Category: F.D.A.

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Infant RSV Shots May Cause RSV, Other Infections or Death in Some Babies, Study Finds – Brenda Baletti, Ph.D. 7/11/24

Source: ChildrensHealthDefense.org

The results from the first immunization campaign for nirsevimab, the monoclonal antibody shot approved to protect infants from RSV-related illness, raise questions about mass infant vaccination with the drug, according to a new preprint study.

The study by French scientist Hélène Banoun, Ph.D., which analyzed outcomes from the 2023-2024 respiratory syncytial virus (RSV) immunization campaign in the U.S., France, Spain and Luxembourg, contradicts some claims of success by U.S. public health agencies and medical associations.

Continue reading “Infant RSV Shots May Cause RSV, Other Infections or Death in Some Babies, Study Finds – Brenda Baletti, Ph.D. 7/11/24”

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White House Pressured FDA to Cut Corners on COVID Vaccine Approvals in Order to Push Mandates – Brenda Baletti, Ph.D. 6/28/24

Source: ChildrensHealthDefense.org

The Biden administration pressured the U.S. Food and Drug Administration (FDA) to “change its procedures, cut corners, and lower agency standards,” to approve Pfizer’s COVID-19 vaccines and authorize boosters, according to a congressional report released earlier this week.

Continue reading “White House Pressured FDA to Cut Corners on COVID Vaccine Approvals in Order to Push Mandates – Brenda Baletti, Ph.D. 6/28/24”

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Medical Elites’ Disgrace Over Ivermectin – David Gortler 5/11/24

Source: Brownstone.org

In the wake of the FDA settling a lawsuit brought against it for wantonly and aggressively smearing ivermectin, the agency has deleted its postings. That’s good, but we shouldn’t forget how egregiously it mischaracterized the drug, ignored copious evidence in its favor, and portrayed its proponents as dangerous crackpots.

Continue reading “Medical Elites’ Disgrace Over Ivermectin – David Gortler 5/11/24”

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Moderna Developing mRNA Vaccines for Diseases Linked to COVID Shots – John-Michael Dumais 4/2/24

Source: ChildrensHealthDefense.org

During its Vaccines Day Event for investors on March 28, Moderna announced progress on multiple mRNA-based vaccines and therapeutic candidates in its “pipeline.”

Three vaccines targeting Epstein-Barr virus (EBV), Varicella-zoster virus (VZV, chickenpox and shingles) and Norovirus are advancing to “pivotal late-stage development,” the company said.

Continue reading “Moderna Developing mRNA Vaccines for Diseases Linked to COVID Shots – John-Michael Dumais 4/2/24”

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Groups Sue FDA Over Livestock Drug Banned or Restricted in 160 Countries – Suzanne Burdick, Ph.D. 4/1/24

Source: ChildrensHealthDefense.org

Food safety, environmental and animal rights groups last week sued the U.S. Food and Drug Administration (FDA) in federal court in a bid to force the agency to ban or reduce the allowable levels of a widely used livestock growth drug that the groups said causes harm to humans, animals and the environment.

Ractopamine — banned or restricted in about 160 countries — is used by U.S. industrial livestock producers to rapidly grow muscle in cows, pigs and turkeys.

Continue reading “Groups Sue FDA Over Livestock Drug Banned or Restricted in 160 Countries – Suzanne Burdick, Ph.D. 4/1/24”

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FDA Will Remove Anti-ivermectin Social Media, Website Posts Under Lawsuit Settlement Agreement – Brenda Baletti, Ph.D. 3/22/24

Source: ChildrensHealthDefense.org

The U.S. Food and Drug Administration (FDA) agreed to take down its website and social media posts warning people not to use ivermectin to treat COVID-19 under terms of a settlement reached Thursday in a lawsuit alleging the agency exceeded its authority when it directed health professionals and patients not to use the drug.

Continue reading “FDA Will Remove Anti-ivermectin Social Media, Website Posts Under Lawsuit Settlement Agreement – Brenda Baletti, Ph.D. 3/22/24”

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RSV Vaccines Aren’t Even a Year Old but Some Experts Say It’s Time to Pull Them From the Market – Michael Nevradakis, Ph.D. 3/5/24

Source: ChildrensHealthDefense.org

It’s been less than a year since the Centers for Disease Control and Prevention (CDC) recommended two new respiratory syncytial virus (RSV) vaccines — yet CDC data and the Vaccine Adverse Event Reporting System (VAERS) already show reports of 34 deaths, 302 serious adverse events and according to news reports this week, a safety signal for Guillain-Barré syndrome (GBS).

Continue reading “RSV Vaccines Aren’t Even a Year Old but Some Experts Say It’s Time to Pull Them From the Market – Michael Nevradakis, Ph.D. 3/5/24”

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FDA Makes It Official: Informed Consent Not Required for ‘Minimal Risk’ Studies – Suzanne Burdick, Ph.D. 1/30/24

Source: ChildrensHealthDefense.org

Clinical researchers no longer have to obtain informed consent from human subjects when their research poses “no more than minimal risk,” the U.S. Food and Drug Administration (FDA) ruled last week.

Continue reading “FDA Makes It Official: Informed Consent Not Required for ‘Minimal Risk’ Studies – Suzanne Burdick, Ph.D. 1/30/24”

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The Decades of Evidence That SSRI Antidepressants Cause Mass Shootings – A Midwestern Doctor 11/4/23

Source: MidwesternDoctor.com

Story at a Glance:

•SSRI antidepressants have a variety of horrendous side effects. These include sometimes causing the individual to become agitated, feeling they can’t be in their skin, turning psychotic, and occasionally becoming violently psychotic.

•During these psychoses, individuals can have out of body experiences where they commit lethal violence either to themselves or others.

•As lawsuits later showed, this violent behavior (and the frequent suicides that followed it) were observed throughout the SSRI clinical trials, but were covered up by the SSRI manufacturers and then the drug regulators (e.g., the FDA).

•Once the SSRIs entered the market, there has been a wave of SSRI suicides and unspeakable acts of violence.

•Sadly, the idea that SSRIs could cause any of this has always been viewed as a “conspiracy theory” or “mistaking correlation with causation” because very few are aware of the extensive evidence linking SSRIs to violent and psychotic behavior—despite it now being on the warning label of those drugs.

Continue reading “The Decades of Evidence That SSRI Antidepressants Cause Mass Shootings – A Midwestern Doctor 11/4/23”

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How Far Will the Government Go to Cover Up Vaccine Injuries? – Dr. Joseph Mercola 12/6/23

Source: ChildrensHealthDefense.org

The U.S. government and Big Pharma have long suppressed evidence and dissent regarding unsafe, rushed vaccines, covering up injuries and disasters to maintain profits and vaccination programs. But social media is raising public awareness of vaccine injuries — and that may finally force accountability.

Continue reading “How Far Will the Government Go to Cover Up Vaccine Injuries? – Dr. Joseph Mercola 12/6/23”

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Owner Of Chinese Biolab Busted In California Linked To CCP Military Program: House Report – ZeroHedge 11/16/23

Source: ZeroHedge.com

The Chinese owner of a makeshift biolab discovered in a remote California city has ties to the People’s Republic of China (PRC) and a Chinese military program, according to a report by the House Select Subcommittee on the CCP.

Continue reading “Owner Of Chinese Biolab Busted In California Linked To CCP Military Program: House Report – ZeroHedge 11/16/23”

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DNA Integration Risk: Moderna Knows, FDA Denies – Robert W. Malone MD 11/10/23

Source: rwmalonemd.substack.com

Both Moderna and Pfizer/BioNTech SARS-CoV-2 vaccines are contaminated with plasmid DNA fragments which have not been removed during the current manufacturing processes. This proven fact has been acknowledged by the US FDA, Health Canada, and the European Medicines Agency. In yet another clear breach of informed consent and labeling requirements, this was not previously disclosed to physicians, public health officials, or patients. Furthermore, the presence of highly active promoter/enhancer DNA sequences (and fragments) derived from the SV40 virus, present in the Pfizer/BioNTech product, was not disclosed and discussed with either the public or to the regulatory agencies. This has also been clearly established. Prior FDA guidance concerning the closely related DNA vaccine technology cited the presence of such highly active regulatory sequences as being of particular concern due to potential insertional mutagenesis (integration).

Continue reading “DNA Integration Risk: Moderna Knows, FDA Denies – Robert W. Malone MD 11/10/23”

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SARS-CoV-2 Variant HV.1; Obsolete Boosters – Robert W Malone MD 11/4/23

Source: rwmalonemd.substack.com

As previously covered (here), the currently available FDA emergency use authorized “booster vaccines” were designed based on recommendations developed at the FDA VRPBAC (vaccine and related products biological advisory committee), which predicted that the dominant SARS-CoV-2 variant this fall would be the “Kraken” (XBB.1.5) viral variant of Omicron.

To re-cap, the FDA and it’s advisory committee are operating based on the hypothesis that the dominant mechanism of protection against SARS-CoV-2 infection, spread, and COVID-19 disease afforded by vaccination or natural immunity involves “neutralizing antibodies”. This hypothesis is unproven, and no immunologic “correlate of protection” which predicts protection from either infection or disease has been clinically proven. To the extent that high levels of human “neutralizing antibodies” from the SARS-CoV-2 genetic “vaccines” provide any protection, they seem to “correlate” to reduced disease severity for some period after dosing, but do not prevent infection, replication, spread, disease or death.

Continue reading “SARS-CoV-2 Variant HV.1; Obsolete Boosters – Robert W Malone MD 11/4/23”

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FDA Responds After Being Urged to Recall Pfizer’s Vaccine Over DNA Fragments – Zachary Stieber 10/31/23

Source: TheEpochTimes.com

Dr. Robert Malone and other experts say the COVID-19 shot should be recalled.

The U.S. Food and Drug Administration (FDA) is refusing to recall the Pfizer-BioNTech COVID-19 vaccine, promoting the view that the inclusion of a previously-undisclosed DNA sequence that leaves behind fragments is not of concern.

Continue reading “FDA Responds After Being Urged to Recall Pfizer’s Vaccine Over DNA Fragments – Zachary Stieber 10/31/23”

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The FDA’s Ties to the Gates Foundation – Maryanne Demasi 10/20/23

Source: Brownstone.org

In 2017, the US Food and Drug Administration (FDA) entered into a memorandum of understanding (MOU) with the Bill & Melinda Gates Foundation.

Under the MOU, the two entities agreed to share information to “facilitate the development of innovative products, including medical countermeasures,” such as diagnostics, vaccines, and therapeutics to combat disease transmission during a pandemic.

Continue reading “The FDA’s Ties to the Gates Foundation – Maryanne Demasi 10/20/23”

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Lipid Nanoparticles and mRNA Shots – David Gortler, Robert Malone 9/13/23

Source: rwmalonemd.substack.com

In response to the worldwide-spread of COVID-19, a disease caused by Coronavirus SARS-CoV-2, several pseudo-mRNA “gene therapy”-based products were rapidly developed and deployed as prophylactic vaccines.  In contrast to recombinant viral “gene therapy”-based vaccines such as those developed by Janssen (J&J) and Astra-Zeneca, these RNA products employ non-viral self-assembling Lipid NanoParticle (LNP) technology to deliver genetic information coding for a viral protein (SARS-CoV-2 Spike) into the cells of the patient.  Each of these complicated combination products, which include both a biological component (the RNA) and a complex new ingredient (the LNP), were brought to market by private pharmaceutical companies in a rapidly assembled government-corporate collaboration, operating at “warp speed.”

Continue reading “Lipid Nanoparticles and mRNA Shots – David Gortler, Robert Malone 9/13/23”

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Pfizer Documents Show COVID-19 Vaccines Contain Potentially Harmful ‘Modified’ RNA, not mRNA – Megan Redshaw, J.D. 8/23/23

Source: TheEpochTimes.com

Although we’ve been told Pfizer’s COVID-19 vaccine is manufactured with harmless messenger RNA (mRNA), the U.S. Food and Drug Administration’s (FDA) product label shows it contains artificially modified RNA—a key ingredient that is not naturally occurring and poses a substantial risk to human health.

Continue reading “Pfizer Documents Show COVID-19 Vaccines Contain Potentially Harmful ‘Modified’ RNA, not mRNA – Megan Redshaw, J.D. 8/23/23”

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Once Again, the FDA Admits it Lied to us. And Once More, we Yawn – Jonathan Cook 8/21/23

Source: jonathancook.substack.com

The reality is that most of us are not ready for the truth. We want reassurance. We cling to our comfort blankets because the idea that we live in a world in which our and our families’ interests are not paramount is too disturbing.

The idea that our fates are entirely dependent on a giant Ponzi scheme that might come crashing down at any moment from any one of multiple design flaws – an ecological crisis, a nuclear catastrophe, a pandemic or a hubristic mis-step with Artificial Intelligence – is simply too terrifying.

Continue reading “Once Again, the FDA Admits it Lied to us. And Once More, we Yawn – Jonathan Cook 8/21/23”

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Have the Regulators Approved a Trojan Horse? – Julie Sladden and Julian Gillespie 8/16/23

Source: Brownstone.org

The alarming discovery by scientist Kevin McKernan, of DNA contamination in vials of Pfizer and Moderna Covid vaccines has raised significant concern in the scientific community. Meanwhile, the reported finding has attracted criticism from those quick to ‘demonise’ anyone questioning the safety, efficacy, and sanctity of the ‘vaccines.’ McKernan’s detractors – and there have been plenty of them – have criticised everything from lack of peer-reviewed publication to speculation about the viability of the anonymously sent vials.

Continue reading “Have the Regulators Approved a Trojan Horse? – Julie Sladden and Julian Gillespie 8/16/23”

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FDA Approved 65 Percent of New Drugs in 2022 Based on a Single Study – Megan Redshaw, J.D. 8/10/23

Source: TheEpochTimes.com

The 21st Century Cures Act (Cures Act), signed into law in December 2016, was created to help accelerate medical product development and “bring new innovations and advances” to patients quicker and more efficiently. Yet some researchers suggest the law is being used to bypass the once rigorous and evidenced-based standards for new drug approvals, allowing novel drugs to flood the market without adequate data and public transparency.

Continue reading “FDA Approved 65 Percent of New Drugs in 2022 Based on a Single Study – Megan Redshaw, J.D. 8/10/23”

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Doctors Can Prescribe Ivermectin for COVID-19: FDA Lawyer – Zachary Stieber 8/10/23

Source: TheEpochTimes.com

Doctors are free to prescribe ivermectin to treat COVID-19, a lawyer representing the U.S. Food and Drug Administration (FDA) said this week.

“FDA explicitly recognizes that doctors do have the authority to prescribe ivermectin to treat COVID,” Ashley Cheung Honold, a Department of Justice lawyer representing the FDA, said during oral arguments on Aug. 8 in the U.S. Court of Appeals for the 5th Circuit.

Continue reading “Doctors Can Prescribe Ivermectin for COVID-19: FDA Lawyer – Zachary Stieber 8/10/23”

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Puppet Masters of the Pandemic. Part 2: What Did The CIA Do in Wuhan?” – Robert W. Malone MD 8/5/23

Source: rwmalonemd.substack.com

From Part I – the interview left of with the big question of who is the puppet master? What’s behind all this propaganda and control over the past three years? I spoke of different theories that people had put out there, and ended with the beginning of the hypothesis that the CIA may in fact be that controlling element. Part II picks up the thesis there.

Continue reading “Puppet Masters of the Pandemic. Part 2: What Did The CIA Do in Wuhan?” – Robert W. Malone MD 8/5/23″

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‘It’s Murder’: Remdesivir Victims Decry FDA’s Shocking New Move – Stella Paul 7/28/23

Source: AmericanThinker.com

Remdesivir may be the most despised drug in American history, earning the nickname Run Death Is Near for its lethal record during COVID.  Experts claimed that it would stop COVID; instead, it stopped kidney function, then blasted the liver and other organs.  Now this reviled destroyer of kidneys has been approved by the FDA for COVID treatment of kidney patients.  Does anybody else feel as if the FDA is shoving its power in our faces and laughing at us?

Continue reading “‘It’s Murder’: Remdesivir Victims Decry FDA’s Shocking New Move – Stella Paul 7/28/23”

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What’s in New Anthrax Vaccine? Aluminum, Formaldehyde and Benzethonium Chloride – Brenda Baletti, Ph.D. 7/24/23

Source: ChildrensHealthDefense.org

Emergent BioSolutions’ new anthrax vaccine contains dangerous toxins and may cause severe side effects, according to the product’s package insert.

The U.S. Food and Drug Administration (FDA), which approved the vaccine last week, posted the package insert late Friday.

“Is this a label or a cartoon?” asked Meryl Nass, M.D., a bioterrorism and anthrax expert who published an analysis of the insert on Substack. “You can’t make this stuff up,” she said.

Continue reading “What’s in New Anthrax Vaccine? Aluminum, Formaldehyde and Benzethonium Chloride – Brenda Baletti, Ph.D. 7/24/23”

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Solutions to Vaccine Troubles in Ten Sentences – Clayton J. Baker, MD 7/24/23

Source: Brownstone.org

The uncritical, blind faith in vaccines is the preeminent sacred cow of modern medicine. (It happens to be its preeminent cash cow as well.) It is a quasi-religious, dogmatic article of conviction, rather than a sound scientific theory or an empirically-based clinical precept.

Vaccines have been controversial since their introduction centuries ago. Only in very recent history has there been a rigidly enforced orthodoxy of belief within the medical establishment that vaccines must be unanimously regarded as “safe and effective,” no questions asked.

Continue reading “Solutions to Vaccine Troubles in Ten Sentences – Clayton J. Baker, MD 7/24/23”