Kennedy's advisory panel recommends new restrictions on MMRV vaccines

The Advisory Committee on Immunization Practices put off an expected vote on hepatitis B shots given to infants on the day they are born. On Friday, it’s expected to decide whether to recommend that some babies can wait a month for those shots, and to also take up COVID-19 shots.

The committee makes recommendations to the CDC director on how already-approved vaccines should be used. CDC directors have almost always accepted those recommendations, which are widely heeded by doctors and guide vaccination programs. Committee Chairman Martin Kulldorff said committee members aim to reassure the public and remove unnecessary risks and harms.

But many doctors and public health experts say the committee is creating fear and mistrust around vaccines at a time when U.S. vaccination rates are already falling. Kennedy, a leading antivaccine activist before becoming the nation’s top health official, has made or proposed numerous changes to the nation’s vaccine system, including firing the entire 17-member panel earlier this year and replacing it with a group that includes several anti-vaccine voices.

Thursday's meeting “promoted false claims and misguided information about vaccines as part of an unprecedented effort to limit access to routine childhood immunizations and sow fear and mistrust in vaccines,” Dr. Susan Kressly, president of the American Academy of Pediatrics, said in a statement. “Instead of emerging with clear guidance about vaccines that we know protect against serious illnesses, families are left with confusion, chaos and false information.”

Experts are also concerned the panel's actions could narrow access to the vaccines. The group voted 8-1, with three abstentions, to keep MMRV covered for kids as young as 12 months under the Vaccines for Children program, which pays for about half the shots given to kids in the U.S.

Several committee members expressed confusion during that follow-up vote on whether to align payments under the program with the more restrictive vaccine guidance they had just passed. Another federal official noted that there are other government insurance programs, including Medicaid, that will need to stop paying for that early combo dose because they have to follow CDC recommendations.

Panelists focus on rare seizures

Discussions on the MMRV vaccine focused largely on rare instances of feverish seizures associated with the first dose, given to kids between ages 1 and 2.

Committee member Dr. Cody Meissner said such seizures may be “a very frightening experience” for families, but medical experts agree they're not linked to brain function or school problems.

The panel last dealt with the issue in 2009, when it said either the combination shot or separate MMR and chickenpox shots were acceptable for the first dose, but that separate doses were generally preferred. Today, 85% of kids receive separate doses for the first round, according to information presented at the meeting.

Some doctors and public health experts say they are not aware of any new safety data that would explain the revisiting of those vaccination recommendations — and, in fact, many of the studies discussed Thursday were more than a decade old.

Dr. Richard Haupt, a vice president at Merck, which makes the MMRV vaccine ProQuad, said it’s been evaluated through clinical trials and post-approval studies, and the slight increase in feverish seizures after the first dose led to current CDC recommendations. Combination vaccines improve completion and on-time vaccination at a time when the nation is seeing a troubling decline in vaccination coverage, he said.

Mike Osterholm, a University of Minnesota expert on infectious diseases, said he doesn't see the need for a new recommendation.

“It’s solution looking for a problem,” he said in an interview. “We have managed the MMRV vaccine situation for a number of years without any issues in terms of safety. It is a situation where it also allows a parent to have that discussion with their healthcare provider."

The vaccine panel also discussed the hepatitis B shot

As many as 2.4 million people in U.S. are estimated to have hepatitis B, which can cause serious liver infections, and half are unaware of infection, a CDC presenter told the panel.

In adults, the virus is spread through sex or through sharing needles during injection-drug use. But it can also be passed to a baby from an infected mother, and as many as 90% of infected infants go on to have chronic infections. The virus can also live on surfaces for more then seven days at room temperature, and unvaccinated children living with anyone with a chronic infection are at risk.

A hepatitis B vaccine was first licensed in the U.S. in 1981. In 2005, the ACIP recommended a dose within 24 hours of birth for all medically stable infants who weigh at least 4.4 pounds (2 kilograms). The infant shots are 85% to 95% effective in preventing chronic hepatitis B infections, studies have shown.

Following the 2005 recommendation, hepatitis B cases among infants fell from 5,494 cases per year in 2005 to 2,214 cases in 2023.

During Thursday’s discussion, some committee members questioned whether babies born to moms who test positive for hepatitis B are the only ones who truly need a vaccine in the first day of life.

By giving virtually all babies the hepatitis B right after birth, “Are we asking our babies to solve an adult problem?” asked committee member Dr. Evelyn Griffin.

But Meissner expressed bewilderment at some of this discussion.

“This an absolutely safe vaccine,” he said. “I’m not sure what we’re gaining by avoiding that first dose within 12 to 24 hours after birth.”

Several outside medical experts asked why the committee was debating the issue at all.

“The signal that is prompting this is not one of safety," committee member Dr. Robert Malone responded. "It’s one of trust. And it’s one of parents uncomfortable with this medical procedure being performed at birth in a rather unilateral fashion without significant informed consent.”

Osterholm said there will be consequences.

“As more doubt is sown in the safety of vaccines by this committee and political leaders in our health department, we’re going to see fewer people getting vaccinated and the return of the diseases we largely conquered," he said. "It will make us less safe and less healthy as a nation.”

Ungar reported from Louisville, Kentucky. AP Medical Writer Lauran Neergaard contributed to this story.

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.