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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. 

Continue reading “JNJ COVID-19 vaccine trial – FDA rejects another ICAN petition”
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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

Continue reading “COVID-19 vaccine trials – FDA rejects ICAN petition to stop the 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.

Continue reading “Lipid nanoparticles in COVID-19 mRNA vaccines – ICAN fails science”

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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”

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ACIP COVID-19 vaccines meeting – summary of August 2020 discussions

This article about the August 2020 ACIP COVID-19 vaccines meeting was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.

Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable disease.

On August 26, 2020, the Advisory Committee on Immunization Practices (ACIP) held an emergency meeting to discuss COVID-19 vaccines. This was an emergency meeting, as opposed to one of its three annual scheduled meetings, but it was not “emergency” in the sense of being unplanned – it was announced long in advance, and the announcement was repeated during the June and July emergency meetings.

The ACIP COVID-19 vaccines meeting consisted of four to five hours of presentations from the COVID-19 vaccines workgroup, convened in April, and one hour of public comments that included multiple pro-vaccine speakers and four anti-vaccine individuals.

The main takeaway most people would have from the meetings are, I expect, the same as mine – that COVID-19 vaccines safety is taken extremely seriously by the workgroup and the committee, that there is still a lot of uncertainty about which of the vaccine in the pipeline will be effective, and that there are thorny, hard questions in deciding how to allocate the first vaccine doses.

This will be a very short overview of the meeting. The next meeting is on September 22, and I encourage and urge people to listen and learn from it. The presentation slides for the previous meetings can be found here. Continue reading “ACIP COVID-19 vaccines meeting – summary of August 2020 discussions”

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Post vaccination mortality – another anti-vaccine myth without merit

post vaccination mortality

One of the most pernicious myths of the anti-vaxxers is the claim that post-vaccination mortality is a rampant “epidemic.” Their evidence of such an issue with vaccines is non-existent, but it continues to be pushed by notable anti-vaccine missionaries like Del Bigtree and Robert F. Kennedy, Jr. 

The anti-vaxxer world seems to use anecdotes and VAERS (Vaccine Adverse Event Reporting System) to create fear, uncertainty, and doubt about vaccines by claiming that vaccines kill children. Well, anecdotes do not equal data (they are filled with bias) and dumpster-diving into VAERS which does not establish correlation, let alone causation. 

In other words, the anti-vaccine world relies on bad data to make claims about post-vaccination mortality. 

But is there a plague of vaccine-related deaths across the world? I have long stated that there have been few, if any, documented post-vaccination deaths over the past 40 years. I determined that by attempting to search for post-vaccination mortality reported in the peer-reviewed literature, but trying to prove a negative is difficult. 

But I’m just a science blogger who hasn’t published an article in years, so even the best scientific skeptic amongst you will say, “OK, you old feathered dinosaur, I trust you, but I need something more to deal with these anti-vaxxers.”

Well, this old feathered dinosaur happens to agree. Lucky for us, a group of researchers did some investigative research a few years ago to determine if there were any cases of post-vaccination mortality that have been documented. And what they found was – not so much. Continue reading “Post vaccination mortality – another anti-vaccine myth without merit”

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Evee Gayle Clobes – another tragedy incorrectly blamed on vaccines

Evee Gayle Clobes

This article about the tragic death of Evee Gayle Clobes was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.

Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable disease.

On March 1, 2019, Evee Gayle Clobes, a six-month-old baby, died in her mother’s bed. Because Evee had received her vaccines 36 hours before her death, and with the urging, courting, and support of anti-vaccine activists eager to use her and her story, her mother blamed vaccines.

However, this tragedy is even less appropriately blamed on vaccines than most, because there is a clear other cause for Evee’s death: According to the evidence detailed in a letter from the medical examiner, Evee Gayle Clobes, sadly, tragically, suffocated to death because of unsafe sleep conditions.

It is horrible to lose a child, and no parent should have to pay such a heavy price for a choice that could be mistakenly thought to be a reasonable one. But blaming vaccines incorrectly here can actively hurt others in multiple ways. Continue reading “Evee Gayle Clobes – another tragedy incorrectly blamed on vaccines”

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MMR vaccine sytematic review – science finds no link to autism AGAIN

MMR vaccine systematic review

With so much sense and nonsense about coronavirus, I set to the side an important MMR vaccine systematic review that I’ve been wanting to review for a few weeks. Well, it’s time to focus on that.

Ever since Mr. Andrew 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. Of course, they ignore over 150 published scientific articles that show that there are, in fact, no links at all.

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. 

And now we have a new, large, impressive MMR vaccine systematic review that once again provides affirmative evidence that there are no links between ASD and the MMR vaccine. None. Continue reading “MMR vaccine sytematic review – science finds no link to autism AGAIN”

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ICAN FOIA lawsuit – misrepresenting another non-win from anti-vaccine group

ICAN FOIA lawsuit

This article about another ICAN FOIA lawsuit was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.

Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable disease.

The Informed Consent Action Network (ICAN) is an anti-vaccine organization, founded in 2016 by Del Bigtree, largely funded by a New York couple, Bernard and Lisa Selz.

On March 4 and March 5, 2020, ICAN claimed a “win” against the CDC that, they said, prevented CDC from claiming vaccines don’t cause autism. In reality, the ICAN Freedom of Information Act (FOIA) lawsuit was settled, and the settlement doesn’t counter the existing scientific consensus that vaccines do not cause autism. Continue reading “ICAN FOIA lawsuit – misrepresenting another non-win from anti-vaccine group”

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2020 Vaccine Day – reminders about their safety and effectiveness

2020 vaccine day

Today is 2020 Vaccine Day. It’s not an official holiday with Hallmark cards but it is an annual event where #DoctorsSpeakUp about vaccines and remind the world that vaccines stop diseases.

And they are safe.

And they are effective.

This article isn’t here to argue about some obscure point about vaccines like they don’t cause autoimmune diseases, because they don’t. I just want to cover some of the more important issues about vaccines about which I wrote over the past few years (I’ve been writing here since January 2012).

So, let’s celebrate the 2020 Vaccine Day, and I’m here to help #DoctorsSpeakUp. Continue reading “2020 Vaccine Day – reminders about their safety and effectiveness”