Tag: fda

Government of Canada data suggests the Triple Vaccinated are suffering Antibody Dependent Enhancement; and Pfizer & the FDA knew it would happen

Official Government data coming out of Canada shows that fully vaccinated individuals are now statistically over four times more likely to be infected with Covid-19, 1.5 times more likely to be hospitalised with Covid-19, and twice as likely to die of Covid-19 than not-vaccinated individuals.

The horrifying thing about these stats is that they do not take into account age or the length of time since a person was vaccinated, but still equate to an average that shows the Covid-19 injections are not just ineffective but actually seem to worsen the effects of Covid-19 infection.

These are the sort of figures you would expect to see if a vaccine was causing Vaccine-Associated Enhanced Disease and antibody-dependent enhancement, and it turns out the latest round of confidential Pfizer documents confirm that both Pfizer and the US Food & Drug Administration knew it was a possibility upon emergency approval of the mRNA jab.

Then they received evidence of it occurring, including several deaths, but decided to ignore it and claim “no new safety issues have been raised”.

Keep reading

The FDA’s Own Experts Have No Idea Why It Approved Another COVID Booster Dose

The Food and Drug Administration (FDA) bypassed many of its own protocols to speed through the authorization of Pfizer’s second booster dose of the COVID-19 vaccine last week.

Multiple medical experts, including some who sit on the FDA’s top vaccine advisory committee, said they had no idea why the agency skipped over its normal approval process to authorize the fourth vaccine dose for Americans aged 50 and older. The authorization was even broader than the drug company requested, which was that it be greenlit for those aged 65 and older.

That FDA vaccine panel, the Vaccines and Related Biological Products Advisory Committee (VRBPAC), is meeting Wednesday, and part of the agenda will be to discuss the fourth vaccine dose and the Israeli studies which are being used to exhibit its effectiveness. Typically, the vaccine authorization process would involve a meeting and vote by VRBPAC on whether to recommend authorization, followed by the FDA head granting that authorization. Then, the Centers for Disease Control and Prevention’s (CDC) vaccine committee would vote on how to recommend the vaccine, which would then be determined by the CDC director.

Dr. Paul Offit, a co-inventor of the rotavirus vaccine and member of VRBPAC, said he couldn’t explain why the FDA didn’t present its data to the committee first before moving ahead with authorization: “The way it’s working here is that the government basically just declares that this is what they’re going to do.”

Keep reading

Recently Unredacted Documents Prove Pfizer & FDA Knew Antibody-Dependent Enhancement Occurring in Vaccinated

The Food and Drug Administration (FDA) has released another batch of internal Pfizer documents under court order showing even more evidence that Pfizer and the FDA knew of the antibody dependent enhancement (ADE) phenomenon and tried to cover it up.

The trove of 11,000+ pages of documents, released on April 1, reveal both agencies knew that vaccine-induced ADE was occurring and worked to cover it up by claiming “no new safety issues have been raised.”

ADE occurs after the mRNA vaccine primes the immune system for a potentially deadly overreaction.

Numerous Vaccine-Associated Enhanced Disease (VAED) cases were outlined in Pfizer’s post-marketing experience report that’s just been unredacted.

From the Daily Exposé:

An investigation of official Government data has uncovered that fully vaccinated individuals are up to 3 times more likely to be infected with Covid-19, 2 times more likely to be hospitalised with Covid-19, and 3 times more likely to die of Covid-19 than unvaccinated individuals.

The question is, why?

One possibility is that as feared, the vaccinated are suffering Vaccine-Associated Enhanced Disease leading to conditions such as antibody-dependent enhancement, and cytokine storm. In effect, this means the Covid-19 injections cause a vaccinated person’s immune system to go into overdrive when they come into contact with the virus, causing harm to the person and worsening disease.

Keep reading

Beef from gene-hacked ‘super cows’ can now be sold in the US

You could soon be eating genetically modified beef thanks to the US Food and Drug Administration.

The FDA claims that two gene-edited breeds of beef cattle produced by a major breeder are safe for human consumption.

The two breeds of cow in question have been edited so they grow short slick coats.

This change is not thought to be harmful to the meat or the cow.

Experts suggest this genetic modification is “low risk”.

That means Acceligen, the company which produces the breed, doesn’t need to seek approval to sell it.

This is said to be the first time that the FDA has made such an assessment.

The federal agency has never given a “low-risk” premarket approval before to a gene-edited animal food product.

Keep reading

Just Released Documents by Pfizer Show BioNTech Paid FDA $2,875,842.00 “Drug User Fee” for COVID-19 Vaccine Approval

As the news cycle continues to focus on the Ukraine situation, the FDA complied with a court order to begin releasing 55,000 pages of Pfizer data per month that was used to authorize their COVID-19 vaccine produced with BioNTech, with the first batch quietly released yesterday, March 1st.

There are 150 documents that the public can now download here.

One of the documents released was the “Prescription Drug User Fee Payment” that BioNTech paid to the FDA on 4/20/2021 for the “COMIRNATY COVID-19 mRNA Vaccine” which the FDA subsequently approved in August of 2021.

That “Prescription Drug User Fee Payment” was $2,875,842.00. (Source.)

Another interesting document I found was the “EXTERNAL DATA MONITORING COMMITTEE” found here.

Here is the stated purpose of this “External Data Monitoring Committee”:

This External Data Monitoring Committee (E-DMC) (hereafter referred to as “the committee”) is a single, external,  independent, expert advisory group established to oversee safety and efficacy data from the BNT162 Vaccine Program. The  primary rationale for establishing the committee is to make certain that appropriate external safeguards are in place to help ensure the safety of subjects and to maintain scientific rigor and study integrity while the trial is on-going.

The committee will review accumulating safety data across all studies, as well as efficacy data in the Phase 2/3 portion of the C4591001 study. The committee will advise Pfizer regarding the safety of current participants and those yet to be recruited, as well as the continuing scientific validity of the trial. In addition to safety review by the committee, qualified Pfizer personnel will review safety data as specified in the safety surveillance review plan and will inform the committee of  significant findings. Efficacy data from the C4591001 study will be available to the committee when there is a planned  interim analysis of efficacy or if this is considered necessary to conduct a risk-benefit assessment.

And to make sure that this Committee is doing their job properly to ensure “the safety of subjects and to maintain scientific rigor,” who at the FDA is responsible to make sure this happens?

Well, that would be no one. Pfizer is the one who was responsible, and BioNTech funded it.

“Pfizer is responsible for conducting this study. BioNTech is the regulatory sponsor of this study.”

The committee members are to be free from “conflicts of interest.”

The committee members will complete a CT22-GSOP-RF01 Independent Oversight Committee Member Conflict of Interest Form. Committee members should be free of apparent significant conflicts of interest. Any potential conflict of interest that develops during a member’s tenure on the committee must be disclosed by the committee member.

And who at the FDA is responsible for assuring that this committee who is overseeing “safety and efficacy data” is free from conflicts of interest?

Well, that would be no one. Again, Pfizer is responsible for that.

“Pfizer will determine if any potential conflict requires termination of committee membership.”

The question that then begs to be answered here is, what role did the FDA play, if any, in the “external” monitoring of the data to ensure integrity and safety of a new vaccine about to be injected into hundreds of millions people in the U.S.?

Keep reading

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.

Keep reading

“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.”

Keep reading

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.

Keep reading

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.

Keep reading