Kevin Ault, MD on ACIP Shared Decision-Making, Informed Consent, and Vaccine Policy
In part 1 of our conversation, the VP of the NFID discusses ACIP’s recent meeting, including COVID-19 shared decision-making, informed-consent debates, and new policy actions on hepatitis B and MMRV.
This is part 1 of our conversation with Kevin A Ault, MD, vice president of the National Foundation for Infectious Diseases (NFID) and professor of obstetrics and gynecology at Western Michigan University Homer Stryker MD School of Medicine. Ault previously served on the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP), where he helped shape multiple recommendations concerning COVID-19 vaccines in adults, adolescents, and children. He was also an author of the 2023 adult, adolescent, and pediatric US immunization schedules, which include recommendations for maternal immunization and adult hepatitis B vaccination.
In this discussion, Ault reflects on ACIP’s recent meeting, including the shift to shared clinical decision-making for COVID-19 vaccination, the debate over informed consent, and how clinicians in obstetrics, pediatrics, and family medicine can operationalize new policy actions around hepatitis B and MMRV.
“I think shared decision-making has a specific meaning when the ACIP uses that terminology. I think the last time I was on the ACIP, they voted for shared decision-making. And I might not be remembering this correctly, but I’m certainly familiar with the example of human papillomavirus vaccination.”
He added, “There are certain populations where there may not be as much benefit to HPV vaccines. And so in that theory, or in that spirit, you would give COVID vaccination to people who you thought most likely to benefit from vaccination.”
When reflecting on the most recent ACIP meeting, Ault admitted, “I was a little confused about that discussion…because that’s not something that ACIP usually gets into. It was a little unusual to hear that discussion, and we didn’t have an opportunity to look at the questions being voted on, or the materials before the meeting.”
He explained that while most clinicians are familiar with the Vaccine Information Statements (VIS sheets), “ACIP doesn’t really have any jurisdiction over that. That’s a separate committee that actually makes those up. So…I thought that was a little muddled. You know, informed consent is something that’s done on a very local level, literally in doctors’ offices, and…the ACIP is supposed to be the 35,000-foot viewpoint as far as clinical recommendations.”
Turning to hepatitis B policy, Ault noted, “Prenatal testing for hepatitis B status has been the standard of care since the early 1980s, and so I’m not sure where that was coming from. And again, I’m not sure why ACIP was voting on something that’s already the standard of care.”
He emphasized that the recommendation has been in place for decades, but implementation gaps remain: “Even though we had that recommendation, we still continue to have pediatric and newborn cases of hepatitis B despite a recommendation to universally screen. So we’re never going to get to the point where we have 100% accurate screening 100% of the time. And I don’t think a vote of the ACIP is going to change that.”
He also pointed to disparities in practice: “For women with insurance, there’s about 12% that aren’t tested during pregnancy. Could we make that higher? We certainly could. I have not seen equivalent data on Medicaid, but it boils down to about 10,000 infants are exposed to hepatitis B every year.”
On MMRV, Ault reflected on longstanding safety concerns: “There is an increased risk of seizure with the combined vaccine, especially during that vulnerable period, the first year of life. And so that risk has been known for a long time.” He recalled, “If I remember correctly…it’s about one extra seizure for 2,300 doses. And so some parents may look at that and say, well, that’s 2,299 times out of 2,300 it’s not going to be an increased risk.”
Despite the risks, he stressed the broader safety context: “Febrile seizures are certainly frightening…I understand that they don’t have longer term health consequences. Febrile seizures can certainly occur because of measles and chickenpox.”
By comparison with COVID-19 deliberations, Ault suggested the hepatitis B birth dose requires no change: “The birth dose is inexpensive, has been around for 30 years, [and] has worked remarkably well at reducing pediatric hepatitis infections by about 99%. So I’m not sure we’re going to improve on that number.”
ACIP Meeting Recap: September 18–19
- COVID-19 Vaccination: ACIP kept vaccination for people 6 months and older under shared clinical decision making, emphasizing individualized counseling on age, prior infection, immunosuppression, and comorbidities. Prescriptions are not required.
- MMRV in Pediatrics: To reduce febrile seizure risk, ACIP recommended separate MMR and varicella doses before age 4, rather than the combined MMRV product.
- Hepatitis B: The committee tabled a proposal to delay the newborn birth dose to 30 days, leaving the current schedule unchanged, while reaffirming universal HBV testing in pregnancy.
ACIP members also urged CDC to provide clearer, plain-language informed-consent materials and called for more transparent posting of vote language with consistent use of the evidence-to-recommendation framework.
Clinically, the playbook remains stable: continue COVID-19 vaccination via shared decision making for higher-risk patients, maintain HBV birth-dose practices and universal prenatal testing, and use separate MMR and varicella doses before age 4. Coverage through VFC, Medicare/Medicaid, and commercial plans is expected to continue without new prescription requirements.
Stay tuned for part 2 of our conversation with Ault, where we’ll dive deeper into the outcomes from the recent ACIP meeting.
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