9m ago
Vote on hepatitis B vaccine recommendation pushed to Friday
Before moving on to public comments, Kulldorff said there is a “slight discrepancy in these two votes,” adding that the committee will plan to vote on the hepatitis B vaccine recommendation tomorrow instead of today.
The committee is also scheduled to vote on COVID-19 vaccine recommendations tomorrow.
12m ago
Committee shares proposed hepatitis B vaccine recommendation changes ahead of vote
On the topic of hepatitis B, there will be votes on two different recommendation changes.
The language for the first proposed change was presented as: “All pregnant women should be tested for hepatitis B infection.”
The second proposed change was presented as follows:
“The pediatric vaccine schedule should be updated to reflect the following change:
- If a mother tests HBsAG-negative:
- The first dose of the Hepatitis B vaccine is not given until the child is at least one month old.
- Infants may receive a dose of hepatitis B vaccine before one month according to individual based decision-making.*
*Also referred to as shared clinical decision-making.”
13m ago
Why hep B discussions now? To help regain trust in public health, ACIP member says
In response to the questions brought up by the liaison members, ACIP member and RFK Jr. ally Dr. Robert W. Malone said that, to him, the question sounded “a little disingenuous or at least self-evident.”
“It’s clear that a significant population of the United States has significant concerns about vaccine policy and about vaccine mandates,” he said. “There has been a significant decrease in public support for vaccination and a significant increase in concerns about public health and the ability of the population to rely on public health — and the hepatitis B birth dose has been a focus of folks that have these types of concerns.”
Malone said he had no direct communication with CDC leadership or HHS leadership about why this was a priority for this week’s meeting.
“I’m just inferring based on what I understand about public opinion,” he said.
15m ago
Multiple organization liaisons ask why proposed change is being discussed
Middleman and other organization representatives, including Dr. Flor M. Muñoz with the National Foundation for Infectious Diseases, asked the committee why this proposed change to hepatitis B was even brought up for discussion for a vaccine that has a long-standing recommendation and history of safety.
“Why are we addressing this hepatitis B vaccine recommendation? Is there really a reason that the committee can provide for making a change?” Muñoz asked.
“I’m wondering what problem exists in the current schedule that has prompted this entire discussion?” Middleman previously asked.
Kulldorff announced a 10-minute break, leaving the questions unanswered.
35m ago
Chair responds to doctor on why medical organizations were excluded from working groups
After not being called on during a previous discussion period, Dr. Amy Middleman, a liaison for the Society for Adolescent Health and Medicine, brought up the importance of top medical organizations such as herself and others on the call who have recently been excluded from the ACIP’s working groups.
“How can we make sure that we add the liaison members back into the working group so that they can contribute, on behalf of their patients and their knowledge base?” she asked.
ACIP chair Kulldorff blamed the removal of the organization members from the working groups on a FACA, or Federal Advisory Committee Act, requirement.
“This is a policy across all of CDC that is sort of outside the control of this committee,” he said. “In the past, ACIP did not meet this FACA requirement, which is a formal legal requirement.”
He agreed, to Middleman’s point, that input from others is “enormously valuable,” adding that the committee does have “many outside experts that we call in.”
57m ago
Some ACIP members clash in discussion on hep B risk evidence
After all presentations on the potential risks of hepatitis B vaccination, some members of the ACIP clashed on what the data meant for the vote they would be taking later today.
Member Vicky Pebsworth, a regional director of the National Association of Catholic Nurses, said “there are gaps in what we know and understand about the effects of hepatitis B, particularly on very young infants, and I think that the conclusion that it is safe is perhaps premature.”
Dr. Cody Meissner, a pediatrics professor who previously served as a member of the Food and Drug Administration’s vaccines panel, however, called the vaccine “safe” with “no evidence of harm.”
If the recommendation changes, he added, it would “increase the risk of harm based on no evidence of benefit, because there will be fewer children who will get the full hepatitis B vaccine series.”
2:09 PM
Changing hep B recommendation could put more infants at risk of infection, presenter says
In the first presentation for the hepatitis B vaccine, presenter Dr. Adam Langer with the CDC outlined how changing the current recommendation for a first dose within 24 hours of birth could put more children at risk, even those born to mothers who test negative for the disease.
Langer gave examples of situations where unvaccinated infants are at risk of HBV infection, including:
- They live with a person who has chronic hepatitis B, not necessarily their mother
- People who have an HBV infection come to visit their homes
- They go to daycare or other places where even “minuscule amounts of infectious blood or fluids might be present.”
“About half of people with HBV infection are unaware of their infection so they could unknowingly expose infants that are in their care,” he said.
Additionally, he said there is “no evidence that the risk of already rare adverse events is any greater among newborns than among older infants.”
The only potential benefit to rescinding the current recommendation is a potential reduction in rare cases of adverse effects from the birth dose vaccine, according to the presentation.
“When they do occur, these adverse events tend to be mild. The worst adverse event you could imagine, anaphylaxis has been very rarely reported at only 1.1 cases per 1 million vaccine doses administered,” Langer said.
1:37 PM
Hepatitis B presentations, discussions begin after break
After the lunch break, presentations and discussions shifted to the hepatitis B vaccine.
ACIP chair Martin Kulldorff reminded the group that the proposed recommendation changes concern only the hep B birth dose — the dose given to babies within 24 hours of birth — to mothers who test negative for the disease.
“So if the women test positive for hepatitis B, or if it’s unknown, we are not considering any changes for that population,” he said.
1:02 PM
Recommendation change would take away parents’ choice, ACIP member says
Just before the group paused for lunch, ACIP member Dr. Joseph Hibbeln brought up the impact the proposed recommendation change for MMRV vaccines would have on parents who want the single, combined measles, mumps, rubella and varicella shot for their children, since they would no longer be covered by the Vaccines for Children program which helps pay for immunizations.
“So that implies that the parents’ choice, unless they want to pay for it themselves, the parents’ choice is taken away,” he said, adding even if parents wanted the single shot, understood the benefits and risk, or even had a hard time accessing clinical care, “that option is basically taken away from them.”
Andrew Johnson, a representative with the Centers for Medicare & Medicaid Services, added that the change would also have coverage implications in the Medicaid and Children’s Health Insurance Program as well as individual and group markets.
12:42 PM
American College of Physicians president says “this was not a thoroughly vetted discussion”
Dr. Jason Goldman, president of the American College of Physicians, shared his concerns about the MMRV presentation at the meeting following a recent change in the ACIP process that removed top medical organizations from the committee’s working groups.
“You do not have those subject matter experts with the real-world experience to understand the implementation of these vaccines and the concerns of the patients,” Goldman said. “You don’t have the voice of the patients we take care for. You’re not looking at all of the aspects of how we evaluate vaccine implementation. You’re looking at very small data points and misrepresenting how it works in the real world and how we take care of our patients. So no, this was not a thoroughly vetted discussion”
Other medical organization leaders chimed in to echo his concern and message.
12:32 PM
Committee shares proposed MMRV vaccine recommendation ahead of vote
The proposed recommendation language, which will later go to a vote, was presented as follows:
“The pediatric vaccine schedule should be updated to reflect the following change:
- For measles, mumps, rubella and varicella vaccines given before age 4 years, the combined MMRV vaccine is not recommended.
- Children in this age group should receive separate measles, mumps, and rubella vaccine and varicella vaccine (MMR+V).”
Currently, the CDC says the MMRV vaccine may be used in that age range if preferred by parents or caregivers to reduce the number of shots.
12:23 PM
Measles vaccine presentations wrap with questions about febrile seizure risk
After presentations on the background and potential risks of febrile seizures with an MMRV vaccine — which combines the MMR and varicella shots — versus separate MMR and varicella shots, members discussed whether guidance should be changed.
Some members were satisfied with the current recommendations, which make clear the slightly higher risks of febrile seizures with the combined shot.
“I think the current wording is appropriate,” Dr. Cody Meissner, a pediatrics professor who previously served as a member of the Food and Drug Administration’s vaccines panel, said.
Others were not assured, saying there were too many assumptions being made. Some also pointed out that even if there are no worries about the physical impact of febrile seizures, the mental impact the event can have on children and families could affect vaccine compliance.
Dr. Richard Haupt, the head of global medical and scientific affairs, vaccines and infectious diseases at Merck, the vaccine’s manufacturer, noted the recent decline in vaccination rates among kindergarten children and highlighted the need to make guidance clear for the public.
“Considering these trends, any policy decision that compromises the clarity or consistency of vaccination guidance has the potential to further diminish public confidence,” he said.
10:55 AM
ACIP chair says he was never contacted by ousted CDC director about vaccine concerns
During Thursday’s meeting, ACIP chair and biostatistician Martin Kulldorff noted the removal of CDC Director Dr. Susan Monarez and other members of CDC leadership, including former chief medical officer Dr. Debra Houry — both of whom testified a day prior about their removal.
“On vaccines, this committee is the key adviser to the CDC director, but during her short tenure, she never contacted me as the ACIP chair about any of her questions or concerns, which would have been natural if she had such concerns, neither was I contacted by any of the three CDC leaders, who subsequently resigned,” he said.
Kulldorff said the CDC leadership left citing divergent opinions about vaccines, but Monarez said she was also pressured by Kennedy to fire career experts without cause and approve vaccine recommendations without scientific evidence.
Kulldorff also said the American Academy of Pediatrics ended its participation with the committee and ignored invitations for open discussion about vaccines.
Last month, for the first time in 30 years, the AAP shared guidance that differed from the U.S. government. The organization said it is “strongly recommending” COVID-19 shots for children ages 6 months to 2 years old. Under Kennedy, the CDC doesn’t recommend COVID-19 shots for healthy children of any age. Instead, it says parents may get their kids vaccinated in consultation with physicians.
10:29 AM
ACIP members highlight vaccine views during meeting roll call: “I’m not anti-vax”
As the meeting kicked off Thursday with a roll call, ACIP members presented some of their career backgrounds — and some took the time to highlight their views on vaccines.
Dr. Evelyn Griffin, an obstetrician and gynecologist based in Louisiana who was added to the panel earlier this week, said she would call herself “pro-informed consent.”
“Because of medical ethics, for discussing risk benefits and alternatives with the patient,” she said. “During the pandemic, I myself was COVID vaccinated.”
An earlier Kennedy pick, Dr. Joseph Hibbeln, who is retired from the National Institutes of Health, said he has a “neutral mind towards vaccines” and is “approaching this with a scientific equity.”
Dr. James Pagano, described by Kennedy as a “strong advocate for evidence-based medicine,” disclosed that he’s been vaccinated numerous times against various diseases.
“So I’m not anti-vax,” he said. “I am pro-intelligent and informed utilization of these potentially life-saving medications in a manner that reflects the current state of the art regarding their benefits, the target populations, optimal dosing and timing and, yes, of their potential adverse effects in some people.”
10:19 AM
Science, politics and the future of vaccination in spotlight
The ACIP is convening under an unaccustomed spotlight. The committee usually attracts little attention as it deliberates vaccine schedules and eligibility, but suddenly finds itself navigating political scrutiny, public skepticism and internal upheaval.
The stakes extend well beyond the technical details of dosing intervals or eligibility cutoffs. The panel’s decisions could reshape public trust in childhood vaccines, restrict access to vaccines through Medicaid and Medicare, and signal whether scientific consensus or political pressure will steer the nation’s vaccination strategy.
Read more here.
10:11 AM
Current recommendations for hepatitis B and MMRV vaccines
For hepatitis B, the CDC currently recommends the first dose within 24 hours after birth. Universal infant vaccination became the norm in 1991 after data showed too many cases of hepatitis B among pregnant women were missed during prenatal care.
A universal birth dose acts as a safety net, protecting infants whose parent’s infection might have been missed. Before birth-dose policies, the U.S. saw an estimated 1,000 preventable infections in newborns each year.
To protect against measles, mumps, rubella and varicella (or chickenpox), there are two options: a combo MMRV vaccine or separate MMR and varicella vaccines.
The CDC currently recommends a two-dose series beginning at age 12 to 15 months. However, the combination vaccine contains certain risks for younger age groups; specifically, the combo shot carries a slightly higher risk of fever-related “febrile” seizures when used as the first dose in young toddlers aged 12-23 months.
“For dose 1 in children age 12–47 months, it is recommended to administer MMR and varicella vaccines separately,” the CDC says, but adds MMRV may be used if preferred.
10:02 AM
Former CDC director said she is “very nervous” about the upcoming childhood vaccine panel recommendations
While testifying at a Senate hearing Wednesday about why she was ousted as CDC director, Dr. Susan Monarez said she’s “very nervous” about the newly appointed ACIP members and what their recommendations might be.
“I know that the medical community has raised concerns about whether or not, again, they have the commensurate backgrounds to be able to understand the data, the evidence, and to evaluate it appropriately, but I certainly will be watching,” she said.
In another part of the hearing, Monarez said she refused to rubber-stamp vaccine recommendations without seeing the evidence behind them because she “built a career on scientific integrity.”
“My worst fear was that I would then be in a position of approving something that would reduce access to lifesaving vaccines to children and others who need them,” she said.
Monarez added she is not aware of any scientific evidence to support changing the childhood vaccination schedule for measles, chicken pox and hepatitis B.
10:02 AM
Kennedy’s newly appointed ACIP members include allies and vaccine critics
After firing all 17 of the committee’s previous members in June, Kennedy named eight new advisers to the ACIP, one of whom later withdrew. They include several allies he has worked with closely over the years and some have a history as vaccine critics.
Kennedy appointed the new members directly, breaking with the past practice of agency officials vetting potential experts before sending them to the secretary for approval.
Just this week, the group gained five new members, the HHS announced. The latest additions include some who have questioned established medical research on immunizations and the COVID-19 pandemic.
10:02 AM
Panel to consider COVID vaccine recommendations Friday as West Coast states move ahead
A day before the ACIP meetings kicked off, a group of four West Coast states recommended that all adults and children in those states who want them can receive the COVID-19 vaccine and other common shots.
The announcement was made in a joint statement from Oregon Gov. Tina Kotek, Washington Gov. Bob Ferguson, California Gov. Gavin Newsom and Hawaii Gov. Josh Green, all Democrats, saying they were putting safety before politics.
The guidance, which aligns with mainstream medical groups like the American Academy of Family Physicians and American Academy of Pediatrics, comes amid confusion over the CDC’s messaging on vaccinations.
