CDC Vaccine Advisers Vote No on COVID Shot Prescription, Unanimously Recommend ‘Individual Decision-Making’

ACIP just held its first meeting since RFK Jr. overhauled the CDC’s vaccine advisers—here’s everything you need to know.

Sep 22, 2025

This article originally appeared on The Defender and was republished with permission.

Guest post by Michael Nevradakis, Ph.D. and Brenda Baletti, Ph.D.

In the first two-day meetings of the new vaccine advisers to the CDC, ACIP members tabled a vote on whether to recommend delaying the first Hep B vaccine until age 1 month. The committee engaged in spirited debate about COVID-19 vaccine safety, the need to vaccinate infants and children for COVID-19, and the need for better informed consent for the vaccines.

Members of the CDC vaccine advisory committee today voted to recommend that the decision to get a COVID-19 vaccine, for all age groups, be made through consultation with a provider who fully informs them of their individual risks and benefits. Everyone ages 6 months and older can still get the shot.

The committee also voted to table a proposed vote to delay the Hep B vaccine for newborns to age 1.

Friday’s meeting of the Advisory Committee on Immunization Practices concluded with the committee voting on four issues:

1. Unanimous yes: that the pediatric and adult immunization schedules be updated to recommend that for people ages 65 and older, vaccination be based on “individual-based decision-making.”

And that for people ages 6 months to 64 years, vaccination should be based on “individual-based decision-making,” emphasizing that the risk-benefit of vaccination is most favorable for those at increased risk for severe disease.

That means everyone ages 6 months or older can get the shot, based on individual decision-making. For people under 65, the committee recommended they be advised that the shot is more beneficial for those at increased risk of disease.

Kulldorff confirmed this would allow for insurance coverage for everyone ages 6 months and up.

2. Yes, 11-1: that the CDC should engage in an effort to promote “more consistent and comprehensive informed consent processes,” which would include adding accessible language to describe the six risks and uncertainties the working group presented in its discussion.

Levi said this proposal was meant to send a strong message that informed consent should be obtained before vaccination.

Kulldorff said this is not a type of recommendation typically made by ACIP and he thinks the CDC staff can take up this type of initiative on their own.

Levi said they are recommending that the Vaccine Information Statements be changed, and that the CDC would have to consider that. Levi said this type of proposal is within the charter of ACIP and the current sheet does not do what is being proposed here. He said as ACIP, they should “call it out” and make specific recommendations about what should be done.

3. No, after Kulldorff broke the 6-6 tie: that the CDC should recommend state and local jurisdictions require a prescription for COVID-19 vaccination.

Blackburn, the only pharmacist on the committee, moved to amend the proposal to remove the prescription requirement, but did not propose alternative language to be voted on.

Several ACIP members expressed concern about the proposed vote, resulting in an extensive debate.

“Requiring a prescription is going to become a big barrier to people getting this vaccine,” Dr. Cody Meissner said.

Levi said that antibiotics, for example, require prescriptions because the benefits and risks are nuanced and ought to be considered by and discussed with a physician. Given the information presented today about risks associated with the vaccines, he said, this same approach makes sense for the COVID-19 vaccines.

Pagano, Milhoan, Malone, Griffin, Pebsworth and Levi voted yes.

4. Unanimous yes: whether healthcare providers should discuss the risks and benefits for individual patients with them before vaccination as part of the informed consent process.

The committee voted unanimously in favor of the motion.

Minority workgroup: ‘COVID vaccination matters’

Bernstein, a pediatrician from the Vaccines and Related Biological Products Advisory Committee, responded to the workgroup findings, presenting the minority opinion. He said the vaccine “continues to work incredibly well,” and offers additional protection to existing immunity from infection and previous vaccination.

He said safety monitoring has been excellent and underscored that VAERS can’t show causality.

Bernstein argued that “shared clinical decision-making” and the need for a prescription for a COVID-19 vaccine create a significant barrier to access. He added that providers always discuss risks and benefits with their patients.

He said the vaccine is safe and effective for everyone 6 months to 11 years, and is particularly important for children under 5.

He said rates of hospitalization are highest among infants and children less than 2 years of age, and that although it is a small percentage, “a small percentage of a large number of children is a large number.”

He said there are no increased risks for mothers and infants from COVID-19 vaccination. He presented a list of effects not experienced by those groups that included birth defects — contradicting earlier observations by Kulldorff that there was a fourfold higher rate of birth defects among infants born to pregnant mothers who got the shot.

In summary, he said, “COVID-19 vaccination matters.”

‘These kids died from subclinical myocarditis’

Levi outlined the main takeaways from the workgroup.

First, the assessment of the protection levels provided by COVID-19 vaccines and particularly the boosters, against severe outcomes is based on “very low-quality data and analysis.”

Also, vaccine injuries are “demonstrably not recognized by current pharmacovigilance systems, leaving vaccine-injured individuals abandoned and without appropriate care.”

He said they planned to follow up on this issue because it is “morally wrong” and contributes to a lack of trust in the vaccine program.

Third, he said, there is substantial evidence suggesting “serious safety uncertainties and concerns,” including vaccine adulteration, that is not being sufficiently addressed.

They recommend that the risks and uncertainties about the COVID-19 vaccines should be clearly communicated by the CDC to providers and patients, in order to allow for informed consent.

The committee also recommends enhancement of national efforts to better diagnose and care for vaccine-injured people.

The committee also recommends developing better national safety surveillance systems.

To emphasize his first point, Levi said the committee had a very difficult time getting data, including from the FDA, about the number of people who need to be vaccinated to show a benefit from the COVID-19 vaccines that were used for the most recent approvals.

He showed data from the U.K., which estimates that the number of people needed to be vaccinated is six times higher than the CDC’s.

On her live blog, Nass wrote, “The methodological limitations are troubling. The biases are frequent. He does not believe we know current efficacy. CDC is ignoring other better approaches that could be used.”

Levi also noted that the vaccine appears to increase susceptibility to other infections and that the rates of serious illness have been very low this year.

Raising concerns about safety data, Levi mentioned the autopsies of two teens who died in the days following vaccination. CDC disputed the autopsy finding, he said.

“Do we have a culture of safety? What would it take for us to acknowledge that there is a problem when, at the same time, someone that died two weeks after a positive COVID infection will be considered a COVID-associated death, whereas two kids that die three days from a known mechanism of the vaccine in their sleep are not counted as vaccine deaths?”

“These kids died from subclinical myocarditis,” and said that many other countries had published peer-reviewed literature showing the link between death and subclinical myocarditis.

He said the evidence shows that it also affects women, and that “subclinical myocarditis can cause death. It’s proven. It’s not questionable.”

He added that the U.S. has no monitoring system in place to monitor that. He also added that there is no system in place to monitor post-vaccination syndrome.

He added that most people in the workgroup thought that COVID-19 vaccination shouldn’t be recommended in pregnancy, but that they opted not to bring it to a vote today.

Levi also discussed the issue of public trust.

He said the working group was very concerned with issues of informed consent and felt the Vaccine Information Statements need to be improved and given to all vaccine recipients before vaccination.

Liaisons criticize ACIP, advocate for COVID vaccines for 6-month-olds

Stein asked why, given the long list of adverse events of special interest presented, the CDC presentation focused only on ischemic stroke.

Su said focused on ischemic stroke as an example, and did not mean to imply it was the only adverse event for which a safety signal connected to the COVID-19 shots was detected.

Liaisons were again critical of the entire process, and several took their allotted space to comment on ACIP, rather than on the COVID-19 issues up for discussion.

Carol Hayes from the American College of Nurse-Midwives took the floor only to give a “shout out” to former head of the CDC’s Immunization Safety Office under the previous administration, Dr. Tom Shimabukuro. Congress recently subpoenaed Shimabukuro to respond to allegations that he may have mishandled or deleted official vaccine injury records.

American Medical Association (AMA) liaison Dr. Sandra Fryhofer questioned the conclusions of the day’s presentations on COVID-19, saying that COVID-19 vaccines “saved us during the pandemic.”

She asked the committee to ensure that “little babies continue to get COVID protection from maternal vaccination” and from vaccination at the age of 6 months.

Fryhofer also addressed recent changes to ACIP’s membership, saying it’s “troubling to see the erosion of the committee’s integrity.”

Last month, the AMA and several other medical organizations were removed from ACIP’s workgroups.

Dr. Flor Munoz-Rivas, a member of the FDA’s Vaccines and Related Biological Products Advisory Committee, also urged the committee to maintain childhood COVID-19 recommendations and support for mRNA vaccines more broadly.

“We do need the research money, we do need the follow-up, and we do need a long-term investigation so that [mRNA] technology can also be applied to future vaccines,” she said.

According to the federal Open Payments platform, Munoz-Rivas 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.

Pfizer trial had fourfold higher rate of birth defects in vaccinated group

After lunch, Kirk Milhoan, M.D., Ph.D., began the Q&A section, talking about the low uptake rate and its implications for the credibility of the health agencies.

He also said no data had been presented on whether any COVID-19 cases had been prevented. The CDC said there wasn’t adequate data to answer that question.

“What percentage of patients failed to make an antibody response to the vaccine?” Milhoan asked. He also suggested that people who did not develop antibodies following previous doses of the COVID-19 vaccine should not receive subsequent boosters.

He said he was shocked at the lack of pharmacological rigor regarding dosing and shot timing, especially given concerns raised about contamination.

He asked, given the contamination concerns, why haven’t the vaccines been pulled from the market?

The FDA’s Høeg said the FDA takes the issue seriously and is discussing investigating it further.

ACIP member Dr. Raymond Pollak raised concerns about the evidence showing the vaccine confers protection against COVID-19.

A representative from the NCIRD said, “We have done quite a lot of antibody studies … and the manufacturers have done quite a lot of antibody studies,” she said. “Most people do produce very robust neutralizing antibodies.”

She said, however, that levels of neutralizing antibody protection vary per person and due to other factors, such as the strain of a virus that’s in circulation at any given time.

Malone took issue with Høeg’s response. “There is no established correlative protection for COVID, period, full stop, and stop saying otherwise,” he said, adding that current standards do not measure correlative protection but instead measure “indirect indicators of an immune response.”

“In other words, FDA has been breaking its own rules when it approved covid and anthrax vaccines using fake correlates of protection,” Nass wrote on her live blog.

Malone emphasized that the presence of vaccine-induced antibodies does not necessarily confer protection.

Pollak said that any recommendation made by the committee should make it clear that the committee is recommending the vaccine even if it doesn’t protect against the disease.

The lay public believes that if you get vaccinated, you will be immune, he said, “and if I’m not immune, then I have to weigh up the benefit and risk of getting the vaccine, and if I think the vaccine doesn’t make me immune, why should I bother to expose myself to the risk of the vaccine.”

Blackburn raised concerns that the COVID-19 package inserts state they have not been tested for carcinogenicity and other related issues, including impacts on fertility.

She asked, given the earlier presentations, rising cancer rates, and her own observations of aggressive cancers in vaccinated people in her community, should additional studies be conducted to investigate these issues more fully?

Kulldorff asked Pfizer representatives about a “fourfold excess risk in birth defects” in babies born to vaccinated mothers that was identified in a study the company performed.

Pfizer’s head of vaccine development said the rates “match what you would expect in the general population.”

Kulldorff noted there were eight birth defects in the vaccinated group in Pfizer’s study, compared to two in the unvaccinated group. Despite this data, Pfizer’s representative denied there was a fourfold increase in the incidence of birth defects among vaccinated mothers.

“Are you denying that there were eight birth defects in the vaccinated and two in the vaccinated? Are those numbers wrong?” he asked.

She said the tables were published on the Pfizer website.

When pressed by Kulldorff, the Pfizer rep declined to provide further clarification. Other Pfizer representatives also declined to comment.

Pfizer, Moderna dodge questions on DNA contamination in COVID shots

Meissner kicked off the Q&A session. He concurred that COVID-19 can’t be differentiated from other respiratory diseases by symptoms and mentioned that data from Massachusetts showed that about 30% of people hospitalized with COVID-19 suffered from it as a primary illness.

He asked for clarification about how they were classifying infants hospitalized due to COVID-19.

The CDC experts confirmed that it is difficult to identify why people are hospitalized and that the method for identifying COVID-19 hospitalizations is “not perfect.”

Meissner pointed out that this is the basis on which many people are advocating the shot for pregnant women and said, “I don’t think there’s acknowledgement that this is a very uncertain parameter, and I think this should be more widely noted.”

The CDC said that hospitalization rates for infants are the same as for people over age 65, based on cumulative data.

Meissner cited the data that the CDC provided to them, and said that this past season, the hospitalization rates for infants since February were less than 0.8 per 100,000. He argued that decisions on vaccine recommendations should be based on current data, not cumulative data.

“The virus is becoming less invasive, it causes less severe disease, and everyone has immunity to it from infection or vaccination,” Meissner said.

Meissner questioned the need for continued CDC recommendations on COVID-19 vaccination. “At what point does the low uptake of a vaccine affect CDC recommendations?” he asked. “If you make recommendations that people are not going to follow, I don’t think that’s wise.”

ACIP member Dr. Evelyn Griffin asked the manufacturers which regulatory bodies allowed Pfizer and Moderna to determine the distribution of DNA contaminants and spike protein throughout the body using products different from the vaccines that received FDA approval.

Moderna evaded the question, saying their biodistribution studies didn’t find the long-term distribution of the spike proteins.

Pfizer said its studies were done in consultation with the FDA.

Malone said they used the least sensitive method available and the data submitted were edited. He asked them to comment on that.

Pfizer said it had no further comment.

Moderna said Pfizer used detection methods specific to the spike protein. Its representative did not provide any further comment.

Griffin asked whether the companies measured impurities. Moderna said its purity tests do test for DNA impurities, but not RNA and conceded this is a problem. Pfizer said that was also true for them.

Malone asked whether the thresholds they used to determine whether the vaccines contained residual DNA relied upon existing regulatory limits and standards — designed for traditional vaccines — or whether they set new standards adequate to measure the possible contamination by the new mRNA products.

The manufacturers admitted that their testing used “existing standards.”

Commenting on her CHD.TV live blog, Nass said “this was ridiculous” and that “Neither Pfizer nor Moderna says how much [DNA contamination] they found.”

Griffin also asked if Pfizer and Moderna were aware of DNA contamination in their products and if they tried to replicate the results of any such studies or perform population-level studies to ascertain such contamination.

Griffin said “this is where the rubber meets the road” for her as an OB-GYN because women want to know if the spike protein ends up in breast milk. She highlighted studies that have shown that.

Pfizer ‘constantly analyzing’ COVID vaccine safety data

After the economic presentation, the COVID-19 vaccine manufacturers made statements.

Sanofi’s representative, Dr. Katie Sharff, spoke on behalf of Sanofi and Novavax. She emphasized that their shot, Nuvaxovid, is the only non-mRNA vaccine available in the U.S. and is important for providing Americans with “choice.”

The vaccine is “safe and effective,” she said and the companies are dedicated to sharing data with regulatory agencies to continue monitoring any new safety signals. Sanofi will be producing and marketing the shot starting this fall.

Nass wrote on her live blog, “OMG!!! Sanofi purchased Katie [Sharff], the ID [infectious disease] doctor who reported on the fraud regarding the rates of myocarditis that had been too low.

“She previously worked for Kaiser [Permanente] in Oregon when she revealed the myocarditis scam, Nass said. “I guess they made her an offer she could not refuse.”

Moderna’s representative celebrated the company’s work during the pandemic, and emphasized how safe the vaccine is. He also addressed the earlier presentation on safety issues directly. He said the information presented today “contain assertions not aligned with the broader scientific evidence.”

“Some conclusions extend beyond what referenced studies support or contradict careful reading by others.” He said that claims of spike protein persistence contradict findings in the studies approved by the regulators.

Pfizer’s representative also assured the committee that Pfizer is constantly analyzing safety data and has found that its shots are safe. He said last year in the U.S. the shot saved between 5,000-7,000 lives.

COVID vaccines: ‘Insufficient data’ available for pediatric and adolescent age groups

Srinivasan then gave the final COVID-19 research presentation titled “Economic Analysis of COVID-19 Vaccination.”

He sought to estimate the annual population burden of disease in a cohort representative of the U.S. population, to estimate the number of COVID-19 cases that were avoided because of vaccination, and the resulting cost-effectiveness for different subgroups, defined by age and risk status.

Srinivasan’s analysis analyzed adverse events and costs, such as hospitalizations, recorded within one year of vaccination, and deaths spanning beyond one year of vaccination.

Srinivasan concluded by emphasizing that vaccination is important, but saying that “economic favorability has declined” compared to estimates from earlier seasons.

He said there was insufficient data available for pediatric and adolescent age groups.

In her live blog for CHD.TV, Nass questioned Srinivasan’s conclusions.

“Everything in this presentation is theoretical,” Nass wrote.

Genetic markers may increase susceptibility to myocarditis after mRNA vaccines

Carleton, who earlier today was announced as a member of ACIP’s new workgroup on COVID-19 vaccine safety, delivered a presentation on the “Genomics of Vaccine-Induced Myocarditis.”

He presented preliminary findings from 50 patients who received either the Pfizer or Moderna shots and later were diagnosed with myocarditis.

Carleton’s research is funded by the CDC, by various Canadian government agencies and also by React19, an organization that advocates on behalf of COVID-19 vaccine injury victims.

Much of Carleton’s presentation focused on genetic markers that may increase susceptibility to developing myocarditis following vaccination.

In her live blog for CHD.TV, Nass said that Carleton’s research identified “several common mutations that appear … that may identify susceptibility to vaccine AEs [adverse events] such as myocarditis.”

Carleton suggested further research into genetic markers of risk for all kinds of vaccine-related adverse events. He said this would facilitate a better understanding of how such adverse events develop in people, and would allow for the development of “personalized vaccine schedules” that would reduce the risk of adverse events.

He noted that genomic studies of drugs have “revolutionized drug therapy,” and argued that it could do the same for vaccines.

Carleton said the Global Vaccine Data Network, a collaborative network of 32 countries, will soon be publishing “the largest myocarditis and pericarditis COVID-19 vaccine study to date,” which will also include an analysis of such injuries following booster doses.

mRNA can cross the brain-blood barrier, study shows

El-Deiry and Kuperwasser delivered a presentation on COVID-19 vaccine-related safety issues, including changes to the immune system, biodistribution of mRNA throughout the body, “off-target” protein production in the body and the presence of impurities, including DNA contaminants.

Their presentation, titled “Workgroup Safety Uncertainties of mRNA COVID Vaccines,” stated that there are significant gaps in knowledge about these safety concerns, particularly on a long-term basis.

El-Deiry and Kuperwasser’s membership in ACIP’s new workgroup on COVID-19 vaccine safety was announced earlier today.

“There is evidence that COVID vaccination, especially after multiple doses, is associated with immune changes,” Kuperwasser said. And key questions remain regarding the “persistence, clinical significance and potential long-term consequences” of these changes.

“Elevated inflammatory cytokines persisted for months,” Kuperwasser said, noting that this increases the risk of persistent and/or recurrent infections.

Kuperwasser said that Pfizer did not study the biodistribution of the actual spike protein in its clinical trials and that its rat studies showed that most of the spike protein remained close to the injection site. However, even these studies showed that some of the spike protein spread to other parts of the body, including the liver.

Moderna did not perform an mRNA biodistribution study with its approved COVID-19 vaccine, but for a different candidate vaccine that used the same lipid nanoparticle — which transports mRNA into the body. The results of Moderna’s rat study showed that high levels of mRNA were found in multiple organs, including the spleen, eye and liver, and lower levels in other tissues, including the heart, testes and brain.

“Importantly, this study clearly showed that the mRNA can cross the blood-brain barrier,” Kuperwasser said.

“These studies make it clear that the mRNA does not remain confined to the injection site,” and may remain in the body for up to 706 days following COVID-19 vaccination, Kuperwasser added. Her presentation noted that mRNA has been detected in breast milk for up to 45 hours.

These findings “raise important questions for ongoing research and safety monitoring,” Kuperwasser said.

El-Deiry referenced “multiple reports of DNA impurities” in the mRNA COVID-19 vaccines.

Their presentation also noted that both the Pfizer and Moderna vaccines exceed regulatory limits for the presence of DNA contaminants. In the Pfizer vaccine, the SV40 promoter/enhancer sequences have also been detected.

They said there have been no safety considerations or guidelines established for the lipid nanoparticle-enveloped DNA impurities, and there are known concerns regarding DNA integration by the SV40 sequences.

El-Deiry said the lipid nanoparticles in the vaccines can transfer DNA contaminants throughout the body and that existing regulatory limits do not take this possibility into account.

He also said there have not been any reliable “or really any” population study done in the U.S. regarding cancer associated with vaccination, but cancers have been reported with temporal association to immunization.

They listed 48 case reports and a study of 96 cases of pancreatic carcinomas, and a case-controlled study of 76 colorectal cancers.

El-Deiry said that little is known about the extent of DNA contamination in current COVID-19 vaccines, genomic integration of this DNA into the human body, the prevalence of adverse events related to such contaminants, the ongoing persistence of spike proteins in the body, and cancer mechanisms related to such contamination.

He summarized, “There are COVID-19 vaccine safety concerns that stem from unexpected biological activities of mRNA gene therapy platforms, raising questions about potential pathogenic mechanisms and human subjects research protections.”

El-Deiry recommended “proactive and modernized surveillance programs,” epidemiologic studies, expanded autopsy programs to identify causality, programs that systematically evaluate COVID-19 vaccine safety, updated FDA policies on DNA contaminant limits, new CDC guidelines on risk disclosure and “robust” informed consent, and increased pharmaceutical company accountability.

Safety signals for ischemic stroke identified for previous years’ COVID shots

During a presentation on vaccine safety signal detection and evaluation, John Su, M.D., Ph.D., of the CDC’s Immunization Safety Office said that safety signals were detected for ischemic stroke — referring to a blood clot in the brain — connected to the 2022-2023 and 2023-2024 versions of the mRNA COVID-19 vaccines.

Su said the CDC maintains “strong, complementary systems” to monitor vaccine safety signals, and explained how these systems, including the Vaccine Adverse Event Reporting System (VAERS), Vaccine Safety Datalink (VSD), the Clinical Immunization Safety Assessment (CISA) Project and V-safe.

According to Su’s presentation, despite the safety signals identified, further analyses “have not confirmed an increased risk of ischemic stroke.”

No statistically significant increased risk of ischemic stroke was found following combined COVID-19 and flu vaccination, either on the same day or on separate days.

Su’s presentation did not include a discussion of any other adverse events potentially connected to the COVID-19 vaccines.

According to an Aug. 25 memo, the FDA is now requiring vaccine makers to conduct clinical trials to study the potential adverse effects of simultaneously giving multiple shots for respiratory viruses, including COVID-19, flu and RSV, before they can market the vaccines as “safe and effective” when administered at the same time.

Last week, the FDA announced it had identified a link between 25 child deaths and the COVID-19 vaccines. As part of its “intense investigation” into these deaths, the FDA drew upon reports submitted to VAERS.

Only 13% of Kids under 17 ‘up to date’ on COVID shots

Srinivasan presented updates to 2023-2025 COVID-19 implementation considerations, reporting the results of a National Immunization Survey, a random cellphone call survey of tens of thousands of people in the U.S.

Vaccination coverage reached 44.1% for adults 65 and over, 24.6% for adults 50-64, and 14.1% for adults 18-49.

In the most recent season, people in the older age groups, 50 and up, had increased coverage over last season.

Only 13% of children between 6 months and 17 years of age were “up to date” on COVID-19 vaccines by the end of April 2025.

Among healthcare personnel, the data showed “fairly consistent” influenza vaccine coverage in the U.S. since 2022, but “COVID vaccination season continues to decline across seasons,” with only about 10% of healthcare workers receiving a COVID-19 shot.

Srinivasan also presented on COVID-19 vaccine effectiveness, including for children, pregnant women and adults. His analysis looked at observational data from the 2023-2024 and 2024-2025 cold and flu seasons.

According to Srinivasan, the COVID-19 vaccines provided additional protection from emergency room and urgent care visits for children and adults, for adults 65 and over with and without comorbidities, and against critical illness for adults 65 and over, although the vaccines were not as effective against less severe outcomes.

Srinivasan said natural immunity from prior SARS-CoV-2 infection provides protection, although it “wanes over time.”

Malone questions CDC COVID childhood hospitalization data

Dr. Arjun Srinivasan from the CDC’s National Center for Immunization and Respiratory Diseases (NCIRD) is making four presentations on the COVID-19 vaccine today.

First, Srinivasan presented updates on COVID-19 hospitalizations in the U.S. from the COVID-NET database, which captures data from about 10% of the U.S. population.

In her live blog for CHD.TV, Dr. Meryl Nass said that by capturing such a small sample of the overall population, the data “may not be accurate.”

“CDC is still using an inappropriate definition that will give much higher case numbers than justified. For example, it categorized hospitalizations ‘with’ (a positive swab) as ‘due to’ COVID,” Nass wrote.

In his presentation, Srinivasan said that hospital admission surveillance systems face difficulties in differentiating between hospital admissions “with” COVID-19 or “due to” COVID-19, but that 87% of recent hospital admissions of COVID-19-positive patients in the U.S. were classified as being “due to” infection.

People ages 65 and over accounted for 70% of COVID-19-associated hospitalizations, of which 91% were considered to be “due to” COVID-19 infection. Adults hospitalized due to COVID-19 had “generally higher” rates of chronic conditions, including diabetes, chronic kidney disease and obesity, compared to the general population.

Overall, COVID-19 hospitalization rates were highest among adults ages 75 and over, followed by infants 6 months of age and younger.

Nass questioned this conclusion. “COVID-associated hospitalizations suggest many of the children hospitalized were hospitalized for something else,” she wrote.

Malone questioned the numbers in the presentation, saying there is significant overlap in the clinical diagnosis of COVID-19 and other respiratory illnesses — meaning they have the same symptoms. Srinivasan agreed.

“It’s lovely that you created all of this data, but the two underlying theses underlying all of your data are tenuous,” he said.

That’s because the COVID-19 tests have issues with accuracy, or “sensitivity and specificity.” The CDC responded that FDA-approved tests are used to identify patients who test positive for SARS-CoV-2.

‘Safe and effective’ language not scientific or appropriate for discussing vaccines

Retsef Levi, Ph.D., who last month was tapped to lead a new ACIP workgroup tasked with examining COVID-19 vaccine safety and efficacy, made opening comments introducing his new workgroup

The workgroup, established last month amid objections by U.S. government lawyers, will review scientific data and studies on the safety and efficacy of the COVID-19 vaccines, including data related to adverse events and deaths associated with the shots, and will present its findings to ACIP.

The CDC previously said the workgroup will use the results of its review “to help develop [the agency’s] COVID-19 immunization policy options.

Presenting the group, Levi said the only debates they had with former CDC leadership was around the scope of the questions the workgroup was able to investigate.

“We believe that ACIP and the workgroup should really be able to ask and consider any potential information or knowledge that is relevant to vaccine policies,” he said.

Levi also said the workgroup would stay away from the narratives of “safe and effective,” because “We don’t believe that these are appropriate or scientific language” to discuss vaccination.

Today, Levi revealed the full lineup of the workgroup today. Investigative journalist Maryanne Demasi, Ph.D., was the first to report the story.

Fifteen new members were named to the workgroup, including current ACIP members Malone and Dr. James Pagano, and:

Christine Stabell Benn, M.D., Ph.D., a professor of global health at the University of Southern Denmark and an expert on vaccines’ non-specific effects.
Henry “Hank” Bernstein, D.O., a pediatrician and former member of ACIP with extensive experience in vaccine schedule development.
Bruce Carleton, Ph.D., director of the Canadian Pharmacogenomics Network for Drug Safety, with expertise in genetic predispositions to vaccine-related adverse events.
Dr. Joe Fraiman, an emergency physician and expert on serious adverse events.
Wafik El-Deiry, M.D., Ph.D., an oncologist and director of the Legorreta Cancer Center at Brown University with expertise on DNA integration and cancer risks.
Dr. Suzanne Gazda, a neurologist with expertise in post-vaccination neurological syndromes and long COVID.
Tracy Beth Høeg, M.D., Ph.D., a physician and epidemiologist who is senior advisor for clinical sciences at the FDA and is known for her critical research into COVID-19 vaccine safety.
Charlotte Kuperwasser, Ph.D., a Tufts University cancer biologist with expertise in mammary gland biology and endocrine signalling.
Dr. Douglas Jones, an allergist and immunologist with expertise in autoimmune and allergic responses following vaccination.
Dr. Mitchell Miglis, a Stanford University neurologist with expertise in neurological and cardiovascular adverse events and long COVID.
Stanley Perlman, M.D., Ph.D., a University of Iowa virologist and pediatrician who is a former ACIP member and is considered one of the world’s foremost experts in coronaviruses.
Erle Robertson, Ph.D., a University of Pennsylvania virologist with expertise in long-term mRNA and spike protein persistence in the body.
Dr. Jordan Vaughn, an internist and president of the Microvascular Research Foundation, with expertise in microclots and endothelial injury in long COVID and post-vaccine patients.

Three of the new workgroup members will deliver presentations at today’s meeting.

Vote to Change Hep B Vaccine Recommendations Tabled in an 11-1 Vote

ACIP voted on whether all pregnant women should be tested for hepatitis B infection. The vote passed unanimously with 12 votes in favor.

The second vote, on whether to change the recommendation that infants get the shot at birth to a recommendation that they get it at one month, was postponed.

ACIP member Vicky Pebsworth, Ph.D., said that she went back and reviewed the information they were given yesterday.

She said most of the countries, including most European countries, who recommend the shot to infants, actually give the shot at 2-3 months. The CDC presentation implied that those countries gave a birth shot.

She added that a closer look at the CDC’s data showed that systemic immune reactions among infants who got a birth shot were “in fact, not rare.” Up to one-third of children experienced fever, drowsiness, or with severe irritability and fussiness in the first five days of life.

She cited another study published in a top journal that the CDC didn’t present data from, which found that up to 30% of children experienced a “robust inflammatory response,” which they experienced during a key period of neurodevelopment.

Pebsworth said the committee should “err on the side of caution” and follow the example of many European countries, which do not vaccinate infants at low risk even after 1 month of life.

Malone said that a lack of studies assessing whether the Hep B vaccine causes harm shouldn’t be interpreted as confirmation that the vaccine is safe.

“To interpret that the absence of data implies safety is, I think, a perversion,” Malone said. “The burden is to generate safety, not to generate the statistics to demonstrate the converse, non-safety.”

Dr. Robert Malone moved to postpone the vote “indefinitely,” saying that a “vote today would be premature.” The motion passed with 11 votes in favor and one against.

The vote means that current Hep B vaccination birth recommendations will remain in place until a new vote is held.

Committee clarifies yesterday’s vote on MMRV vaccine

Chair Martin Kulldorff opened the meeting addressing the confusion around yesterday’s second vote. In the first vote, the committee decided to change the recommendations for the MMRV vaccine. However, in the second vote, they voted not to change the VFC program funding to match the new recommendations.

Typically, those votes match, because their purpose is to keep vaccine access the same for all children — so what the ACIP recommends, the VFC funds.

Kulldorff said the conflicting votes happened because they are “rookies,” to the ACIP meetings — all members are there for either the first or second time — and proposed that the group clarify the motion and revote.

A motion to reconsider Thursday’s vote to update VFC guidelines for the MMRV vaccine passed with 10 votes in favor and two abstentions. In the subsequent vote, the updated VFC guidelines passed with 9 votes in favor and 3 abstentions.

“What all this means is that every child, including every child in the … VFC program will have access to be vaccinated against measles, to be vaccinated against mumps, against rubella, which is German measles, and to be vaccinated against varicella, which is chicken pox.

Live Updates Day 2: CDC Advisers to Vote on COVID Vaccines for Kids, Hep B for Newborns

Members of the CDC Advisory Committee on Immunization Practices (ACIP) are meeting again today to discuss, among other issues, possible changes to the childhood vaccine schedule, including Hep B and COVID-19 vaccine recommendations.

On Thursday, the committee voted on two recommendations related to the MMRV vaccine.

The committee, by a vote of eight to three, recommended that toddlers through age 3 be immunized for varicella (chickenpox) through standalone vaccination rather than through the combination measles, mumps, rubella, and varicella (MMRV) vaccine.

According to the U.S. Department of Health and Human Services (HHS), the agency will examine “all insurance coverage implications” of the recommendation before the acting director of the Centers for Disease Control and Prevention, Jim O’Neill, adopts a final decision.

O’Neill replaced Susan Monarez, Ph.D., who President Donald Trump fired last month after she clashed with U.S. Health Secretary Robert F. Kennedy Jr., including on whether to accept ACIP’s vaccine recommendations. Monarez sharply criticized Kennedy during a U.S. Senate hearing on Wednesday.

ACIP delayed voting on whether to delay the first Hep B vaccine for newborns until babies are 1 month old.

The committee also will hear presentations on COVID-19 vaccines for children, and according to the agenda, will vote on that at 2:15 p.m. ET.

Before the vote, the committee is also expected to hear the findings of an “intense investigation” by the U.S. Food and Drug Administration (FDA) which identified a link between 25 child deaths and the COVID-19 vaccines.

ACIP will also hear presentations on “safety uncertainties” of mRNA COVID-19 vaccines and on myocarditis induced by the COVID-19 shots.

COVID-19 vaccine manufacturers are expected to provide statements.

Earlier this month, The New York Times reported that the FDA’s Tracy Beth Høeg, M.D., Ph.D., was scheduled to present the findings on the child deaths related to the COVID-19 vaccines. However, her presentation is not listed on the meeting schedule.

ACIP will also vote on whether to continue the inclusion of the Hep B and COVID-19 vaccines in the federal Vaccines for Children Program (VFC), which provides routine childhood immunizations at no cost to uninsured and underinsured children.

More than 5,000 written public comments have been submitted to the committee in advance of this meeting.