Tag: fda

Dr. McCullough Drops the Hammer in the Senate — FDA Concedes with Expanded Myocarditis Warning

“When a product causes death, that demands a black box warning — immediately.”

That was the clear and urgent message from Dr. Peter McCullough, testifying before the Senate Homeland Security and Governmental Affairs Committee this week at a hearing titled: “The Corruption of Science and Federal Health Agencies: How Health Officials Downplayed and Hid Myocarditis and Other Adverse Events Associated with the COVID-19 Vaccines.”

Dr. McCullough presented data from both his clinical experience and the peer-reviewed literature, exposing the widespread risks of COVID-19 mRNA injections — particularly myocarditis in young men and fatal vaccine outcomes confirmed by autopsy.

“I’ve examined thousands of patients with this problem,” he told the Senate. “Before the pandemic, I had seen just two cases in my entire career.”

Just one day before the hearing, likely for preemptive damage control purposes, the FDA quietly updated its myocarditis warning on Pfizer and Moderna’s COVID-19 vaccines, expanding the risk category to males aged 16 to 25 and citing an incidence of 8 cases per million doses for the 2023–2024 formulations. Unfortunately, no mention of death was added — despite robust, peer-reviewed autopsy evidence confirming fatal vaccine-induced myocarditis.

Dr. McCullough referenced multiple such cases, including the tragic findings of Gill et al, who documented two teenage boys (ages 16 and 17) found dead at home just days after receiving the Pfizer vaccine. Autopsies confirmed unequivocal myocarditis as the cause of death.

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FDA Directs COVID-19 Vaccine Makers to Expand Heart Inflammation Warning

The Food and Drug Administration (FDA) has directed COVID-19 vaccine manufacturers to expand the warning for two forms of inflammation, according to letters made public on May 21.

The FDA told BioNTech, which produces a vaccine with Pfizer, and Moderna to update warnings regarding myocarditis—or heart inflammation—and the related condition pericarditis.

Richard Forshee, acting director of the FDA’s Office of Biostatistics and Pharmacovigilance, said that new information has emerged, including a 2024 FDA study that found that some myocarditis patients had signs of heart scarring months after vaccination.

The companies must update labels to state that following administration of the 2023–2024 versions of the vaccines, “the highest estimated incidence of myocarditis and/or pericarditis was in males 16 through 25 years of age,” Forshee said. The highest estimated incidence of the post-vaccination inflammation is about 38 cases per million doses for both vaccines, according to the proposed update.

The current warnings say that the highest observed risk after Moderna vaccination is in males aged 18 to 24 and that the highest risk after Pfizer-BioNTech vaccination is in males aged 12 to 17.

The companies were also directed to add new information summarizing the FDA study, including that “at a median follow-up of approximately 5 months post-vaccination, persistence of abnormal cardiac magnetic resonance imaging (CMR) findings that are a marker for myocardial injury was common.” The updates should also state that “it is not known if these heart MRI findings might predict long-term heart effects of myocarditis,” according to the letters.

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The First Step on the Covid Shots

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) is holding a very important meeting on May 22, 2025. Under consideration at this meeting is the fate of the Covid booster shots. There has been considerable anticipation as well as media claims that current recommendations and authorization for these products’ use, particularly in children and pregnant women, may be discontinued. 

Public comments are currently being solicited for the meeting, and wide public interest surrounds this event. Unfortunately, I have received reports from colleagues that some comments submitted to the committee calling for discontinuation of these vaccines have disappeared from the FDA website.

Furthermore, an important article from the FDA published today in the New England Journal of Medicine acknowledges the huge discrepancies in Covid vaccine recommendations in the US vs. other countries – as I describe in detail below. The article hints yet again at possible changes in official recommendations regarding the Covid vaccines. In terms of actual changes, however, none have yet been made official 

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FDA plans to require clinical trials before approving annual COVID vax boosters for healthy people

Food and Drug Administration plans to require new clinical trials before approving annual COVID-19 vaccine boosters for healthy Americans under 65 years old.

The plan appears in a paper published Tuesday in the New England Journal of Medicine, in which FDA Commissioner Dr. Marty Makary and Dr. Vinay Prasad, the FDA’s vaccine chief, wrote any new COVID shot must undergo placebo-controlled clinical trials, NBC News reported. 

This means that the release of updated COVID vaccines for healthy children and adults this fall will likely be delayed.

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FDA To Tighten Review Process for Food Additives

The Food and Drug Administration (FDA) is planning a major overhaul of the way food additives are reviewed for safety.

The move, announced on Thursday, will be a “major step to increase transparency and ensure the safety of chemicals in our food,” according to a statement made by Secretary of Health and Human Services Robert F. Kennedy Jr.

“No parent should ever worry about what’s in their child’s food,” Kennedy said in a statement.

“We’re taking decisive action and using every authority we have to clean up the food supply and protect American families.”

The new process will include a “modernized, evidence-based prioritization scheme” for existing chemicals, a “systematic post-market review process” for food chemicals that will be “shaped by stakeholder input,” and the development of an “updated list of chemicals under review.”

Chemicals subject to review include BHA and BHA, which are used as preservatives; ADA, a foaming agent added to sandwiches; phthalates; propylparaben, a preservative; and titanium dioxide. These chemicals have all been linked to chronic diseases, including reproductive harms and cancer.

The new review process will be rolled out over the coming months.

Health advocates have hailed the changes. Kendall Mackintosh, a member “MAHA Moms” movement, said they were “a long-overdue and necessary step in the right direction.”

“The announcement signals progress toward more transparency and accountability, and I’m hopeful this opens the door for deeper systemic reform,” Mackintosh added.

The FDA is also looking to eliminate its Generally Recognized as Safe loophole, which allows companies to self-regulate additives and use them in the food supply without independent testing.

In April, HHS announced it would phase out all petroleum-based synthetic dyes from U.S. foods and medications.

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The FDA Just Approved Another COVID Vaccine — But RFK Jr. Has Already Intervened

The Food and Drug Administration (FDA) on Friday approved the Novavax COVID-19 vaccine, but RFK Jr. is stepping in to limit its avaliability.

The latest Novavax vaccine will only be avaliable to the elderly and those over the age of 12 with an underlying medical condition.

The approval of the vaccine, named Nuvaxovid, is contingent on the company conducting studies to assess potential links to various heart conditions.

However, Some of these investigations can be carried out using existing data sources.

The New York Times has more details:

Scientific advisers to the Centers for Disease Control and Prevention, who typically make decisions on who should get approved shots and when, have been debating whether to recommend Covid shots only to the most vulnerable Americans.

The F.D.A.’s decision appeared to render at least part of their discussion moot.

The vaccine had previously been authorized under emergency use. Covid vaccines developed by Pfizer-BioNTech and Moderna, which are more widely used by Americans, were granted full approval in 2022. However, the companies are working on updated shots for the fall, and the new restrictions on the Novavax shot portend a more restrictive approach from the F.D.A.

The F.D.A.’s new restrictions also appeared to reflect the high degree of skepticism about vaccines from Robert F. Kennedy Jr., the health secretary, and the other leaders he has appointed at health agencies.

The jab is said to have fewer side effects than mRNA based vaccines because it is built on a more traditional vaccine platform.

Figures in the scientific establishment are already complaining about the restrictrions.

”This is incredibly disappointing,”said Dr. Camille Kotton, an infectious disease physician at Massachusetts General Hospital nd former adviser to the C.D.C.

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FDA Announces ‘Radical Framework’ for Overhauling Vaccine Approval Process

The U.S. Food and Drug Administration (FDA) is preparing to issue new guidance for vaccine manufacturers in the coming days as part of a new “radical framework.” The guidance will likely focus on the COVID-19 shots, The Washington Post reported Thursday, citing comments by FDA Commissioner Marty Makary earlier this week.

The Post published its story earlier Thursday, before The Wall Street Journal reported that unnamed sources at the U.S. Department of Health and Human Services (HHS) said HHS is expected to announce within days that it will no longer recommend COVID-19 shots for children, teens and pregnant women.

Speaking at the Food & Drug Law Institute’s conference in Washington, Makary gave few specifics about the upcoming new framework but said it will help ensure the pharmaceutical industry understands “exactly what we’re thinking,” Endpoints News reported.

According to the Post, this may entail “guidance to companies so that they know the agency’s approach to vaccine approvals.”

“We want to be very transparent, and we want to create a framework for vaccine makers that they can use so they have a predictable FDA where they don’t have to worry, ‘How is this going to be received?’” Makary said at the conference.

The announcement comes just a month before government regulators are set to review COVID-19 vaccines for the next cold and flu season.

James Lyon-Weiler, Ph.D., president and CEO of the Institute for Pure and Applied Knowledge and editor-in-chief of the journal Science, Public Health Policy & the Law, said the new framework is “long overdue” and “may represent an inflection point — if it goes beyond mere optics and addresses the core systemic failures that have plagued vaccine policy for decades.”

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FDA Says It Plans to Remove Some Fluoride Drugs for Children From Market

The Food and Drug Administration (FDA) plans to remove ingestible prescription drugs for children that contain fluoride, the agency announced on May 13.

The ingestible products have been linked to issues such as a disrupted gut microbiome.

“The best way to prevent cavities in children is by avoiding excessive sugar intake and good dental hygiene, not by altering a child’s microbiome. For the same reason that fluoride may kill bacteria on teeth, it may also kill intestinal bacteria important for a child’s health,” Dr. Marty Makary, commissioner of the FDA, said in a statement.

Researchers reported in a review article in March that multiple studies have found that the gut microbiota was negatively impacted in people who ingested high amounts of fluoride, a disruption that can lead to problems such as cancer.

The FDA said it plans to complete a safety review by Oct. 31 before “taking appropriate action regarding removal of these products from the market.” At the same time, its parent agency, the Department of Health and Human Services, is planning to provide the public with guidance on strong dental hygiene for children that does not alter gut health.

“Ending the use of ingestible fluoride is long overdue,” Health Secretary Robert F. Kennedy Jr. said in a statement. “I’m grateful to Commissioner Makary for his leadership on this vital issue—one that directly safeguards the health and development of our children.”

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FDA warns seniors to avoid this vaccine after deadly complications

Older adults are being warned against receiving the chikungunya vaccine before traveling.

The Ixchiq vaccination, developed by Valneva to prevent the mosquito-borne chikungunya virus, was approved by the Food and Drug Administration (FDA) in November 2023 as the first of its kind.

The approval applies to anyone aged 18 and older who has a risk of being exposed to the virus.

But the FDA and the Centers for Disease Control and Prevention (CDC) released a safety notice on May 9 recommending that adults over 60 years old pause use of the vaccine due to fatal complications.

“FDA and CDC will continue the evaluation of post-marketing safety reports for Ixchiq,” the release reads.

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FDA To Deploy Artificial Intelligence Across Agency

The Food and Drug Administration (FDA) is planning to roll out artificial intelligence across the agency following a successful pilot program.

FDA Commissioner Dr. Marty Makary has directed all FDA centers to immediately start using artificial intelligence (AI) and fully integrate it by the end of June, the FDA said in a May 8 statement.

By June 30, all centers will use what the agency described as a “common, secure generative AI system integrated with FDA’s internal data platforms.”

“I was blown away by the success of our first AI-assisted scientific review pilot,“ Makary said in a statement. ”We need to value our scientists’ time and reduce the amount of non-productive busywork that has historically consumed much of the review process. The agency-wide deployment of these capabilities holds tremendous promise in accelerating the review time for new therapies.”

AI refers to computer systems that can carry out complex tasks typically performed by humans.

“AI can be generally described as a branch of computer science, statistics, and engineering that uses algorithms or models to perform tasks and exhibit behaviors such as learning, making decisions, and making predictions,” FDA officials said in 2023.

Makary said on Thursday that past years have featured discussions on utilizing AI and that it’s time to start using it to save time, with some tasks that once took days now taking mere minutes.

“We at the FDA now have to ask big questions that we’ve never asked before. Why does it take over 10 years for a new drug to come to market? Why are we not modernized with AI and other things? We’ve just completed our first AI-assisted scientific review for a product and that’s just the beginning,” he said earlier in the week on social media platform X.

The rollout across the FDA is being coordinated by Jeremy Walsh, Booz Allen Hamilton’s former chief technologist, who was recently appointed as the agency’s chief AI officer, and Sridhar Mantha, who previously led the Office of Business Informatics at the FDA’s Center for Drug Evaluation and Research.

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