Tag Archives: FDA approval

HEARING WITHOUT LISTENING: FDA COMMITTEE APPROVING AT “WARP SPEED.” CHILLING!

Dr. Arnold Monto, the acting chairman of the vaccines advisory committee, curbed and corralled the discussion to authorize emergency use of the Pfizer vaccine — cutting off questions, limiting debate, and forcing committee members to vote without giving them a chance for any refinement to the authorization. This video is “unlisted” on YouTube… meaning it won’t come up by searching. Here’s the link: https://www.youtube.com/watch?v=SeiBhOai_dI&feature=emb_logo
Thank you Children’s Health Defense for finding it! https://childrenshealthdefense.org/defender/how-fda-approved-pfizer-covid-vaccine-warp-speed/

PLEASE SHARE!!!

Source: MarcusTwain22

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DO NOT ACCEPT COVID EUA JAB! FDA SAYS NOT REQUIRED

Source: Dr. Rima

FDA Admits Your Right to Refuse COVID EUA Vax

THE SYRINGE WAS EMPTY!

FAKE “SAFETY” DEMONSTRATION VIDEO

http://www.opensourcetruth.com/busted-covid-vaxx-safety-demo-uses-empty-syringe/

More trending stories at:

www.OpenSourceTruth.com

TRENDING ON OPEN SOURCE TRUTH

Copyright Disclaimer Under Section 107 of the Copyright Act 1976, allowance is made for “fair use” for purposes such as criticism, comment, news reporting, teaching, scholarship, and research. Fair use is a use permitted by copyright statute that might otherwise be infringing. Non-profit, educational or personal use tips the balance in favor of fair use.

NIH and Moderna Phase 1 Clinical Trial

Repost from  The Highwire with Del Bigtree

After months of objections, the National Institutes of Health (NIH) and Moderna have capitulated and provided ICAN a copy of their internal 322-page Safety Summary Report for the Phase I trial of their COVID-19 vaccine (mRNA-1273). A full copy of this report is available below and this is the first time it is being made available to the public.

On May 18, 2020, Moderna issued a press release claiming the data from its Phase I trial “substantiate our belief that mRNA-1273 has the potential to prevent COVID-19 disease.” Since this trial was actually conducted by the NIH, ICAN submitted a FOIA request on May 22, 2020 to NIH for: “All safety and efficacy data and information regarding mRNA-1273, including from the Phase I clinical trial of this experimental vaccine conducted by the National Institute of Allergy and Infectious Diseases.” ICAN requested that NIH grant expedited processing for this request. 

On June 8, 2020, NIH recognized the “compelling need” to expeditiously release to the public the information ICAN sought by granting its request for expedited processing. But then NIH failed to produce anything. Therefore, ICAN sued the NIH on August 13, 2020 in federal court to force NIH to release this data. NIH then finally sent a “final response” to ICAN stating: “The safety data for this study comprises 1,093 pages. I have determined to withhold those records in their entirety pursuant to [exemptions that] protect information that constitutes trade secret information and information that is confidential and commercial or financial in nature.” 

ICAN did not accept this objection and its attorneys, led by Aaron Siri, informed the court that we would argue for the documents via briefs to the court. NIH’s opening brief – explaining why it should not produce this data – was set to be due to the Court on October 30, 2020. Eight days before that due date, on October 22, 2020, NIH and Moderna abruptly reversed their position and advised that they would produce all of the data. 

On October 29, 2020, ICAN received the first 332 of 1,093 pages — the remainder of which will be produced shortly. It can be downloaded here. ICAN and its subscribers are the first people in the world, outside of NIH and Moderna, to actually see this data. We will be carefully studying all of the disclosed data but ICAN wanted to widely disseminate it immediately so that others have the opportunity to do the same.  

Despite only receiving a portion of the data, what ICAN has already received provides important information for the public to know in evaluating Moderna’s vaccine. For example, the documents ICAN received reveal that approximately 70% of participants reported unsolicited adverse events, many of which are extremely concerning.  

Just as the pharmaceutical companies will never rest when it comes to promoting and selling their vaccine products, we will never rest in exposing the truth regarding these products or in demanding full transparency and full informed consent for any and all vaccines.

Fair Use: In some instances, we include someone else’s footage that is covered in Fair Use for Documentary and Educational purposes with the intention of driving commentary and allowing freedom of speech.

COVID’S SILVER BULLET?

Repost from the-highwire-with-del-bigtree/

Dr. Richard Bartlett’s #Covid19 protocol has successfully treated thousands of patients using an asthma drug that has been commonly prescribed in the U.S. for over 25 years. He joins Del in studio for an in-depth interview discussing his “silver bullet” treatment, and why our gov’t health agencies refuse to investigate his simple solution to the pandemic.

#COVID #Budesonide #FDAapproved #SaveLives #FauciFail

Fair Use: In some instances, we include someone else’s footage that is covered in Fair Use for Documentary and Educational purposes with the intention of driving commentary and allowing freedom of speech.

FDA FINALLY RELEASES MERCURY WARNING

FDA FINALLY RELEASES MERCURY WARNING
A hundred years after dentists started using mercury in dental fillings, the FDA has finally decided “certain high-risk groups” should avoid the dental amalgam because of “harmful health effects.” Some are even calling for a complete abolishment of the archaic practice, which is missing proper safety science, while thousands of peer-reviewed articles support ending its use.

#MercuryFillings #FDA #HighRisk #Dangerous #Pregnant #Moms #Children

Fair Use: In some instances, we include someone else’s footage that is covered in Fair Use for Documentary and Educational purposes with the intention of driving commentary and allowing freedom of speech.

Informed Consent Action Network: Merk VARIVAX – Chicken Pox Vaccine

Reposted by permission from The Highwire with Del Bigtree

Merck sells the first and only chicken pox vaccine (VARIVAX) sold in the United States. VARIVAX is produced by growing chicken pox virus on the cell strain from aborted fetal tissue and was licensed by the FDA in 1995 for people aged 12 months and older.

Prior to FDA licensure of a new experimental vaccines, such as VARIVAX, are expected to undergo long-term placebo-controlled clinical trials with typically tens of thousands of participants to assure their safety.

To evaluate whether Merck met any of these criteria, ICAN, through its attorneys, headed by Aaron Siri, demanded that the FDA produce copies of all the clinical trial reports relied upon to license Merck’s chicken pox vaccine. After the FDA stonewalled ICAN for 14 months, failing to produce even a single document, ICAN sued the FDA in federal court to receive the clinical trial reports for this vaccine.

In this lawsuit, the FDA finally capitulated and began its production of the requested clinical trial reports, the last of which were recently received. A total of 10,796 pages were produced encompassing all the clinical trial reports submitted by Merck to get the VARIVAX license approved. A complete copy of the production is available here.

What do these documents show? They show that this product should never have been licensed.

Only one trial relied upon to license this vaccine included a placebo control. Buried deep in the reports, however, it admits that this “placebo” is an injection of lyophilized stabilizer containing approximately 45 mg of neomycin per milliliter. This is not a placebo! A placebo is an inert substance like saline — it is not another drug! Worse, this trial only contained 956 children, of which 491 received VARIVAX and 465 received the alleged “placebo.” Compounding its fake placebo and miniscule number of participants, these children were only monitored for clinical complaints for 56 days and then for an additional 14 days thereafter for serious adverse reactions.

Nonetheless, even in this shoddy, underpowered study, four serious adverse events (including seizure, ulcer, and viral enteritis) were reported in the group of children receiving VARIVAX and none were reported in the group receiving the alleged placebo. That differential was deemed acceptable by the FDA because Merck’s paid investigator did not consider these serious adverse events to be related to VARIVAX.

Nine months after this study began, the children from the “placebo” group were administered VARIVAX. This assured that any differences in the longer-term reaction profile between those that received VARIVAX and those that received the “placebo” in this miniscule trial could never be uncovered.

There was also one study that involved just 61 children in which 32 received VARIVAX and 29 received nothing. At the 8-week mark, the control group (the children who did not receive an injection) were vaccinated with VARIVAX. During that 8-week period, the children receiving VARIVAX had triple the rate of temperatures above 102 ̊F, nearly double the rate of ear infections, 50% increased rate of upper respiratory illness, and 33% increased rate of systemic clinical complaints.

The rest of the trials produced by the FDA were not blinded, not randomized, nor did they include a control group. These trials could therefore not provide scientifically valid data to support the product’s safety for licensure.

The FDA’s basis for licensing VARIVAX is incredible when considering that: (i) states mandate by law that millions of children receive VARIVAX every year; (ii) Merck cannot be sued for most injuries caused by this product under federal law; and (iii) Merck’s sales of this product, alone or in combination with another of its products, was $2.275 billion in 2019. But yet, the FDA licensed this product based on one fake “placebo” controlled trial, with less than 1,000 children, that reviewed safety for only around 2 months, and then vaccinated the “placebo” group at nine months!

The FDA should be ashamed to call itself a regulatory agency. ICAN will be taking additional formal legal action regarding the lack of safety relied upon to license this product.

Fair Use: In some instances, we include someone else’s footage that is covered in Fair Use for Documentary and Educational purposes with the intention of driving commentary and allowing freedom of speech.

#PropagandaAlert: CDC COVID Number

This week the CDC quietly updated the Covid number to admit that only 6% of all the 153,504 deaths recorded actually died from Covid That’s 9,210 deaths The other 94% had 2-3 other serious illnesses & the overwhelming majority were of very advanced age” facebook.com/1566405890/pos

 

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So that means that H1N1 was officially more deadly.

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CDC quietly updated Covid number only 6% of 153,504 deaths died from C19?

This links directly to this article to show how after 17 years of the same system they decided to change the classification on death certificates just this year.

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BOMBSHELL: WHO Coronavirus PCR Test Primer Sequence is Found in All Human DNA

<img class=”i-amphtml-intrinsic-sizer” style=”max-width: 100%; display: block !important;” role=”presentation” src=”data:;base64,” alt=”” aria-hidden=”true” />WHO Primer

This was important enough that I wanted to get it out immediately. My research into the NCBI database for nucleotide sequences has lead to a stunning discovery. One of the WHO primer sequences in the PCR test for SARS-CoV-2 is found in all human DNA!

 

The sequence “CTCCCTTTGTTGTGTTGT” is an 18-character primer sequence found in the WHO coronavirus PCR testing protocol document. The primer sequences are what get amplified by the PCR process in order to be detected and designated a “positive” test result. It just so happens this exact same 18-character sequence, verbatim, is also found on Homo sapiens chromosome 8! As far as I can tell, this means that the WHO test kits should find a positive result in all humans. Can anyone explain this otherwise?

I really cannot overstate the significance of this finding. At minimum, it should have a notable impact on test results.

<img class=”i-amphtml-intrinsic-sizer” style=”max-width: 100%; display: block !important;” role=”presentation” src=”data:;base64,” alt=”” aria-hidden=”true” />WHO Primer 2

Homo sapiens chromosome 8, GRCh38.p12 Primary Assembly
Sequence ID: NC_000008.11 Length: 145138636
Range 1: 63648346 to 63648363 is “CTCCCTTTGTTGTGTTGT”

Update: After some effort, I have finally discovered a way to display proof (beyond my screenshots) that human chromosome 8 has this exact same 18-character sequence. Please try the link below. The sequence is shown at the bottom of the page.

https://www.ncbi.nlm.nih.gov/nucleotide/NC_000008.11?report=genbank&log$=nuclalign&from=63648346&to=63648363

Source:

https://pieceofmindful.com/2020/04/06/bombshell-who-coronavirus-pcr-test-primer-sequence-is-found-in-all-human-dna/amp/?__twitter_impression=true

THE HCQ SCANDAL

#Hydroxychloroquine studies conducted by Oxford and the WHO produced an astounding mortality rate 34 times that of other recent studies. As a result, the FDA revoked emergency use of the drug in the U.S. Now, data shows potentially lethal doses of HCQ were used on trial participants. Dr. Jim Meehan details this developing scandal.

Top Docs Sue FDA To End HCQ Restrictions”

It’s a political lie that is killing people. The left is nuts. And they are using the riots and protests as a fundraising campaign since the Ds were bankrupt, they get hundreds of millions through Act. Blue.

The FDA and the AMA are two of the biggest problems with the medical system in America!

HHS Chief Reverses FDA Stand on HCQ

Make no mistake, Fauci is ultimately responsible for those deaths.

HCQ is not effective because the NEW drug is $1000 a pop.. that is the ONLY reason. ALL studies showed HCQ WITH the Z-Pack absolutely has efficacy in use for CoVid19.. As you said Bill, “NONSENSE!”

 

The Corruption of Science. The Hydroxychloroquine Lancet Study Scandal. Who Was Behind It? Anthony Fauci’s Intent To Block HCQ on Behalf of Big Pharma

Hydroxychloroquine, WHO and The Lancet Controversy | A blow by blow account

Source:

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Eliminating Informed Consent on Human Experimentation with Vaccines and Drugs

The 21st Century Cure Act would demand that the Food and Drug Administration (FDA) add an exemption from informed Consent requirements for those clinical trials that pose no more than minimal risks and the appropriate safeguards protecting the right, safety and welfare of subjects.

Informed Consent Waiver

The above can be found in section 3024 – Informed Consent Waiver or Alterations for Clinical Investigations.

So what they are saying now they don’t have to obtain informed consents to test vaccinations or drugs on humans beings if it has been determined that the proposed pose no more than minimal risks.

Let’s review the Exemption  for Devices for Investigational Use

(g)(1) The purpose of this section to encourage to the extent consistent with the protection of public health and safety and ethical standards, the discovery and development of useful devices intended for human use and to that end to maintain optimum freedom for scientific investigators in their pursuit of that purpose.

In other words, you can get an exemption for certain conditions.

Question: if you don’t have informed consent in clinical trials experimentation on people, then how does anyone knows you are not part of an experiment?

If sponsors and clinical researchers not longer has to tell you that you are part of it or get your consent to informed you what they are doing? That may sound a little crazy.

Further source of research:

The 21st Century Cures Act Implications

Say Goodbye to Vaccine Safety Science by Barbara Loe Fisher

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U.S. Food & Drug Administration (FDA) Clinical Pharmacology Corner Update: FDA Approves COTELLIC (Cobimetinib)

U.S. Food & Drug Administration (FDA) Clinical Pharmacology Corner Update: FDA Approves COTELLIC (Cobimetinib)

Clinical Pharmacology Corner Banner

*FDA Approves COTELLIC^® (Cobimetinib) for the Treatment of Patients with Unresectable or Metastatic Melanoma with a BRAF V600E or V600K Mutation, in Combination with Vemurafenib *

On November 10, 2015, the United States Food and Drug Administration (FDA) approved COTELLIC (Cobimetinib) in combination with vemurafenib for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K Mutation. The approved recommended dosage of COTELLIC tablets is 60 mg orally once daily with or without food for the first 21 days of each 28 day cycle until disease progression or unacceptable toxicity. The dosage of COTELLIC may be reduced to 40 mg or 20 mg once daily for adverse reactions. Clinically relevant QT prolongation has been reported with vemurafenib, further QTc prolongation was not observed when cobimetinib 60 mg daily was co-administered with vemurafenib. Monitor ECG and electrolytes before initiating treatment and routinely during treatment with cobimetinib, when administered with vemurafenib.

_Mechanism of Action (MOA), General Pharmacokinetics (PK) and Pharmacodynamics (PD) of Cobimetinib_

* /MOA:/ Cobimetinib reversibly inhibits mitogen-activated protein kinase (MAPK)/extracellular signal regulated kinase 1 (MEK1) and MEK2. * /Dose proportionality:/ Exhibited dose-proportional increases in systemic exposure over the dose range of 3.5 to 100 mg (i.e., 0.06 to 1.7 times the approved recommended dosage).
* /Accumulation:/ Mean of 2.4-fold at the approved recommended dosage. * /Absorption:/ The absolute bioavailability of COTELLIC was 46% in healthy subjects. The Tmax was 2.4 hours (range:1 to 24 hours) in cancer patients.
* /Plasma protein binding:/ Approximately 95%.
* /Terminal half-life (mean):/ Approximately 44 hours (range: 23 to 70 hours) in cancer patients.
* /Metabolism:/ Primarily metabolized by CYP3A and glucuronidated by UGT2B7.
* /Excretion:/ Approximately 76% of the total recovered radio-labeled cobimetinib dose was eliminated in the feces (with 6.6% as unchanged drug) and 17.8% was eliminated in the urine (with 1.6% as unchanged drug).

_Drug Interaction Potential_

* Avoid strong or moderate CYP3A inhibitors. If concurrent short term (14 days or less) use of moderate CYP3A inhibitors including certain antibiotics (e.g., erythromycin, ciprofloxacin) is unavoidable for patients who are taking COTELLIC 60 mg, reduce COTELLIC dose to 20 mg. After discontinuation of a moderate CYP3A inhibitor, resume COTELLIC at the previous dose. Use an alternative to a strong or moderate CYP3A inhibitor in patients who are taking a reduced dose of COTELLIC (40 or 20 mg daily). Coadministration of the strong CYP3A inhibitor itraconazole increased cobimetinib AUC by 6.7-fold and Cmax by 3.2-fold.
* Avoid strong or moderate CYP3A inducers. Cobimetinib exposures are estimated to decrease by 83% when coadministered with a strong CYP3A inducer and by 73% when coadministered with a moderate CYP3A inducer. * Cobimetinib is a substrate of efflux transporter P-glycoprotein (P-gp) in vitro. Drugs that inhibit P-gp may increase cobimetinib concentrations; however, the clinical relevance of this finding is unknown.
* Clinically relevant pharmacokinetic interactions were not observed following coadministration of COTELLIC with the following medications: vemurafenib, midazolam (sensitive CYP3A substrate), dextromethorphan (sensitive CYP2D6 substrate), or rabeprazole (proton pump inhibitor).

_Use in Specific Populations_

The following population characteristics were not associated with a clinically significant effect on the pharmacokinetics of cobimetinib: sex, age (19 to 88 years), race/ethnicity, mild to moderate renal impairment (creatinine clearance [CLcr] 30 to 89 mL/min), and mild hepatic impairment (total bilirubin ≤ upper limit of normal [ULN] and AST > ULN or total bilirubin > ULN but ≤ 1.5 × ULN and any AST). The effect of moderate to severe hepatic impairment (total bilirubin > 1.5 to 3 × ULN and any AST), severe renal impairment or end-stage renal disease with or without hemodialysis (CLcr less than 29 mL/min) on cobimetinib exposure (i.e., AUC and Cmax) is unknown.

_Safety and Efficacy_

Clinical effectiveness and safety of cobimetinib were demonstrated at the approved recommended dosage in a multicenter, randomized (1:1), double-blinded, placebo-controlled trial in patients with previously untreated, BRAF V600 mutation-positive, unresectable or metastatic, melanoma. The median progression-free survival (PFS) was 12.3 months in patients treated with cobimetinib and vemurafenib compared with 7.2 months in those receiving vemurafenib as a single agent [hazard ratio: 0.56 (0.45, 0.70, p < 0.001)].

The most common adverse reactions were diarrhea, photosensitivity reaction, nausea, and vomiting. Advise patients to avoid sun exposure. Monitor for severe skin rashes and interrupt, reduce, or discontinue COTELLIC if required.