CDC advisers vote to recommend against combo vaccine for young kids, delay vote on newborn hepatitis B shot
CNN
By Brenda Goodman, CNN
(CNN) — A meeting of advisers chosen by US Health and Human Services Secretary Robert F. Kennedy Jr. to guide US Centers for Disease Control and Prevention vaccine recommendations ended abruptly Thursday with a delayed vote on one vaccine, a vote against a vaccine used for young children and confusion around access for some kids.
The CDC’s Advisory Committee on Immunization Practices delayed an expected vote on hepatitis B vaccines for newborns until Friday. The highly anticipated vote could change longstanding US vaccine policy that has driven down infections among babies to only double digits per year.
But committee did vote 8-3 that the combined measles, mumps, rubella and varicella (MMRV) vaccine is not recommended before age 4. They said children in this age group should receive the measles, mumps and rubella, or MMR, vaccine separately from the varicella vaccine. Varicella is the virus that causes chickenpox.
Dr. Joseph R. Hibbeln, Dr. Hilary Blackburn and Dr. Cody Meissner voted no, and Dr. Robert Malone abstained from the vote due to conflicts of interest.
However, the committee also voted against changing the previous MMRV recommendation for the Vaccines for Children program, which provides access for low-income children. That means kids who get free vaccines through the federal program will still be able to choose between a single combination shot or two separate injections for their first vaccination.
Eight members voted not to change the recommendation for the VFC program. One member voted yes, and three abstained; Meissner did so, he said, because he wasn’t sure what they were voting on. Several members expressed confusion about the impact of their Vaccines for Children votes.
“If we vote no on this, we’re essentially saying there will be different recommendations for children who get the vaccine through VFC, compared to children who do not,” Meissner asked.
The advisory group’s recommendation isn’t final. HHS said in a statement Thursday that it “will examine all insurance coverage implications following today’s ACIP recommendation, prior to a final decision on adoption by the Acting Director.” Kennedy deputy Jim O’Neill is serving as acting CDC director after Dr. Susan Monarez was ousted abruptly as head of the agency last month.
The CDC vaccine committee has changed dramatically in just a few months. In June, Kennedy abruptly removed all 17 sitting members and then replaced them with eight of his own picks, although one withdrew during the vetting process. This week, Kennedy added five more new members.
Processes, committees and priorities have shifted, and that can affect the vaccines people can get. ACIP’s recommendations shape doctors’ guidance to patients as well as state vaccine policy, the Vaccines for Children program and insurance coverage.
While actions like Thursday’s vote on the MMRV shot may seem like a small tweak, experts said the fact that ACIP was revisiting older vaccines can have a bigger impact.
“It is the beginning of the end, because they are eroding confidence in the process,” said Dr. Jason Goldman, president of the American College of Physicians and a non-voting ACIP liaison member who attended Thursday’s meeting.
“They are taking away the freedom of choice of individuals to decide with their physician what is best for their health care,” he told CNN. “It affects coverage of vaccines, and it is laying the groundwork for decisions to be made without good scientific discussion or evidence.”
Changes to MMRV vaccines for kids
Currently, parents can choose whether to vaccinate babies at around 1 year of age with a single MMRV shot or with two shots: one that covers measles, mumps and rubella, and another that covers varicella. Giving the shots separately reduces the rare chance of seizures after a high fever, called a febrile seizure.
In clinical studies, getting an MMRV vaccine for the first dose around 12 months of age approximately doubled the risk a child would have a febrile seizure, compared with getting the MMR and varicella vaccines separately. But that risk of febrile seizure was still small: about 4.3 cases for every 10,000 doses given, according to the CDC’s Vaccine Safety Datalink, a safety monitoring system.
ACIP first recognized this risk in 2009 and recommended that the measles, mumps and rubella vaccine and the chickenpox vaccine be given in two separate shots to children getting their first dose of these vaccines. But the committee also said parents could still choose the combined MMRV shot if that’s what they preferred.
About 85% of children currently get the MMR and chickenpox vaccines separately for their first dose, according to data collected by the CDC. About 15% of kids get a single dose of the combination MMRV vaccine.
Indeed, some ACIP members questioned Thursday why the guidance was being revisited at all.
“This discussion is really déjà vu for me because we had extensive discussions on this topic 15 years ago,” said Meissner, a pediatrician affiliated with the Geisel School of Medicine at Dartmouth who also served on ACIP from 2008 to 2012.
No new safety concerns about the vaccines or problems have been identified.
“I haven’t heard any information about urgency related to this decision. I’m not sure why it has to be made today,” said Dr. Amy Middleman, a pediatrician who attended the meeting as a representative of the Society for Adolescent Health and Medicine.
If the CDC accepts its vaccine advisers’ recommendation, there could eventually be changes to insurance coverage — but it may not happen yet.
The nation’s largest trade association for health insurers indicated in a statement this week that any recommendations stemming from ACIP’s meeting would not have an impact on its members’ coverage, at least for now.
AHIP, formerly America’s Health Insurance Plans, said its members — which provide coverage to more than 200 million Americans — would continue to cover all immunizations that ACIP had recommended as of September 1 at no cost to patients through the end of 2026. This includes the updated Covid-19 and influenza vaccines.
Potential changes to hepatitis B shots for newborns
At the conclusion of Thursday’s meeting, a separate vote that could change the longstanding recommendation to vaccinate newborns against hepatitis B was delayed until Friday.
Hepatitis B is a viral infection that can linger in the body silently for years, damaging the liver. When adults are infected with the virus, they usually clear it with no lasting impacts.
It’s a different story for kids: Nearly 90% of infants who are infected go on to develop chronic infections. People who have chronic hepatitis B infections are more likely to develop liver scarring or cancer, or need a liver transplant, later in life. Roughly 1 in 4 children who are infected will die prematurely from their infections.
Since 1991, the CDC has recommended that babies get their first dose of a hepatitis B vaccine soon after birth, before they go home from the hospital. This policy has helped slash reported hepatitis B infections in babies each year from an estimated 18,000 cases to about 20 cases.
Anti-vaccine activists have long questioned the need for the birth dose of the vaccine, since hepatitis B is mainly transmitted through dirty drug needles or sexual activity.
“Why would you give that to a 1-day-old child?” Kennedy asked in a June town hall hosted by NewsNation. “It’s really a profit motive.”
On Thursday, ACIP members considered whether the first dose of the hepatitis B vaccine should be given at birth or when babies are a month old, if their mothers tested negative for the virus.
Babies born to mothers who test positive for hepatitis B would still be vaccinated right away, as would those whose mothers’ hepatitis B status was unknown.
But delaying a baby’s vaccination also increases the risk they won’t get their shot at all. Even if a baby’s mother is negative, other members of their household may carry the virus, and vaccinations at 1 month of age can leave them unprotected for those first few weeks.
Hepatitis B is highly contagious – about 100 times more contagious than HIV – and can survive on surfaces for up to seven days. It can potentially be transmitted through contact with tiny amounts of blood on razors or toothbrushes or even bites from another child in day care.
Some of the CDC committee members felt that the potential change ignored the possibility of this kind of transmission.
“This assumes implicitly that all the infections are coming from moms, whether they’re positive or negative, and this is obviously not the case. So the most prudent thing would be to vaccinate and protect as many people as possible,” said Hibbeln, a psychiatrist.
Dr. Evelyn Griffin, an obstetrician-gynecologist in Louisiana who joined ACIP this week, felt that the birth dose was a matter of informed consent.
“If half the people don’t know that they’re hepatitis B-positive, how can you get informed consent?” Hibbeln countered.
Since most mothers stay in the hospital for at least 24 hours after birth, Griffin said, there is time to test the mother and let her know her status before a decision is made to vaccinate the baby
Although the forthcoming ACIP vote wouldn’t be a complete overhaul of vaccine policy, waiting to vaccinate could do damage, some experts said.
“This still misses the most highly vulnerable window for protection of infants,” said Dr. Ravi Jhaveri, who heads the division of pediatric infectious disease at the Ann & Robert H. Lurie Children’s Hospital of Chicago. “The first recommendation is one we have had in place and is the standard of care.”
A challenge to former CDC leaders
It was already unusual for ACIP to revisit longstanding vaccine recommendations without new evidence. Thursday’s meeting also opened in an unusual way, with the recently installed committee chair inviting several of the agency’s former directors to “a live public debate on vaccines.”
In his remarks, Kulldorff said that only through debate could members of the public know who to trust for scientific advice.
“We are currently experiencing heated controversies about vaccines, and a key question is: Who can you trust? Here is my advice. When there are different scientific views, only trust scientists who are willing to engage with and publicly debate the scientists with other views,” he said.
Kulldorff pushed back on perceptions of the committee as anti-vaccine after Kennedy rapidly named new members, many of whom lack expertise on vaccines or have made unproven claims or criticisms about them.
“The fact is that we are honest vaccine scientists that let the data speak whether the results go in one direction or the other. That is always how science should operate,” Kulldorff said. “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, a Swedish epidemiologist and biostatistician who was a prominent early critic of the US government’s coronavirus response, invited debate from nine former CDC directors or acting directors who wrote a New York Times op/ed criticizing Kennedy’s vaccine moves – Dr. Richard Besser, Dr. Mandy Cohen, Dr. William Foege, Dr. Tom Frieden, Dr. Jeffrey Koplan, Dr. William Roper, Dr. David Satcher, Dr. Anne Schuchat and Dr. Rochelle Walensky — as well as recently departed officials Monarez, Dr. Debra Houry, Dr. Demetre Daskalakis and Dr. Dan Jernigan.
In the op/ed, the former directors wrote that Kennedy’s decisions and impacts are “unlike anything we have ever seen at the agency, and unlike anything our country has ever experienced.” They said that they worried about the “wide-ranging” health security impacts and said Kennedy had stacked CDC advisory committees with “unqualified individuals who share his dangerous and unscientific views.”
Besser, who is now president and CEO of the Robert Wood Johnson Foundation, said in response to Kulldorff’s comments that “ACIP should not be reduced to political theater or gamesmanship” and said its recommendations for physicians and families “are no longer reliable.”
“If the committee continues down this path, the health repercussions for our nation will be severe,” Besser warned. “I urge the ACIP chair and its members to approach their work with the seriousness of purpose and commitment to science that this responsibility demands. Lives are at stake.”
CNN’s Meg Tirrell, Jamie Gumbrecht, Tami Luhby and Katherine Dillinger contributed to this report.
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