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”

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”

ICAN claims win because CDC reformatted Vaccines and Autism page

ICAN claims win

This article about how ICAN claims a win as a result of the CDC reformatting its Vaccines and Autism page 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. She is also a member of the Vaccines Working Group on Ethics and Policy.

On January 21, 2021, the anti-vaccine organization Informed Consent Action Network (ICAN) published an article titled “The CDC Finally Capitulated To ICAN’s Legal Demands and Removed the Claim that “Vaccines Do Not Cause Autism” From Its Website!”.

The article is even less convincing than ICAN’s usual claims, because the CDC’s Vaccines and Autism page still, essentially, states there is no link between vaccines and autism, and that vaccines do not cause autism. The CDC just changed its title and reformatted it – probably for reasons that have nothing to do with ICAN.

I am going to review why ICAN claims a win, and why it really isn’t – the CDC hasn’t changed its view on autism and vaccines.

Continue reading “ICAN claims win because CDC reformatted Vaccines and Autism page”

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”

Anti vaccine groups receive over $850,000 in pandemic bailout money

anti-vaccine groups

On 18 January 2020, The Washington Post reported that several prominent anti-vaccine groups received over $850,000 from the Paycheck Protection Program (PPP), a government plan that provides loans to small businesses to assist in paying wages and certain other expenses during the COVID-19 pandemic. 

Generally, I don’t spend a lot of time discussing recent news events because real newspapers, like the Washington Post, do a much better job than I would. I wouldn’t even have thought in my wildest imagination that this bailout money would have gone to these groups that have only one purpose – reducing vaccine uptake so that more children and adults will suffer from diseases.

I find it particularly ironic that these groups, which are not only anti-vaccine but populated with right-wing COVID-19 deniers, would take bailout money that was expressly set up to help businesses deal with the COVID-19 pandemic. 

When I read the article, I was livid. And I’m going to express my anger in this post, but I don’t think I’m the only person who wants to write the same things. So, this is like the old feathered raptor’s op-ed piece on this story.

Continue reading “Anti vaccine groups receive over $850,000 in pandemic bailout money”

Massachusetts influenza vaccine mandate withdrawn – an analysis

Massachusetts influenza vaccine mandate

This article about why Massachusetts withdrew its influenza vaccine mandate for children 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. She is also a member of the Vaccines Working Group on Ethics and Policy.

On August 19, 2020, the Massachusetts Department of Public Health announced that the influenza vaccine will be required from all children “6 months of age or older who are attending Massachusetts child care, pre-school, kindergarten, K-12, and colleges and universities.”

The requirement was only for children attending in-person (not online) education and had a deadline of December 31, 2020. A lawsuit was filed against the mandate, apparently, according to the anti-vaccine organization Informed Consent Action Network (ICAN), funded by that organization, and brought by the law firm they habitually employ, Siri & Glimstad LLP (In 2019, ICAN paid the law firm $1,263,432 for “legal services” out of over $3.4 million the organization took in as income, according to their 990 filings).

After the Massachusetts Department of Public Health pushed off that deadline to February, they decided to withdraw the influenza vaccine mandate on January 15, 2021.

The Public Health Department explains in a letter:

Preliminary data show that this has been a mild flu season to date, presumably as people have received their seasonal flu vaccine and have been adhering to mask-wearing and social distancing due to COVID-19. Given the intensive Commonwealth-wide efforts regarding COVID-19 vaccination, DPH wants to alleviate the burden to obtain flu vaccination and focus on continuing our COVID -19 vaccination efforts. DPH continues to strongly recommend that everyone age six months and older receive their seasonal flu vaccine each year.

ICAN is celebrating this as a victory of their lawsuit. We do not know which other considerations went into the decision, and the lawsuit may have had an effect, if only by adding to the already full plate of the department during a pandemic.

But the reality is that given the jurisprudence on vaccine mandates, and given the deference most courts show public health authorities during a pandemic, if there were good grounds to insist on the mandate, the department would likely have held its grounds. A number of other factors likely fed into the decision, including, as pointed out, a relatively mild flu season (in part thanks to public health measures against COVID-19), Massachusetts stated desire to bring children back to in-person education, which may have led the department to seek to remove barriers, and the need to focus on the COVID-19 vaccine effort.

Plus, it is mid-January. The benefit of being distracted by a fight over an influenza mandate this late is probably less than the harm to other important efforts.

2020 top 10 articles – not all about vaccines and COVID-19

2020 top 10 list

It’s that time of the year, the top 10 articles of 2020 on the Skeptical Raptor website. As years go, 2020 is quite at the level of 1939, when WWII started that killed six million Jews and over 50 million other people, or 1347, the first year of the Black Death, which eventually killed up to 200 million people.

But in my lifetime, 2020 ranks at or near the top 10 of the “years that suck” list. 

Traditionally, I repost the top 10 list of articles that I have written over the past year, but 2020 is different. The news about COVID-19, vaccines, and quack treatments have required constant writing so, I never got to do the reposts. So, I’m just going to list the 2020’s top 10 list of articles.

Please take time to read some of them, repost them if they’re interesting, and comment. It helps this website grow and gets out facts about important science and medical issues that are the target of science deniers.

Continue reading “2020 top 10 articles – not all about vaccines and COVID-19”

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”

Vaccine adjuvants – another misguided FOIA request from ICAN

vaccine adjuvants

This article about an FOIA request for information about vaccine adjuvants 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.

In August 2020, the anti-vaccine organization, the Informed Consent Action Network (ICAN), posted on their site a letter from the National Institutes of Health (NIH) dated July 19, 2019, under the (misleading) title that “NIH Concedes It Has No Studies Assessing The Safety of Injecting Aluminum Adjuvants.”

As in the past, ICAN’s use of the Freedom of Information Act (FOIA) request result is highly misleading, in at least three ways. First, FOIA is not a mechanism for science query, only a way to get existing administrative records, and this is a misuse of FOIA. Second, there are abundant scientific studies on the safety of aluminum vaccine adjuvants, but this request was not a way to get them. And third, even if there were no studies on the safety of aluminum adjuvants in vaccines, vaccines are tested as a whole, and the safety data on them cover all their ingredients. Continue reading “Vaccine adjuvants – another misguided FOIA request from ICAN”

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”