ACIP relies on evidence, transparency, critical reviews, vice chair says

Scientific evidence, transparency, and critical review remain the guiding principles of the Advisory Committee on Immunization Practices (ACIP), the board’s vice chairman said.

On Dec. 4, ACIP, a leading federal reviewer of vaccine science, convened for its third regular two-day meeting during the tenure of Health and Human Services Secretary (HHS) Robert F. Kennedy, Jr., who has expressed skepticism about the safety and efficacy of inoculations against disease.

The first day’s agenda included presentations and discussion about the hepatitis B vaccine, with presentations by ACIP member Vicky Pebsworth, PhD, RN, and U.S. Centers for Disease Control and Prevention staffers Cynthia Nevison, PhD, and Mark Blaxill. The meeting started with a roll call of ACIP members and advisory liaisons.

The other ACIP members are: Chair Kirk Milhoan, MD, PhD; Vice Chair Robert W. Malone, MD, MS; Hillary Blackburn, PharmD, MBA; Evelyn Griffin, MD; Joseph R. Hibbeln, MD, ABNP, Capt. USPHS (Ret.); Retsef Levi, PhD; H. Cody Meissner, MD; James V. Pagano, MD, FACEP; Raymond Pollak, MD, FACS, FRCS; and Catherine M. Stein, PhD.

Introducing the new chair

To open deliberations, Vice Chair Robert Malone, MD, offered an opening statement introducing new Milhoan, who participated virtually. Milhoan succeeds Chair Martin Kulldorff, PhD, who has been appointed chief science officer in the Office of the Assistant Secretary for Planning and Evaluation (APSE) within the U.S. Department of Health and Human Services (HHS).

“Speaking personally, I've known Kirk as well as his amazing wife, Dr. Kim Milhoan, for a few years now, and when asked, I endorsed his appointment without reservation,” Malone said. He presided because he was able to attend in person.

ACIP’s guiding principles

To formally open this meeting, Malone said he would acknowledge the principles that must guide ACIP's work.

“These are key: evidence, transparency, and a willingness to look critically at the data before us to ensure that the recommendations we make are grounded in evidence-based science and best medical practices,” Malone said.
“The primary mission of the ACIP committee is to provide independent advice — I underscore independent — to the CDC director,” Malone said, referring to the U.S. Centers for Disease Control and Prevention. “Our responsibility when developing advice is to evaluate the totality of the evidence as it exists today with scientific rigor, intellectual honesty, and courage to ask and answer the hard questions.

“Once we reach a majority opinion, we're also tasked with clearly communicating our advice and reasoning to both of our key clients,” Malone said. “Two key clients, I want to emphasize: the CDC director and the American public.”

Hepatitis B vaccination

In September, ASAP deferred a vote on proposed changes to the hepatitis B vaccination schedule, Malone said.
That decision “was not about hesitation or reluctance. It was about standards,” he said. “Several data elements the committee requested were incomplete, and the evidence did not yet meet the level of clarity required for a confident, evidence-based recommendation. When gaps in the evidence emerge, the responsible action is not to push forward.

“It's to pause, review, ensure that we fully understand what the data can and cannot support, and then formulate independent advice to the CDC director,” Malone said. “This is our charter.”

Since September, CDC convened a group to examine the outstanding issues in greater depth, Malone said.

“That group has been working diligently, I can attest to that, many hours have been invested since then,” he said. While “the nuance” of that group remains undisclosed, Malone said. The membership is quite diverse and represents a full spectrum of opinion, he said.

“Their work has helped sharpen the questions we need to answer and improve the quality of the discussion we will have today,” Malone said. “I want to emphasize this is exactly how the scientific process is supposed to function. When data are complete, we say so. When additional analyzes is needed, we conduct it. When assumptions need to be revisited, we revisit them. We're not here to reach quick conclusions. We're here to reach accurate ones and to provide independent assessment and advice to the director and to the public.”

Malone said he hoped the meeting’s discussion would be similar to the September discussion about the COVID-19 vaccine, with seriousness, clarity and a willingness to challenge ACIP’s own prior assumptions.

“ACIP's credibility depends on our commitment to a deliberative, transparent, evidence-based process. You'll see that in play during the discussions today and tomorrow,” Malone said.

He also thanked the CDC staff, along with contributions from affiliate agencies under HHS, such as the National Institute of Health and the Food and Drug Administration.

“Their technical work, from surveillance to modeling to implementation research, is essential,” Malone said. “The ACIP depends on their diligence and all of the appointed members are grateful for their contributions.”