Tag: fda

US Agencies Quietly Studying Reports of Post-Vaccination Neurological Issues

Two U.S. agencies have been quietly studying neurological problems that have appeared in people who have had COVID-19 vaccines, The Epoch Times has found.

The Food and Drug Administration (FDA) and National Institutes of Health (NIH) have been conducting separate research projects into post-vaccination neurological issues, which have manifested with symptoms like facial paralysis and brain fog and have been linked in some cases with the vaccines, according to emails reviewed by The Epoch Times.

One attempt to gain understanding of a problem that experts around the world are struggling to understand is being carried out by Dr. Janet Woodcock, who was acting commissioner of the FDA until Feb. 17.

Woodcock, now the FDA’s principal deputy director, has been personally evaluating neurologic side effects from the COVID-19 vaccines since at least Sept. 13, 2021, according to the emails, many of which have not been reported on previously. FDA epidemiologists are also gathering data to look into the issues, according to messages from Dr. Peter Marks, another top FDA official.

A team at the NIH’s National Institute of Neurological Disorders and Stroke (NINDS), meanwhile, started seeing patients reporting vaccine injuries for a study in early 2021 after receiving complaints shortly after the vaccines were made available. A portion of the patients was examined in person at the Bethesda, Maryland, facility.

None of the reviews or studies appear to have been announced, and health officials have said little about them publicly, despite a growing recognition among experts that at least some issues are likely linked to the vaccines.

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“A Recurring Fountain Of Revenue”: FDA Exec Admits Biden Planning Annual Jabs, Including Toddlers

Food and Drug Administration (FDA) Executive Officer Christopher Cole was caught on undercover camera by Project Veritas, where he revealed that his agency plans to announce that annual Covid-19 vaccinations will become official policy.

As Project Veritas reports (emphasis ours):

Cole is an Executive Officer heading up the agency’s Countermeasures Initiatives, which plays a critical role in ensuring that drugs, vaccines, and other measures to counter infectious diseases and viruses are safe. He made the revelations on a hidden camera to an undercover Project Veritas reporter.

Cole indicates that annual COVID-19 shots isn’t probable — but certain. When pushed on how he knows an annual shot will become policy, Cole states, “Just from everything I’ve heard, they [FDA] are not going to not approve it.”

The footage, which is part one of a two-part series on the FDA, also contains soundbites from Cole about the financial incentives pharmaceutical companies like Pfizer have to get the vaccine approved for annual usage.

“It’ll be recurring fountain of revenue,” Cole said in the hidden camera footage. “It might not be that much initially, but it’ll recurring — if they can — if they can get every person required at an annual vaccine, that is a recurring return of money going into their company.”

Perhaps the most explosive part of the footage is the moment where Cole brazenly talks about the impact that an Emergency Use Authorization has on overcoming the regulatory concerns of mandating vaccines on children.

“They’re all approved under an emergency just because it’s not as impactful as some of the other approvals,” Cole said when asked if he thought there was “really an emergency for kids.”

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University That Funds Biden’s Think Tank And Hosts FactCheck.Org Has Contract With BioNTech, Gets Paid For Vaccine Sales And FDA Approvals

Documents obtained by NATIONAL FILE show that the University of Pennsylvania, which hosts and funds Joe Biden’s think tank called the Penn Biden Center, directly profits from the sale of Pfizer-BioNTech and Moderna Coronavirus vaccines. The University gets more money if more vaccines are sold. The University of Pennsylvania also gets “milestone payments” when the Food and Drug Administration (FDA) approves a Pfizer-BioNTech vaccine. BioNTech pays the University of Pennsylvania Board of Trustees directly, and the university is protected from civil liability if people try to sue for “bodily injury” or “death” caused by BioNTech vaccines.

BioNTech signed a licensing agreement in 2018 with the University of Pennsylvania, which directly funds the Penn Biden Center for Diplomacy and Global Engagement. Even though Coronavirus had not yet broken out when the deal was made, the 2018 agreement ensured massive payments for the University of Pennsylvania if its technology ended up getting used in new mRNA-based vaccines. Well, UPenn’s technology did end up getting used in the mRNA-based Coronavirus vaccine produced by Pfizer and BioNTech, and the deal has led to massive revenue for the university. Joe Biden, who was working for the University of Pennsylvania when the deal was made, received more than $900,000 from the University of Pennsylvania in the two years before he ran for president in this past election.

The University of Pennsylvania also houses the pro-vaccine website FactCheck.org. University of Pennsylvania president Amy Gutmann is now Biden’s nominee for Ambassador to Germany. The Biden administration’s FDA has speedily approved or authorized Pfizer-BioNTech vaccines including for children — all while the Penn Biden Center’s parent university enjoys massive profits from vaccine sales and FDA approval. And the Pfizer-connected FDA even knew about numerous adverse events for children related to the Pfizer-BioNTech vaccine, but allowed children to be injected with it anyway. Now, as the FDA considers emergency use authorization for a Pfizer-BioNTech vaccine for children as young as six months old, the direct financial relationship between these vaccines and Joe Biden’s think tank must be exposed.

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FDA Document on Moderna Vaccine Approval Removed From Agency’s Website

A Food and Drug Administration (FDA) document explaining why the agency approved Moderna’s COVID-19 vaccine was removed from the agency’s website overnight.

The Summary Basis for Regulatory Action gave more details on how regulators reached the approval decision, and included references to an unpublished analysis that found the rates of post-vaccination heart inflammation were higher than any U.S. agency had found before.

After The Epoch Times reviewed the document and sent questions about it to FDA spokespersons, it disappeared from the agency’s website.

“We are aware of the issue and hope to have the document reposted as soon as possible,” a spokesperson told The Epoch Times in an email on Thursday.

Reached by phone and asked for more details about the issue, the spokesperson said: “I reached out to the website people. I don’t really have any more information to tell you.”

The Epoch Times has submitted Freedom of Information Act requests for the document and several unpublished analyses referenced in it, including the FDA meta-analysis.

Barbara Loe Fisher, president of the National Vaccine Information Center, a nonprofit that advocates for informed consent, told The Epoch Times in an email that “the public has the right to review the evidence FDA is using to license new mRNA vaccines as safe and effective.”

“Lack of transparency only fosters distrust in government agencies charged with protecting the public health. FDA should immediately release all information related to the incidence of myocarditis and other serious adverse events following mRNA COVID-19 vaccinations, whether that information has been provided to the agency by vaccine manufacturers or discovered through in-house analyses of additional data collected by federal officials,” she added.

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COVID COVER-UP: Pfizer INTERFERES Just Days Before Massive FOIA Vaccine Data Drop, FDA Claims The Vaccine Manufacturer Must Help Review and Redact Documents Before Public Release

Who does the US FDA answer to? Well, apparently it’s Pfizer, the German-based Big Pharma megalith.

Just days before the FDA was set to release over 12,000 documents related to the experimental Covid-19 vaccines, Pfizer asked a federal court to allow it to intervene before any information is released to the public.

Unsurprisingly, the FDA wholeheartedly agreed, asking the court to allow the vaccine maker to ‘help’ curate the documents, which would also buy the agency more time to release the much anticipated, and likely damning, data.

Conflict of interest? What’s that?

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A Myth Is Born: How CDC, FDA, & Media Wove A Web Of Ivermectin Lies That Outlives The Truth

New Mexico officials admit they were wrong: Two people died from covid. NOT from ivermectin. Yet the CDC generated the nation’s highest health alert and a thousand fake headlines on false cases.

Linda Bonvie  and Mary Beth Pfeiffer

When a Texas cattleman, seventy-nine, died last September in New Mexico after contracting covid, his family never anticipated the worldwide headlines that would ensue.

In a ballyhooed press conference, New Mexico Human Services Secretary Dr. David Scrase, the state’s top health chief, announced New Mexico’s first ivermectin “overdose,” soon adding a second fatality allegedly from “ivermectin toxicity.”

Now, Scrase has acknowledged that his repeated, what he called “offhand,” assertions were groundless. Two deaths were not caused by ivermectin, a long-used generic drug that was emerging as a covid treatment. Instead, he said that the pair died because they “actually just delayed their care with covid.” 

That is a big difference.

Scrase backpedaled on December 1 in a little-noticed online press briefing and only after we pressed his agency to provide evidence for its claims of so-called “ivermectin deaths.” Officials had repeatedly said they were awaiting a toxicology report on the cattleman’s death. Yet we learned that the report was never even ordered or done, and, moreover, the man’s death was ruled by the state’s coroner as being from “natural” causes.

Not a single media outlet reported Scrase’s admission, even as dozens, including the The Hill and The New York Times, had eagerly covered his original assertions about ivermectin, an anti-parasitic drug awarded the Nobel Prize in Medicine in 2015.

“I don’t want more people to die,” read one early headline, quoting Scrase. “It’s the wrong medicine for something really serious,” Scrase said in the Times article.

Doctors, scientists, and toxicologists worldwide were puzzled by the assertions, because ivermectin is an extraordinarily safe, FDA-approved drug. A fixture on the WHO’s list of 100 essential medicines all hospital systems are recommended to carry, nearly four billion doses have been given in four decades.

New Mexico became a key player in a broad pattern of governmental deception late last summer to portray ivermectin as dangerous, in tandem with three related developments. Research strongly supported the drug’s efficacy against covid; prescriptions were soaring; and public health officials were single-mindedly focused not on treatment but on vaccination.

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 Govt. continues to stall in releasing public documents on vaccine safety

A few updates on the battle to get FDA to release the licensure documents for Pfizer’s vaccine, which will hopefully address most of the inquiries on this matter:

1.      The FDA incredibly failed to send a representative to a federal court hearing in this matter on December 14th because of the “FDA’s protocols” regarding COVID-19. Meaning, despite the federal health agencies’ compliance rate with its mandatory vaccination policy of over 98.8% and its resounding claim that the vaccines are “effective,” the FDA is apparently still scared.  Its actions speak volumes and cast serious doubt on its words.

2.      Just prior to the Court hearing, the FDA released additional documents.  These included a report on vaccine safety and a report on vaccine efficacy.  There are many notable portions, but we will leave that to the scientists to analyze noting that, as the experts in the plaintiff’s group have explained, adequate analysis of the vaccines’ safety and efficacy is nearly impossible to complete without the full universe of documents.

3.      Contrary to what has been reported elsewhere, there has been no decision issued in this case yet and any documents produced to date have been produced by the FDA apparently in the hopes of softening any decision the Court may render. 

4.      Regarding the hearing this week, the public will get to read the transcript when it is released, which we expect should be soon.  In the meantime, it is noteworthy that the DOJ attorney who appeared without an FDA representative effectively argued that the American people and the plaintiff should just trust the FDA that it will produce documents as fast as possible even though it has now been over 110 days since the request was made to the FDA and it has produced on average only ~29 pages per day.  The FDA also continued to maintain that it does not want the Court to require it to produce at a rate faster than 500 pages per month as it continued to harp on Pfizer’s interests and its trade secrets, for the most part ignoring the interests of the American people.  For our part, we had the privilege of arguing many of the points that you can read below in our papers. 

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An FDA Official Demanded Google Censor A YouTube Video The Agency Didn’t Like

Federal efforts to censor social media extend past discussions with companies like YouTube over broad guidelines about Covid-19 “misinformation” to specific demands for suppression of individual posts, an email from an FDA official reveals.

In the April 30 email, the Food and Drug Administration director of social media, Brad Kimberly, told a Google lobbyist about that the agency expected YouTube to pull a video touting the potential of a new monoclonal antibody treatment for Covid. (Google owns YouTube.)

“Overall, the video is very problematic when it comes to COVID misinformation,” Kimberly wrote to the lobbyist, Jan Fowler Antonaros.

“This video should be pulled.”

YouTube initially declined to remove the video. However, it has since been taken offline.

How often the FDA has made other censorship demands is unknown, because the agency is apparently hiding the existence of its efforts in response to Freedom of Information Act requests.

In October, I asked the FDA and several government agencies to disclose both their internal discussions about me and their communications with social media companies like Twitter and YouTube about censoring Covid “misinformation” in general.

On Nov. 30, the FDA responded it had found some emails about me – mainly in response to questions I had asked in April and May for a story about VAERS, the federal vaccine adverse events reporting system. But FDA said it could not find any emails between its officials and social media companies that met my request.

Yet at the bottom of the emails containing the agency’s discussions about me was the email between Kimberly and Antonaros – apparently attached there by accident, as it had nothing to do with me.

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