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Wednesday, July 2, 2025

What’s Next for CDC’s Remade Vaccine Advisory Committee

 by Zachary Stieber

The vaccine advisory committee remade by Health Secretary Robert F. Kennedy Jr. plans to look at multiple other vaccines, after it voted to advise officials to stop recommending influenza shots that contain mercury.

Martin Kulldorff, the new chair of the Advisory Committee on Immunization Practices (ACIP), said on June 26 that one proposal is to tell the Centers for Disease Control and Prevention (CDC) to make clear that young children should not receive the measles, mumps, rubella, varicella (MMRV) combination immunization.

Instead, the CDC would recommend that children under the age of 47 months receive two separate vaccines: the measles, mumps, rubella shot, and the varicella, or chickenpox, vaccine.

The change would reflect data that indicate the MMRV combination vaccine causes more febrile seizures, he said. The CDC said the same thing in a background paper on the subject dated June 25.
A vote on the matter could occur as early as the next meeting, which is expected to take place in August or September.

2 New Subcommittees

Kulldorff, an epidemiologist who was fired by Harvard Medical School for declining a COVID-19 vaccine, also announced two new work groups, or subcommittees.

One will examine the impact of vaccines on the childhood immunization schedules.

“It is important to evaluate the cumulative effect of the recommended vaccine schedule,” Kulldorff said. “This includes interaction effects between different vaccines, the total number of vaccines, cumulative amounts of vaccine ingredients, and the relative timing of different vaccines.”

Researchers with the CDC and other institutions said in a 2022 paper that exposure to aluminum in vaccines was associated with asthma, although they said that additional investigation was required to confirm a link.

The second subcommittee will examine vaccines that have not been reviewed in more than seven years, including the hepatitis B vaccine, the first dose of which the CDC recommends at birth for infants.

“Unless the mother is hepatitis B positive, an argument could be made to delay the vaccine for this infection, which is primarily spread by sexual activity and intravenous drug use,” Kulldorff said.

Kulldorff declined in an email to The Epoch Times to say whether he'd been directed by Kennedy to look at the measles vaccines, or to reveal any other proposals the committee plans to take up at its next meeting.

The Department of Health and Human Services, the CDC’s parent agency, did not respond to a request for comment, including on whether Kennedy directed the committee to vote on vaccines containing the mercury-based preservative thimerosal.

Kennedy, earlier in June, removed all 17 members of the ACIP and replaced them with Kulldorff and others.

RSV Antibody, Influenza Vaccines

During the committee’s first meeting since the replacements, it advised the CDC to add a second monoclonal antibody treatment against respiratory syncytial virus (RSV) for infants.

Dr. Robert Malone, a new ACIP member, told The Epoch Times that there was extensive discussion on the antibody at the subcommittee level and that one of the reasons he voted in favor was to provide another option against the virus, given how stock of the existing antibody ran low in the past.

Retsef Levi, another ACIP member, told The Epoch Times he voted against making the second antibody available to all infants because of concerns over a lack of granular data from clinical trials for both products. He would have supported letting high-risk infants receive the new antibody.

Kulldorff also voted in favor of the antibody. He participated despite being a paid witness in a legal case against Merck, which manufactures the new antibody, in January.

Dr. Joel Lexchin, a professor at the University of Toronto who has studied conflicts of interest, told The Epoch Times via email that Kulldorff “had a clear conflict and should not have voted.”

Kulldorff has not responded to requests for comment about potential conflicts of interest. He said during the meeting he did not have any conflicts related to the issues at hand.

Lexchin previously told The Epoch Times that some of the members ousted by Kennedy should have abstained from certain votes after they received money from pharmaceutical companies that stood to be affected.

The new advisers also voted to keep in place the CDC’s recommendation that virtually all individuals aged at least 6 months receive an influenza vaccine on an annual basis, before they advised the CDC to stop recommending thimerosal-containing flu shots.

About 5 percent of the flu shots administered in recent months contained thimerosal, according to the Food and Drug Administration.

Members who voted in favor of removing thimerosal said they wanted to cut down on controllable sources of mercury exposure. Dr. Cody Meissner, the only no vote, said he didn’t see a safety issue with the amount of mercury in influenza vaccines and that he was concerned the vote would imperil influenza vaccine access for some.

The FDA and Sanofi, an influenza vaccine manufacturer, said that the supply would be sufficient without the thimerosal-containing vaccines.

The meeting did not involve much debate or discussion on general influenza vaccination, according to Malone.

“We were presented with essentially language that was already approved and and had to make a decision about whether or not to endorse ... a universal influenza vaccine recommendation, as has been the case for decades. The decision was that this was not the time to fight on that hill about the universal influenza vaccine recommendation,” Malone told The Epoch Times.

Panel member Vicky Pebsworth abstained from the vote, citing a lack of discussion.

Immune Imprinting

Malone said at the close of the meeting that he would be part of a subcommittee focused on influenza and that he anticipated considering “the long-standing issue of immune imprinting and original antigenic sin, which may or may not be a concern in the case of routine annual influenza vaccination.”

Immune imprinting refers to when previous vaccinations or infections leave behind an immune memory, causing the body to produce antibodies targeting that memory, even if a new variant or vaccine is introduced.

Vaccinating people annually against influenza may be counterproductive due to imprinting, Malone told The Epoch Times.

“It might be tempting to think that vaccinating everybody with the same vaccine every year is the best strategy, but I think there is actually quite a lot of evidence that suggests that that might not be the case,” Levi said.

Levi also said that he’s aware that some people want the remade panel to make radical changes, while others have expressed concern that that the panel will do just that.

“I think that the fact that we are not rushing to make fast decisions on radical changes should hopefully give people some indication that we are going to be very, very thoughtful and thorough in first understanding why people make decisions the way they are now before we are going to recommend changes,” he said.

The new members stated in a joint statement after the meeting: “Our central duty is to protect public health, and we understand that we must answer the call for reestablishing confidence in the scientific examination process. This committee strongly supports the use of vaccines, and other countermeasures, predicated on evidence-based medicine, including rigorous evaluation and expansive, credible scientific data, for both safety and efficacy.”

‘A Welcome Change’

Barbara Loe Fisher, cofounder and president of the National Vaccine Information Center, and a former vaccine adviser to the government, told The Epoch Times in an email that historically, most of the ACIP work groups have focused on promoting vaccination rather than examining vaccine safety or effectiveness.

“From a consumer perspective, it is a welcome change to see ACIP form work groups to tackle topics that are of concern to increasingly well-educated Americans paying more attention to the impact of vaccine policies on health outcomes,” she said.

Pebsworth is a volunteer director for the center. Fisher said Pebsworth won’t speak to media outlets during her time on the panel.

Some other organizations criticized ACIP’s focus on the childhood schedule and thimerosal.

“Re-examining the childhood vaccine schedule and the use of thimerosal are both politically motivated actions that are not based on science,” Dr. Tina Tan, president of the Infectious Diseases Society of America, said in a statement. “Raising questions without adequate data casts doubt on vaccination, which can further drive down confidence in vaccines. More than any other medications, vaccines are extensively and constantly reviewed and evaluated.”

Kulldorff said during the meeting that Kennedy had given the committee “a clear mandate to use evidence-based medicine for making vaccine recommendations.”

“Vaccines are not all good or bad. If you think that all vaccines are safe and effective and want them all, or if you think that all vaccines are dangerous and don’t want any of them, then you don’t have much use for us—you already know what you want,” he said.

“But if you wish to know which vaccines are suitable for you and your children and at what ages, then we will provide you with evidence-based recommendations.”

https://www.theepochtimes.com/article/whats-next-for-cdcs-remade-vaccine-advisory-committee-5879188

CytoSorbents receives FDA appeal hearing date for DrugSorb-ATR device

 CytoSorbents Corporation (NASDAQ:CTSO), a medical device company with a market capitalization of $81 million and impressive YTD returns of 42%, announced today that the U.S. Food and Drug Administration has scheduled an appeal hearing for the company’s DrugSorb-ATR device, following the FDA’s earlier denial of its De Novo marketing application. 

The hearing, confirmed on June 27, is part of CytoSorbents’ supervisory review process under 21 CFR 10.75 and is expected to conclude by the end of August 2025. The company is seeking approval for its blood purification device designed to reduce bleeding severity in patients undergoing coronary artery bypass grafting surgery within two days of stopping the blood thinner Brilinta.

In a separate development, Health Canada issued a Notice of Refusal for the company’s Medical Device License application on June 26, citing non-compliance with certain regulations. CytoSorbents plans to file a Request for Reconsideration with Health Canada by July 25.

"We believe DrugSorb-ATR addresses a critical and growing need in cardiac surgery," said Dr. Phillip Chan, Chief Executive Officer of CytoSorbents, in the company’s press release statement. The device has previously received FDA Breakthrough Device Designation.

The DrugSorb-ATR system uses polymer technology to remove blood thinners during surgery. CytoSorbents’ flagship product, CytoSorb, is already approved in the European Union and distributed in over 70 countries, though not yet approved in the United States.

The company expects final regulatory decisions from both the FDA and Health Canada by the end of 2025. DrugSorb-ATR is not currently authorized for commercialization in the U.S. or Canada.

https://ca.investing.com/news/company-news/cytosorbents-receives-fda-appeal-hearing-date-for-drugsorbatr-device-93CH-4088127


Med pros: Avoid viral ‘Innotox’ trend — which can cause muscle paralysis and worse

 Talk about a shot in the dark. 

Experts are sounding the alarm about a growing number of Americans injecting themselves at home with so-called “Korean Botox,” drawn in by promises of smooth skin at a fraction of the cost.

Those jumping on the viral Innotox trend, they warn, are playing a game of cosmetic roulette that comes with risks far more serious than a few forehead wrinkles and crow’s feet.

Self-injecting Innotox is the latest DIY beauty trend going viral.Eva March – stock.adobe.com

What is Innotox ?

Innotox is a South Korean treatment that contains botulinum toxin type A, the same active ingredient found in Botox, according to Korean Beauty Tech.

It works by temporarily relaxing facial muscles to reduce contractions, which softens the appearance of fine lines and wrinkles, resulting in smoother, more youthful-looking skin.

But unlike Botox, which arrives freeze-dried and must be reconstituted with a sterile solution, Innotox comes as a ready-to-use liquid — making the injection process simpler and more tempting for those looking for a DIY option.

Why are people choosing Innotox?

Aside from the convenience, Innotox fans point to two big draws: faster, longer lasting results and a lower price tag.

While Botox typically takes four to seven days to show effects, some Innotox users report visible changes within two to three days. Its results can last up to six months — outpacing the usual three-to-four-month lifespan of Botox.

“It works amazing, almost three months and I’m not moving my forehead,” Karen Freeman, a content creator on TikTok, said in a recent video.

Innotox is approved for use in other countries, including South Korea, but not in the US.Derma Solution

“Normally it would be time for me to do this again, but no, good ol’ Innotox is still working and ain’t mad about it,” she added.

Then there’s the cost. A vial of Innotox can be found on third-party sites for as little as $60 to $100, depending on the number of units and the supplier.

By comparison, the average Botox treatment cost was $528 in 2022, according to GoodRx.

What are the risks of self-administering Innotox?

First and foremost, Innotox is not FDA-approved.

Karen Freeman is among the Innotox users pleased with her results.TikTok / @karen74_
That means it’s not subject to the same strict safety and efficacy standards as Botox or other botulinum toxin products available in the US.

It also raises questions about quality control — especially when it’s purchased from unverified sellers online.

“Don’t inject yourself with fake Botox products from the internet, I beg of you,” warned Molly O’Rourke, a clinical nurse injector, in a recent Instagram video.

“This is coming from a safety standpoint because these medications are not regulated,” she added. “It already comes pre-diluted, which should frighten you because what is that?”

The Centers for Disease Control and Prevention has echoed similar warnings, noting that counterfeit or improperly sourced botulinum toxin has been linked to serious medical complications.

Even if the product is genuine, the DIY approach carries major risks.

Medical experts are warning against self-injecting Innotox at home.Instagram / @nurseinjectormolly_
Online videos often show people injecting Innotox with minimal training or understanding of facial anatomy — something medical professionals say is highly dangerous.

“If you have real neurotoxin there and you’re just injecting it into the wrong places, you could have facial muscle weakness or facial muscle paralysis,” Dr. Evan Rieder, who is board-certified in dermatology and psychiatry, told Today.com.

But the potential dangers aren’t limited to your face.

Dr. Michelle Henry, a board-certified dermatologist, told the outlet that the trend is “dangerous” and “terrifying.”

“If you have too much botulinum toxin in your body, you get flaccid paralysis, meaning all of your muscles stop working and contracting, including the muscles you need to breathe,” she said. “That’s how patients die.”

While Henry added that there are “ways that I won’t even inject myself,” both Rieder and O’Rourke said they won’t inject themselves at all.

While not everyone will experience complications, experts warn that those self-injecting at home may lack the knowledge to properly treat issues or recognize when urgent medical care is needed.

“Just leave it to the professionals,” O’Rourke said. “I’m all for wanting to learn to do something yourself, but this isn’t one of those things.”

Medytox, the biopharmaceutical company that makes Innotox, told Today.com that it “only sells prescription products to authorized medical providers and medical distribution companies” and it is “unaware that some of the product is being offered online in unapproved countries or available to consumers.”

“Medytox certainly does not endorse the self-injection of botulinum toxins by consumers,” they said in a statement.

https://nypost.com/2025/07/02/health/medical-pros-warn-against-viral-innotox-self-injection-trend/