Judge Gives FDA Just Over 8 Months to Produce Pfizer’s Safety Data

The decision rejects the FDA’s request to release the data over what would be 75 years

By Mimi Nguyen Ly January 6, 2022 Updated: January 7, 2022

A federal judge on Thursday ordered the U.S. Food and Drug Administration to produce, at a rate of 55,000 pages per month, the documents it relied on to license the Pfizer-BioNTech COVID-19 vaccine.

The rate of 55,000 pages a month would mean the FDA has just over eight months to fully produce all of Pfizer’s pre-licensure safety data. That is much faster than the 500 pages-per-month rate the FDA proposed in December 2021. That rate would have effectively given the agency roughly 75 years to fully produce the data, Aaron Siri, a lawyer working on the case, previously observed.

U.S. District Judge Mark Pittman ordered the FDA to produce more than 12,000 pages on or before Jan. 31, which was what the FDA had proposed in part. Pittman then ordered the agency to “produce the remaining documents at a rate of 55,000 pages every 30 days, with the first production being due on or before March 1, 2022, until production is complete.”

“Here, the court recognizes the ‘unduly burdensome’ challenges that this FOIA request may present to the FDA … But, as expressed at the scheduling conference, there may not be a ‘more important issue at the Food and Drug Administration … than the pandemic, the Pfizer vaccine, getting every American vaccinated, [and] making sure that the American public is assured that this was not rush[ed] on behalf of the United States.

“Accordingly, the court concludes that this FOIA request is of paramount public importance,” Pittman wrote in the order (pdf).

The FDA did not immediately respond to a request for comment on the latest ruling.

The case was brought by the Public Health and Medical Professionals for Transparency (PHMPT), which said the data should be made public quickly because the FDA took just 108 days to review the data before granting the Pfizer-BioNTech COVID-19 vaccine full approval.

“Pfizer began its rolling submission on May 7, 2021, and the vaccine was licensed on August 23, 2021, a total of 108 days from initial submission to licensure,” the non-profit group noted in a December filing (pdf).

The group, which comprises public health professionals, medical professionals, scientists, and journalists, includes Dr. Harvey Risch, a professor of epidemiology at the Yale School of Public Health, Dr. Aaron Kheriaty, who was until recently a professor of psychiatry at UC Irvine’s School of Medicine, and Dr. Peter McCullough, a cardiologist, epidemiologist, and internist.

The Pfizer vaccine is currently the only COVID-19 vaccine that has been approved by U.S. drug regulators.

“All the documents sought in the FOIA request are urgently needed to allow independent scientists to review the FDA’s work and to provide assurance to the public that the liability-free vaccine [Americans] are being mandated to receive has truly passed the most rigorous review possible,” the group said in its filing in December, adding, “[T]he need for this information will be lost if all the documents are not promptly produced because people and governments are making decisions regarding the Pfizer vaccine now, not in 75 years.”

In the initial complaint (pdf), the PHMPT said there is an “urgent” need for the public to access the data and information underlying the FDA’s licensure of the Pfizer vaccine, due to widespread and ongoing debate in the medical community about whether the vaccine is “safe and effective,” and due to the “objections of many” regarding current vaccine mandates across the United States.

“This is a great win for transparency and removes one of the strangleholds federal ‘health’ authorities have had on the data needed for independent scientists to offer solutions and address serious issues with the current vaccine program—issues which include waning immunity, variants evading vaccine immunity, and, as the CDC has confirmed, that the vaccines do not prevent transmission,” Siri said in a blog post on Jan. 6.

The FDA previously told the judge in December (pdf) that its Center for Biologics Evaluation and Research (CBER), which maintains the records being sought, has just 10 staff in the branch responsible for processing FOIA requests, two of whom are new and “are not yet able to review records at the same rate as more experienced staff members.”

The FDA added it has to make sure it protects certain confidential information as required under the law, as well as protect other information subject to withholding under FOIA exemptions, and so must carefully review the documents on a line by line basis to apply the redactions.

“In sum, FDA’s proposed processing schedule is fair to plaintiff,” the agency argued at the time.

New level of COVID fakery; I’m doubling down

by Jon Rappoport

I’m expanding the claim I’ve made in several recent articles.
I wrote that, by accepting current statistics on COVID cases in the US, you’re committed to concluding that everyone in America is going to be infected.
That was an UNDERESTIMATE.
If you accept the official figures—56 million COVID cases since the beginning of the pandemic, and one million new cases on the day of January 3rd—you’re committed to this:
Not only will all 330 million people in the US become infected, everyone in a nation of a billion people would become infected.
In the US, with 330 million people, everyone would become infected five, six, or seven times.
No matter what.
—Regardless of vaccines, quarantines, isolation, lockdowns, distancing, masks, everyone moving to underground bunkers and permanently wrapping themselves in stitched-together plastic shower curtains.
If you accept the existence of the virus, the supposed extent and speed of its rapid spread, the validity of the test, the accuracy of the case numbers, the meaning of what constitutes a case, you’re committed to:
EVERYONE GETS INFECTED AT LEAST HALF-A-DOZEN TIMES.
It’s really worse, because the official reports on the virus imply it’s behaving unlike any other germ in history. It’s not burning out. Natural immunity isn’t taking hold.
Therefore, everyone will become infected and re-infected an UNLIMITED number of times. And if naturally acquired immunity doesn’t take hold in the future, we’re all going to die.
That’s the actual COVID narrative, once you accept the basic premises.
Face it.
Or do something revolutionary: think about the basic premises.
For the past two years, I’ve written over 450 articles rejecting every single premise, with explanations and evidence.
And when I say “every premise,” I include the fatuous and bloated and preposterous and kindergarten assertion that the virus—SARS-CoV-2—exists.
Because it doesn’t. The virus doesn’t exist.
Once you extract that rotting piece of nonsense from the COVID story, all the other premises, and the whole narrative, collapse.
Sanity returns.
Of course, I’m aware that many people prefer to remain blindly insane. They prefer to accept the official COVID fairy tale, while at the same time refusing to realize the implications of what they are buying.
I’m not writing for them.
I’m not writing for the people who hold out hope that “a vaccine will save us.” Think that through. In the last year, we’ve seen two significant variant strains of the virus, according to the lying public health leadership. If that were true, we would expect to see more variants—and the vaccine would stop working each time a new variant appeared. As one researcher recently pointed out, are we supposed to believe the whole country (and the world) can be injected with a useful booster EVERY SIX MONTHS?
Of course, there are no variants, because there is no virus. There is nothing to vary FROM.
Everywhere you look, the official story implies doom, and everywhere you look, the official story is false.
Here is another article I wrote about the virus that isn’t there:
~~~
CDC/FDA smoking gun of smoking guns.
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.
The 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.”
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.
To confirm this, the CDC document links to an FDA release titled, “SARS-CoV-2 Reference Panel Comparative Data.” Here is a killer quote:
“During the early months of the Coronavirus Disease 2019 (COVID-19) pandemic, clinical specimens [of the virus] were not readily available to developers of IVDs [in vitro diagnostics] to detect SARS-CoV-2. Therefore, the FDA authorized IVDs based on available data from contrived samples generated from a range of SARS-CoV-2 material sources (for example, gene specific RNA, synthetic RNA, or whole genome viral RNA) for analytical and clinical performance evaluation. While validation using these contrived specimens provided a measure of confidence in test performance at the beginning of the pandemic, it is not feasible to precisely compare the performance of various tests that used contrived specimens because each test validated performance using samples derived from different gene specific, synthetic, or genomic nucleic acid sources.”
Translation: We, at the CDC, did not have a specimen of the SARS-CoV-2 virus when we concocted the PCR test for SARS-CoV-2. Yes, it’s unbelievable, right? And that’s the test we’ve been using all along. So we CONTRIVED samples of the virus. We fabricated. We lied. We made up [invented] synthetic gene sequences and we SAID these sequences HAD TO BE close to the sequence of SARS-CoV-2, without having the faintest idea of what we were doing, because, again, we didn’t have an actual specimen of the virus. We had no proof THERE WAS something called SARS-CoV-2.
This amazing FDA document goes to say the Agency has granted emergency approval to 59 different PCR tests since the beginning of the (fake) pandemic. 59. And, “…it is not feasible to precisely compare the performance of various tests that used contrived specimens because each test validated performance using samples derived from different gene specific, synthetic, or genomic nucleic acid sources.”
Translation: Each of the 59 different PCR tests for SARS-CoV-2 told different lies and concocted different fabrications about the genetic makeup of the virus—the virus we didn’t have. Obviously, then, these tests would give unreliable results. THE PCR TESTS USED CONTRIVED SPECIMENS OF THE VIRUS WE DIDN’T HAVE.
BUT, don’t worry, be happy, because NOW, the CDC and the FDA say, they really do have actual virus samples of SARS-CoV-2 from patients.
In other words, they were lying THEN, but they’re not lying NOW. They were “contriving,” but now they’re telling the truth.
If you believe that, I have Fountain of Youth water for sale, extracted from the lead-contaminated system of Flint, Michigan.
Here, once again, I report virology’s version of “we isolated (discovered) the virus”:
They have a soup they make in their labs.
This soup contains human and monkey cells, toxic chemicals and drugs, and all sorts of other random genetic material. Because the cells start to die, the researchers ASSUME a bit of mucus from a patient they dropped in the soup is doing the killing, and THE VIRUS must be the killer agent in the mucus.
This assumption is entirely unwarranted. The drugs and chemicals could be doing the cell-killing, and the researchers are also starving the cells of vital nutrients, and that starvation could kill the cells.
There is no proof that SARS-CoV-2 is in the soup, or that it is doing the cell-killing, or that it exists.
Yet the researchers call cell-death “isolation of the virus.”
To say this is a non-sequitur is a vast understatement. In their universe, “We assume, without proof, we have the virus buried in a soup in a dish in the lab” equals, “We’ve separated the virus from all surrounding material.”
Virology equals “how to spread bullshit for a living and scare the world.” Other than that, it’s perfect.
~~~

Study: Vaccines don’t stop covid outbreaks

Wednesday, January 05, 2022 by: Ethan Huff

(Natural NewsNew research published in the European Journal of Epidemiology has found that mass “vaccinating” people for the Wuhan coronavirus (Covid-19) is not helping to stop the continued outbreaks.

Even though governments and vaccine corporations claim that the injections are the best tool currently available to “stop the spread,” the data shows that the areas being hardest hit by new “variants” and waves of disease and death are those that have the highest injection rates.

Vermont is a perfect example of this. It is currently one of the most highly vaccinated states in the country, and is also seeing the greatest spikes in hospitalizations.

Israel is another prominent example, and one of the countries mentioned in the case study to show that the jabs do not “work” as claimed – unless by work you mean genocide.

Using data provided by the Our World in Data for cross-country analysis, the research team looked at health outcomes in 68 different countries that met specific reporting criteria. They also looked at data specifically in the United States.

“We computed the number and percentages of counties that experienced an increase in COVID-19 cases by levels of the percentage of people fully vaccinated in each county,” the study explains.

“The percentage increase in COVID-19 cases was calculated based on the difference in cases from the last 7 days and the 7 days preceding them.”

What they found is that there is “no discernible relationship between percentage of population fully vaccinated and new COVID-19 cases in the last 7 days.”

“In fact, the trend line suggests a marginally positive association such that countries with higher percentage of population fully vaccinated have higher COVID-19 cases per 1 million people,” the paper further explains.

Highly vaccinated Israel currently leads the world in new covid cases

As for Israel, where more than 60 percent of the population is now fully vaccinated, the worse spike in new covid cases per one million people was observed.

Even though Israel has rolled out not one but two “booster” shots, citizens and residents are getting sick and dying in record numbers.

Much the same situation is occurring in Iceland and Portugal, both of which have reached a more than 75 percent injection rate. Both countries currently have more covid cases per one million people than do the countries of Vietnam and South Africa, where only around 10 percent of the population is vaccinated.

Even at the county level, looking again at U.S. data, researchers found that there is no significant decrease in covid cases even among the most highly vaccinated counties – including counties where almost 100 percent of the population has gotten injected.

“Of the top 5 counties that have the highest percentage of population fully vaccinated (99.9–84.3%), the US Centers for Disease Control and Prevention (CDC) identifies 4 of them as ‘High’ Transmission counties. Chattahoochee (Georgia), McKinley (New Mexico), and Arecibo (Puerto Rico) counties have above 90% of their population fully vaccinated with all three being classified as ‘High’ transmission,” the paper explains.

“Conversely, of the 57 counties that have been classified as ‘low’ transmission counties by the CDC, 26.3% (15) have percentage of population fully vaccinated below 20%.”

What this all means, of course, is that the world is being lied to by the powers that be concerning these so-called “vaccines.” Not only are they not helping to “flatten the curve,” but they are also making people sicker than they otherwise would be had they simply relied on their own natural immunity for protection.

“The sole reliance on vaccination as a primary strategy to mitigate COVID-19 and its adverse consequences needs to be re-examined, especially considering the Delta (B.1.617.2) variant and the likelihood of future variants,” the paper concludes.

The latest news coverage about covid injections can be found at Genocide.news.

Sources for this article include:

Springer.com

NaturalNews.comPrevious :Technological parasitism: Covid vaccines appear to contain self-assembling “nano-octopus” microparticlesNext :Austria now a giant PRISON CAMP for the unvaccinated as “lockdown” extended another 10 days

Situation Update, Jan 5, 2022 – Was Omicron engineered by WHITE HATS as a self-spreading ANTIDOTE to end the covid pandemic?

https://www.brighteon.com/92bf362d-4675-4404-ae1e-61e1fa8335f3

0:00 Intro
8:15 Winter Storm
19:00 Sheep and Goats
20:22 Predictions
34:07 Vaccines and Infertility
50:42 Omicron Cure

For more updates, visit: http://www.brighteon.com/channel/hrreport

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