FDA approves Pfizer jab

KS

Jedi
There are some interesting points made by Robert Malone regarding recent FDA authorization. What strikes me the most:
Letter to Pfizer
https://www.fda.gov/media/150386/download

  • DOES NOT GIVE FULL APPROVAL
  • Extends EUA to allow supply of current Pfizer under EUA because limited supply of BioNTech version.
  • “The products are legally distinct with certain differences that do not impact safety or effectiveness. (page 2, Pfizer letter)
    • here FDA quietly admits that the licensed Pfizer vaccine and the authorized Pfizer vaccine are identical with regard to safety/efficacy, but they are "legally distinct." That's code for one has manufacturer liability, while the other doesn't. It is also code for "we don't want to impose a mandate on the EUA product cause it is illegal, but we can probably get away with a mandate on the licensed product."
    • page 12 AA (Conditions with Respect to Use of Licensed Product). This tells you that yes, we licensed the vaccine, but...there is a lot of the old vaccine out there, actually "a significant amount" and this amount will be considered an EUA and will continue to be used.
    • Now, why would they do that? Why specify that identical versions of the product will be legally different? Because they need the license to impose the mandates. But they need the EUA to evade liability.
    • Along with the license comes liability for the manufacturer. (While all EUA products were given a liability shield.)
    • Unfortunately, our federal governments would prefer us to be without recourse if we are injured, rather than have Pfizer defend its product in court. So, the feds want us to THINK the vaccine we are receiving is licensed, which will make people submit because they think it can now be mandated, but instead we are almost certain to receive the EUA vials instead, to save Pfizer's behind. Yes, a stingy CICP injury program exists, but it has not paid out for a single COVID vaccine injury yet.
So, as I understand, there are two versions of the vaccine: Pfizer's one still under EUA and BioNTech's one, which is licensed. But the EUA one seems to be (I suspect) the one that is in circulation right now. So, they will mandate the vaccinations, and still not be liable for any damages, because the large part of the population is not aware of that distinction. My mind is blown...
 
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Hi_Henry

Dagobah Resident
There are some interesting points made by Robert Malone regarding recent FDA authorization. What strikes me the most:

So, as I understand, there are two versions of the vaccine: Pfizer's one still under EUA and BioNTech's one, which is licensed. But the EUA one seems to be (I suspect) the one that is in circulation right now. So, they will mandate the vaccinations, and still not be liable for any damages, because the large part of the population is not aware of that distinction. My mind is blown...
I think this is the trick.

ShellGame.png
 

Roadhizzy

Padawan Learner
The approval was to change the name and to assign all previous EUA terms for production and labeling etc to Comirnaty
 

sbeaudry

Jedi Council Member
Two good articles below concerning FDA approval of the Pfizer jab from Children's Health Defense (RFK Jr.):
The data article, listed here first, predates the approval, asking whether approval is imminent, but is rather interesting. The approval article is also good.

Data:

Does the FDA Think These Data Justify the First Full Approval of a COVID-19 Vaccine?​

The U.S. Food and Drug Administration should have demanded adequate, controlled studies with long-term follow up, and made data publicly available, before granting full approval to COVID-19 vaccines, says BMJ Associate editor Peter Doshi.
By
Peter Doshi

EDITOR’S NOTE: This analysis was published Monday before the U.S. Food and Drug Administration announced it had granted full approval to Pfizer’s COVID vaccine. The information in this piece provides insightful arguments for why the FDA should not have rushed to license Pfizer’s COVID vaccine.

On July 28, 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 (March 13, 2021) as the April 1 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 U.S. 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.

The concern, of course, was decreased efficacy over time. “Waning immunity” is a known problem for influenza vaccines, with some studies showing near zero effectiveness after just three months, meaning a vaccine taken early may ultimately provide no protection by the time “flu season” arrives some months later.

If vaccine efficacy wanes over time, the crucial question becomes what level of effectiveness will the vaccine provide when a person is actually exposed to the virus? Unlike COVID vaccines, influenza vaccine performance has always been judged over a full season, not a couple months.

And so the recent reports from Israel’s Ministry of Health caught my eye. In early July, they reported that efficacy against infection and symptomatic disease “fell to 64%.” By late July it had fallen to 39% where Delta is the dominant strain. This is very low. For context, the FDA’s expectation is of “at least 50%” efficacy for any approvable vaccine.

Now Israel, which almost exclusively used Pfizer vaccine, has begun administering a third “booster” dose to all adults over 40. And starting September 20, the U.S. plans to follow suit for all “fully vaccinated” adults eight months past their second dose.

Delta may not be responsible

Enter Pfizer’s preprint. As an RCT reporting “up to six months of follow-up,” it is notable that evidence of waning immunity was already visible in the data by the March 13 data cut-off.

“From its peak post-dose 2,” the study authors write, “observed VE [vaccine efficacy] declined.” From 96% to 90% (from two months to <4 months), then to 84% (95% CI 75 to 90) “from four months to the data cut-off,” which, by my calculation (see footnote at the end of the piece), was about one month later.

But although this additional information was available to Pfizer in April, it was not published until the end of July

And it’s hard to imagine how the Delta variant could play a real role here, for 77% of trial participants were from the U.S., where Delta was not established until months after data cut-off.

Waning efficacy has the potential to be far more than a minor inconvenience — it can dramatically change the risk-benefit calculus. And whatever its cause — intrinsic properties of the vaccine, the circulation of new variants, some combination of the two, or something else — the bottom line is that vaccines need to be effective.

Until new clinical trials demonstrate that boosters increase efficacy above 50%, without increasing serious adverse events, it is unclear whether the 2-dose series would even meet the FDA’s approval standard at six or nine months.

The “six month” preprint based on the 7% of trial participants who remained blinded at six months

The final efficacy timepoint reported in Pfizer’s preprint is “from four months to the data cut-off.” The confidence interval here is wider than earlier time points because only half of trial participants (53%) made it to the four month mark, and mean follow-up is around 4.4 months (see footnote).
This all happened because starting last December, Pfizer allowed all trial participants to be formally unblinded, and placebo recipients to get vaccinated. By March 13 (data cut-off), 93% of trial participants (41,128 of 44,060; Fig 1) were unblinded, officially entering “open-label followup.” (Ditto for Moderna: by mid April, 98% of placebo recipients had been vaccinated.)

Despite the reference to “six month safety and efficacy” in the preprint’s title, the paper only reports on vaccine efficacy “up to six months,” but not from six months. This is not semantics, as it turns out only 7% of trial participants actually reached six months of blinded follow-up (“8% of BNT162b2 recipients and 6% of placebo recipients had ≥6 months follow-up post-dose 2.”)
So despite this preprint appearing a year after the trial began, it provides no data on vaccine efficacy past six months, which is the period Israel says vaccine efficacy has dropped to 39%.

It is hard to imagine that the <10% of trial participants who remained blinded at six months (which presumably further dwindled after March 13) could constitute a reliable or valid sample to produce further findings. And the preprint does not report any demographic comparisons to justify future analyses.

Severe disease

With the U.S. awash in news about rising cases of the Delta variant, including among the “fully vaccinated,” the vaccine’s efficacy profile is in question. But some medical commentators are delivering an upbeat message. Former FDA commissioner Scott Gottlieb, who is on Pfizer’s board, said: “Remember, the original premise behind these vaccines were [sic] that they would substantially reduce the risk of death and severe disease and hospitalization. And that was the data that came out of the initial clinical trials.”

Yet, the trials were not designed to study severe disease. In the data that supported Pfizer’s EUA, the company itself characterized the “severe COVID-19” endpoint results as “preliminary evidence.” Hospital admission numbers were not reported, and zero COVID-19 deaths occurred.

In the preprint, high efficacy against “severe COVID-19” is reported based on all follow-up time (one event in the vaccinated group vs. 30 in placebo), but the number of hospital admissions is not reported so we don’t know which, if any, of these patients were ill enough to require hospital treatment. (In Moderna’s trial, data last year showed that 21 of 30 “severe COVID-19” cases were not admitted to hospital; Table S14.)

And on preventing death from COVID-19, there are too few data to draw conclusions — a total of three COVID-19 related deaths (one on vaccine, two on placebo). There were 29 total deaths during blinded follow-up (15 in the vaccine arm; 14 in placebo).

The crucial question, however, is whether the waning efficacy seen in the primary endpoint data also applies to the vaccine’s efficacy against severe disease. Unfortunately, Pfizer’s new preprint does not report the results in a way that allows for evaluating this question.

Approval imminent without data transparency, or even an advisory committee meeting?

Last December, with limited data, the FDA granted Pfizer’s vaccine an EUA, enabling access to all Americans who wanted one. It sent a clear message that the FDA could both address the enormous demand for vaccines without compromising on the science. A “full approval” could remain a high bar.
But here we are, with FDA reportedly on the verge of granting a marketing license 13 months into the still ongoing, two year pivotal trial, with no reported data past March 13, unclear efficacy after six months due to unblinding, evidence of waning protection irrespective of the Delta variant and limited reporting of safety data. (The preprint reports “decreased appetite, lethargy, asthenia, malaise, night sweats, and hyperhidrosis were new adverse events attributable to BNT162b2 not previously identified in earlier reports,” but provides no data tables showing the frequency of these, or other, adverse events.)
It’s not helping matters that FDA now says it won’t convene its advisory committee to discuss the data ahead of approving Pfizer’s vaccine. (Last August, to address vaccine hesitancy, the agency had “committed to use an advisory committee composed of independent experts to ensure deliberations about authorization or licensure are transparent for the public.”)
Prior to the preprint, my view, along with a group of around 30 clinicians, scientists and patient advocates, was that there were simply too many open questions about all COVID-19 vaccines to support approving any this year. The preprint has, unfortunately, addressed very few of those open questions, and has raised some new ones.

I reiterate our call: “slow down and get the science right — there is no legitimate reason to hurry to grant a license to a coronavirus vaccine.”

FDA should be demanding that the companies complete the two year follow-up, as originally planned (even without a placebo group, much can still be learned about safety). They should demand adequate, controlled studies using patient outcomes in the now substantial population of people who have recovered from COVID. And regulators should bolster public trust by helping ensure that everyone can access the underlying data.

Competing interests: I helped organize the Coalition Advocating for Adequately Licensed Medicines (CAALM), which has formally petitioned the FDA to refrain from fully approving any COVID-19 vaccine this year (docket FDA-2021-P-0786). A full list of competing interests is available here.

Provenance: commissioned; externally peer-reviewed.

Footnote: Calculations in this article are as follows. “About 1 month” past month 4 is based on the final row of Fig 2 in the preprint: 1030/12670*12 = 0.98 months (vaccine group) and 895/11802*12 = 0.91 months (placebo group). “53%” is based on Fig 2: (12670+11802)/(23040+23037). “4.4 months” is based on the average of 8412/22505*12 = 4.5 (vaccine) and 8124/22434*12 = 4.3 (placebo) in Fig 2.

Originally published by The BMJ Aug. 23, 2021, written by Peter Doshi, reproduced here under the terms of the CC BY NC license.
The views and opinions expressed in this article are those of the authors and do not necessarily reflect the views of Children's Health Defense.


Approval:

FDA Grants Full Approval of Pfizer Vaccine, Critics Blast Agency for Lack of Data, Scientific Debate​

Critics said it was concerning that full approval was based on only six months’ worth of data — despite clinical trials designed for two years — and that there was no public discussion of the data.
By
Megan Redshaw

The U.S. Food and Drug Administration (FDA) today granted full approval to the Pfizer/BioNTech COVID vaccine for people 16 years and older — without allowing public discussion or holding a formal advisory committee meeting to discuss data.
This is the first COVID vaccine approved by the FDA, and is expected to open the door to more vaccine mandates by employers and universities.

“For businesses and universities that have been thinking about putting vaccine requirements in place in order to create safer spaces for people to work and learn, I think this move from the FDA, when it comes, will actually help them to move forward with those kinds of plans,” U.S. Surgeon General Dr. Vivek Murthy on Sunday told CNN’s Brianna Keilar.

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic,” said Dr. Janet Woodcock, acting FDA commissioner in a press release issued Monday.

"While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident this vaccine meets the high standards for safety, effectiveness and manufacturing quality the FDA requires of an approved product.”

Woodcock said she believes FDA approval will instill additional confidence in people to get vaccinated.

According to The Washington Post, Pfizer’s vaccine approval was the fastest in the agency’s history, coming less than four months after Pfizer/BioNTech filed for licensing on May 7.

“It’s been remarkably fast,” said Holly Fernandez Lynch, a bioethics expert and lawyer at the University of Pennsylvania, who said careful handling of the approval was crucial to potentially persuading the “vaccine hesitant” to receive the licensed product.

The approval of Pfizer’s COVID vaccine was based on its clinical trial of 44,000 people — half of whom got the shots, the company said. The median six-month follow-up period for safety and efficacy began after participants received their second dose, Pfizer said.

“Based on the longer-term follow-up data we submitted, today’s approval for those aged 16 and over affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed,” Pfizer CEO Albert Bourla said in a statement. “I am hopeful this approval will help increase confidence in our vaccine.”

The company plans to follow the 44,000 enrollees for a total of 24 months, from the start of the trial. In order to qualify for FDA Emergency Use Authorization (EUA) last December, Pfizer followed trial participants for a median of only two months after participants received their second dose.

Pfizer’s COVID vaccine received EUA on Dec. 11, 2020, for use in individuals 16 years and older. On May 10, the authorization was expanded to include 12- through 15-year-olds.
According to the FDA, EUAs can be used by the agency during public health emergencies to provide access to medical products that may be effective in preventing, diagnosing or treating a disease, provided the FDA determines that the known and potential benefits of a product, when used to prevent, diagnose or treat the disease, outweigh the known and potential risks of the product.

Pfizer’s vaccine will remain under EUA for 12- through 15-year-olds, and for a third dose in certain immunocompromised individuals.
However, full approval gives doctors flexibility in using vaccinations for “off-label use,” which is not permitted for EUA products. This would allow doctors to give patients booster shots before the FDA clears them.

Data released Friday by the Centers for Disease Control and Prevention (CDC) showed that between Dec. 14, 2020 and Aug. 13, 2021, a total of 326,535 adverse events had been reported to the Vaccine Adverse Events Reporting System (VAERS) attributed to Pfizer’s COVID vaccine, including 9,027 deaths and 56,607 serious injuries.

Critics accuse FDA of ‘unprecedented, naked power grab’

According to an article published Aug. 20 in the BMJ, transparency advocates have criticized the FDA decision not to hold a formal advisory committee meeting to discuss Pfizer’s application for full approval — an important mechanism used to scrutinize data.

Last year the FDA said it was “committed to use an advisory committee composed of independent experts to ensure deliberations about authorisation or licensure are transparent for the public.”

But in a statement to The BMJ, the FDA said it did not believe a meeting was necessary ahead of the expected full FDA approval.

An FDA spokesperson said the agency held numerous meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) related to COVID vaccines in 2020, and did not believe a meeting was needed related to this biologics license application for Pfizer.

According to the BMJ, companies typically apply for full approval after a longer period has elapsed so that more data are available for review.

Kim Witczak, a drug safety advocate who serves as a consumer representative on the FDA’s Psychopharmacologic Drugs Advisory Committee, said the decision removed an important mechanism for scrutinizing the data.

“These public meetings are imperative in building trust and confidence especially when the vaccines came to market at lightning speed under emergency use authorization,” said Witczak. Wticzak was one of 27 experts who launched a citizen’s petition demanding the FDA “slow down and get the science right” before approving COVID vaccines.

“The public deserves a transparent process, especially as the call for boosters and mandates are rapidly increasing,” Wticzak said. “These meetings offer a platform where questions can be raised, problems tackled and data scrutinised in advance of an approval.”

Witczak said it’s concerning that full approval is based on only six months’ worth of data — despite clinical trials designed for two years — and there’s no control group after Pfizer offered the product to placebo participants before the trials were completed.

“They know they can’t win this argument on the science and that’s why they had to abolish the public process and independent oversight,” said Children’s Health Defense Chairman Robert F. Kennedy Jr. “They believe themselves so powerful now that they are stripping off all pretenses that this is about public health, and are baldly revealing the corruption.”

Kennedy told The Defender:

“This is a sinister scheme for mandating a badly flawed vaccine that has already made history with record deaths and injuries, that neither prevents disease nor transmission, and does not improve mortality. Pfizer’s most recent six-month data show that while the jab prevents some COVID deaths, it causes more heart attacks yielding a net loss of life.”

Diana Zuckerman, president of the National Center for Health Research, told The BMJ it’s obvious the FDA has no intention of hearing anyone else’s opinion, and says making decisions behind closed doors can feed vaccine hesitancy.

“It’s important to have a public discussion about what kind of data are there, and what the limitations are,” Zuckerman said. “As we think about risk versus benefit, we need to know.”Joshua Sharfstein, vice dean for public health practice and community engagement at the Johns Hopkins Bloomberg School of Public Health and former FDA deputy commissioner during the Obama administration, said advisory committee meetings are more than just a way of receiving scientific input from outside experts.

“It’s also an opportunity to educate the public about the important work that the FDA has done reviewing an enormous amount of data about a product,” Sharfstein told The BMJ. “It’s a chance for questions to be asked and answered, building public confidence.”
 

avia

Padawan Learner
So, what about all the people who said they would get a shot if the FDA "approved" them? What are they going to choose to do now?

The FDA routinely approves all kinds of dangerous substances, only to recall them later. Celebrex, Paxil, Zantac, Zoloft have been recalled after injuring how many people? How many drugs have been recalled in the past twenty years?

The FDA approved antibiotics and hormones for animals in the food supply. Glysophates and GMOs, pesticides, herbicides, let's approve all of it! I don't trust the FDA as far as I can throw Tony Fauci!

(I'm a 4'10" 100 lb woman)
 

XPan

The Living Force
Of course the FDA is not to be trusted.

After all, they KNEW already back in Oct 2020 that the covid 19 vaccines create at least 105+ illnesses. And they knew about the severe multi organ inflammations in children under 12 years of age back then, too, and created a new category for it: MIS-C.

How much worse can an authority really sink ? More than ever; it has become a tool of evil. 5+ and more years ago, I never envisioned that it could be this sinister…

I sound angry. But deep down, I am endless sad, that everything has gone this far…
 

psychegram

The Living Force
But the EUA one seems to be (I suspect) the one that is in circulation right now. So, they will mandate the vaccinations, and still not be liable for any damages, because the large part of the population is not aware of that distinction. My mind is blown...
As per usual, they lie about everything. That really just has to be the default assumption about anything and everything they say.
The FDA routinely approves all kinds of dangerous substances, only to recall them later. Celebrex, Paxil, Zantac, Zoloft have been recalled after injuring how many people? How many drugs have been recalled in the past twenty years?
That's what makes this particular move amusing. The kind of person who trusts the FDA, or anything else in officialdom, is already vaxxed. Those who haven't gotten an armful of mystery juice are not the type to trust the FDA. All they've done with this blatant corruption is to further immolate their credibility, and with it, their legitimacy.

Which is really the theme of the last few years: obvious lies spewing from the open sewer of the media, with each foetid exhalation earning them a temporary tactical victory at the cost of sacrificing ever more of their credibility. Since their power rests entirely on deception, they are undermining the very basis of their power even as they reach for absolute power.

When you take the 10,000 foot view it's actually really funny.
 

hlat

The Living Force
FOTCM Member
Here is the FDA's list of approved vaccines.

On that FDA list is comirnaty.

It appears to me from the comirnaty documentation that FDA approval applies to a vaccine that has not been manufactured yet: comirnaty. It appears to me that none of the existing emergency use authorization vaccines are comirnaty, so that none of the existing emergency use authorization vaccines are approved.
Comirnaty is approved but not yet in existence. Pfizer-BioNTech COVID-19 vaccine is not approved and only has emergency use authorization. So the existing vaccines are not approved.
 

stellar

The Living Force
FOTCM Member
[Pfizer’s vaccine will remain under EUA for 12- through 15-year-olds, and for a third dose in certain immunocompromised individuals.

However, full approval gives doctors flexibility in using vaccinations for “off-label use,” which is not permitted for EUA products. This would allow doctors to give patients booster shots before the FDA clears them.]

Off-label use is the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, dosage, or route of administration. Both prescription drugs and over-the-counter drugs can be used in off-label ways, although most studies of off-label use focus on prescription drugs. Wikipedia

So.... how many people are really going to question the 'approval'? Very, VERY few, I think.
 

stellar

The Living Force
FOTCM Member
Malone on FDA approval of Pfizer vaccine (that is currently not available):
His last sentence should be a food for thought for some.

Edit: Thinking about that whole lie in a plain sight, PTB are getting desperate.
Well, Australia has a helluva lot of vials of a vaccine that does not exist yet.:cool2:
 

Hi_Henry

Dagobah Resident
Someone suggested an interesting method to arrive at the Pfizer gene therapy elixir name COMIRNATY.

Yes, WTH? Small interfering RNAs? Micro RNAs? miRNA? Co miRNA ty?

THE VIRUS IS CAUSING (RANDOM?) GENETIC DISEASES TO MANIFEST DE NOVO BUT HOW???!!!!! "...de novo mobile element insertions that come about as a result of transposon movements and are often overlooked in genetic screens and analyses." Geneticists?

 
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