The Center for Disease Control and Prevention (CDC) vaccine advisory group met today in the first day of a shortened meeting, with seven of its participants newly appointed by Health and Human Services (HHS) Secretary Robert F. Kennedy Jr.
The group was slated to take its first vote today—on a recommendation for Merck’s new respiratory syncytial virus (RSV) monoclonal antibody for newborns and infants—but it ran behind schedule and postponed it for tomorrow. Tomorrow the members are expected to address two topics that are priorities for vaccine critics, and during today's proceedings they signaled that ACIP will take on further topics on the theme in the future.
Closely watched developments have major implications
Earlier this week on X, Sen. Bill Cassidy, MD, (R-LA) called for postponement of the meeting owing to the small number of members, some without significant experience in related scientific areas and some that may have preconceived biases. Cassidy played a pivotal role in approving Kennedy's nomination after receiving assurances about vaccines, including that he would uphold ACIP recommendations.
Cassidy also emphasized that the meeting was taking place without a CDC director in place. He added that, without a fully staffed group and a more robust balanced representation, ACIP's recommendations will be met with skepticism, which he said would work against the Trump administration's efforts.
Ahead of today’s meeting, Kennedy removed 17 previous ACIP members and on June 11 announced eight new members, some of whom are vaccine skeptics and close allies of Kennedy, raising worries that the changes could sow distrust in vaccines and whether ACIP will continue as a trusted vaccine advisory body. Reuters reported yesterday that one of the new members has withdrawn. HHS spokesman Andrew Nixon told Reuters that Michael Ross, MD, withdrew during a financial holdings review that was required before the members started their ACIP work.
ACIP recommendations have traditionally supported health insurance companies' coverage of vaccines, which underpins access and uptake. Yesterday ahead of the meeting, America's Health Insurance Plans (AHIP), an industry trade group, issued a statement that said that, amid an evolving healthcare landscape, maintaining robust immunization coverage continues to be a top priority for protecting individual and community health.
"We are committed to ongoing coverage of vaccines to ensure access and affordability for this respiratory virus season. We encourage all Americans to talk to their health care provider about vaccines," AHIP said.
We are committed to ongoing coverage of vaccines to ensure access and affordability for this respiratory virus season.
The American Academy of Pediatrics (AAP) said today on X that ACIP's meeting today doesn't reflect a gathering of experts to inform the future of vaccines. "The AAP will continue to recommend its own childhood vaccine schedule—just as we have since the 1930s."
Working groups will take on more vaccine critic topics
When the CDC released the draft ACIP agenda before the meeting, many health experts were alarmed by the appearance of two hot-button topics that have long been talking points of vaccine critics, thimerosal as a vaccine ingredient and the measles, mumps, rubella, and varicella (MMRV) vaccine in children younger than 5 years old. Both topics will be up for discussion tomorrow, with a vote scheduled on thimerosal in influenza vaccine.
At the start of today’s meeting, ACIP's new chair, Martin Kulldorff, PhD, a statistician and epidemiologist formerly at Harvard University, announced that there will be changes to the membership of the CDC's 11 different vaccine working groups and that two more working groups will be added. Both are boilerplate topics of vaccine critics.
One group will evaluate the cumulative effects of vaccines on the CDC's recommended schedule for children and adolescents. The other will examine vaccines that have been in use for more than 7 years, which will likely include hepatitis B vaccination at birth and the use of MMRV vaccine in young children.
The AAP on X today quickly pushed back on plans to reconsider hepatitis B vaccination for newborns, saying that passing the virus from parent to baby at birth can be deadly. "It is unscientific & dangerous to ignore the success of U.S. vaccination programs or argue that the U.S. should not vaccinate babies for hepatitis B at birth."
COVID data discussions
During the morning half of today’s meeting, the group heard from CDC experts on the most recent COVID data, which included discussions on epidemiology, vaccine effectiveness, safety, and vaccine coverage.
Some members raised concerns about what they saw as weaknesses in case-control and test-negative research study designs. Others raised questions about CDC safety monitoring, including its ability to identify any possible long-term complications from COVID vaccination. The tone was collegial, with CDC experts calling on other subject matter experts to answer ACIP member questions in more detail.
Cody Meissner, MD, who has served on both CDC and Food and Drug Administration (FDA) vaccine advisory committees and is a professor of pediatrics at Dartmouth Geisel School of Medicine, questioned if poor uptake of the COVID vaccine should influence ACIP recommendations.
ACIP members will not be voting on a COVID vaccine recommendation at this meeting, because the previous working group didn't meet on June 12 as scheduled following the disbanding of the previous ACIP panel earlier this month. ACIP working groups typically develop recommendations to be considered by the larger group. Also, on May 27, Kennedy announced sweeping changes in the CDC's COVID vaccine policy, saying that immunization is no longer recommended for healthy children and healthy pregnant women.
RSV monoclonal antibody vote postponed a day
During the afternoon session, ACIP members discussed updates on the safety, efficacy, and uptake of maternal respiratory syncytial virus (RSV) vaccine and the nirsevimab monoclonal antibody shot for infants in their first season of RSV circulation.
They also considered a new recommendation for clesrovimab, Merck's new monoclonal antibody for newborns and infants, which the FDA approved on June 9, making it the second such product for the US market.
Tomorrow, the group will vote on the working group's recommendation that clesrovimab be used in infants younger than 8 months old born during and entering their first RSV season. They will also consider its inclusion in the Vaccines for Children program.
Typically the working group considers seven elements in its recommendations, which range from the importance of the public health problem to whether the intervention is a reasonable allocation of resources. In an usual departure, the group's analysis did appear to cover the impact of the intervention on health equity.
Meissner, a pediatrician who has seen the RSV impact on children and is familiar with the CDC's data tracking on the shots, praised the RSV monoclonal antibody products. "People need to understand what an astonishing accomplishment this is."
