Tag Archives: FDA

FDA Detects Serious Safety Signal for COVID-19 Vaccination Among Children

Children of certain ages who received Pfizer’s COVID-19 vaccine face an elevated risk of heart inflammation, according to a new federally funded study.

Vaccinated children aged 12 to 17 face a heightened risk of myocarditis, a form of heart inflammation, and a related condition called pericarditis, U.S. Food and Drug Administration (FDA) researchers found.

The number of myocarditis and pericarditis events in that age group met the threshold for a safety signal, the researchers reported in the Journal of the American Medical Association on May 22.

The elevated risk was present within seven days of vaccination, according to the data.

Researchers identified 89 cases among 12- to 15-year-olds and 64 cases among 16- and 17-year-olds after reviewing records from commercial databases run by CVS Health, HealthCore, and Optum.

The claims were made between Dec. 11, 2020, when Pfizer’s vaccine was cleared by the FDA, and mid-2022.

Researchers looked at data to determine whether any of the 20 health problems were experienced at higher rates by the vaccinated. The problems included myocarditis or pericarditis, Bell’s palsy, appendicitis, and stroke.

Only myocarditis or pericarditis met the criteria for a safety signal, which may be related to vaccination.

U.S. officials have already concluded that the conditions are caused by the Pfizer and Moderna COVID-19 vaccines, although the vaccines didn’t carry a warning for months after authorization. One possible mechanism is excessive immune responses triggered by lipid nanoparticles. Novavax’s vaccine, authorized in 2022, can also cause the heart conditions, authorities say.

More on Study

Researchers looked at health plan members who received a Pfizer vaccination, excluding those who lost their insurance during a certain window of time, which was 365 days for most outcomes.

Researchers then examined the number of each outcome in a different window of time, referred to as a risk window, which varied from a single day to as long as 42 days after vaccination.

The study then took the rates of problems from each database and compared them with expected rates, which are based on pre-pandemic numbers.

Out of 3 million children who received at least one vaccine dose, 153 cases of myocarditis or pericarditis were identified in the 12- to 17-year-old age group. More cases were identified among children aged 5 to 11, but not enough to trigger a signal.

A medical record review of the 37 cases for which records were obtainable confirmed 27 cases as true myocarditis or pericarditis.

None of the other 19 outcomes examined met the signal criteria, according to researchers.

“These results provide additional evidence for the safety of the COVID-19 vaccines in the pediatric population,” the researchers said.

Dr. Peter McCullough, a cardiologist, disagreed.

“My concern is that these data represent a gross under-reporting of the frequency and severity of COVID-19 vaccine-induced myocarditis,” McCullough, who has called for the withdrawal of the Pfizer vaccine, told The Epoch Times via email.

Since the FDA and the U.S. Centers for Disease Control and Prevention acknowledged in mid-2021 concerns that the vaccines might cause heart inflammation, “there have been [more than] 200 papers in the peer-reviewed literature and over 100 fatal documented cases largely among young men, peak ages 18–24 years, some with autopsy proven COVID-19 vaccine heart inflammation resulting in death,” according to McCullough.

That includes five people who suddenly died in Germany and six people who perished in the Nordic countries.

A request for comment sent to Steven Anderson, the FDA official listed as the study’s corresponding author, sparked a response by an FDA spokesperson, who declined to provide additional citations for the safety claim.

Anderson’s co-authors included researchers with Acumen, Optum, HealthCore, CVS, and IQVIA, with multiple members reporting connections with Pfizer. The time period included when the old Pfizer vaccine, which is no longer available in the United States, was used.

‘Pretty Ludicrous’

Norman Fenton, emeritus professor of risk at the Queen Mary University of London, said the researchers’ safety claim doesn’t hold up in light of the facts that the study shows a signal for myocarditis and pericarditis and that children are unlikely to benefit from the COVID-19 vaccines.

“The conclusion that ‘these results provide additional evidence that COVID-19 vaccines are safe in children’ is pretty ludicrous,” Fenton told The Epoch Times in an email.

The researchers also failed to take into account what’s known as the healthy vaccine bias; previous research has found that people who decide to get vaccinated tend to be healthier than those who don’t.

“They are comparing a highly select group of child and adolescent insured vaccine recipients to a historical baseline population consisting of everyone in the relevant age group who were insured,” Hebrew University lecturer Josh Guetzkow said.

Experts also said the risk windows appeared short, as post-vaccination conditions can sometimes crop up months afterward, and noted that the signal criteria were structured so that some outcomes would need to happen at more than double the rate among the vaccinated to meet them.

The shortest risk window was just one day, for anaphylaxis, or severe allergic shock. Some others were just one week. The rest were 28 days or 42 days.

In their protocol (pdf) for conducting the research, FDA officials said they chose risk windows based on pre-pandemic studies, including one from 2007. Source the Epoch Times

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A Potentially Toxic Chemical Is Added to Many Foods and Products

food red yellow colorful

Editors Note: Folks titanium dioxide is horrible in so many ways but one of the first things it does is affect your gut health aka your microbiome. It facilitates the production of the bad bacteria our guts don’t want which can directly affect our health in other areas of our lives. I had this happen to me as I was eating some crackers and some bread that had this stuff in it and I didn’t realize it at the time. READ THE LABELS ON EVERYTHING YOU BUY! If you don’t know what an ingredient is then look it up on your phone before you buy it! This is so important as they are poisoning everything today! Johnny

From the Epoch Times

In the summer of 2022, at least two consumer lawsuits were filed against the manufacturer of Skittles candy due to the presence of a known toxin in the product. The ingredient in question is titanium dioxide, also known as E171, which the manufacturer, Mars, Inc., had pledged to phase out six years prior.

Titanium dioxide has been banned as a food additive in the European Union since February 2022, nine months after the European Food Safety Authority published a report calling it unsafe as a food additive.

Titanium Dioxide Has Long Been Common in the US

Titanium dioxide has been approved as a food ingredient, with specific restrictions, by the U.S. Food and Drug Administration (FDA) since the mid-1960s. This common food additive—a white, odorless, and tasteless powder—is used as a whitening agent, thickener, and texturizer. Titanium dioxide is a naturally occurring mineral that can also be found in some non-food products, such as sunscreen.

The range of edibles that contain titanium dioxide might be surprising to some.

Here are several examples of foods that may contain titanium dioxide:

  • Candy: Candy coatings are often made shiny and colorful by adding titanium dioxide.
  • Gum: Many types of chewing gum contain titanium dioxide.
  • Baked goods: Titanium dioxide is frequently added to baked goods like bread and pastries to enhance their texture and appearance.
  • Dairy products: Titanium dioxide is sometimes used as a whitening agent in some types of yogurt, cheese, and low-fat milk.
  • Condiments: Titanium dioxide is sometimes used to add creaminess to sauces, such as mayonnaise and salad dressing.

“The FDA continues to allow for the safe use of titanium dioxide as a color additive in foods generally according to the specifications and conditions, including that the quantity of titanium dioxide does not exceed 1 percent by weight of the food,” the federal agency told The Epoch Times in an emailed statement.

Health Risks Associated With Consuming Titanium Dioxide

While titanium dioxide, also referred to as TiO2, is generally considered safe in the United States, studies highlighting potential health risks associated with its consumption are being conducted.

One study from 2019 showed that mice given titanium dioxide in their water experienced changes in their gut microbiome and inflammation. Another 2009 study involving rats found that inhalation of the substance caused respiratory tract cancer.

“There have been studies to indicate that titanium dioxide may negatively impact gut health by increasing ‘bad’ bacteria, thus generating more inflammation in the body,” said Emily Feivor, a registered dietitian at Northwell Health. “Most research concludes that the amount consumed from food is so low that it poses no risk to human health,” she added.

Another variant of the additive, known as titanium dioxide nanoparticles—which are significantly smaller particles of titanium dioxide—have been shown to have harmful effects in some studies. According to a 2015 review of studies, when titanium dioxide nanoparticles were inhaled, they could travel to the brain and other organs, such as the kidney and liver.

“In most studies, TiO2 nanoparticles appeared to have caused oxidative stress, histopathological alterations, carcinogenesis, genotoxicity, and immune disruption,” the study authors wrote. Based on these findings, they concluded that using titanium dioxide nanoparticles and similar materials in humans must be “avoided or strictly managed” to minimize potential health risks.

Other Food Additives Banned in Europe but Allowed in the US

Titanium dioxide isn’t the only food additive banned overseas, but that is still allowed in U.S. products.

Potassium bromate, which is banned countries in Canada, the UK, and the EU, is used commonly used in the United States in retail bread, but it may irritate the nose, throat, and lungs, and cause shortness of breath and wheezing, according to the New Jersey Department of Health. In addition, some research has shown that the compound caused renal and thyroid tumors in rats.

Another food additive used in the United States but banned in Europe is propylparaben (E217), as long as it does not exceed 0.1 percent in food products. It is used in some processed foods, drugs, and cosmetics as an antimicrobial preservative. However, a 2018 study review found that propylparaben is an endocrine disruptor, meaning that it can interfere with the hormones in the endocrine system, potentially leading to cancer and developmental disorders. Additionally, a study in mice found that propylparaben was associated with problems in embryo development.

Chlorine washing—the process of rinsing meat in chlorinated water—is a common practice in the U.S. poultry industry to reduce the risk of bacterial contamination. While it is not considered a food additive, the process has been a topic of debate due to its potential health and environmental risks. The EU banned chlorine washing in 1997 over food safety concerns, so U.S. producers cannot export chicken to the region. Read the rest at the Epoch times here: https://bit.ly/41YXlul

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When Will People Finally Stand up and Say “ENOUGH IS ENOUGH”? Now They Want Your Children!

Parents You will Have to Answer for this…

The scripture I quoted above from the Book of Isaiah could be applied to many things we see in the world today, but none fit the picture more than the death shots called vaccines. We have heard the media and government toads lie to us nonstop for a year about how “safe” these shots are and now they’re going to give them to children aged 5-11. This is where it just turned completely Satanic. There is NO JUSTIFICATION for jabbing children with this poison cocktail as they’re not dying or even getting severely ill according to the CDCs own statistics and they’re not transmitting it so what gives???

I mean can’t people see what’s happening? Doesn’t it seem convenient to you that the FDA just approved a BLOOD THINNER DRUG FOR CHILDREN THIS YEAR??? Yes this past June the FDA gave its approval for a new oral blood thinner for children aged 3 MONTHS TO 12 YEARS! Since when does a child let alone a 3 month old baby need blood thinners??? It won’t stop at the 5 year olds guys, it will go all the way back to the 3 month old babies! Are you getting the picture yet??? Here is a link to the FDA press release from June 2021.

Then there is the US Military and the vaccine mandates they face. Thousands of them are opting to get out vs staying in and taking the death jab. Listen to what a former US Army brigade surgeon had to say regarding the Army and it’s helicopter pilots after taking the jab!

Does that sound like an Army that will be ready to fight a large war against Russia, China and other adversaries? Hell no it doesn’t and it won’t be and guess what? That is also by design as the USA is on its last legs and the final takedown of Mystery Babylon isn’t far away! Everyone still in government has sold us down the river to China! Everyone, not just the Biden administration.

Then there is this study I found on Infowars.

This finding can only be described as a true “horror” in its implications. Stunning new research published in Viruses, part of the SARS-CoV-2 Host Cell Interactions edition of MDPI (Open Access Journals) reveals that vaccine spike proteins enter cell nuclei and wreak havoc on cells’ DNA repair mechanism, suppressing DNA repair by as much as 90%.

The research paper is entitled, “SARS–CoV–2 Spike Impairs DNA Damage Repair and Inhibits V(D)J Recombination In Vitro” and is authored by Hui Jiang and Ya-Fang Mei, at the Department of Molecular Biosciences, The Wenner–Gren Institute, Stockholm University, SE-10691 Stockholm, Sweden, and the Department of Clinical Microbiology, Virology, Umeå University, SE-90185 Umeå, Sweden, respectively.

In the conclusion of the paper, authors write, “We found that the spike protein markedly inhibited both BRCA1 and 53BP1 foci formation (Figure 3D–G). Together, these data show that the SARS–CoV–2 full–length spike protein inhibits DNA damage repair by hindering DNA repair protein recruitment.”

Did you catch that? The spike proteins they’re using in the jabs are preventing your DNA from repairing itself! This will lead to a massive cancer explosion not to mention a lot of sickness and death which is of course what they want. Here is more from that study.

As a result, the following “errors” are introduced into chromosomes inside the nuclei of human cells, all due to the presence of the spike protein from mRNA vaccines:

  • Mutations or “errors” in the genetic sequence.
  • DELETIONS of entire segments of genetic code.
  • INSERTIONS of incorrect segments.
  • Mixing and matching / permutations of genetic code.

These errors, when expressed through cell division and replication, result in:

  • An explosion of cancer and cancer tumors throughout the body
  • Loss of production of immune system B and T cells (i.e. induced immunodeficiency)
  • Autoimmune disorders
  • Accelerated aging and reduced telomere length
  • Loss of functioning of complex organ systems such as circulatory, neurological, endocrine, muskuloskeletal, etc.
  • Cellular damage resembling radiation poisoning as cells destroy themselves from within

Many of these effects are, of course, fatal. Others will burden vaccine victims with horrendous debilitating injuries and organ malfunctions that will require a lifetime of medical intervention.

This is coming for the 5-11 year olds now!

Yet no matter how many studies like this that you show people they won’t believe you because no one on mainstream TV said it. So millions of children in America will get the shot and millions of children will have a lifetime of problems and many will also die. Then the parents who didn’t listen to us will be screaming bloody murder and they will have no one to blame but THEMSELVES for failing to do even the most basic research in order to protect their children.

Are you seriously going to trust pedophiles in government and business to tell you the shots are safe??? I will say it again, Woe unto YOU parents for calling evil good and good evil. You see most of them know better deep down but they’re so desperate to get back to normal that they will sacrifice their own children to get there.

Woe unto you parents who do this to your children indeed. Below is my video/podcast on this issue.

Enough is ENOUGH!

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Sources:

CDC Authorizes Shots

Natural Immunity 13x Stronger

Emergency Rooms Swamped

FDA Approves Blood Thinners for kids

DNA Damage

DNA Damage Study PDF

Biden Says Shots Ready Nov. 8

Schools Block Parents from Shot Clinic

BOMBSHELL: FDA ALLOWS WHISTLEBLOWER TESTIMONY AT HEARING FOR BOOSTER SHOTS!

I’m still blown away and I found it hard to believe that the FDA would allow dissenting testimony regarding the Covid19 shots! One doctor said that the risks for the young and the healthy far outweigh the risk of getting hospitalized from Covid! They are starting to have to admit what’s really going on and they can’t keep covering up the death! Listen to their own doctors say there have been at least 150,000 deaths, not the 12,000 or so VAERS is showing!

I will let the video do the rest of the talking. Thanks to Health Impact News for posting this on bitchute. I will post their link below.

FDA Testimony on Vaccine Dangers!

Health Impact Bitchute Link

You can support this ministry and keep us on the internet using the links below.  Patreon is gone so we have PayPal and Cash App left to us below.  We have also added a new monthly support option through the website.  That link is below as well.  Thank you again and God bless!

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COVID VACCINES HAVE NEVER BEEN SUCCESSFUL AND ALWAYS WEAKEN AND KILL THE SUBJECTS

In today’s video report we cover the AstraZeneca jab and why it’s been halted in many European nations and how the EU medical authorities, the WHO and AstraZeneca themselves are insisting it’s safe despite reports of abnormal blood clots! Essentially they’re saying that the benefits outweigh the risks including death for some patients. Really? Do you still believe these people care about you?!?

Also we cover what happens when they’ve tested these mRNA vaccines on animals. They ALL DIED. All of that and more is in todays video report below along with links to the material used. God bless and share this with anyone you know who is considering this experimental gene therapy.

Primary article

Report on Suspension of AstraZeneca Vaccine

EMA Says Shots are Worth the Risk

White Paper on Covid Vaccines

Bitchute Channel

US Surgeon General Says "This Week it's gonna get bad"…

Hospitals May Be Overwhelmed Soon in The U.S.

U.S. Surgeon General Dr. Jerome Adams warned Monday that the coronavirus outbreak will worsen this week and said that people across the country are not taking the threat seriously enough.

“I want America to understand this week, it’s going to get bad,” Adams said in an interview on NBC’s “TODAY” show.

The disease is spreading, he said, because many people — especially young people — are not abiding by guidance to stay at home and practice social distancing.
“Right now, there are not enough people out there who are taking this seriously,” he said.

Adams said that young people are flocking to the beaches in California and people are still heading to the National Mall in Washington, D.C. to view the cherry blossom trees that bloom each year. He warned that young people need to understand that they can contract COVID-19, the disease caused by the coronavirus, and they can be hospitalized and potentially die from it.

“Everyone needs to act as if they have the virus right now. So, test or no test. We need you to understand you could be spreading it to someone else. Or you could be getting it from someone else, stay at home,” he said.

Asked about growing pressure for President Donald Trump to use the Defense Production Act to force companies to mass produce critical supplies, Adams suggested that it’s not necessary at this point.

“Here’s the thing that people don’t understand. You don’t need to compel someone to do something they are already doing,” he said, adding that they’re already working with companies Honeywell and Hanes which are already producing large quantities of the items needed.

“The other important point is that we’re not going to ventilator our way out of this problem. We’re not going to treat our way out of this problem,” he said. “The way you stop the spread of an infectious disease like this is with mitigation measures and preventing people from getting it in the first place.”

Folks I can’t urge you enough to be ready! Stay prayed up with Jesus and prepped up with whatever supplies you need. Also don’t forget your neighbors, especially the elderly or those home alone. See if there’s anything you can help with, be of service to your fellow man. God bless and stay safe!

URGENT! FDA Reporting Shortages of Medicines Due to China Not Manufacturing any for 6 Weeks

This is a very important story that isn’t getting NEAR enough attention on mainstream media, most likely because they know people would panic. Keep in mind that China also manufactures 97% of the USA’s antibiotics and how devastating it would be to run out of those life saving drugs!

I’ll put the link to Hal’s article HERE. There you can click on any of the individual medicines listed and see where yours stands as of today. The video below explains where we’re at with this story and other end times news. God bless and stay ready!