ATLANTA (AP) — U.S. Health Secretary Robert F. Kennedy Jr.’s hand-picked vaccine advisory committee on Thursday recommended the Centers for Disease Control and Prevention adopt new restrictions on a combination shot that protects against chickenpox as well as measles, mumps and rubella.
The panel advised that the vaccine known as MMRV not be given before age 4 and that children in this age group instead get separate vaccines — one against MMR and another for varicella, or chickenpox. The vote was 8-3, with one member abstaining.
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 — when it also takes up COVID-19 shots — it’s expected to decide whether to recommend that some babies can wait a month for those 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.
Public health experts worry the votes will raise unwarranted concerns among parents. 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.
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.
Panelists focus on rare seizures
Discussions on the MMRV vaccine focused largely on rare instances of feverish seizures associated with the first dose that is currently 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 varicella 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.
“Considering these trends, any policy decision that compromises the clarity or consistency of vaccination guidance ... has the potential to further diminish public confidence,” he told the committee.
Dr. Mysheika Roberts, health department director in Columbus, Ohio, said one of the benefits of the combined vaccine is it limits the number of shots a child gets, which is useful in certain populations of patients, such as newly arrived immigrants who need lots of vaccines at the same time.
But she also acknowledged concerns about feverish seizures among children under age 4 and said, “maybe the guidance needs to be tweaked a little bit on that.”
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 use 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 is at risk of infection.
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). Infant vaccinations are stressed for women who have hepatitis B or those who have not been tested for it. 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.”
He later added: “We will be creating new doubts in the mind of the public that are not justified.”
Some who spoke during the public comment portion of the meeting said they don't see the need for a change.
“Why? Why are we addressing this hepatitis B vaccine recommendation?” said Dr. Flor Munoz-Rivas, of the Infectious Diseases Society of America. “Is there really a reason that the committee can provide for making a change?”
Committee member Dr. Robert Malone responded to that question.
“The signal that is prompting this is not one of safety. It’s one of trust,” he said. “And it’s one of parents uncomfortable with this medical procedure being performed at birth in a rather unilateral fashion without significant informed consent.”
Committee chair defends its work
In his opening remarks, committee Chairman Martin Kulldorff defended the group against critics who say it leans toward anti-vaccine views.
“The members of this ACIP Committee are committed to reassuring the public and restoring public confidence by removing unnecessary risks and harms whenever possible. That is a pro-vaccine agenda," Kulldorff said.
He later added: “We welcome scientific critique of any of our votes, as there are gray areas due to incomplete scientific knowledge.”
The committee is scheduled to make COVID-19 vaccine recommendations on Friday.
The AAP and some others groups have issued their own vaccination recommendations, which disagree with recommendations put out by federal officials this year.
In recent weeks, several states have announced policies to help residents maintain access to vaccines, in some cases signing orders that ensure COVID-19 vaccinations at pharmacies without individual prescriptions. Wisconsin this week joined a list of more than a dozen to take steps, when Gov. Tony Evers signed an executive order for state health officials to follow the guidance of national physician organizations.
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Ungar reported from Louisville, Kentucky.
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