhoan is one of the ACIP members who was handpicked by Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. during his overhaul of the committee last summer. Since then, the panel has voted for recommendations challenging established vaccine policy.
Most recently, the ACIP voted to tweak the CDC’s longstanding recommendation that a dose of the universal hepatitis B virus (HBV) vaccine be given to newborns, favoring instead “individual-based decision making” for parents deciding “when or if” to give the HBV vaccine to children born to women who test negative for the virus.
Individual autonomy vs public health
Many of the ACIP’s recent discussions involve this individual-based approach, which essentially boils down to a conversation between doctor and patient to assess “the best available evidence of who may benefit from vaccination,” according to the CDC.
Milhoan called this a reflection of the panel’s focus on “returning individual autonomy to the first order—not public health, but individual autonomy,” he said on the podcast, expressing that this viewpoint is “very important” to the ACIP members. The chairman further described individual decision-making as opposite to the previous “heavy-handed, authoritarian thought of the vaccine schedule.”
“This is a risk-benefit that I believe needs to be discussed with everything. But there’s always going to be a tension between what is supposedly good for all and what is good for the individual,” he said.
Despite this stated focus, it appears that many members of the committee are still getting used to the “individual-based” language, with specific word choices proving a logistical hindrance for the ACIP on meeting days. Last month, when the committee was set to vote on the childhood HBV vaccine guidance after a delay at its September meeting, the committee again pushed back the vote for a day after much debate on phrasing issues.
Although that vote eventually passed, the committee was warned at the time that the wording of the new recommendation may create additional barriers to care by potentially confusing physicians, Natasha Bagdasarian, M.D., chief medical executive for the State of Michigan, pointed out during the meeting.
Word choice seems to be a pivotal concern for Milhoan, even when it comes to standard clinical phrases. When asked by podcast host Brenda Adhikari why he may take issue with the measles, mumps and rubella (MMR) vaccine even though it has “proven to really stem the disease in its tracks,” the ACIP chairman replied that “proven may be a bit harsh.”
Milhoan considers there to be “an emotion” attached to the word “proven,” arguing that the phrase “scientifically proven” would be a contradiction to the word “science.”
The chairman clarified that he wasn't “being anti-science,” but rather urged, “let’s be honest about the words.”
He views the word “safety,” meanwhile, as an “emotional response to a risk.” On that topic, he also argued that vaccines have not been appropriately studied for safety, instead having been “mostly studied for efficacy.” Post-vaccine monitoring, he said, is “very poor.”
Although the CDC committee is “bringing in an increased level to examine safety,” Milhoan admitted he doesn't have a “new solution” to this qualm.
“There’s an assumption that it’s safe. But have we looked at it and have we studied it? We need to have rigor in doing that,” he said.
Milhoan more or less avoided Adhikari’s initial blunt questioning on “do you like” vaccines, instead highlighting the informed consent route.
“I think that we’ve talked a lot about the efficacy of vaccines, but I think what has been neglected is really looking deeply at what the risks are,” he said.
Polio vaccine
One vaccine that the new ACIP hasn’t yet touched is the polio vaccine. Responsible for eradicating polio in the U.S. in the late 1970s, the vaccine is “safe and effective,” according to the CDC’s polio-specific webpage, and is recommended for children in four doses before the age of 6.
Milhoan openly questioned the recommendation, noting that “we need to not be afraid to consider that we are in a different time now than we were then.”
Concerns about how a Kennedy-led HHS would handle the polio vaccine are what prompted the sole vote of Republican dissent upon Kennedy’s confirmation to the position.
Mitch McConnell was the lone Republican senator to cross party lines in voting against Kennedy’s confirmation last February. The senator is a known survivor of childhood polio and contracted the disease before the vaccine became widely available.
“In my lifetime, I've watched vaccines save millions of lives from devastating diseases across America and around the world. I will not condone the re-litigation of proven cures, and neither will millions of Americans who credit their survival and quality of life to scientific miracles,” McConnell said in a statement at the time.
Polio vaccine or not, Milhoan made it clear that he does not hope that fewer people get vaccinated—just that immunization is “more of an informed decision” and that vaccines have “as little of a side effect profile as we can.”
“If you want your vaccine, you can have it,” he said. “We haven’t taken anything away. What we’re trying to do is we’re trying to update the vaccine safety sheets.”
Milhoan’s comments on the polio vaccine and informed consent, which he doubled down on in statements to The New York Times, have already sparked public outcry. The American Medical Association (AMA), for one, is “deeply alarmed by efforts to weaken long-standing evidence-based vaccine recommendations, including suggestions that polio vaccination should seemingly not be routinely recommended to patients,” AMA trustee Sandra Adamson Fryhofer, M.D., said in a statement.
“Vaccines have saved millions of lives and virtually eliminated devastating diseases like polio in the United States. There is no cure for polio. When vaccination rates fall, paralysis, lifelong disability, and death return. The science on this is settled,” Fryhofer said. “Moving away from routine immunizations, which involves discussions between clinicians and patients, does not increase freedom – it increases suffering.”
On the podcast, Milhoan spoke on “different pressures and threats” the committee has received, although he made a point to clarify that he has not felt pressure from the White House specifically.
“We’re just an advisory panel,” he emphasized. “We can’t make any declarations.”
While this is true, the CDC typically does follow the advice of the ACIP. The CDC, in turn, does not need ACIP’s sign-off to make changes to vaccine guidance, as evidenced by the six vaccines abruptly chopped from the list of recommended immunizations for children earlier this month. That move came from an HHS review of global vaccine schedules, it said.
Meanwhile, recent changes to vaccine recommendations have sparked fervent backlash from medical groups and are even the subject of an ongoing lawsuit from organizations including the American Academy of Pediatrics (AAP) and the American College of Physicians. The lawsuit claims in part that ACIP promotes an “anti-vaccine agenda” and is being “inappropriately influenced” by Kennedy.
“Pediatricians have seen firsthand the harm created by the disruptive and politicized decisions to overturn decades of evidence-based federal guidance on immunizations,” AAP President Susan J. Kressly, M.D., said in a statement earlier this month. “These changes have caused fear, decreased vaccine confidence, and barriers for families to access vaccines.”