No FDA Approval for COVID-19 Shots https://lc.org/newsroom/details/100821-no-fda-approved-covid19-shots-available
Federal Judge Rejects DOD Claim That Pfizer EUA and Comirnaty Vaccines Are ‘Interchangeable’
A federal district court judge rejected a claim by the U.S. Department of Defense that the Pfizer-BioNTech COVID-19 vaccine being administered under Emergency Use Authorization is interchangeable with Pfizer’s fully licensed Comirnaty vaccine.
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A five-day course of ivermectin for the treatment of COVID-19 may reduce the duration of illness
Published PubMed
Abstract
Ivermectin, a US Food and Drug Administration-approved anti-parasitic agent, was found to inhibit severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) replication in vitro. A randomized, double-blind, placebo-controlled trial was conducted to determine the rapidity of viral clearance and safety of ivermectin among adult SARS-CoV-2 patients. The trial included 72 hospitalized patients in Dhaka, Bangladesh, who were assigned to one of three groups: oral ivermectin alone (12 mg once daily for 5 days), oral ivermectin in combination with doxycycline (12 mg ivermectin single dose and 200 mg doxycycline on day 1, followed by 100 mg every 12 h for the next 4 days), and a placebo control group. Clinical symptoms of fever, cough, and sore throat were comparable among the three groups. Virological clearance was earlier in the 5-day ivermectin treatment arm when compared to the placebo group (9.7 days vs 12.7 days; p = 0.02), but this was not the case for the ivermectin + doxycycline arm (11.5 days; p = 0.27). There were no severe adverse drug events recorded in the study. A 5-day course of ivermectin was found to be safe and effective in treating adult patients with mild COVID-19. Larger trials will be needed to confirm these preliminary findings.
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Dr. Peter McCullough
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Dr. Peter McCullough with Dr. Peter Breggin
Interview September 12, 2021
COVID Vaccine Breakthrough Information
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2 Things Mainstream Media Didn’t Tell You About FDA’s Approval of Pfizer Vaccine
There are several bizarre aspects to the FDA approval that will prove confusing to those not familiar with the pervasiveness of the FDA’s regulatory capture, or the depths of the agency’s cynicism.
First, the FDA acknowledges that while Pfizer has “insufficient stocks” of the newly licensed Comirnaty vaccine available, there is “a significant amount” of the Pfizer-BioNTech COVID vaccine — produced under Emergency Use Authorization (EUA) — still available for use.
The FDA decrees that the Pfizer-BioNTech vaccine under the EUA should remain unlicensed but can be used “interchangeably” (page 2, footnote 8) with the newly licensed Comirnaty product.
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The false claim that the fully-approved Pfizer vaccine lacks liability protection
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FDA/Media Shell Game: Pfizer ‘Vaccine’ Was Not Approved After All
The drug giant Pfizer did not directly develop its mRNA shot: it hired a German company in 2018, BioNTech, to do that for them. They subsequently entered into a joint marketing/manufacturing agreement to deliver the resulting product to the world. Thus BioNTech is not a subsidiary of Pfizer. According to their joint 2018 press release, we learn that:
“Under the terms of the agreement, BioNTech and Pfizer will jointly conduct research and development activities to help advance mRNA‐based flu vaccines. Pfizer will assume sole responsibility for further clinical development and commercialization of mRNA‐based flu vaccines, following BioNTech’s completion of a first in human clinical study.”
The latter human clinical study is what was delivered to the FDA for evaluation, on behalf of BioNTech, in order to get FDA “approval”. BioNTech named the shot Comirnaty. Pfizer has not conducted its own trial, much less submitted it to the FDA.
Because of the contractual development agreement between the two companies, it is unclear that the BioNTech shot is identical to whatever Pfizer is distributing in America, or anywhere else, for that matter. Nevertheless, the media and the FDA promote Pfizer/BioNTech without making any distinctions between the two.
What was “approved” by the FDA on Monday (8/23) was Comirnaty, which belongs to the BioNTech side of the Pfizer/BioNTech working agreement.
In other words, Pfizer is not even in the picture for approval and continues to sell its version of the shot under the Emergency Use Authorization. To repeat, Pfizer has no approval for any mRNA vaccine.
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Major MED Journal: Criticizes “RUSHED” FDA approval of COVID vaccine Dr. Suneel Dhand - MedStoic Lifestyle Medicine
Informed consent disclosure to vaccine trial subjects of risk of COVID-19 vaccines worsening clinical disease
The Smoking Jab: Fauci and the NIH Knew Covid-19 “Vaccines” Could Lead to Antibody-Dependent Enhancement
FDA Fraud: Pfizer’s Covid-19 “Vaccine” Was Not Approved, FDA Ratified a Non-Existent Off-Brand and Reaffirmed Pfizer’s EUA
Dr. Malone Sounds Alarm On Liability Coverage Of Pfizer Vax
Johnson has been open about her “health journey” that she has been on for the past year and has stated she lost weight as part of an effort to be healthier. As part of her vitamin regimen, she takes the following supplements:
- Vitamin D
- Vitamin C
- Zinc
- Magnesium
- Quercetin
- Melatonin
As she considered her headache to be abnormal, and given the fact that her son had tested positive, she “made a telehealth appointment with America’s Frontline Doctors from their website.”
America’s Frontline Doctors (AFLDS) have been leading the charge against the government and mainstream media narrative regarding the coronavirus and associated treatments. Among other things, AFLDS have advocated for the off-label use of Hydroxychloroquine (HCQ), and Ivermectin as a treatment for COVID-10. Their website states, “AFLDS-trained and licensed physicians are available via telemedicine for a short consultation. Our physicians know that HCQ and Zinc are effective both prophylactically and when used early. The telemedicine physician will review your history. Almost all patients can safely take these medications.”
- Ivermectin
- Prednisone
- Zithromax
She began taking them “immediately” and monitored her oxygen levels. She says that after her first day of taking Ivermectin her “fever and headache stopped and didn’t return,” and by the fifth day she “felt back to 100%.”
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Dr Robert Malone Calls Out CDC for Using Hope Rather Than Data
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IS IT ETHICAL TO DEMAND VACCINE FOR EMPLOYMENT?
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interesting interview against giving the vaccine to
women of childbearing years or pregnant.
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Letter from Doctors in British Colombia
Open Letter to Dr. Bonnie Henry, Adrian Dix, and Premier John Horgan From Doctors in British Colombia!
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The medical community should be ashamed of itself. You’d think that the entire academic community would be outraged at the scientific abuses that are happening in medical science today.
But you’d be wrong. Everyone ignores the transgressions.
Welcome to the new normal
Here are the new rules (in case you didn’t get The Memo from President Biden) for how to behave in the new world:
The objective is to vaccinate every human in the world with the vaccine. No iffs, ands, or butts. Safety isn’t an issue. We don’t care how many people we have to kill. We don’t care if the vaccine kills more people than it saves. Those are details. Vaccinate everyone. And quash any dissenting opinions.
No more need for anyone to investigate serious adverse events (like death, etc) in clinical trials or under EUA. So, for example, the 8,000+ deaths reported in VAERS can all be ignored despite the fact that Dr. Peter Schirmacher definitively determined the vaccines are killing people. We made sure the US press didn’t report that, so nobody here will know. And Congress won’t investigate since they don’t want to look bad. Nobody is going to hold you accountable. So just lie about it like what Pfizer did in their Phase 3 trial. You will not be prosecuted and the outside advisory committees will not ask any questions. Trust us. It’s all wired in. And the public is completely clueless because we made sure the press wouldn’t ask any questions.
Phase 3 clinical trial fraud is now expected: If anything bad happens, don’t worry; just cover it up! Take Maddie de Garay, a 12-year old injured in the Pfizer 12-15 year old trial who is now paralyzed for life. It started less than 24 hours after her second dose. Pfizer handled it brilliantly by saying it “abdominal pain.” This made it much easier to get FDA approval. The FDA will not believe the family or medical records. They will never investigate. They will only listen to the drug company. Compensation received by the family: ZERO. The trial documents they signed promised that there were no serious adverse events, but that was necessary to get the kids to enroll. If they get injured, tough luck for them. DO NOT send a letter of apology. Have no fear either. The medical community will look the other way. They really don’t care if kids are injured in vaccine trials. If they did, they would have demanded an investigation. If you had any doubts that we have this whole thing rigged, Maddie de Garay is proof we have them all locked up. That story will never get out so have no fear about getting caught. It just will not happen. Ever. And even if it does, don’t worry because you have a liability shield just like you wanted.
Papers that endanger the “safe and effective” narrative must be censored. No appeals. It used to be that papers that pass peer review get published. That is so old school. Here’s a great example… Jessica Rose’s paper, A Report on Myocarditis Adverse Events in the U.S. Vaccine Adverse Events Reporting System (VAERS) in Association with COVID-19 Injectable Biological Products was published. But we called the publisher and they took down the paper over the objections of the editor of the journal. The reason they cited was brilliant: the publisher claimed the paper was “not invited.” Nobody will question that. The paper exposed the fact that myocarditis is more dangerous than people had been led to believe. It was removed because it would have upset the false narrative that the vaccines are safe and effective. As you can see, there were no objections from the medical community at all. Just another day. Censorship of science that doesn’t support the false narrative is not only acceptable today, it’s expected. If you don’t censor stuff that goes against the narrative, you will pay a heavy price.
Evidence-based medicine hierarchy principles no longer apply. There is a new Sheriff in town. The highest level of evidence in evidence-based medicine used to be the peer-reviewed meta-analysis and systematic review. No longer. Expert opinion, formerly the lowest level of evidence, is now the highest if it is from any of these sources: the NIH, FDA, WHO, AMA, Gates Foundation, GAVI, or a major drug company. If any of them say “don’t use it,” follow orders. Ivermectin is the poster child here. We suppressed that totally even though formerly it would have been embraced. The world will trust us, not the stupid medical journals. The medical journals that published those systematic reviews will be punished. But it doesn’t matter anyway, since when the AMA says something, it overrides anything in the medical literature.
Drugs that work against COVID must be suppressed since they would jeopardize the EUA of the vaccines. We’re going to sabotage all the US trials that work against the narrative. Unfortunately, Fluvoxamine was shown in a large Phase 3 trial to reduce the risk of death from COVID by 12X. They did it outside the US. While that’s better than anything we have today, it doesn’t fit the narrative so the NIH and WHO continue to ignore it. They will simply say, “we need more evidence.” Doesn’t matter how many people die in the meantime. Doctors like George Fareed and Brian Tyson who discover early treatment multi-drug protocols with 99.76% risk reduction are have been “persona non grata” at all government agencies. All attempts to contact the NIH or FDA will be ignored on repurposed drugs that work. Vaccine must be the only option. Otherwise, nobody will take it. Get it?
Open scientific oral discussion/debate questioning the safe and effective narrative is forbidden. It used to be that if you had a scientific disagreement with a colleague, you’d talk to them. No longer. That’s so old school. The new way is dueling documents, progressively longer and longer. Generally 100 pages or more. And you only get to play that game after you have your side published. No more real-time discussions and debates that would settle issues quickly. That would be bad news. This is a pandemic but we can’t sacrifice written documentation just to settle an argument quickly. We need to take time to do it right and document everything, no matter how long it takes. Using document battles, we can string people out for years before they figure it out. By then, it will be too late. Again, never ever engage any of these people who are trying to tell the truth. You should label them as “misinformation spreaders.” We have a deal with Wikipedia that they will trash all their reputations by relying on the fact checkers that we’ve all paid off.
You must not question the mainstream narrative. Nobody prominent who supports the narrative that the vaccines are safe and effective shall agree to debate any prominent opponent of the narrative. Only bad outcomes can come of that. Challengers of the narrative should be ignored, censored, intimidated, jailed, or killed if necessary.
No more accountability. CDC scientists who don’t do their job (like John Su by failing to compute a key number needed for risk benefit analysis) will not be held accountable any longer. So if they screw up, they screw up. Even if millions of people die. Big fucking deal. Look, the new rule is that the CDC and FDA are always right and cannot be questioned. If they release a report saying vaccines reduce all-cause mortality by 66%, instead of laughing at how absurd that is (since it would mean that nobody could die from anything except accidents and even those would be reduced), everyone is expected to suck it up and say nothing if you don’t like it. If the CDC says cloth masks work for COVID, it’s true. If they say they don’t work for smoke, it’s true. If you point out that the virus is 25x smaller than smoke, you will have your medical license revoked for endangering the public. Got it?
Did I miss any changes? Does anyone have a copy of the original memo that was circulated to the medical community? I had to piece together this list just from my personal experience, but I hope I captured the essence for those in the medical community who did not get The Memo.
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