Tag Archives: FDA

FDA Now Wants 75 Years to Release Pfizer Vaccine Documents, by Michael Nevradakis, Ph.D.

The FDA went through the documents in question in 108 days to approved Pfizer’s vaccine application but it will take them 75 years to release the same documents to the public. Smells fishy. From Michael Nevradakis, Ph.D. at lewrockwell.com:

“ … it is dystopian for the government to give Pfizer billions, mandate Americans to take its product, prohibit Americans from suing for harms, but yet refuse to let Americans see the data underlying its licensure.”

The U.S. Food & Drug Administration (FDA) now says it needs 75 years — up from the 55 years the agency initially requested — to fully release redacted versions of all documents related to the agency’s approval of Pfizer’s Comirnaty COVID-19 vaccine.

In a legal brief filed Dec. 7, the FDA said 59,000 additional pages of documents, not included in the agency’s earlier filings, need to be processed. The agency did not offer an explanation for why those documents initially were overlooked.

The agency said it can release an initial batch of approximately 12,000 pages by the end of January. Past that date, the FDA said it can process and disclose only 500 pages of documents per month.

This would mean the entire cache of documents would not be fully released until 2096. The FDA’s initial timeline would have meant the release of the documents would not be completed until 2076, or 55 years from now.

The FDA did not divulge the criteria it will use to select the initial 12,000 pages of documents, or how the agency will prioritize the release of those pages, or of additional pages going forward.

The documents in question stem from a Freedom of Information Act (FOIA) request filed in August by Public Health and Medical Professionals for Transparency (PHMPT).

In its FOIA request, the group asked the FDA to release “all data and information for the Pfizer vaccine,” including safety and effectiveness data, adverse reaction reports, and a list of active and inactive ingredients.

In a filing submitted to a federal judge in November, the U.S. Department of Justice (DOJ), arguing on behalf of the FDA, initially claimed the agency could process some 329,000 pages of documents at a rate of only 500 pages per month, in order to have time to redact legally exempt material.

According to the DOJ, such material includes “confidential business and trade secret information of Pfizer or BioNTech and personal privacy information of patients who participated in clinical trials.”

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Legal Push: Vaccine Data Transparency at the FDA, by Aaron Kheriaty, MD

The FDA wants to wait 55 years before it releases its date on Pfizer’s Covid-19 vaccines. That puts the data right up there with the CIA files on the Kennedy assassination as something the Establishment really really wants to hide. From Aaron Kheriaty, MD, at aaronkheriaty.substack.com:

In response to my FOIA request for the data relied upon for the Pfizer vaccine approval, the FDA indicated in would release it all… by the year 2076 (yes, you read that right).

Along with 30 other academic physicians and scientists I submitted a Freedom of Information Act (FOIA) request to the FDA for the Pfizer vaccine data. This week, in response, the FDA claimed that it will take them 55 years to release this data, though it only took them 108 days to review this same data for the vaccine approval process. Here’s the full story, along with the initial commentary in the press on the FDA’s absurd response.

In previous posts I’ve described my legal action pushing the CDC to acknowledge natural immunity and describing their telling response to a FOIA request we submitted. Keep in mind that the CDC is the federal agency that makes recommendations on the use of vaccines after they are approved, whereas the FDA is the federal agency responsible for approving vaccines (as well as medications and medical devices) for use. Both agencies, along with the NIH (and Anthony Fauci’s NAIAD division of NIH), report to the HHS Secretary, Xavier Becerra—a lawyer with no public health experience whose previous term as Attorney General of my home state of CA was disastrous.

But back to the FDA story. In September I organized 30 distinguished academic physicians and scientist colleagues to form Public Health and Medical Professionals for Transparency. This group included, among other luminaries, my friends Harvey Risch of Yale, Andrew Bostom of Brown, Joseph Ladapo of UCLA (who has since been appointed Surgeon General of Florida), Paul Alexander, formerly of HHS and WHO, Aditi Bhargava of UCSF, and other scientists from the U.S., Canada, Denmark, Australia, Germany, and the University of Oxford in the U.K.

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The FDA’s War Against The Truth On Ivermectin, by David R. Henderson and Charles L. Hooper

The FDA radically toned down its online warnings about Ivermectin after David R. Henderson, Charles L. Hooper, and the Wall Street Journal called them out. From Henderson and Hooper at aier.org:

On July 28, the Wall Street Journal ran our article “Why Is the FDA Attacking a Safe, Effective Drug?” In it, we outlined the potential value of the antiparasitic drug ivermectin for Covid-19, and we questioned the FDA’s vigorous attack on ivermectin. Many people praised us and many criticized us. We had clearly covered a sensitive subject. It didn’t help that one of the studies we referenced was retracted shortly before we submitted our article. Within hours of learning that fact, we sent a mea culpa to the Journal’s editors. They acted quickly, adding a note at the end of the electronic version and publishing our letter. It’s important to address two criticisms of our work. The first is that we exaggerated the FDA’s warning on ivermectin. The second is that Merck’s stance on ivermectin proved that even the company that developed ivermectin thought that it doesn’t work for Covid-19.

First, we didn’t exaggerate the FDA’s warning on ivermectin. Instead, the agency changed its website after our article was published, probably to reflect the points we made. Second, Merck had two incentives to downplay ivermectin’s usefulness against the novel coronavirus. We’ll explain both points more fully.

Ivermectin was developed and marketed by Merck & Co. while one of us (Hooper) worked there years ago. Dr. William C. Campbell and Professor Satoshi Omura were awarded the 2015 Nobel Prize for Physiology or Medicine. They earned it for discovering and developing avermectin. Later Campbell and some associates modified avermectin to create ivermectin. Merck & Co. has donated four billion doses of ivermectin to prevent river blindness and other diseases in areas of the world, such as Africa, where parasites are common. The ten doctors who are in the Front Line Covid-19 Critical Care Alliance call ivermectin “one of the safest, low-cost, and widely available drugs in the history of medicine.” Ivermectin is on the WHO’s List of Essential Medicines and ivermectin has been used safely in pregnant women, children, and infants.

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Horse-Bleep: How 4 Calls on Animal Ivermectin Launched a False FDA-Media Attack on a Life-Saving Human Medicine, by Mary Beth Pfeiffer and Linda Bonvie

There has never been such an ungrounded and intense official effort to prevent the use of a proven safe and effective human drug. From Mary Beth Pfeiffer and Linda Bonvie at rescue.substack.com:

Our investigative reporters dug up the FDA memos documenting the start of a propaganda campaign, and got The New York Times to correct its false reporting.

The Propaganda That Started The Big Lie:

In a hokey tweet on August 21, the U.S. Food and Drug Administration told Americans the obvious: “You are not a horse. You are not a cow. Seriously, y’all. Stop it.”

Everyone knew what “it” was: an animal form of the drug ivermectin that folks were said to be using, widely, for covid-19. Don’t, said FDA.

Within two days, 23.7 million people had seen that Pulitzer-worthy bit of Twitter talk. Hundreds of thousands more got the message on Facebook, LinkedIn, and from the Today Show’s 3 million-follower Instagram account.

“That was great!” declared FDA Acting Commissioner Janet Woodcock in an email to her media team. “Even I saw it!” For the FDA, the “not-a-horse” tweet was “a unique viral moment,” a senior FDA official wrote to Woodcock, “in a time of incredible misinformation.”

There was one problem, however. The tweet was a direct outgrowth of wrong data—call it misinformation—put out the day before by the Mississippi health department. The FDA did not vet the data, according to our review of emails obtained under the Freedom of Information Act and questions to FDA officials. Instead, it saw Mississippi, as one email said, as “an opportunity to remind the public of our own warnings for ivermectin.”

The story behind the tweet that went ’round the world shows how a myth was born about a safe, if now controversial, human drug that was FDA-approved for parasitic disease  in 1996  and bestowed the Nobel Prize in Medicine in 2015. It is a story in which the barest grain of truth morphed into an anything-goes media firestorm.

It began with one sentence in a Mississippi health alert on reports to the state’s poison control center: At least 70% of the recent calls have been related to ingestion of livestock or animal formulations of ivermectin purchased at livestock supply centers.” In the thick of a fierce covid wave in the American South, no official at the FDA, or reporter for that matter, seemed to ask: 70 percent of what? Instead, government and media joined forces against a public health threat that, in retrospect, was vastly exaggerated.

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The Coordinated Attack on Ivermectin Is a Crime Against Humanity, by Louie Gohmert

The official concerted attacks on Ivermectin and Hydroxychloroquine to withhold cheap and effective medications from people who either want to prevent Covid or who have it and want to cure themselves, especially when the alternatives are ineffective and dangerous vaccines, is indeed a crime against humanity. From Louie Gohmert at amgreatness.com:

Make no mistake, the evil, deadly, coordinated globalist attacks we are currently witnessing on ivermectin will go down in history as a vicious crime against humanity.

Just as we saw with hydroxychloroquine last summer, government alphabet agencies, the medical industrial complex, and their willing accomplices in the media have recently made it clear that there is yet another safe, effective treatment for COVID-19 they wish to torpedo. It’s the latest naughty word which will get you censored on social media and mocked and belittled by late-night “comedians”: ivermectin.

While ivermectin has been used by certain brave doctors around the world to treat COVID-19 for over a year now, it only recently became the target of a multi-pronged attack, with the U.S. government, the media, and Big Pharma all playing important roles in the deadly dystopian disinformation campaign against the drug. As more Americans became aware of ivermectin’s efficacy against COVID-19, like clockwork the government and its propaganda arm in the press jumped in to discredit it, referring to the drug snidely as a “horse dewormer.” 

We watched the FDA embarrass itself with its ridiculing tweet telling people “You are not a horse. You are not a cow. Seriously, y’all. Stop it,” while linking to an agency article on why people should not use ivermectin to treat or prevent the China Virus. We saw Rolling Stone magazine forced to admit that its recent story about Oklahoma hospitals being overwhelmed by patients who overdosed on ivermectin was completely false.

Omar Marques/SOPA Images via Getty Images

Pharmaceutical company Merck, which produces ivermectin, discredited its use for COVID by irresponsibly stating, “We do not believe that the data available support the safety and efficacy of ivermectin beyond the doses and populations indicated in the regulatory agency-approved prescribing information.” It is worth noting that Merck and Pfizer are developing their own oral antivirals that would directly compete with the cheap and effective ivermectin. These antivirals, unlike ivermectin, would be patented, creating the potential for pharmaceutical companies to rake in billions of dollars from their use.

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The Meaning of the FDA Resignations, by Jeffrey A. Tucker

A couple of staffers at the FDA suffered an attack of integrity. From Jeffrey A. Taylor at brownstone.org:

How significant is it that the two top FDA officials responsible for vaccine research resigned last week and this week signed a letter in The Lancet that strongly warns against vaccine boosters? This is a remarkable sign that the project of government-managed virus mitigation is in the final stages before falling apart.

The booster has already been promoted by top lockdown advocates Neil Ferguson of Imperial College and Anthony Fauci of NIH, even in the face of rising public incredulity toward their “expert” advice. For these two FDA officials to go on record with grave doubts – and their perspective is certainly backed by the unimpressive booster experience in Israel – introduces a major break in the narrative that the experts in charge deserve our trust and deference.

What’s at stake here? It’s about more than the boosters. It’s about the whole experience of taking away the control of health management from individuals and medical professionals and handing it over to modelers and government officials with coercive power.

From the first week of March 2020, the US embarked on a wild experiment in virus mitigation, deploying a series of measures with a sweep and scope that had never previously been attempted, not in modern times and not even in ancient times. The litany of controls and tactics is long. Many of these measures survive in most parts of the US. The retail landscape is still filled with plexiglass. We are still invited to sanitize ourselves when going indoors. People still mask up in proximity to others. The “Karens” of the world are still actively shaming and denouncing anyone suspected of non-compliance.

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CDC/FDA Smoking Gun of Smoking Guns, by Jon Rappoport

Has the SARS-Cov-2 virus ever been isolated? If so, where is the scientific evidence? If not, then how can tests measure it and treatments treat it? From Jon Rappoport at lewrockwell.com:

They confess: they had no virus when they concocted the test for the virus; they “contrived” a model by pretending to find what they wanted to find; it’s called a self-fulfilling prophecy

This is the con and the crime that drove millions of lives, and economies, into ruin

he CDC has issued a document that bulges with devastating admissions.

The release is titled, “07/21/2021: Lab Alert: Changes to CDC RT-PCR for SARS-CoV-2 Testing.” It begins explosively:

“After December 31, 2021, CDC will withdraw the request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel, the assay first introduced in February 2020 for detection of SARS-CoV-2 only. CDC is providing this advance notice for clinical laboratories to have adequate time to select and implement one of the many FDA-authorized alternatives.”

Many people believe this means the CDC is giving up on the PCR test as a means of “detecting the virus.” The CDC isn’t saying that at all.

They’re saying the PCR technology will continue to be used, but they’re replacing what the test is looking FOR with a better “reference sample.” A better marker. A better target. A better piece of RNA supposedly derived from SARS-CoV-2.

CDC/FDA are confessing there has been a PROBLEM with the PCR test which has been used to detect the virus, starting in February of 2020—right up to this minute.

In other words, the millions and millions of “COVID cases” based on the PCR test in use are all suspect. Actually, that statement is too generous. Every test result of every PCR test should be thrown out.

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The Lies Must Stop, by Raúl Ilargi Meijer

Reading the fine print on the FDA’s recent “approval” of the Pfizer vaccine reveals a convoluted state of affairs that’s deliberately being used to get people to take the shot. From Raúl Ilargi Meijer at theautomaticearth.com:

The FDA. the U.S. Food and Drug Administration, announced on Monday that it gave full approval to a vaccine. But it didn’t. Or rather, it did, but the approval is for a vaccine that doesn’t exist. Or rather, it exists, but it’s not being produced. Or rather, it’s being produced, but under different names and with different legal statuses.

The FDA is playing a game with Americans, in order to get them to submit to being vaccinated. And this has to stop. No more. The role of the FDA is to protect people, not cajole them into politically desired but illegal actions. Below are 3 -bullet points of- articles about the (non-) approval. One from Peter Doshi, senior editor at The BMJ, and a powerful foe to the FDA, one from Robert Kennedy jr, and one from Jill Malone, wife of Dr. Robert Malone.

But first, yet another lie -BIG, not noble- from Anthony Fauci, as told to Anderson Cooper. There is no approval for “the Pfizer product”, and Fauci knows that very well. Or rather, there is approval for a Pfizer product that is not available to anyone. And that should never have been approved the way it was in the first place, but that’s another story. Still, Fauci said it.

In theory, if he were called on it (but of course he won’t be by any reporter he talks to), he could say that the products are the same anyway. But he won’t say that, because he realizes full well that they have different legal statuses; they are “legally distinct” in the words of the FDA. So Fauci can’t say they are the same. Even if it’s just a matter of a different label on a vial.

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With Pfizer Likely to Get FDA Approval Monday It’s Worth Remembering Pfizer and Moderna Lost The Clinical Trial Control Group Testing Vaccine Efficacy and Safety, by sundance

You can’t conduct a randomly controlled trial if you “decontrol” the control group before the trial is complete. From sundance at theconservativetreehouse.com:

According to the New York Times and multiple media outlets, Pfizer is expected to get full FDA approval today.  “The move would make it the first Covid vaccine to go from emergency use authorization to full FDA approval.” (read more)  With that in mind, it is worth a reminder that both Pfizer and Moderna stopped the clinical trials the FDA was using in their review:

The Moderna and Pfizer vaccine tests were conducted, as customary, with a control group; a group within the trial who were given a placebo and not the test vaccine.  However, during the trial -and after the untested vaccines were given emergency use authorization- the vaccine companies conducting the trial decided to break protocol and notify the control group they were not vaccinated.  Almost all the control group were then given the vaccine.

Purposefully dissolving the placebo group violates the scientific purpose to test whether the vaccine has any efficacy; any actual benefit and/or safety issues.  Without a control group there is nothing to compare the vaccinated group against.  According to NPR, the doctors lost the control group in the Johnson County Clinicial Trial (Lexena, Kansas) on purpose:

(Via NPR) […] “Dr. Carlos Fierro, who runs the study there, says every participant was called back after the Food and Drug Administration authorized the vaccine.

“During that visit we discussed the options, which included staying in the study without the vaccine,” he says, “and amazingly there were people — a couple of people — who chose that.”

He suspects those individuals got spooked by rumors about the vaccine. But everybody else who had the placebo shot went ahead and got the actual vaccine. So now Fierro has essentially no comparison group left for the ongoing study.  “It’s a loss from a scientific standpoint, but given the circumstances I think it’s the right thing to do,” he says.

People signing up for these studies were not promised special treatment, but once the FDA authorized the vaccines, their developers decided to offer the shots. (read more)

Just so we are clear, the final FDA authorization and approval for the vaccines are based on the outcome of these trials.  As noted in the example above, the control group was intentionally lost under the auspices of  “the right thing to do”, so there is no way for the efficacy, effectiveness or safety of the vaccine itself to be measured.

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Does the FDA think these data justify the first full approval of a covid-19 vaccine? by Peter Doshi

The FDA has never approved a drug or vaccine with as short a testing period, plethora of documented adverse side effects (including death), and incomplete testing as it just did with Pfizer’s Covid-19 vaccine. From Peter Doshi at blogs.bmj.com:

The FDA should demand adequate, controlled studies with long term follow up, and make data publicly available, before granting full approval to covid-19 vaccines, says Peter Doshi

On 28 July 2021, Pfizer and BioNTech posted updated results for their ongoing phase 3 covid-19 vaccine trial. The preprint came almost a year to the day after the historical trial commenced, and nearly four months since the companies announced vaccine efficacy estimates “up to six months.”

But you won’t find 10 month follow-up data here. While the preprint is new, the results it contains aren’t particularly up to date. In fact, the paper is based on the same data cut-off date (13 March 2021) as the 1 April press release, and its topline efficacy result is identical: 91.3% (95% CI 89.0 to 93.2) vaccine efficacy against symptomatic covid-19 through “up to six months of follow-up.”

The 20 page preprint matters because it represents the most detailed public account of the pivotal trial data Pfizer submitted in pursuit of the world’s first “full approval” of a coronavirus vaccine from the Food and Drug Administration. It deserves careful scrutiny.

The elephant named “waning immunity”

Since late last year, we’ve heard that Pfizer and Moderna’s vaccines are “95% effective” with even greater efficacy against severe disease (“100% effective,” Moderna said).

Whatever one thinks about the “95% effective” claims (my thoughts are here), even the most enthusiastic commentators have acknowledged that measuring vaccine efficacy two months after dosing says little about just how long vaccine-induced immunity will last. “We’re going to be looking very intently at the durability of protection,” Pfizer senior vice president William Gruber, an author on the recent preprint, told the FDA’s advisory committee last December.

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