Category: FDA

Feds AMBUSH 30+ Philadelphia Gang Members & Destroys CJNG’s Multi State Rings

A deep dive into how federal teams moved in fast on more than 30 gang members tied to violent crews in Philly and cracked open a CJNG network spread across multiple states. This breakdown looks at how the ambush unfolded, how agents tracked the crews, and what the takedown means for the cartel’s U.S. pipelines. The operation shows how far CJNG influence had reached and how the feds used surveillance, intel sharing, and coordinated raids to shut it down. It also digs into the overlap between local gangs and cartel supply lines, why Philly became a key node, and what’s coming next as investigations expand.

FDA Bans Red No. 3 Used in Many Processed Foods

  • by Natasha Hobley
  • Published 
  • Federal Agencies
FDA Bans Red No. 3 Used in Many Processed Foods

The artificial coloring, known as Red Dye No. 3 has been banned in cosmetics in the U.S. for 35 years, but it has been allowed to stay in food and medicine. The synthetic dye that gives foods a cherry red color is an ingredient in more than 9,200 products on store shelves in the country.  It was only last month that the U.S. Food and Drug Administration (FDA) finally moved to ban Red Dye No. 3 in food and medicine due to its link to cancer in animals, but other food dyes, including the controversial Red Dye No. 40, are not banned at this time.1

Red Dye No. 3 ban came in response to a color additive petition filed in 2022 by food safety advocates providing evidence of the dye’s links to cancer and behavioral issues. Because the dye is iodine based, it is also linked to thyroid issues.2 Red Dye No.3 can be found in many candies, baked goods and snacks, dairy and frozen desserts, fruit products, beverages, and some medications and supplements.3

Dyes Derived from Petroleum, Banned in Cosmetics Since 1990

Red Dye No. 3., which is derived from petroleum, was initially approved by the U.S. government for use in foods in 1907 even though little research had been conducted to demonstrate its safety. The FDA banned the additive in cosmetics in 1990 under the Delaney Clause, a federal law that requires the FDA to ban additives found to cause or induce cancer in either humans or animals.

The FDA has given food manufacturers until Jan. 15, 2027 to reformulate their products. Companies that make dietary supplements that contain Red Dye No. 3 will have an additional year to comply with the FDA ban.

“At long last, the FDA is ending the regulatory paradox of Red 3 being illegal for use in lipstick, but perfectly legal to feed to children in the form of candy,” said Peter Lurie, MD, MPH, president of the Center for Science in the Public Interest.1

Since Red Dye No. 40 is not banned, but there is concern about products with Red Dye. No 3 will simply be swapped for Red Dye 40, which is commonly linked to behavioral issues. Joshua Lachter of The Free Press writes:

If we wait for years of painstaking research to show that a particular compound is harmful— only to replace it with other compounds— we will simply swap the shunned for the suspect.4

“There is a growing national movement around this that we have seen. It is a bipartisan movement,” Lachter said. “This is an important moment, but I think it’s just the beginning of a lot more to come.”1

Red Dye No. 3 Restricted in Several Other Countries, State of California

In 2023, California became the first state to ban four food ingredients linked to disease, including Red Dye No. 3, brominated vegetable oil, potassium bromate, and propylparaben. Like the FDA’s ban, the law will not go into effect until 2027.

“It’s unacceptable that the U.S. is so far behind the rest of the world when it comes to food safety,” said California assemblymember Jesse Gabriel, who sponsored the state bill.  “This bill will not ban any foods or products — it simply will require food companies to make minor modifications to their recipes and switch to the safer alternative ingredients that they already use in Europe and so many other places around the globe,” he added.5

Countries that have restricted the use of Red Dye No. 3 for decades now, including Australia, New Zealand, and the European Union.5

Click here to view References:

1 Lovelace B, Chuck E. FDA bans Red No. 3, artificial coloring used in beverages, candy and other foods. NBC News, Jan. 15, 2025.
2 Neely, S. Red Dye No. 3 versus Red 40: what is the difference, why is only one being banned? Yahoo News, Jan. 22, 2025.
3 Mesa J. Full list of foods and drinks that contain Red Dye 3 after FDA bans additive. Newsweek, Jan. 15, 2025.
4 Lacher, J. It’s not just Red Dye No. 3. It’s all our stuff. The Free Press, Jan. 21, 2025.
5 Hernandez, J. California becomes the first state to ban 4 food additives linked to disease. NPR, Oct. 10, 2023.

If you would like to receive an e-mail notice of the most recent articles published in The Vaccine Reaction each week, click here.

FDA Hasn’t Reviewed Some Food Additives in Decades

There’s a long list of chemicals and additives that are allowed in the U.S. but are banned in Europe and other places over health concerns. There are more than 10,000 chemicals and additives are allowed in food in the U.S., often in small amounts. But many have not been evaluated by the FDA in decades. The majority are safe, but some chemicals allowed here have been banned overseas after research has linked them to cancer and developmental or behavioral issues.

Federal Court Sides With Doctors on Ivermectin Lawsuit Charging FDA Overreach

  • Published September 18, 2023
  • Federal & State Courts
Ivermectin antiparisitic drug

The Fifth Circuit Court of Appeals in New Orleans has given new life to a lawsuit brought by three doctors claiming the U.S. Food and Drug Administration (FDA) overstepped its authority and acted as a medical doctor rather than as a regulating authority in the agency’s campaign promoting a ban on the use of the drug Ivermectin in the treatment of COVID-19.1

The court’s decision overturned U.S. District Judge Jeffrey Vincent Brown’s lower court’s order dismissing the doctors’ lawsuit. Judge Brown agreed with the government that it was protected from the lawsuit due to sovereign immunity.2 Sovereign immunity provides that the government may not be sued without its consent. The purpose behind the legal doctrine of sovereign immunity is to protect the government from being forced to change policies should someone disagree with them and bring legal action.3

The medical doctors, Mary Bowden, Paul Marik, and Robert Apter, argue that the FDA’s actions of interfering with their prescribing of Ivermectin harmed their reputation caused punitive action to be taken against them, and interfered with the practice of medicine, which included pharmacies failing to fill their prescription orders for Ivermectin.

Jared Kalson, the lawyer for the plaintiffs argued:

If the government is going to label Ivermectin a horse medicine or a horse dewormer and promulgate the idea that it is only for animals, then the natural correlation is that doctors who prescribe it are horse doctors or quack doctors, which has played out. The government engaged in a singularly effective campaign here to malign a common drug that has been used for a very long time and has been dispensed in billions of doses. It’s one of the most famously safe drugs in the history of human medicine. And when people did exactly what the FDA said to ‘Stop it. Stop it with the Ivermectin,’ I don’t understand how that would not be traceable back to the FDA.4

Court Rules “FDA Not a Physician”

The plaintiffs appealed the lower court order to the Fifth Circuit Court of Appeals. The panel of three appellate judges, including Judge Don Willet, Judge Jennifer Walker Elrod, and Judge Edith Brown Clement agreed with the plaintiffs that the FDA committed government agency overreach and allowed the doctors to proceed with their lawsuit.5

The Order read,:

FDA is not a physician. It has authority to inform, announce, and apprise—but not to endorse, denounce, or advise. The doctors have plausibly alleged that FDA’s posts fell on the wrong side of the line between telling about and telling to. As such, the doctors can use the APA to assert their ultra vires claims against the agencies and the officials.6

Judge Willet took issue with the FDA’s Aug. 21, 2021 Twitter post stating, “You are not a horse. You are not a cow. Seriously, y’all. Stop it.” The judge wrote, “Even tweet-sized doses of personalized medical advice are beyond FDA’s statutory authority.”7

How a Licensed Inexpensive Antiparasitic Drug Helped Treat COVID

Merck originally marketed Ivermectin, which was licensed in 1981, as a veterinary antiparasitic drug. By the late 1980s, Ivermectin became the most widely used antiparasitic drug in both animals and humans and has been especially useful in Africa to effectively and safely control malaria.8 9 A Nobel prize-winning drug, doctors have been prescribing Ivermectin to patients for decades.10

So how did a cheap, accessible antiparasitic become such a popular drug used to treat SARS-CoV-2 infections during the COVID pandemic?

In 2020, Australian researchers from the Biomedicine Discovery Institute (BDI) at Monash University made the discovery that Ivermectin could neutralize the novel SARS-CoV-2 virus within 48 hours. The study, a joint effort between Monash Biomedicine Discovery Institute, Monash University in Clayton, Australia, and the Peter Doherty Institute of Infection and Immunity—a joint venture between the University of Melbourne and the Royal Melbourne Hospital, both in Melbourne, Australia—found that, in vitro, the drug proved effective against a number of viruses, including HIV, dengue, influenza, and Zika. The findings suggested that just a single dose of Ivermectin could remove or significantly reduce viral RNA within 24 to 48 hours of SARS-CoV-2 .

Dr. Kylie Wagstaff, Monash Biomedicine Discovery Institute scientist and leader of the study said: “We found that even a single dose could essentially remove all viral RNA by 48 hours and that even at 24 hours there was a really significant reduction in it.”

A study was published in 2021 in the American Journal of Therapeutics providing evidence that the use of Ivermectin reduces morbidity and mortality from SARS-CoV-2 infections, including time to recovery and viral clearance.11 In addition, Ivermectin is being investigated as an option for treating certain other human viral infections like latent Epstein Barr, which can be reactivated in some individuals when they are infected with SARS-CoV-2 and lead to long COVID.12 13 14

Ivermectin Showed Antiviral Effects Against Omicron and Other Variants

Off-label use of Ivermectin has been the source of much scrutiny among many public health officials throughout and even following the pandemic. And while historically prescribed as an antiparasitic for humans and animals, the drug did show and other variants in 2022 during joint nonclinical research conducted by Japanese pharmaceutical company, Kowa Co. Ltd.15

Additionally, another study published in The Lancet in 2021 found Ivermectin to incite “antiviral activity against SARS-CoV-2 and provides insights into the type of evaluations to be considered in the assessment of antiviral drugs for the control of COVID.”16

Popular podcast host and health and wellness influencer Joe Rogan posted a video only days after the FDA urged people to stop taking the drug to prevent or treat COVID-19 to share he was taking Ivermectin after contracting the virus. He said that taking Ivermectin in conjunction with monoclonal antibodies, prednisone, azithromycin, a NAD drip, and a vitamin drip, a protocol he shared with his followers, helped him feel “great” only three days later.

FDA’s Condemnation of Ivermectin-Blocked Doctor Prescriptions for COVID Patients

Judge Willet further pointed out that Ivermectin is available in both animal and human form and that doctors have been prescribing the drug to patients for decades. However, after the FDA’s condemnation of Ivermectin as an ineffective and potentially dangerous treatment for COVID-19, pharmacies across the country began refusing to fill doctors’ prescriptions for patients.

A Department of Justice attorney, Ashley Cheumg Honold, clarified the FDA’s position to the court stating…

FDA explicitly recognizes that doctors do have the authority to prescribe ivermectin to treat COVID.17

Despite the FDA’s statement that doctors have the authority to prescribe Ivermectin to treat COVID, pharmacies continue to refuse to fill prescriptions for the drug, leaving patients scrambling. Dr Bowden told The Epoch Times:

This needs to come to an end. In telling my patients what medicines they can and cannot have access to, we effectively have a large group of pharmacists practicing medicine without a license. They have no accountability for this yet they are allowed to dictate patient care. … I see it every single day. Enough is enough.18

If you would like to receive an e-mail notice of the most recent articles published in The Vaccine Reaction each week, click here.

Click here to view References:

1 Robertson N. Federal appeals court revives lawsuit against FDA over COVID-19 ivermectin messaging. The Hill. Sept. 2, 2023.

2 Stieber Z. Judge Rules on Lawsuit Against FDA Over Ivermectin. The Epoch Times. Dec. 6, 2022.
3 What Is Sovereign Immunity? Definition and Examples. ThoughtCo.
4 Stieber Z. Judge Rules on Lawsuit Against FDA Over Ivermectin. The Epoch Times. Dec. 6, 2022.
5 Lysiak M. ‘FDA Is Not a Physician’: Appeals Court Sides With Doctors on Ivermectin for COVID-19. The Epoch Times Sept. 2, 2023.
6 Ibid.
7 Ibid. 
8 Laing R, Gillan V, Devaney E. Ivermectin – Old Drug, New Tricks? Trends Parasitol June 2017; 33(6): 463-472.
9 Foy BD, Alout H, Seaman JA et al. Efficacy and risk of harms of repeat Ivermectin mass drug administrations for control of malaria (RIMDAMAL): a cluster-randomised trial. The Lancet 2019; 393 (10180): 1517-1526.
10 Santin AD, Scheim DE, McCullough PA et al. Invermection: a multifaceted drug of Nobel prize-honoured distinction with indicated efficacy against a new global scourge, COVID-19. New Microbes New Infect 2021; 42.
11 Kory P, Meduri GU, Varon J et al. Review of the Emerging Evidence Demonstrating the Efficacy of Ivermectin in the Prophylaxis and Treatment of COVID-19. Am J Ther 2021; 28(3).
12 Gold JE, Ikyay RA, Licht WE, Hurley DJ. Investigation of Long COVID Prevalence and its Relationship to Epstein-Barr Virus Reactivation. Pathogens 2021; 10(6).
13 Na L, Zhao L, Zhan X. Quantitative proteomics reveals a broad-spectrum antiviral property of ivermectin benefiting for COVID-19 treatment. J Cell Physiol 2021; 236(4): 2959-2974.
14 Bernal KDE, Whitehurst CB. Incidence of Epstein Barr virus reactivation is elevated in COVID-19 patients. Virus Res 2023; 334: 199157.
15 Reuters. Ivermectin shows ‘antiviral effect’ against COVID, Japanese company says. Jan. 31, 2022.
16 Krolewiecki A et al. Antiviral effect of high-dose ivermectin in adults with COVID-19: A proof-of-concept randomized trial. The Lancet June 17, 2021.
17 Lysiak M. ‘FDA Is Not a Physician’: Appeals Court Sides With Doctors on Ivermectin for COVID-19. The Epoch Times Sept. 2, 2023.
18 Lysiak M. Doctor: Pharmacists Continuing to Refuse Ivermectin Prescriptions, Raising Ethical Concerns. The Epoch Times. Sept. 1, 20223.

Federal Appeals Court Revives FDA Lawsuit Regarding Anti-Ivermectin Campaign

Federal Appeals Court Revives FDA Lawsuit Regarding Anti-Ivermectin Campaign

A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland. (Photo by Sarah Silbiger/Getty Images

OAN’s Brooke Mallory
11:48 AM – Monday, September 4, 2023

SEE: https://www.oann.com/newsroom/federal-appeals-court-revives-fda-lawsuit-regarding-anti-ivermectin-campaign/;

Republished below in full unedited for informational, educational, & research purposes.

A federal appeals court overturned a prior judgment on Friday, enabling a Food and Drug Administration (FDA) lawsuit involving its campaign against the use of ivermectin to treat COVID-19 to proceed.

In a lawsuit filed against the FDA last year, three different doctors asserted that the agency had overstepped its boundaries in its anti-ivermectin campaign, “acting more like a medical body than a regulator.”

A district judge had originally ruled that the lawsuit could not proceed, but in a Friday decision, the 5th Circuit Appeals judge gave the physicians new hope by remanding the matter to a lower court for reconsideration.

“FDA is not a physician. It has authority to inform, announce, and apprise — but not to endorse, denounce, or advise,” said Judge Don Willett. “The Doctors have plausibly alleged that FDA’s Posts fell on the wrong side of the line between telling about and telling to.”

Ivermectin is an anti-parasite drug that is frequently prescribed to horses but also occasionally prescribed to people as well. The FDA’s campaign, which featured viral posters stating “You are not a horse,” underscored the agency’s warnings that it should not be used to treat the COVID-19 virus.

“Although [the] FDA has approved ivermectin for certain uses in humans and animals, it has not authorized or approved ivermectin for use in preventing or treating COVID-19, nor has the agency stated that it is safe or effective for that use,” the agency’s recommendations stated.

While a handful of people were reportedly hospitalized and some even died from the drug, which occurs if one takes ivermectin in addition to certain other medications, many groups still welcomed it as a miracle cure and claimed to receive beneficial results for their health.

However, In 2021, a review of 14 studies on the use of ivermectin concluded that there was insufficient evidence to justify its usage, adding that “few [of the studies] are considered high quality.”

Yet, “It must be acknowledged that some of these studies were possibly intentionally designed to yield predetermined findings,” researchers maintained.

Besides COVID-19, there have also been reports from those suffering from autoimmune disorders who claim that ivermectin helped combat their negative symptoms and that they have been taking the anti-parasite drug for years.

The National Institutes of Health and the World Health Organization are two organizations that have consistently advised against using ivermectin to treat COVID-19.

The anti-ivermectin FDA campaign, according to the three doctors, damaged their doctoral reputations since they had previously encouraged the use of the drug. One doctor was expelled from medical school, and another was even suspended from working at a hospital.

“This case has broad implications for protecting the practice of medicine from unlawful interference by the FDA,” the doctors’ attorney, Jared Kelson, said in a statement. “It’s about ensuring that federal agencies act only within their statutory authority. The FDA crossed a bright line here.”

One of the pro-liberty plaintiffs in the case, Mary Talley Bowen, praised the decision on Friday.

“A small win, or at least a step forward, in a monumental battle to protect the doctor-patient relationship from government tyranny… ONWARD!” Bowen said.

Stay informed! Receive breaking news blasts directly to your inbox for free. Subscribe here. https://www.oann.com/alerts

Techno-Hell: FDA Approves the Release of 2.4 Million Bioengineered Designer Mosquitoes in Florida, California

Techno-Hell: FDA Approves the Release of 2.4 Million Bioengineered Designer Mosquitoes in Florida, California

BY BEN BARTEE

SEE: https://pjmedia.com/news-and-politics/benbartee/2023/06/30/techno-hell-fda-approves-the-release-of-2-4-million-bioengineered-designer-mosquitoes-in-florida-california-n1707642;

Republished below in full unedited for informational, educational, & research purposes.

The U.S. Environmental Protection Agency has approved a British biotech firm’s application to release 2.4 million genetically altered mosquitoes into the wild as an “experimental pesticide product.”

Via NBC News:

The experimental public health effort, which still requires final approval from state regulators, follows the 2021 release of 144,000 genetically modified mosquitoes in the Florida Keys by British biotech firm Oxitec.

Oxitec said its genetically modified male, and thus non-biting, mosquitoes “find and mate with invasive female Aedes aegypti mosquitoes, mediating a reduction of the target population as the female offspring of these encounters cannot survive,” thus reducing the overall population…

Oxitec’s mosquito release — which the EPA calls an “experimental pesticide product” — can take place in a 34,760-acre area across the two states between now and April 30, 2024, when the experiment ends.

Via Oxitec’s press release announcing FDA approval (emphasis added):

Oxitec, the leading developer of biological pest control solutions, is proud to announce the publication by the U.S. Environmental Protection Agency (EPA) of its approval to conduct pilot projects of Oxitec’s safe, non-biting, Aedes aegypti mosquitoes in California and Florida. Two pilot projects were approved, one with the Delta Mosquito and Vector Control District (Delta MVCD) in California and one with the Florida Keys Mosquito Control District (FKMCD) in Florida.

This approval is an extension of the Experimental Use Permit (EUP) granted in 2020 by the EPA for a pilot project in the Florida Keys, which was successfully carried out in 2021. Alongside its in-depth scientific evaluation process was a 30-day period for public comments. The EPA reviewed and responded to each public comment before issuing its approval…

Oxitec’s safe, sustainable and targeted biological pest control technology does not harm beneficial insects* like bees and butterflies and is proven to control the disease transmitting Aedes aegypti mosquito, which has invaded communities in Florida, California and other U.S. states. In California, since first being detected in 2013, this mosquito has rapidly spread to more than 20 counties throughout the state, increasing the risk of transmission of dengue, chikungunya, Zika, yellow fever and other diseases.

We’ve seen the fruits of “experimental” regulatory approval in the context of the emergency use authorizations granted to the manufacturers of the COVID-19 shots (potentially granted under fraudulent pretexts), and they’re not pretty.

Regarding the second claim — that Oxitec’s product “does not harm beneficial insects” — there is, of course, no way to affirmatively know the long-term effects of this product on local fauna because three years is a blip on the radar in the Public Health™ domain.

The most that could honestly be said — assuming robust, good-faith studies on the ecological impacts thus far have, in fact, been conducted and Oxitec hasn’t doctored the evidence — is that, at this stage, there appear to be no adverse impacts on the local ecology.

Twelve Infants Die During Clinical Trials for FDA-Endorsed RSV Drug

BY AMBER BAKER

SEE: https://thevaccinereaction.org/2023/06/twelve-infants-die-during-clinical-trials-for-fda-endorsed-rsv-drug/;

Republished below in full unedited for informational, educational, & research purposes.

On June 8, 2023, the U.S. Food and Drug Administration’s (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) voted unanimously (21-0) in favor of AstraZeneca and Sanofi’s new nirsevimab (Beyfortus) monoclonal antibody drug believed to provide protection for infants from respiratory syncytial virus (RSV) disease and other lower respiratory tract infections during their first year of life.1

Citing a “favorable benefit-risk profile for the prevention of RSV lower respiratory tract disease (LRTD) in newborns and infants born during or entering their first RSV season,” AstraZeneca/Sanofi stated in a press release that the antibody may also have the potential to protect those born healthy at term or preterm, as well as with conditions that make them more susceptible to RSV disease.2

RSV is a common, typically-mild lower respiratory illness. In serious cases, the disease can lead to pneumonia or bronchiolitis, putting infants and the elderly at high risk for complications.

The RSV antibody comes on the heels of the world’s first RSV vaccine, GSK’s Arexvy, which was approved by the FDA last month for use in people 60 years of age and older. Pending final FDA approval, nirsevimab would become the first single-dose pharmaceutical intervention in the U.S. aimed at protecting babies from RSV infections through the age of two years.3

RSV Labeled a Major Public Health Threat After Unprecedented Surge in Cases

After COVID infections decreased, there was an “unprecedented” spike in RSV infections in infants that overwhelmed hospitals in 2022 and prompted pediatric health organizations to call on President Biden to declare a public health emergency after 17 states reported that more than 80 percent of their beds were full last fall.4

While some experts suggest the surge in respiratory viruses is a result of relaxing COVID-19 measures, others attribute the spike to “immunity debt,” or the idea that people’s immune systems were weakened from lack of normal, natural exposure to pathogens like RSV and influenza because of stay-at-home orders, prolonged mask-wearing, and social distancing that persisted for the better part of three years.5

The path to pharmaceutical RSV protection spans several decades, with clinical trials for an RSV vaccine ending abruptly in the 1960s after the shot unexpectedly sickened and hospitalized 80 percent of children in the trial. The inactivated virus used in the shot exacerbated the disease once trial participants caught RSV naturally, leading to two children’s deaths and researchers going back to the drawing board.6

Today, more than 60 years later, 12 infants have died during clinical trials of the new nirsevimab, two from “unknown causes” thought to be linked to sudden infant death syndrome (SIDS).7

Infant Deaths Attributed to Underlying Disease Despite Clinical Trials Requiring Healthy Participants

The other 10 infant deaths were attributed to “underlying disease.” However, according to Pfizer, clinical trials typically include healthy participants to assess the safety of the drug and any side effects, and only certain types of trials—such as those for oncology—would warrant the inclusion of sick patients versus healthy people.7 8

Before joining a clinical trial, according to the U.S. National Institutes of Health (NIH), participants must be given informed consent, as well as any information that allows the research team to determine whether or not they can participate in the study safely.9

As for the other 10 children’s deaths—attributed to a number of varying causes such as cardiac disease, a tumor, COVID, a skull fracture, pneumonia, two from gastroenteritis, and two from unknown causes—FDA official Melissa Baylor, MD said none of the deaths appeared to be related to the experimental drug nirsevimab.7

SIDS and the Importance of Black Box Warnings on Drugs

By definition, SIDS is an unexpected and unexplainable death that occurs in a “seemingly normal, healthy infant under one year of age.” In fact, nine out of 10 deaths in the study occurred around the two- and four-month mark, when well-baby visits to the pediatrician commonly precede the administration of multiple vaccines, such as the combined DTaP (diphtheria, tetanus, and acellular pertussis) in one visit, according to the U.S. Centers for Disease Control and Prevention’s (CDC) Immunization Schedule.10

Many drugs, including some routine childhood vaccinations for newborns, contain black box warnings on the manufacturer’s product inserts. A black box warning, the highest safety-related warning intended to alert the consumer to major risks of the drug, stamps the insert of any drug where trial participants died during clinical studies. Still, more often than not, as with the clinical trials of nirsevimab, the diagnosis of SIDS often overrules the occurrence of a potentially lethal drug reaction as the cause of death in an otherwise healthy infant.11

The FDA is slated to make a final decision on nirsevimab later this year. To date, the agency maintains it has not identified any safety concerns in its review of the drug.7

If you would like to receive an e-mail notice of the most recent articles published in The Vaccine Reaction each week, click here.

Click here to view References:

1 Pinsk A. A New Shot Prevents Serious Illness from RSV. Johns Hopkins Bloomberg School of Public Health Mar. 30, 2022.
2 Press Release. Nirsevimab unanimously recommended by FDA Advisory Committee for the prevention of RSV lower respiratory tract disease in infants. AstraZeneca June 8, 2023.
3 Press Release. FDA Approves First Respiratory Syncytial Virus (RSV) Vaccine. U.S. Food and Drug Administration May 3, 2023.
4 Kimball S. Children’s hospitals call on Biden to declare emergency in response to ‘unprecedented’ RSV surge. CNBC Nov. 18, 2022.
5 Christensen J. Pandemic ‘immunity gap’ is probably behind surge in RSV cases, scientists say. CNN Oct. 28, 2022.
6 Harding A. Research shows why 1960s RSV shot sickened children. Reuters Dec. 3, 2008.
7 Kimball S. FDA advisors recommend AstraZeneca, Sanofi antibody to protect babies from RSV. CNBC June 8, 2023.
8 Reed J. Do You Have What It Takes to Join a Phase 1 Clinical Trial? Pfizer 2021.
9 U.S. National Institutes of Health. NIH Clinical Research Trials and You, The Basics. Oct. 3, 2022.
10 Sudden Infant Death Syndrome (SIDS). Boston Children’s Hospital 2012.
11 Vitamin K Injection [PACKAGE INSERT]. Novaplus 2021.

Mary Holland: FDA Withholding VAERS Data on Injuries, Deaths

BY VERONIKA KYRYLENKO

SEE: https://thenewamerican.com/mary-holland-fda-withholding-vaers-data-on-injuries-deaths/;

Republished below in full unedited for informational, educational, & research purposes.

Americans have been promised complete transparency on Covid shots safety. Yet, the nation’s top healthcare agencies are suspiciously reluctant to release the data that they use to advertise these injections as “safe.”  

Last year, Children’s Health Defense (CHD) submitted two separate-but-related FOIA requests to the U.S. Food and Drug Administration (FDA) to obtain data related to the agency’s obligatory work on analyzing the safety signals for Covid shots. When both requests were rejected, the non-profit took the agency to court.

In this interview with The New American, Mary Holland, the CHD’s president and general counsel, explains the basics of what the Vaccine Adverse Effects Reporting System (VAERS) is and how it is used to detect safety signals. It was recently uncovered that the CDC, the FDA’s sister agency that co-runs VAERS, identified more than 770 different types of adverse events that showed safety signals. The FDA must be open about the disastrous safety profile of the shots, which are long overdue for a recall, emphasized Ms. Holland.

To learn more about and support Children’s Health Defense, please click here.

Moderna Withheld Data From FDA Regulators to Get Bivalent Booster Approved

Moderna Withheld Data From FDA Regulators to Get Bivalent Booster Approved

BY BEN BARTEE

SEE: https://pjmedia.com/news-and-politics/benbartee/2023/01/15/moderna-withheld-data-from-fda-regulators-to-get-bivalent-booster-approved-n1661950;

Republished below in full unedited for informational, educational, & research purposes.

How many times have we been treated, in the era of the New Normal, to exasperated corporate media hacks complaining about “misinformation” pushed by “conspiracy theorists” regarding the COVID-19 mRNA gene therapies deceptively marketed as “vaccines”?

As it turns out, the biggest purveyor of misinformation is the pharmaceutical industry, followed closely by the government and corporate media.

Via CNN:

The pharmaceutical company Moderna didn’t present a set of infection data on the company’s new Covid-19 booster during meetings last year when [FDA] advisers discussed whether the shot should be authorized and made available to the public…
That data suggested the possibility that the updated booster might not be any more effective at preventing Covid-19 infections than the original shots.

Specifically, Moderna hid data on actual infection rates among patients who were administered the original booster and those who got the bivalent “vaccine.” The reason is obvious: The data showed that the original booster resulted in fewer infections than the bivalent version, which clearly wouldn’t be good news for sales.

Related: Judicial Watch Releases Damning New Information on the Moderna Vaccine

1.9% of the study participants who received the original booster became infected. Among those who got the updated bivalent vaccine – the one that scientists hoped would work better – a higher percentage, 3.2%, became infected.

Research released by the New England Journal of Medicine found that “boosting with new bivalent mRNA vaccines targeting both the BA.4–BA.5 variant and the D614G strain did not elicit a discernibly superior virus-neutralizing peak antibody response as compared with boosting with the original monovalent vaccines.”

In English, that means they don’t work as promised.

So…

When will Moderna get its Twitter account suspended for promulgating dangerous misinformation?

When will the White House collude to censor Moderna’s free speech?

When will Moderna’s licenses to create drugs get suspended, the way doctors were threatened with having their medical licenses suspended for spreading COVID “misinformation”?

When will CNN begin conducting ambush interviews of Moderna executives, as they do with defenseless independent practitioners like Dr. Mercola who challenge big pharma orthodoxy?

FDA approves OMICRON booster shots for babies, children

BY CAROLYN HENDLER, J.D.

SEE: https://thevaccinereaction.org/2023/01/fda-approves-u-s-babies-and-young-children-to-get-omicron-covid-booster-shots/;

Republished below in full unedited for informational, educational, & research purposes.

In early December 2022, the U.S. Food and Drug Administration (FDA) amended the Emergency Use Authorization (EUA) for the Pfizer/BioNTech and Moderna/NIAID mRNA Covid-19 shots to include administration of the Omicron Covid booster shots to children as young as six months old. The action allows everyone over the age of six months to get the newest booster shot.1

The FDA made the decision to authorize the vaccination of infants and very young children just three days after Pfizer submitted an application to the regulatory agency for the Omicron BA.4/BA.5-Adapted Bivalent Covid vaccine.2

The bivalent Covid booster, which contains the original strain of the SARS-COV-2 virus along with spike proteins from the BA.4 and BA.5 variants of the Omicron strain, was approved for children five years of age and older on Oct. 12, 2022.3 FDA commissioner Robert Califf, MD said:

More children now have the opportunity to update their protection against Covid-19 with a bivalent Covid-19 vaccine, and we encourage parents and caregivers of those eligible to consider doing so–especially as we head into the holidays and winter months where more time will be spent indoors.4>

COVID Vaccination Uptake Has Been Slow Among Babies and Young Children

Omicron Covid booster shot uptake is limited because it is only available to infants and children who have received both doses of the original Covid shots developed by Pfizer and Moderna. Children who have already received three doses of the original Pfizer Covid shot are not eligible for the booster.

U.S. Centers for Disease Control and Prevention (CDC) officials have reported that less than five percent of children aged two to four and only three percent of children and babies under the age of two have received the original Covid shots.5 Therefore, there is not much demand for Omicron booster shots among very young children. Meanwhile, 32 percent of children aged five to 11 years are fully vaccinated against Covid.6

Yale School of Medicine pediatrician Leslie Sude, MD said:

While a significant proportion of the population was not eligible for vaccination, there was still the opportunity for widespread circulation of COVID among children, who could then keep transmitting it to older people. And as long as the virus spreads from person to person, the virus can keep changing and evolving into new variants.7

However, Dr. Sude’s comment conflicts with CDC director Rochelle Walensky’s acknowledgment that getting a Covid shot does not prevent infection with and transmission of the SARS-CoV-2 virus to others. Dr. Walensky stated:

 Our vaccines are working exceptionally well … but what they can’t do anymore is prevent transmission.8

Covid Shot Study Data Not Peer Reviewed or Published

The FDA and a committee of independent vaccine experts relied on data provided by the vaccine manufacturers when extending the EUA for the bivalent Omicron Covid booster shot to infants and very young children. The data presented by vaccine manufacturers have not been peer-reviewed or published.9

When extending the EUA status of the Moderna Covid booster shot to babies and young children, the FDA relied on a clinical study looking at the immune response of adults to the Moderna product.  The FDA also compared a clinical study looking at the immune response of 56 children aged 17 months through five years after getting the full dose series of the original Covid shots plus the booster dose to a study examining the immune response of 300 young adult participants, who received the two-dose original Moderna Covid shot. The FDA concluded that the immune response of infants and very young children were comparable to the immune response in young adults.10

The FDA also looked at a clinical study examining the safety of a single dose Moderna Covid booster shot in 145 children aged six months through five years old. The study showed the common side effects in babies 17 through 36 months old were irritability/crying, sleepiness, and loss of appetite. Previous clinical trials showed the common side effects in this age group to also include fatigue, muscle pain, headache, joint pain, nausea/vomiting, and chills.11

The third dose of the monovalent Pfizer Covid shot will no longer be used in very young children and will, instead, be replaced with the booster dose. The FDA relied on efficacy data previously submitted by the drug manufacturer in individuals aged six months through four years old, 16 years and older, and adults aged 55 years and up who received the original two-dose series of shots, the monovalent booster as well as the bivalent booster dose.12

The safety of the Pfizer Covid booster shot for children aged six months through five years old was determined by looking at safety data from a clinical study of the bivalent booster shot in participants aged 55 years and older; clinical trials looking at the safety of the primary vaccine series in children six months and older with the monovalent booster, as well as safety data from clinical trials and post-marketing safety data of the booster shot in participants five years and older.

Even though the safety data presented did not include the bivalent Covid booster shot, the FDA concluded the previous trials and studies on the monovalent booster were relevant to the approval process of the bivalent Omicron version due to the fact the same manufacturing process was used to make both versions of the shot.13

If you would like to receive an e-mail notice of the most recent articles published in The Vaccine Reaction each week, click here.

Click here to view References:

1 Gumbrect J. Children as young as 8 months can now receive an updated COVID-19 vaccine. CNN Dec. 9, 2022.
2 Pandolfo C. FDA authorizes bivalent COVID-19 booster shots for children under 5. Fox News Dec. 8, 2022.
3 Cáceres M, Fisher BL. FDA Authorizes COVID Bivalent Shots for Children as Young as Five Years Old. The Vaccine Reaction Oct. 17, 2022.
4 Gumbrect J. Children as young as 8 months can now receive an updated COVID-19 vaccine. CNN Dec. 9, 2022.
5 Pandolfo C. FDA authorizes bivalent COVID-19 booster shots for children under 5. Fox News Dec. 8, 2022.
6 MacMillan C. COVID-19 Vaccines for Kids Under 5; What Parents Need To Know. Yale Medicine Dec. 12, 2022.
7 Ibid.
8 Stykes E. CDC Director: Covid vaccines can’t prevent transmission anymore. MSN Jan 10, 2022.
9 MacMillan C. COVID-19 Vaccines for Kids Under 5; What Parents Need To Know. Yale Medicine Dec. 12, 2022.
10 News Release. Coronavirus (COVID-19) Update: FDA Authorizes Updated (Bivalent) COVID-19 Vaccines for Children Down to 6 Months of Age. U.S. Food and Drug Administration Dec. 8, 2022.
11 Ibid.
12 Ibid.
13 Ibid.

Nuremberg II: Mass-murder trials could commence after midterms for the vaccine-pushing genocidal maniacs Fauci, Walenski and more

Image: Nuremberg II: Mass-murder trials could commence after midterms for the vaccine-pushing genocidal maniacs Fauci, Walenski and more

BY S.D. WELLS

SEE: https://www.naturalnews.com/2022-11-15-nuremberg-ii-mass-murder-trials-could-commence-after-midterms.html;

Republished below in full unedited for informational, educational, & research purposes.

(Natural News) The Covid crimes are years in the making and more than a handful of vaccine manufacturers and promoters could be on trial soon for mass murder and conspiracy to commit genocide. Senator Rand Paul puts Dr. Anthony Fauci at the forefront of the whole plandemic brigade since Fauci lied and DID help fund gain-of-function research that led directly to the (Wuhan Flu) virus outbreak in humans across planet Earth. Already those who planned and propagated the scamdemic are begging for forgiveness, knowing that Nuremberg II trials are coming, sooner or later, for them. There are too many people involved in this mass murder scheme, but the ones at the top should be tried first.

Anthony “Fraudulent” Fauci is the King of Misinformation when it comes to anything related to Covid-19

Fauci flip-flopped on mask-wearing, social distancing, lockdowns, medications, vaccinations, and just about every piece of “advice” that spewed from his mouth for the past two years. Back and forth he went, talking about mandates that were vital to ‘flattening the curve’ and saving lives, when, come to find out, most of his advice is responsible for killing millions, if not billions, of people. Then he wrote a book on it all so he can further pad his rich pockets from the whole scamdemic, that’s ongoing and may never end. That’s why Fauci is the King of Misinformation. Then there’s Bill Gates, Peter Daszak, Dr. Walenski, and their scamdemic-planning cohorts at the regulatory agencies, and those who literally invested in the pandemic and made a fortune also.

Turns out the masks cause bacterial infections in the mouth, throat, and lungs, leading to worsened cases of Covid and pneumonia. Turns out that the #1 recommended drug in hospitals for Covid patients is remdesivir, which decimates kidney function, and all the leading doctors, CDC, and FDA “experts” know it. Turns out lockdowns and ‘virtual learning’ destroys children’s cognitive AND social development. Oops.

Fauci swore up and down that the vaccines were safe and effective, but they cause myocarditis, pericarditis, severe inflammation, and strange rubbery vascular clots that lead to SADS (Sudden Adult Death Syndrome).

It’s time to try the Covid-19 criminals for their crimes of murder and conspiracy to commit murder

Most of the people taking direct orders from Adolf Hitler in Nazi Germany were GUILTY of mass murder, not just “taking orders.” They saw firsthand the concentration death camps and they knew, at least to some extent, the genocide of Jews that was taking place. Hitler was also exterminating anyone with autism, handicaps, deformations, or senility. Today, depopulation agendas are rooted in “vaccination” agendas instead of gas chambers. The only difference is the victims are slowed and walked into their own demise by their own choice, after being conned and brainwashed by fear and CDC-scripted MSM propaganda.

Dr. Rand Paul is on the record stating, “To arrive at the truth, the U.S. government should admit that the Wuhan Virology Institute was experimenting to enhance the coronavirus’s ability to infect humans.” The Jews in WWII were not “subhuman,” and the vaccinated masses now are not supposed to be slated for execution either, but the clot shots are setting up this mass tragedy we are seeing take place, under the media’s radar.

Though many of the mass murderers from WWII only got 4 to 7 years in federal prison for their crimes, at least they were found guilty and served time. Justice must be served again, for WWIII is underway, and just because the plandemic masterminds are not using guns and bombs to kill millions, they are using weapons of mass destruction (biological weapons or B-WMDs).

Support Dr. Rand Paul as he moves forward with the goal of bringing justice to these pandemic-spreading criminals. Bookmark Vaccines.news to your favorite independent websites for updates on the next wave of Fauci-funded Covid-19 that Biden says is coming to America soon.

Sources for this article include:

MSN.com

NaturalNews.com

ConservativeBrief.com

1 2 3 … 5