JNJ COVID-19 vaccine trial – FDA rejects another ICAN petition

JNJ vaccine clinical trial

This article about the Informed Consent Action Network’s petition to halt the JNJ COVID-19 vaccine trial was written by Viridiana Ordonez, a J.D. candidate at the University of California, Hastings College of Law

This is a summary of the FDA’s response to a citizen petition dated October 16, 2020, filed on behalf of the petitioner, Del Bigtree’s Informed Consent Action Network (ICAN), relating to the clinical trial of Ad26.COV2S, a Janssen Biotech, Inc. (a subsidiary of Johnson & Johnson, JNJ) COVID-19 vaccine.

Like a previous ICAN petition about COVID-19 vaccine trials, the FDA denied the petition in its entirety. FDA concluded that the vaccine trials were thorough, vaccine safety was carefully tested and monitored, and ICAN’s requests are not well-founded. 

This summary is divided into three parts: (1) ICAN’s specific requests; (2) FDA’s description of the vaccine process and safety; and (3) FDA’s response to six specific requests. 

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Joe Mercola warned by FDA about quack COVID-19 treatments

joe mercola

One of our favorite alternative medicine quacks, Dr. Joe Mercola, DO, has been warned by the FDA to cease promoting useless COVID-19 treatments. This is not the first time that Dr. Mercola has run afoul of the FDA, and given his past activities, I doubt it’s his last.

The FDA told Joe Mercola that three products he markets with COVID-19 treatment claims are are “unapproved new drugs” and “misbranded drugs” being sold in violation of the Food, Drug, and Cosmetic Act. The three products are – Liposomal Vitamin C, Liposomal Vitamin D3, and Quercetin and Pterostilbene Advanced.

In case you don’t feel like reading what Joe Mercola has done this time, I’ll save you a bit of time. There is no evidence that any of these products do anything to treat COVID-19. But let’s take a look at Mercola and his quack treatments.

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Vitamin D treatment for COVID-19 – the evidence is really weak

Two recent papers have been published recently that seem to support that vitamin D does something to prevent or treat COVID-19. Except for a tiny little problem – both of the studies terribly weak and are unconvincing except to those who just want supplements to do something to end this pandemic. Don’t get your hopes too high.

Of course, the COVID-19 pandemic has caused interest in vitamin D to skyrocket, because there has been a belief that vitamin D improves the immune system against the disease. The sales of vitamin D supplements have increased substantially since pre-pandemic times.

But is there any evidence supporting its use to prevent COVID-19 or improve outcomes for serious cases? Yes, there is evidence, but it’s far from convincing. There are better ways to prevent a COVID-19 infection, and vitamin D is not one of them.

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COVID-19 vaccine trials – FDA rejects ICAN petition to stop the trials

COVID-19 vaccine trials

This article about the Informed Consent Action Network’s petition to halt COVID-19 vaccine trials was written by Viridiana Ordonez, a J.D. candidate at the University of California, Hastings College of Law

This article summarizes the FDA’s response to Del Bigtree’s ICAN’s (petitioner) request regarding the Phase III trials for the COVID-19 vaccine.  The summary is divided into three parts:

  1. Petitioner’s Request;
  2. FDA’s description of vaccine process; and
  3. FDA’s response to the petition.


ICAN’s request for COVID-19 vaccine trials

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Lipid nanoparticles in COVID-19 mRNA vaccines – ICAN fails science

lipid nanoparticles

This article about lipid nanoparticles in COVID-19 mRNA vaccines is by VaultDwellerSYR, a pseudonym used by a faculty member of a School of Pharmacy within a large medical school. They have significant research and publications on the effect of certain chemicals on the brain. Although we are opposed to all arguments from authority, the author has a substantial record of actual, published research in this field of brain cell biology and biochemistry. 

The anti-vaccine Del Bigtree‘s Informed Consent Action Network (ICAN), as expected, started to seed doubts and fallacious claims on COVID-19 mRNA vaccines, in an attempt to discredit and reduce the uptake of this vaccine by the population.

In their latest stunt, ICAN posted on January 17th on their Facebook page the following statement with a “legal update” pictogram:

ICAN INQUIRES WITH THE FDA ABOUT THE SAFETY OF LIPID NANOPARTICLES USED IN PFIZER’S AND MODERNA’S COVID-19 VACCINESICAN, through its attorneys, has once again written to Dr. Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research, to demand a response to the question of whether or not lipid nanoparticles used in both of the currently authorized COVID-19 vaccines are safe. 
ICAN is aware that both Pfizer and Moderna have used lipid nanoparticles (“LNPs”) in their vaccines – LNPs are what the manufacturers use to surround the RNA so that it does not fall apart when injected and before reaching its target cells. Some have compared these LNPs to a fatty envelope or a delivery vehicle to get the mRNA into the human body in one piece.

A concern arose when ICAN was alerted to a study published in 2018 titled Lipid Nanoparticles: A Novel Approach for Brain Targeting. The study states: “…lipid nanoparticles are taken up readily by the brain because of their lipophilic nature. The bioacceptable and biodegradable nature of lipid nanoparticles makes them…suited for brain targeting.” The article also states, “these nanostructures need to be investigated intensively to successfully reach the clinical trials stage.”
ICAN wants to fully understand whether the evidence that these LNPs are easily taken up and end up in the brain is a safety concern with these two particular vaccines. ICAN, through its attorneys, led by Aaron Siri, has therefore sent a letter to Dr. Peter Marks, the Director of the Food and Drug Administrations’ Center for Biologics Evaluation and Research. If you recall from previous legal updates, Dr. Marks has referred to himself as “the FDA point person on COVID-19 vaccines” and has assured Americans that the FDA “will make sure they’re safe and effective.” 

ICAN also pointed out to Dr. Marks that there appears to be support for the proposition that the body may react strongly to a second dose of the LNPs. Stated differently, the body is primed to have an immune reaction to the LNPs with the first dose. As explained by Johns Hopkins, “Side effects were more frequent after the second dose in the vaccine trials.” Another article, titled Exogenous nanoparticles and endogenous crystalline molecules as danger signals for the NLRP3 inflammasomes, supports that the increasingly inflammatory side effects observed in those who received the vaccine in Pfizer’s and Moderna’s clinical trials are attributable to the LNPs and that these side effects get worse with repeated injection. We have seen this increased “reactogenicity” clearly in the data from both Pfizer’s and Moderna’s COVID-19 clinical trials. 
ICAN continues to ask the hard questions of Dr. Marks and others: If LNPs from the vaccine, which contain mRNA, are entering brain tissue, and an immune reaction is occurring during the second dose to these LNPs, does this pose a safety concern for vaccine recipients? ICAN asked Dr. Marks to consider the question posed and provide support for the substance of any response he provides.

ICAN will closely review any response from Dr. Marks given his promise that he and the FDA “uphold globally respected standards for product quality, safety, and efficacy” and his statement that he would resign if “something that was unsafe or ineffective [] was being put through.” As always, ICAN offered to provide any additional information or to meet with Dr. Marks to discuss this issue.

As you can see, ICAN is on one of another PR stunt in the attempt to “cease and desist”, as intimidation with little legal merit and certainly not based on an honest and critical review of the existing literature. Let’s critically examine ICAN’s claims about lipid nanoparticles.

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Andrew Wakefield is back and thinks COVID-19 mRNA vaccines change DNA

The cunning fraud  MrAndrew Wakefield is back again pushing a new brand of anti-vaccine gibberish combined with a huge dollop of COVID-19 denialism. Of course, he would jump into the fray pushing debunked and discredited tropes about COVID-19 mRNA vaccines, because he has had nothing factual to say about any vaccine for twenty years. It would be delusional to believe that he would suddenly see the light about these new vaccines.

Of course, the anti-vaccine religion considers Andrew Wakefield one of their high priests, along with Del Bigtree and Robert F Kennedy Jr, all of whom appear to have the power of papal infallibility – whatever they claim is considered dogma, irrespective of science. Of course, Andrew Wakefield’s initial paper about vaccines and autism was retracted, and the overwhelming science debunks this claim.

Wakefield has become so discredited as a “scientist” that he has resorted to “publishing” his most recent gibberish, vaccines are causing the sixth mass extinction, in the discredited Journal of the Association of American Physicians and Surgeons (AAPS), which is not indexed in PubMed. The AAPS is a far-right medical association that rejects most science about climate change, vaccines, HIV, and many other issues. In case you’re wondering, their leader, Dr. Jane Orient, is a COVID-19 denier.

So, what has Mr. Wakefield said now? He’s repeating the debunked myth that the mRNA in the Pfizer and Moderna vaccines will change your DNA. No, they won’t. Here I go again, disputing more garbage spewed by Andrew Wakefield.

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Steven Brandenburg destroys COVID-19 vaccines because they change DNA

Steven Brandenburg

In between all of the bad news going on in the world, you may have missed the story of Steven Brandenburg, the anti-vaccine pharmacist who intentionally destroyed numerous vials of the Moderna COVID-19 mRNA vaccine, which had recently received an emergency use authorization from the US FDA.

At first, it was thought it was unintentional. When you are moving quickly to vaccinate healthcare workers and others against the deadly disease, maybe Steven Brandenburg, a licensed pharmacist, just got so busy that he left the vaccine on a table until it was too late. I have been involved with vaccines for a long time, and I cannot begin to count how many times people have spoiled vaccines because of forgetfulness, not understanding how it should be stored, or a plethora of other reasons.

Once it became clear what had happened, Brandenburg was fired by his employer, Aurora Medical Center in Grafton, Wisconsin, and eventually arrested for destroying over 500 doses in about 53 vials of the vaccine. Maybe one could be excused for accidentally spoiling 5 vials of the critical vaccine. But 53 vials is strong evidence of criminal intent (note, I am not an attorney, nor do I play one on the internet). 

Steven Brandenburg was charged with felony charges of reckless endangerment and property damage, though prosecutors said the charges could be dropped to a single misdemeanor if the vials, which have yet to be tested, are still usable. He is out of jail on a $10,000 bond.

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Flu treatment quackery – it is all woo, so get your influenza vaccine

flu treatment

It’s that time of year when we are bombarded by flu treatment quackery from “immune-boosting” miracle supplements to junk that “cures” every single virus known to medical science. During this world of the coronavirus pandemic, it seems to be even louder

This article will attempt to debunk the myths of flu treatments such as “boosting the immune system,” magical supplements, and other nonsense involved with the world of flu treatment pseudoscience.

The one way to prevent the flu, other than hiding in a bubble during the winter (which may be a good thing with the COVID-19 pandemic), is the seasonal flu vaccine. But that’s not a treatment, it prevents the flu.

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Autism and vaccines – over 150 peer-reviewed science articles say no link

autism and vaccines

Autism and vaccines are not linked or associated according to real science, published in real scientific journals written by real scientists and physicians. But this false claim that vaccines and autism are related is repeated by anti-vaxxers nearly every day.

Let’s be clear – the lack of a link between vaccines and autism is settled science. There is overwhelming evidence, as listed in this article, that there is no link. Outside of anecdotes, internet memes, misinformation, and VAERS dumpster-diving, there is no evidence that there is a link. 

Ever since MrAndrew Wakefield published his fraudulent, and subsequently retracted, study that seemed to show a link between the MMR vaccine and autism spectrum disorder (ASD), the anti-vaccine crowd has embraced it as if it were a scientific fact. 

This Wakefield chicanery has spawned a cottage industry of other anti-vaccine zealots like Del Bigtree and his fraudumentary Vaxxed, Robert F. Kennedy Jr., Christopher Exley, Christopher Shaw, James Lyons-Weiler, Tetyana Obukhanych, and many others. 

This article presents over 150 scientific articles, published in high-quality, peer-reviewed journals. Almost all of them are either primary studies that include large clinical trials or case-control or cohort studies. They also include numerous systematic reviews, which represent the pinnacle of biomedical research.

All of these articles, from some of the top vaccine scientists in the world, show that there are no links between autism and vaccines. None. 

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VARIVAX chickenpox vaccine – newest target of the anti-vaccine ICAN

VARIVAX

And here we go again with more anti-vaccine nonsense from Del Bigtree‘s Informed Consent Action Network (ICAN) – this time it’s about Merck’s VARIVAX chickenpox vaccine. And, of course, there’s nothing that they present that is accurate or worrisome. 

VARIVAX is a well-studied vaccine that is both demonstrably safe and demonstrably effective. However, Bigtree and ICAN always think they have some amazing catch that shows that vaccines are bad. And they are never right, so that’s why we have to spend time taking it down.

Let’s see what they have to say, but first a little bit about chickenpox. Continue reading “VARIVAX chickenpox vaccine – newest target of the anti-vaccine ICAN”