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Editor’s note: This story will be updated throughout the day. Check back here for new updates.
ACIP voted on two recommendations related to the MMRV vaccine to conclude the first day of its meeting.
The first vote, on whether the pediatric vaccine schedule should be updated to say that the MMRV vaccine is not recommended for children under age 4, passed by a vote of 7-4. Malone abstained. He said he had no conflicts of interest, but he had previously agreed not to vote on the MMRV vaccine because of his participation as an expert witness in a whistleblower lawsuit against Merck.
Amid significant confusion expressed by some members of ACIP, who said they were not provided with the full text of what they were asked to vote on, the vote to approve the VFC proposal to change the eligible groups for the MMRV vaccine to children ages 4-12, was rejected, with 8 members voting no, one in favor, and three abstentions.
ACIP’s votes on the Hep B vaccine recommendations were postponed to tomorrow, due to a discrepancy between the ACIP recommendations and the VFC recommendations, which was apparently due to a technical error.
ACIP will convene tomorrow at 8:30 a.m. Eastern to vote on new recommendations related to the Hep B vaccine and to discuss and vote upon recommendations for the COVID-19 vaccines.
‘Secretary Kennedy must go’
Nine presenters were selected to speak during the “public comments” period, out of more than 5,000 written public comments that were submitted in advance of this meeting. Comments were limited to three minutes.
A former CDC staffer criticized Kennedy for his public health policies, including dismissing ACIP’s 17 former members, and said, “Secretary Kennedy must go.”
A representative of the Hepatitis B Foundation said she was presenting in order to remind the committee of the Hep B vaccine’s excellent safety profile.
The National Consumers League expressed “significant concerns” about making any changes to the childhood immunization schedule.
Director of advocacy at HealthHIV, who also spoke about the safety and efficacy of both the Hep B and MMRV vaccines. He urged the committee not to change the childhood vaccine immunization schedule and to maintain a universal COVID-19 vaccine recommendation.
A New York-based mutual aid provider likened vaccination to wearing a seatbelt, in that the two should not be restricted just to “high-risk” people.
A master’s student and private citizen said she lost her uncle, who was in 40s, healthy, with no pre-existing condition. She said he died of COVID-19, because he “couldn’t access” a vaccine. It wasn’t clear why he couldn’t access the vaccine, which had a universal recommendation at the time.
None of the spoken public comments questioned the safety or efficacy of vaccines.
Hep B vote delayed until Friday
Following a short break, Malone addressed a question posed by several ACIP liaisons, regarding why ACIP will vote today to delay administration of the Hep B vaccine to 1 month of age if no safety signal has been identified.
Malone said Americans have “significant concerns about vaccine policy and about vaccine mandates” and “the immediate provision of this vaccine at the time of birth, often in a context in which no true informed consent has been provided,” which has resulted in “a significant decrease in public support for vaccination.”
“The signal that is prompting this is not one of safety, but one of trust, and of parents uncomfortable with this medical procedure being performed at birth in a rather unilateral fashion without significant informed consent at a time where there has been a loss of trust in the public health enterprise and vaccines in general,” Malone said.
Hopefully, they are comforted by some of the data that has been presented, he said, “but I suspect that many concerns will linger.”
Kulldorff previewed the votes ACIP will hold on the Hep B vaccine.
The committee will vote on a recommendation that all pregnant women be tested for a hepatitis B infection, and for a change of the childhood vaccine schedule to forgo administration of the Hep B vaccine until the child is at least 1 month old, if their mother tested negative for hepatitis B.
Infants could still receive a dose of the Hep B vaccine before 1 month if there has been shared clinical decision-making between the mother and medical practitioners.
The committee will also vote on whether the same changes should be made to the recommendations provided by the VFC program.
The committee will not vote on the Hep B vaccine until tomorrow, due to some discrepancy between the ACIP recommendations and the VFC recommendations, which appears to be a technical error.
Do we have evidence of no harm? That’s the question we should be asking
During a question-and-answer session after Su’s presentations, ACIP members asked if the Hep B studies referenced had identified safety as the main outcome of the study. A CDC representative said that only three studies looked at safety, and not necessarily as the primary outcome.
In response to a question about whether the Hep B vaccine contains thimerosal, a preservative used in multidose vaccine vials to prevent the buildup of bacteria and fungi, which was removed from all routine childhood vaccines in 2001, Su deferred to representatives from the CDC’s Immunization Safety Office, who said they did not have the information available.
Su also deferred to CDC investigators in response to a question as to whether any babies studied required advanced care or coded, referring to situations where a patient is not breathing or has no pulse.
The CDC also conceded that no second study had confirmed the conclusion that the shot showed a “slight protective effect” against bronchopulmonary dysplasia. They said they had included that study because it fit their criteria. Several committee members confirmed that this was likely the result of “healthy vaccine bias,” where healthier babies tend to be more vaccinated, rather than an effect of the vaccine.
Vicky Pebsworth, Ph.D., read from the former Institute of Medicine (IOM) reports that have been cited during the hearing as evidence that the Hep B vaccine is safe, and said the IOM found much of the evidence to be inconclusive. That included evidence on the shot’s link to encephalopathy and 24 of the 26 serious adverse events they examined.
“There are gaps in what we know and understand about the effects of hepatitis B [vaccine], particularly among infants, and the conclusion that we know that it is safe is perhaps premature,” she said.
Kirk Milhoan, M.D., Ph.D., urged caution in approving recommendations for the Hep B vaccine for infants. He suggested that public health doesn’t always “favor the individual patient” and said that “When we make decisions on the most vulnerable, we have to have an abundance of caution.”
“Everything that I inject into somebody has a risk,” Milhoan said.
Blackburn made an argument for postponing the first Hep B shot until 1 month of age. She said she was concerned with evidence that it can be linked to fevers. “Any fever in a newborn under 28 days is considered a medical emergency.”
Liaison member Middleman challenged the idea that there is any issue with the current schedule, suggesting that “risk-based” vaccine approaches “don’t work.” Middleman criticized the fact that liaison members like herself have been excluded from ACIP’s working groups and asked how liaisons would be added back into the working groups.
Kulldorff said it was a CDC-level policy that they could not be included.
Levi said Middleman said there was “no evidence of harm” from the Hep B vaccine, but that her comment made him “uneasy” because the safety issue should be asking for “evidence of no harm,” especially when giving a vaccine to a healthy baby on the first day of life.
“What is the reason that we don’t have large RCTs, randomized clinical trials, to actually figure out the answer and finish the debate?” he asked.
Answering his own question, Levi said he thought the Hep B vaccine was crucial for at-risk babies, but added, “This notion that we sit here, with very lousy evidence, and argue that there is no problem whatsoever is not building trust and it’s not scientific, and it’s not what the public should expect from us.”
ACIP liaison Dr. Robert Hopkins, however, said that the vaccine has proven to be safe and should continue to be administered while more safety data is collected.
Dr. Flor Munoz-Rivas, a member of the FDA’s Vaccines and Related Biological Products Advisory Committee who, according to the federal Open Payments platform, has received hundreds of thousands of dollars in consulting fees from Moderna, Seqirus, Sanofi, AstraZeneca — and nearly $9 million in research funding from Moderna and others said the existing vaccine strategy is safe and effective.
“Is there a reason the committee can provide for why we are making a change?” she asked. “The data speaks for itself. We have seen a significant change in the incidence of hepatitis B … not just in young children but also in adults” due to the vaccine.
Merck, Sanofi urge CDC to keep current Hep B recommendation for infants
Su, who earlier gave presentations on the MMRV vaccine and on the results of a safety review of the Hep B vaccine given at birth, now delivered a presentation on non-specific effects following Hep B vaccination.
Non-specific effects refer to changes in the immune system that have broader effects within the body and which are distinct from adverse events directly related to vaccination.
These effects can include an increased risk of allergic and autoimmune conditions and of all-cause mortality. Vaccines containing live viruses may cause different non-specific effects compared to non-live vaccines.
According to the presentation, few studies have examined the non-specific effects of Hep B vaccines, though one cohort study showed an increased risk of all-cause mortality following vaccination. Su presented the findings from that 2004 study and a rapid systematic review of non-specific events.
The 2004 study, conducted in Guinea-Bissau, found higher mortality rates among children between ages 7.5 and 12 months among children who received the Hep B vaccine within a two-dose measles trial. The effect was stronger for girls than for boys.
However, the 2004 study examined a Hep B vaccine that is not administered in the U.S.
The rapid systematic review identified only eight relevant studies on the topic. Two cohort studies performed in high-income countries found no increased risk of death following Hep B vaccination, but a cohort study performed in a lower- to middle-income country identified a higher risk of death.
Su noted that non-specific effects are difficult to quantify in the U.S. because Hep B is often administered in combination with other routine childhood immunizations.
Last month, two doctors who lost their medical licenses because they questioned the CDC’s vaccine recommendations for children sued the CDC for failing to test the cumulative effect of the 72-dose childhood schedule on children’s health.
Su concluded that there is little data available on non-specific effects of the hepatitis vaccine.
A representative from Merck urged the committee to refer back to Langer’s presentation that he said clearly defines the rationale for “vaccination as a crucial public health strategy to prevent chronic viral hepatitis and its severe long-term consequences.”
A representative from Sanofi made a similar appeal, arguing that scientific evidence supports the safety of the vaccines discussed in today’s meeting and urging the CDC to maintain current recommendations.
Delaying Hep B vaccine to age 1 month may reduce rare adverse events
Su, who earlier gave a presentation on the MMRV vaccine, presented the outcomes of a safety review of the Hep B vaccine given at birth, focusing on safety signals identified during the first 30 days of life. The CDC included 20 peer-reviewed studies in its review.
The presentation was compiled in response to a request by Kulldorff to analyze the safety data from the CDC’s Vaccine Safety Datalink and from the FDA’s Biologics Effectiveness and Safety System and assess adverse events, impacts on all-cause morbidity and mortality, short- and long-term safety data.
Summarizing the evidence in the studies — which varied in the timing of the vaccine and the follow-up period for adverse events — Su concluded that there was no identified increased risk among infants who received the shot in allergic reactions, all-cause mortality, expected or unexpected deaths due to SIDS, seizures or other neurologic disease.
He also said that infants who received the Hep B vaccine at birth had a reduction in risk for needing invasive diagnostic procedures and a “slight protective effect” against bronchopulmonary dysplasia.
Referencing a birth cohort study of over 350,000 live births, Su said the study found that the proportion of deaths among babies who received the vaccine was significantly lower than for those that did not.
He noted that limited studies were available that studied the birth dose or that studied effects beyond a few days, and the conclusions were based on those limited studies.
In her live blog for CHD.TV, Nass questioned Su’s conclusions.
“It is impossible to assess adverse reactions in a newborn because you don’t know what is normal for that child,” Nass wrote.
Hep B vaccine debate heats up
A heated debate continued after Langer’s presentation.
Stein and Levi both asked for data on how babies born to mothers who test negative for hepatitis B benefit. The CDC said most data is from positive mothers.
Levi asked how many days the adverse effects were tracked for. The CDC showed a table showing the different studies that they looked at, with some showing up to 24 months, but gave no verbal response other than to direct Levi to look at the column showing how long the studies were for.
However, upon clarification, those results tracked seroprevalence. The CDC said they would have to check and get back to Levi about how long they tracked any adverse events.
Dr. Robert W. Malone asked how many children needed to be treated with the shot to prevent one infant case of hepatitis B. The CDC said they didn’t have that data.
Speaking for the FDA, Tracy Beth Høeg, M.D., Ph.D., said the original clinical trials only tracked adverse events for 4-5 days. She echoed Levi’s question about what data exists for long-term conditions. She said this was important to be able to consider risk-benefit for babies born to mothers who aren’t hepatitis B positive.
The CDC also confirmed there are no records of hepatitis B being transmitted in a school setting, according to Griffin.
Griffin also noted that one key 2012 IOM study saying the vaccine was safe and effective, also “found that the evidence was inadequate to rule out the possibility that hepatitis B vaccination leads to more than two dozen neurologic and autoimmune disorders.”
“How do we reconcile the phrase ‘safe and effective’ with this statement?” she asked.
Hep B: ‘I’m not sure we have any data that suggest current meaningful impact’
Kulldorff opened the second half of the meeting, explaining that the committee will be evaluating the first dose of the Hep B vaccine for mothers who tested negative.
Dr. Adam Langer, acting principal director for the CDC’s National Center for HIV, Viral Hepatitis, STD, and Tuberculosis Prevention, delivered a presentation on Hep B birth dose vaccination, called the “birth dose.”
He said there are “many ways” that infants can be infected with hepatitis B and that 90% of infants perinatally infected will develop chronic hepatitis.
In her live blog, Nass agreed that perinatal infection is dangerous for babies. “Untreated babies of Hep B positive mothers are in trouble — that we well know. But those are not the children we are talking about today,” Nass wrote.
Langer said Hep B vaccination is the “cornerstone” of preventing mother-to-child transmission and has high efficacy. The full dose is a three-dose series, currently given starting at birth.
Since 1998, he said, ACIP has recommended universal hepatitis B testing in the first trimester, with a third-trimester test recommended to women who engage in high-risk behaviors, and a test at birth for women whose hepatitis B status is unknown.
Since 1991, ACIP has recommended a birth dose, originally for infants born to infected mothers. Later, ACIP recommended the universal both dose.
He said that there have been situations where the hepatitis B status of the mother was miscommunicated and babies went untreated and contracted hepatitis B. He cited a case study, but said it was not the only one, citing a study that Nass said was funded by the pharmaceutical industry.
However, he also said that the vaccine is given to all infants whose mother’s status is unknown.
He said infants are at risk for hepatitis B from other environmental exposures. Hepatitis B can remain viable on environmental surfaces where blood or body fluids are present. Most data presented are from modeling studies.
“Where are the real data?” Nass asked on her live blog. “How many babies have died from Hep B infection in the US during the past few years? The high risk moms (drug abusers, sex workers and Asian immigrants) could be screened aggressively during their pregnancy to avoid missing cases. WHY are cases being missed, apart from lack of prenatal care?”
Langer said that after the universal recommendation, the number of cases of hepatitis B dropped significantly, and once it was recommended that the first dose be given before a baby leaves the hospital, the numbers went down further.
Nass noted that the average retail price is about $100 per dose.
Langer said that Gavi, the Vaccine Alliance, has been instrumental in getting the birth dose recommended globally. Thirty-six countries currently give a birth dose universally.
The U.S. does not have a national registry to track hepatitis B screening during pregnancy, so there are no data available on pregnant women with hepatitis B in the last 10 years.
He said that one of the primary reasons to give a universal birth dose is to act as a safety net for infants whose mothers’ hepatitis B status is unknown. He added that no other country has gone from a universal vaccine to a more narrow recommendation.
He briefly summarized existing safety studies on the birth dose done by the CDC. Ten had a high risk of bias, and only three were done in the U.S.
Nass noted that most clinical trials are done with funding from manufacturers and “invariably show few or no serious side effects or fail to screen for them. That is what appears to have happened here.”
Langer concluded that evidence shows that the Hep B vaccine birth dose is effective, safe, and that comparison of different Hep B vaccines has no meaningful differences in safety and efficacy.
Griffin asked how many of the 17 studies had authors with declared conflicts of interest. The CDC expert responded that, to the CDC’s knowledge, there were no conflicts, but they would have to look at it and get back to her.
Griffin said she had access to some of the studies and among those she was able to access, at least eight of the papers that had declared conflicts of interest, including conflicts with vaccine manufacturers.
Griffin also asked what the death rate was from hepatitis B since 1991. No one responded. She said that per CDC numbers in 1991 there were 912 deaths and in 2021 it was 1,740, which showed an increasing death rate, proportional to the population, despite introduction of the vaccine.
Levi noted that after the 1991 recommendation for children born to mothers who have hepatitis B, it was clear that hepatitis b rates dropped significantly. However, he said after 2005, when the universal vaccine was introduced, there was no significant improvement in the rates of acute hepatitis B.
“I’m not sure we have any data that suggest current meaningful impact,” he said.
ACIP will vote later today on changes to MMR, MMRV recommendations
Kulldorff presented the proposals that ACIP will vote on later today regarding the MMRV vaccines. He said the committee is not discussing changes to what children should be vaccinated against, nor on the timing of vaccines.
Instead, they are voting on whether the vaccine schedule should be updated to say that the MMRV vaccine is not recommended for children under age 4, and that children in that age group should receive the MMR and varicella vaccines separately.
That would mean that no first doses of the MMR vaccine would be MMRV, changing the current recommendations slightly.
On her CHD.TV liveblog, Nass questioned why the varicella vaccine is administered to children in any form.
“Only 1 child/year dies from varicella in the U.S., and we have drugs for it that work in patients receive immune-destroying cancer/leukemia treatments. How many of the 4 million children per year who receive the varicella vaccine are damaged or die from it?” Nass wrote.
Dr. Cody Meissner said parents should retain the option to choose between the two vaccines.
Dr. Jason Goldman, President of the American College of Physicians, said this recommendation would create more confusion among the public and give license to insurance and the Vaccines for Children program to not cover the MMRV vaccine. He said it would also take choice away from parents and that all of the data had not been considered.
His comments were echoed by Dr. Amy Middleman, ACIP’s liaison from the Society for Adolescent Health and Medicine.
Levi asked them, given their strong statements, if they could say what additional data they felt was not considered, and asked whether they disputed the findings. Several participants said that parents should be provided the full body of evidence regarding the two vaccines to ensure informed consent.
Goldman said that the experience of the liaisons with real-world experience were missing and complained that those liaisons had been removed from the workgroup committee.
Levi reiterated that members of ACIP were practicing physicians and if Goldman and others could point to data that was lacking, it would be appreciated.
Dr. Jeanne Santoli, a representative from the CDC’s Vaccines for Children Program (VFC), presented the VFC’s resolution on updated guidance on the use of the MMR, varicella and MMRV vaccines.
VFC proposed to change the eligible groups for the MMRV vaccine to children ages 4-12. The recommendation had previously been ages 12 months to 4 years.
Nass called this proposal “a good idea.”
They propose a language change that would reflect the proposed changes. The new language would state that the combined MMRV vaccine is not recommended for children before 4 years of age and that those children should receive separate MMR and varicella vaccines.
VFC provides vaccines on the CDC’s childhood immunization schedule at no cost to children from low-income households. Vaccines that are designated as “not recommended” would not be covered by the VFC and may not be covered by Medicaid or insurance.
Following this presentation, ACIP will take a short break and will return to consider recommendations regarding Hep B vaccines.
No placebo-controlled trials on MMR, MMRV vaccines?
John Su, M.D., Ph.D., a medical officer in the CDC’s Immunization Safety Office, delivered a presentation on febrile seizures following administration of the MMRV vaccine.
Febrile seizures are convulsions most often caused by fevers brought on by infections such as those related to common childhood illnesses.
Overall, Su said, there is an increased risk for febrile seizures after the first dose of MMR and MMRV vaccines. Studies have also shown an increase in febrile seizures during the 5-12 days after a child has received their first vaccination with MMR vaccine.
Su said data shows there is no increased risk of febrile seizures after vaccination with MMRV vaccine in children ages 4-6 years and that studies have not shown an increased risk for febrile seizures after the varicella vaccine.
Dr. Meryl Nass, who is live-blogging the meeting for CHD.TV, noted that not all seizures are due to fever and that non-febrile seizures tend to be associated with more severe outcomes.
Nass pointed out that Su’s presentation contradicted his earlier statement, as five cohort studies have shown that febrile seizures are elevated following MMRV vaccination.
She also said that Su did not address the issue of encephalitis, which occurs in some children a week after getting the vaccines.
Kulldorff asked how the frequency of febrile seizures following vaccination would affect vaccine uptake more generally, generating hesitancy among people who heard about those adverse events occurring.
The data on how vaccine hesitancy would increase is largely lacking, he said after hearing responses from CDC experts.
Dr. Cody Meissner said that MMR alone results in febrile seizures in 1 in 3,000 children vaccinated and adding the varicella vaccine to that vaccine doubles the risk. Su confirmed that was correct.
Retsef Levi, Ph.D., said the lower numbers after the second dose could be due to the fact that children who have a reaction after the first dose simply don’t get the second dose. He asked if there has been research on whether those children have been tested for biomarkers that would help to identify the underlying mechanisms.
“From a safety perspective, I’m very concerned when we just focus on what we measure and we don’t get to understand the biological mechanisms that are taking place here,” he said. “It doesn’t look like we are making any effort to understand the underlying mechanisms here.”
Stein asked how risks are communicated to parents, particularly data that comes out after recommendations are made. The CDC said they develop one-pagers for doctors to talk to patients and they think that one was also made for parents.
Dr. Evelyn Griffin asked if there were any follow-up studies on the neurological effects of febrile seizures following vaccination. The CDC said those studies were not ongoing.
The CDC could not answer whether there are any placebo studies comparing the vaccine to placebo, but said most studies compared the MMR and MMRV vaccines.
Griffin called for a true placebo study.
MMRV vaccine linked to double the rate of post-vaccination seizures
The first presentation today focused on the background of the Measles, Mumps, Rubella, and Varicella (MMRV) vaccines. Dr. Arjun Srinivasan, deputy director for program improvement in the CDC’s Division of Healthcare Quality Promotion, delivered the presentation.
This was the first of several presentations scheduled today on the MMRV vaccines, in the lead-up to a scheduled vote later today on recommendations for their administration to children.
During the presentation, Srinivasan said there are two options available in the U.S., a combined MMRV vaccine or separate MMR and varicella vaccines. The MMRV vaccine is more widely administered in the U.S., and Merck is the only manufacturer with an approved MMRV vaccine here.
The MMRV vaccine was found, soon after approval, to cause double the rate of post-vaccination seizures. However, both versions of the vaccine have been credited with a significant reduction in the incidence of the diseases in question.
According to Srinivasan, the rates of all four diseases are very low and so it has been inferred, without data, that the vaccines are safe and effective.
There is no adjuvant in either MMR or MMRV vaccines, according to CDC subject matter experts.
Malone said that because he had served as an expert witness in the controversial Krahling v. Merck case — in which whistleblowers accused Merck of fraud related to the mumps component of the vaccines — he would not be offering opinions or voting on the MMRV questions.
The committee paused to conduct a separate roll call for the medical societies that were not present at roll call. A representative for the American Geriatrics Society had arrived.
Important to identify how ‘number of needles a child receives’ can be reduced
Kulldorff announced two new ACIP working groups. One will focus on examining the entire childhood and adolescent vaccine, while the other will examine the impact of vaccines during pregnancy.
“It’s important to look at interaction effects,” Kulldorff said regarding the childhood and adolescent immunization schedule. For pregnant women, Kulldorff said possible vaccine-related adverse events, including birth defects, must be studied.
Prior to the start of presentations on the MMRV vaccines, Kulldorff said the committee would seek to identify ways in which “the number of needles a child receives” could be reduced.
Kulldorff invites ex-CDC officials to open vaccine debate
“We’re currently experiencing heated controversies about vaccines, and the key question is, who can you trust?” Kulldorff said, kicking off the meeting.
He added:
“Here’s 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. With such debates, you can weigh and determine the scientific reasoning by each side, but without it, you cannot properly judge their arguments.”
Kulldorff said he lamented that the AAP had ended their participation as a liaison to the committee, and declined his invitation to public debate.
He added that ex-CDC director Susan Monarez never contacted him to discuss concerns, nor had the CDC officials who resigned. “Why would these CDC leaders ignore us?”
He addressed accusations by nine former members of the committee in an NYT editorial that current members have “dangerous and unscientific views,” and calling on Congress to “exercise its oversight authority” over HHS He defended the expertise of the committee and invited those members, and the recently departed CDC to debate them publicly.
“If they want to be trusted, they should all accept,” he said.
Evidence the committee has reviewed shows that many childhood vaccines are safe, he said, and that former CDC officials who have resigned and have since publicly criticized Kennedy and the agency’s new leadership, are questioning science itself.
“We strongly support the use of vaccines,” Kulldorff said. “All of our decisions were pro-vaccine and the committee is “pro-children, pro-science and pro-public health.”
Kulldorff said that included the decision to remove mercury-containing vaccines, because mercury has shown to be toxic.
AAP, ACOG are no-shows
No representative was present from the American Academy of Pediatrics (AAP) the American Geriatrics Society, or the National Medical Association.
Last month, representatives from those groups were removed from the ACIP working groups due to conflicts of interest and they appear to have decided not to participate in the meeting. Representatives from many other professional organizations are present.
In August, AAP issued recommendations diverging from those of the CDC, recommending that parents get COVID-19 shots for their children and infants. In July, the AAP and five other medical organizations sued Robert F. Kennedy Jr. and other public health officials and agencies over the CDC’s new guidance.
In attendance is Phyllis Arthur, executive vice president & Head of Healthcare Policy & Programs of the Biotechnology Innovation Organization (BIO), a major pharmaceutical industry lobbying group which allegedly drafted a $2 million plan to oust Kennedy.
New ACIP members introduce themselves, declare conflicts
The first day of the two-day ACIP meeting is underway, starting with a welcome message and roll call. The committee is chaired by Martin Kulldorff, Ph.D., an epidemiologist formerly with Harvard University who co-authored the “Great Barrington Declaration.”
Twelve ACIP members are in attendance. Five new members, formally announced on Monday, join the committee for this meeting. They include epidemiologist Catherine M. Stein, Ph.D.; OB-GYN Evelyn Griffin; pharmacist Hillary Blackburn — the first pharmacist to join the committee; pediatric cardiologist Kirk Milhoan, M.D., Ph.D.; and surgeon and transplant specialist Dr. Raymond Pollak.
An update on ACIP work groups will follow the welcome and roll call at 10:30 a.m. (all times Eastern). At 11 a.m., ACIP will turn its attention to a series of presentations on MMRV vaccines. Presentations on the Hep B vaccine will follow at 1:30 p.m.
ACIP will hear selected public comments at 4:30 p.m. and will hold a vote on its MMRV and Hep B vaccine recommendations at 5 p.m.
During the roll call, ACIP members shared their experience with vaccines and vaccine policy, and affirmed their ability to effectively assess vaccine recommendations.
Dr. Joseph R. Hibbeln, a psychiatrist and neuroscientist and former chief of the Section on Nutritional Neurosciences at NIH, said he has a “neutral mind toward vaccines.”
Dr. James Pagano, a board-certified emergency medicine physician, said he is “not anti-vax,” but in favor of their “intelligent and informed utilization” while studying “their potential adverse effects in some people.”
CDC Advisers Weigh Changes to Childhood Vaccine Schedule
The CDC Advisory Committee on Immunization Practices (ACIP) meets today and tomorrow to discuss, among other issues, possible changes to the childhood vaccine schedule.
Today’s agenda includes possible changes to recommendations for the Measles, Mumps, Rubella, Varicella (MMRV) vaccine and the hepatitis B (Hep B) vaccine.
Tomorrow’s agenda includes a discussion of COVID-19 vaccines for children.
The committee is responsible for advising the Centers for Disease Control and Prevention (CDC) on vaccination policy. The CDC director typically signs off on ACIP’s vaccine recommendations for the American public, including what vaccines will be covered by the federal Vaccines for Children Program.
Jim O’Neill is acting director of the agency, following the firing last month of Susan Monarez, Ph.D.
Five additional members will join ACIP for the first time today, bringing the number of members on the committee to 12. In June, U.S. Health Secretary Robert F. Kennedy Jr. dismissed all 17 sitting members of ACIP, citing conflicts of interest.
Sparks flew at a U.S. Senate hearing yesterday, as many senators said they oppose possible changes to COVID-19 and Hep B vaccine recommendations for children.
Earlier this month, The New York Times reported that the U.S. Food and Drug Administration’s Tracy Beth Høeg, M.D., Ph.D., was scheduled to present the agency’s findings on the child deaths related to the COVID-19 vaccines. However, her presentation is not listed on the meeting schedule.
More than 5,000 written public comments have been submitted to the committee in advance of this meeting.
Watch today’s hearing here:
