Tag: fda

New York Health Dept Defies FDA: Hochul’s Emergency Order Pushes Off-Label COVID Shots For Kids As Young as 3

New York’s department of public health released a series of odd guidances to pharmacists and physicians on Friday to promote COVID vaccines to children and adults for “off label” use, meaning in conflict with FDA’s official label. Signed by Governor Kathy Hochul, New York’s executive order 52 declares a “disaster in the state of New York due to federal actions related to vaccine access.”

“A friend of mine said they’re contacting the nurse’s union,” a New York City nurse texted me, shortly after New York released their new COVID vaccine guidance. “They don’t know wtf to do with that!”

A New York physician sent me documents the state’s health department sent to physicians and pharmacists, called “providers” in healthcare lingo. She and the majority of her colleagues no longer get COVID boosters, and she’s worried that the new guidance for “off label” use makes no sense, does not fully inform patients, and might be illegal.

Pfizer pled guilty to criminal charges and paid a record $2.3 billion fine for illegal, off label promotion of multiple drugs in 2009. As previously reported here, Biden’s FDA Commissioner and CDC Director both promoted COVID vaccines for uses that the FDA admitted were off label. No evidence exists that pharmaceutical companies helped to shape New York’s off label policy, but CNBC reported in 2021 that Governor Hochul’s daughter-in-law is a top lobbyist at a pharma firm that has sought to influence NY lawmakers.

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FDA Official Pressures YouTube Into Removing a Channel For Posting His Own Vaccine Comments

Last week, a top official with the Food and Drug Administration (FDA) apparently filed a bogus copyright claim to get a critic’s YouTube account taken down. This is an inappropriate act of censorship that, not long ago, conservatives would rightly have stood against.

“Jonathan Howard, a neurologist and psychiatrist in New York City, received an email from YouTube on Friday night, which stated that Vinay Prasad, who is the FDA’s top vaccine regulator, had demanded the removal of six videos of himself from Howard’s YouTube channel,” The Guardian reported this week. “Howard’s entire channel has now been deleted by YouTube, which cited copyright infringement.”

On his channel, Howard hosted videos of public health officials—including Prasad, Department of Health and Human Services Secretary Robert F. Kennedy Jr., and National Institutes of Health Director Jay Bhattacharya—making statements during the COVID-19 pandemic that turned out to be untrue or overly myopic. “I had accumulated about 350 videos, almost all of which were short clips of famous doctors saying absurd things,” Howard wrote in a blog post, “that herd immunity had arrived in the spring of 2021 and that RFK Jr. was an honest broker about vaccines, for example.” Howard is also critical of Prasad’s stance on vaccines, which Prasad now has the authority to regulate.

According to an email Howard posted, YouTube “terminated” his channel after “multiple copyright strikes” against his videos, and the “removal request” came from Prasad.

“Publishing someone else’s videos without modification or commentary is a clear copyright violation,” an FDA spokesperson told The Guardian. “The mission of Johnathan Howard was not medical transparency, but personal profit by grifting and stealing someone else’s intellectual property.”

“My YouTube channel had 256 subscribers and its videos were typically seen by dozens of people,” Howard wrote. “I never promoted the channel and made no money from it.” Besides, U.S. law allows for fair use of copyrighted material, which means someone can use protected content for purposes such as “criticism, comment, news reporting,” or “research” without the creator’s permission.

Howard is the author of the book We Want Them Infected, which criticized doctors and public health officials who advocated a herd immunity strategy for dealing with COVID-19. Howard says such warnings fed into anti-vaccine conspiracy theories. His YouTube channel collected videos of people who are now in charge of public health institutions, making what he feels were irresponsible claims during the pandemic.

But whether you agree with Howard or not, it is wrong and hypocritical for Prasad to silence his critics in this way.

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FDA Revokes Emergency Authorization For COVID-19 Vaccines

The Department of Health and Human Services under Health Secretary Robert F. Kennedy Jr. revoked emergency authorization for COVID-19 vaccines.

“The emergency use authorizations for Covid vaccines, once used to justify broad mandates on the general public during the Biden administration, are now rescinded,” Kennedy posted to X on Wednesday.

The news comes as the FDA, which is part of HHS, announced the approval of the Pfizer-BioNTech COVID-19 vaccine for older adults and children as young as 5-years-old who have at least one condition that puts them at higher risk of severe COVID-19 outcomes, Pfizer said in a Wednesday statement.  

Regulators have issued similar approvals for COVID-19 jabs from Novavax and Moderna. 

HHS revoking emergency approval means that FDA clearance is no longer in place for some 240 million Americans, however “These vaccines are available for all patients who choose them after consulting with their doctors,” Kennedy sai. 

As the Epoch Times notes further, per federal law, the FDA approves products it determines are “safe, pure, and potent.” Emergency authorizations, in contrast, can only be offered under certain circumstances, such as during a public health emergency, and are for products that officials believe “may be effective” in treating or preventing a life-threatening disease or condition.

Updated Approvals

Dr. Marty Makary, the FDA’s commissioner, and Dr. Vinay Prasad, its top vaccine official at the time, signaled the change in May, when they said that the FDA would stop approving COVID-19 vaccines for many Americans absent clinical trial data.

“The FDA can only approve products if it concludes, based on scientific evidence, that the benefit-to-harm balance is favorable. And we simply need more data to have that confidence for younger individuals at low-risk of severe disease,” Prasad said at the time.

In the United States, regulators in recent years have been authorizing updated COVID-19 vaccines annually in a bid to counter waning effectiveness and better match circulating variants. The model is based on the historical approach to influenza vaccines.

Regulators in 2024 cleared updated shots from Moderna, Pfizer, and Novavax without human data, citing animal tests and data from trials for previous versions.

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FDA Suspends License For Chikungunya Vaccine After ‘Serious Adverse Events’

Federal regulators on Aug. 25 said they’ve suspended approval for a vaccine against chikungunya, a mosquito-borne virus.

Due to reports of serious adverse events following administration of the vaccine, the Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) “believes this vaccine is not safe and that continued administration to the public would pose a danger to health,” the FDA said in a statement.

France-based Valneva makes the vaccine, known as Ixchiq.

“As we determine potential next steps, and as the clear threat of chikungunya continues to escalate globally, Valneva remains fully committed to maintaining access to our vaccine as a global health tool for addressing and preventing outbreaks of this devastating illness,” Thomas Lingelbach, Valneva’s CEO, said in a statement.

Zachart Stieber reports for The Epoch Times that the FDA originally approved Ixchiq in 2023 to prevent disease caused by the chikungunya virus in adults deemed to have an increased risk of exposure. The Centers for Disease Control and Prevention in 2024 recommended the vaccine for people traveling to certain countries.

Health officials said in an alert in May that they were advising a pause in administering the vaccine to elderly adults due to reports that some of those vaccinated had been experiencing serious adverse events (SAEs), including neurologic and cardiac problems.

This included 38 SAE reports for 32 unique cases (7 U.S., 25 foreign), including 21 hospitalizations and three deaths.

After CBER Director Dr. Vinay Prasad resigned, the FDA, in early August, ended the recommended suspension, stating that an updated assessment of risks and benefits for Ixchiq showed the benefits still outweighed the risks for some people.

In the new announcement, regulators said that is no longer the case.

The latest risk-benefit assessment includes four new foreign reports that came to light since the FDA lifted the recommended pause, including a report of problems following vaccination in a 55-year-old male.

Prasad said in a memorandum dated Aug. 22 that of the 32 cases, five tested positive for the vaccine strain of the virus, making it nearly certain that the vaccine caused the problem.

“There are reasonable grounds to believe the risks of the vaccine outweigh its benefits, and that it poses a danger to health. Therefore, CBER is suspending approval,” Prasad said.

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The Case of the Damning FDA Memos

On July 21, 2025, the Informed Consent Action Network (ICAN) announced that it had secured the release of over 600,000 pages of Emergency Use Authorization (EUA) data used by the US Food and Drug Administration (FDA) to authorize and approve Pfizer-BioNTech’s COVID-19 vaccine (BNT162b2), following a successful lawsuit, culminating in a late 2024 court ruling.

These documents, now publicly available on ICAN’s website, are part of a broader release of over 1.6 million pages, including data from the vaccine’s licensure in August 2021 and the earlier EUA in December 2020.

This report builds on my prior investigative work analyzing thousands of FDA documents released following the Public Health and Medical Professionals for Transparency (PHMPT) lawsuit, which focused on the biological product file submitted by Pfizer for the full approval of its COVID-19 vaccine in August 2021.

I was one of the initial researchers to uncover and analyse the damning data hidden within Pfizer’s Pregnancy & Lactation Cumulative Review, Interim-Narrative-Sensitive document (3000+ pages), and Cumulative Analysis of Post-Authorization Adverse Event Reports document, among others.

Both ICAN and PHMPT’s lawsuits sought to make public the FDA’s data on the Pfizer-BioNTech’s COVID-19 shot, asserting that transparency is critical for public trust and independent analysis, given the global administration of billions of doses of this experimental gene-based product that was mandated in several countries.

My preliminary review of ICAN’s EUA data reveals several irregularities, outlined below with references to key documents and downloadable sources. This report focuses on four critical issues: manufacturing oversight gaps, missing Bell’s palsy data, clinical trial site deficiencies, and the exclusion of unconfirmed COVID-19 cases.

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FDA Warns About Potentially Radioactive Frozen Shrimp Sold at Walmart Stores

The U.S. Food and Drug Administration (FDA) on Tuesday issued a public warning against potentially radioactive frozen shrimp products sold at Walmart stores in several states.

The FDA alert urged the public not to consume, sell, or serve certain Great Value raw frozen shrimp due to possible contamination with Cesium-137, a radioactive isotope.

Impacted Shrimp Products

Walmart also shared the FDA’s warning on its website.

The impacted raw frozen shrimp products were sold under the Great Value brand at stores in Alabama, Arkansas, Florida, Georgia, Kentucky, Louisiana, Missouri, Mississippi, Ohio, Oklahoma, Pennsylvania, Texas, and West Virginia.

The impacted products have been stamped with lot codes 8005540-1, 8005538-1, and 8005539-1.

They also have Best by Dates of 3/15/2027.

What is Cesium-137?

Cesium-137, also referred to as Cs-137, is a radioactive isotope of cesium that is man-made through nuclear reactions, according to the FDA. The agency says because Cs-137 is “widespread worldwide,” trace amounts of the radioisotope can be found in soil, food, and the air.

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FDA Approves Therapy For Rare Disease Without Randomized Trial Data

The Food and Drug Administration on Aug. 14 approved a therapy for a rare disease called recurrent respiratory papillomatosis (RRP).

Regulators cleared Papzimeos, an immunotherapy made by Precigen, citing data from a single-arm, open-label trial that looked at how it performed in adults with RRP and who needed at least three surgeries a year.

Patients received four injections of the therapy over 12 weeks following surgical procedures.

About half of the participants needed no surgery in the year following treatment. The safety profile was also deemed favorable.

“Randomized trials are not always needed to approve medical products and this approval is proof of that philosophy,” Dr. Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.

“The FDA will always demand the correct clinical study for the specific medical product and disease. Our requirements for products given to tens of millions of healthy people will be different than products given to at most hundreds or thousands of patients with unique diseases.”

The approval is the first announcement from Prasad after he rejoined the FDA following his July resignation.

Prasad had received criticism for not approving enough new drugs and therapies, including from the editorial board of the Wall Street Journal, which said that Prasad “has long criticized such single-arm studies that have no placebo groups.”

Replimune’s treatment for advanced melanoma is among the drugs the FDA has rejected since Prasad became its top vaccine and biologics official.

Prasad said in May that he favors randomized clinical trials but that for some rare diseases, it would be difficult or even impossible to complete such trials. He said that the FDA would have a “flexible regulatory standard” that takes into account “the context of a disease.”

In June, in an article co-authored by FDA Commissioner Dr. Marty Makary, he said that for some products targeting rare diseases, “premarket randomized trials may not be feasible.”

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THE BOMBSHELL THEY COULDN’T BURY— FDA ADMITS IT: mRNA COVID VACCINES CAUSE “EXTREMELY HIGH” RISK OF MYOCARDITIS AND PERMANENT HEART DAMAGE

The FDA has officially labeled mRNA COVID-19 vaccines as carrying an “extremely high” risk of myocarditis and irreversible heart damage — especially in young men.

This is a public admission that the Biden regime, Big Pharma, and the media knowingly hid the dangers. Millions were injected without informed consent.

The truth is now official. And accountability is coming.

THE BOMBSHELL THEY COULDN’T BURY: FDA FORCED TO ADMIT THE TRUTH UNDER TRUMP’S COMMAND

For years, the American people were gaslit, mocked, silenced, deplatformed, and destroyed for daring to speak a single forbidden sentence:

“These vaccines are dangerous.”

In July 2025, the U.S. Food and Drug Administration (FDA) — operating under the restored constitutional leadership of President Donald J. Trump — has formally updated the safety labeling on all mRNA COVID-19 vaccines to include the chilling truth:

“EXTREMELY HIGH RISK of myocarditis, particularly in young males, with a real potential for irreversible heart damage.”

Pfizer’s Comirnaty and Moderna’s Spikevax — the sacred cows of Big Pharma, promoted with religious intensity during the Biden regime — are now officially marked as potential death sentences for America’s youth. This isn’t conspiracy. It’s regulatory fact.

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SHOCKING: FDA Commissioner Dr. Makary Says NIH ‘Brewed Up a Virus That Killed 20 Million People Worldwide’

Newly appointed FDA Commissioner Dr. Marty Makary pulled no punches as he directly accused the National Institutes of Health (NIH) of funding the lab responsible for creating the virus that sparked the COVID-19 pandemic and claimed the lives of over 20 million people globally.

Speaking to NewsNation’s Connell McShane, Dr. Makary blasted the former NIH leadership for pouring taxpayer dollars into unaccountable pet projects, including the now-infamous lab that engineered the virus that triggered a global pandemic.

Dr. Makary:
The way it used to be. We’re planning to change our health agencies for a generation or longer. Look at the NIH. When J. Bhattacharya came in there, it was a mess. Fourteen percent of the grants were descriptive studies on health equity.

And the NIH had just funded a lab that brewed up a virus that killed 20 million people worldwide. So they’re getting back to studying root causes, a cure for cancer, debilitating neurodegenerative diseases, and they’re going to do good work.

Connell McShane:
Right, but you have to do it with fewer people. Is that a challenge with the cuts, or is that not really what it’s made out to be either?

Dr. Makary:
The FDA is strong, and it’s going to continue to be strong. The cuts were consolidations. There were no layoffs to scientific reviewers or inspectors at the FDA.

There was consolidation of the twelve travel offices at the FDA. And so we’re going to institute teamwork and break up the fiefdom culture within the agency. It’s an interesting conversation.

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FDA’s Mercury Cover-Up – – Poison In Our Teeth

 In a shocking betrayal of public trust, the U.S. Food and Drug Administration (FDA) has suppressed vital information about Mercury dental amalgam, misleadingly called “silver fillings,” which contain 50% mercury—one of the most toxic non-radioactive substances known.

The FDA refuses to mandate that dentists disclose this danger to patients, while dental boards, influenced by the American Dental Association (ADA)—a trade organization, not a public health authority—punish dentists who reject Mercury use and prioritize safe removal with rigorous informed consent, threatening their licenses. This double-standard is an outrage, leaving millions – – including South Florida’s families, military personnel and veterans – – unaware of the neurotoxin in their mouths.

A groundbreaking 2025 mini-review by Anita Vazquez Tibau, your author, and Blanche D. Grube, DMD, Will the US Food and Drug Administration (FDA) Follow the European Union’s Mercury Dental Amalgam Ban? A Mini-Review, exposes this scandal and demands reform. A new citizen petition calls for immediate action, and Floridians can join the fight by submitting comments at http://www.regulations.gov.

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