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lipid nanoparticles

Lipid nanoparticles in COVID-19 mRNA vaccines are safe – ICAN is wrong

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 the fields 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 another one of their PR stunts 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.

Read More »Lipid nanoparticles in COVID-19 mRNA vaccines are safe – ICAN is wrong
anti-vaccine groups

Anti-vaccine groups received over $850,000 from Paycheck Protection Program

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.

Read More »Anti-vaccine groups received over $850,000 from Paycheck Protection Program
2020 top 10 list

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

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.

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

COVID-19 herd immunity

COVID-19 herd immunity without vaccines? That will lead to genocide

Yesterday, I spent a bit of your time writing about the Great Barrington Declaration which strives to create COVID-19 herd immunity, without a vaccine,  by opening up the economy and allowing people to get infected. It was based on pseudoscience and callous disregard for the health of people across the world. Numerous other scientists showed their disdain for it like David Gorski and a friendly microbiologist

I was going to move on to other things to discuss when it became clear that Donald Trump supports this pseudoscientific nonsense. Of course, Trump has promoted all kinds of equine feces about the coronavirus from pushing hydroxychloroquine to trying to take shortcuts in producing a vaccine

Then it became clearer to me that trying to create COVID-19 herd immunity without a vaccine was worse than I thought. Maybe I’m buying into hyperbole, but I don’t think so. Let’s get into it.

Read More »COVID-19 herd immunity without vaccines? That will lead to genocide

VARIVAX

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

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.Read More »VARIVAX chickenpox vaccine – newest target of the anti-vaccine ICAN

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.Read More »ACIP COVID-19 vaccines meeting – summary of August 2020 discussions

post vaccination mortality

Post vaccination mortality – another anti-vaccine myth without merit

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.Read More »Post vaccination mortality – another anti-vaccine myth without merit

Evee Gayle Clobes

Evee Gayle Clobes – another tragedy incorrectly blamed on vaccines

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.Read More »Evee Gayle Clobes – another tragedy incorrectly blamed on vaccines

The great vaccine debate – only exists in the brains of anti-vaxxers

Frequently, anti-vaxxers like Robert F Kennedy Jr and Del Bigtree demand a great vaccine debate between whomever they’re targeting, like Paul Offit or our friend Dorit Rubinstein Reiss, and themselves. I find it amusing, and if anyone asks, I tell them that a vaccine debate is worthless for lots of reasons.

The problem is that if you pay attention to any scientific topic, like climate change, evolution, and, yes, vaccines, you’d think that some scientific principles were actually being debated by scientists. The unfiltered information about important scientific subjects allows the science deniers to use a false equivalency to make it appear that the minority and scientifically unsupported point of view is equivalent to the scientific consensus which is always based on huge amounts of published evidence. And for vaccines, the safety and effectiveness are settled science.

From listening to the screaming and yelling, you would think that there is a great vaccine debate. Or an evolution debate. Or a climate change debate. 

There aren’t any debates on any of those (and hundreds of other) scientific topics. Just because someone, like RFK Jr or Bigtree, thinks that there is some “debate,” it doesn’t mean there actually is one. All that happens is one side, almost always the science deniers, use misinformation, lies, anecdotes, and pseudoscience while attempting to scream and yell as loud as possible, then claim they’ve won.

Science can’t be debated. And a corollary is that there is no great vaccine debate.

Read More »The great vaccine debate – only exists in the brains of anti-vaxxers
MMR vaccine systematic review

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

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 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. 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. Read More »MMR vaccine sytematic review – science finds no link to autism AGAIN