CDC Panel Targets Size of Childhood Vaccine Schedule, Safety of Aluminum Adjuvants

 The CDC's revamped Advisory Committee on Immunization Practices (ACIP) discussed shrinking the childhood vaccination schedule and setting up a working group to assess the safety of aluminum adjuvants in vaccines during the final day of its 2-day meeting.

The committee, which was completely overhauled by HHS Secretary Robert F. Kennedy Jr. earlier this year, took no votes Friday on any topics. Instead, the day's agenda showcased vaccine-skeptical arguments and sidelined decades of data and the CDC's own subject matter experts. ACIP presenters launched broadsides against the safety data underpinning approved childhood vaccines, questioned the need for a relatively extensive childhood immunization schedule, and proposed a closer look at the safety of vaccine adjuvants like aluminum, including possible links to autism.

Earlier in the day, the panel had voted to stop recommending that every newborn receive a hepatitis B vaccine at birth.

Hours after the meeting's end, President Donald Trump announced he'd direct HHS to review the U.S. childhood vaccine schedule, compare it with other nations' schedules, and make changes.

The panel gave the presentation stage to vaccine injury lawyer and author Aaron Siri, along with ACIP committee member Evelyn Griffin, MD, an ob/gyn at Baton Rouge General Medical Center in Louisiana, and Tracy Beth Høeg, MD, PhD, the newly appointed acting director of the FDA's Center for Drug Evaluation and Research.

In a presentation that lasted over an hour and a half, Siri delivered an extensive overview of the immunization schedule's history and expansion and questioned the safety data used to license many vaccines. He asserted that there are no studies that have ruled out a causal relationship between autism and vaccines such as the diphtheria, tetanus, and pertussis (DTaP) shot, and repeatedly cited a common argument among vaccine skeptics: that a lack of control or placebo groups in pivotal vaccine trials led to safety gaps, which he called "unethical."

Siri's presentation prompted an incredulous response from ACIP member H. Cody Meissner, MD, of the Geisel School of Medicine at Dartmouth in Hanover, New Hampshire. "What you have said is a terrible, terrible distortion of all the facts," he countered.

"You clearly confuse associations, that is, there is a temporal association and a causal association," he said. "Just because there's an adverse event that occurs around the time of vaccine administration, it doesn't mean there's any causal association. And you're jumping to the conclusion that, yes, there is."

Høeg's presentation compared and contrasted the childhood vaccination schedules in Denmark and the U.S. "Why are we so different from other developed nations, and why is it scientifically justified?" she asked.

Høeg showcased a slide showing 72 total core childhood vaccine doses in the U.S. schedule, compared with 11 in Denmark, though she noted that European countries give more combination vaccines.

She also questioned a vaccines-for-all approach. "Just because the U.S. has a larger population of high-risk children, should the core childhood vaccination schedule be larger?" she asked. "Or should healthy children without underlying risk factors really receive different vaccines than they do in Denmark or other high-income nations?"

"Just because a vaccine is approved, it doesn't mean it should be approved for all children," she added.

The ACIP liaison for the Infectious Diseases Society of America, Flor Munoz-Rivas, MD, questioned the value of Høeg's comparison with Denmark, a nation of 6 million people. "It seems to be irrelevant to compare U.S. policy with Danish policy, given that the data and the decisions need to be based on our local information and needs," she said.

Stacy Buchanan, DNP, RN, of the National Association of Pediatric Nurse Practitioners, agreed. "There are lots of pockets of communities within the United States that are unvaccinated," she said. "It doesn't look like Denmark has those pockets of communities. ... When we talk about changing policy for the entire United States, we need to take that into consideration."

Aluminum Adjuvants Under the ACIP Microscope

In the day's final presentation, panel member Griffin floated the idea of an ACIP working group focused on the safety and effectiveness of adjuvants in vaccines. Griffin's talk included alleged data gaps in aluminum adjuvant safety studies, and the potential risks to infants and children of cumulative aluminum exposure through multiple vaccines.

Among the areas she posed as potential group topics were the administration of multiple aluminum-containing vaccines on the same day in early infancy, a potential preference for lower-aluminum vaccine formulations, and establishing an evidence-based safety margin for the adjuvant.

https://www.medpagetoday.com/pediatrics/vaccines/118888