ICAN anti-vaccine rhetoric — getting it wrong about informed consent

This article about ICAN and its anti-vaccine rhetoric about informed consent 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 vaccination’s social and legal policies. 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 diseases. She is also a member of the Vaccines Working Group on Ethics and Policy.

In a misleading “White Paper,” the anti-vaccine organization, Del Bigtree‘s Informed Consent Action Network (ICAN) argued that “eliminating vaccine exemptions and curtailing criticism is unethical and un-American” because, they argue, it invalidates vaccination informed consent. The initial statement is wrong, and the arguments brought to support it are wrong. This article corrects the record.

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FDA, CDC, and COVID-19 vaccines — who does what?

FDA CDC COVID-19 vaccines

This article about the role of the CDC and FDA concerning COVID-19 vaccines 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 diseases. She is also a member of the Vaccines Working Group on Ethics and Policy.

I write this right after the FDA expert advisory committee, Vaccines and Related Biological Products Advisory Committee (VRBPAC), voted unanimously that the benefits of both Moderna and Pfizer-BioNTech’s COVID-19 vaccines for children 6 months to 5 years of age outweigh their risks, clearing a smooth path for FDA to grant emergency use authorization (EUA) to these vaccines. I was asked about the division of labor between CDC and FDA on COVID-19 vaccines, and it seems like something worth setting out.

So this is a short post about the relative roles of the FDA and CDC in getting COVID-19 vaccines to people in the USA. It is not a full picture of how vaccines get to us; there is a lot more to that. I am not even going into the full requirement for approving or authorizing a vaccine; just who does what. But this piece of the puzzle can be useful by itself.

For those looking for a full description of the vaccine approval process, I recommend either the Skeptical Raptor’s post on that topic or the description by the Vaccine Education Center of the Children’s Hospital of Philadelphia.  

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COVID vaccines are not responsible for mysterious hepatitis outbreak

photography of people on grass field

An outbreak of hepatitis of unknown etiology in children across the world is not caused by COVID-19 vaccines. Of course, anti-vaxxers are trying to use this hepatitis outbreak as more fear, uncertainty, and doubt about the COVID-19 vaccines, but the evidence doesn’t support it.

As of this time, we don’t know a lot about this hepatitis outbreak, like routes of infection and the causative agent, but it is ringing the alarm bells at various public health agencies across the world.

In this article, I will walk you through the hepatitis outbreak and then some limited data that appear to show that there is no link to either COVID-19 or COVID-19 vaccines.

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Smallpox vaccine effectiveness for monkeypox — some facts

monkeypox vaccine

I have read several times that the effectiveness of the smallpox vaccine against monkeypox was over 85%. The number comes from the CDC website information about monkeypox which most of us take as authoritative.

I know that I’m probably rushing a little bit to talk about monkeypox and a potential vaccine, given that there have been only two hundred confirmed and suspected cases in the world (as of the date of this article), but there are some troubling issues with this outbreak including a much higher infectivity rate.

If those of us who have received the smallpox vaccine (which was at least 40 years ago for the youngest of us) retain 85% effectiveness against monkeypox, then I’m going to worry a lot less. However, even though that number was posted by the CDC, they gave no links to peer-reviewed articles that support that number. And it was unclear whether they meant the modern smallpox vaccines or the ancient vaccine that nearly 100% of us received decades ago.

So, I’m going to dig into it because I think we should know. Plus the more accurate information we have, the better we are going to deal with the inevitable anti-vaccine tropes, memes, and outright lies that will soon appear across the internet.

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ICAN lawsuit against CDC statement that vaccines do not cause autism

vaccines autism

This article about another ICAN lawsuit disputing the CDC statement that vaccines do not cause autism 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 diseases. She is also a member of the Vaccines Working Group on Ethics and Policy.

On March 31, 2022, a federal district judge dismissed the Informed Consent Action Network‘s (ICAN) lawsuit demanding that CDC remove the statement that vaccines do not cause autism. The judge dismissed the lawsuit because ICAN failed to show that the alleged harms it claimed were caused by anything CDC did, or that removing the statement would fix the problem that they claim they identified. 

The claim never got to be examined on the merits, and for the purpose of dismissal at this early stage, the judge is required to treat ICAN’s claims as true. But it’s worth reminding readers that extensive data shows that vaccines do not cause autism.

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No evidence of post-vaccine mortality – a systematic review

covid vaccine bottles and syringe

There is a belief by the anti-vaccine world that there is plenty of evidence of post-vaccine mortality. For example, Dorit Rubinstein Reiss and I have written two articles, about Nick Catone and Colton Berrett, that refute parental claims about post-vaccine mortality involving their children. Those boys’ deaths were tragic, but according to the best evidence we have, neither was caused by vaccines.

Post-vaccine mortality is often not causally related. It may feel like one event that follows another event is related, which is the post hoc ergo propter hoc fallacy. There may not be any correlation, let alone causality, that would make us accept that vaccines kill.

Those of us who accept the fact that vaccines are very safe, and indeed, not really a risk for causing death, have found no evidence of post-vaccine mortality over the past couple of decades. This comes from examining the high-quality scientific and medical literature, which may or may not include all incidents of post-vaccine mortality.

Now, I’ve always contended that there is no evidence that there has ever been a death attributed to vaccines. I never agreed with the old adage that “science can’t prove a negative,” but I do think that the burden of proof is on those making that claim. Where is the evidence of a link between vaccines and mortality? Sometimes, the absence of evidence can be evidence of absence, Carl Sagan’s claims notwithstanding, especially if we look very carefully for that evidence.

Let’s move on to an important published study that should help our understanding of whether vaccines kill. They don’t.

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Judge vacates CDC mask mandate in a problematic decision

CDC mask mandate

This article about a judge’s problematic decision regarding the CDC mask mandate 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 diseases. She is also a member of the Vaccines Working Group on Ethics and Policy.

On April 18, 2022, Kathryn Kimball Mizelle, a federal district judge in Florida, struck down the CDC mask mandate on public transportation. The analysis was highly problematic since it second-guessed the agency’s judgment on public health, ignored existing precedent and the natural meaning of the statute interpreted, and implied that COVID-19 is not a serious issue, discounting hundreds of thousands of deaths and millions of cases of serious illness. It also analyzed the procedural framework in a way, not in line with the usual operation of administrative law. 

It is a strong example of judicial aggressive second-guessing of the political branches’ choices. And doing so in a way that will, literally, kill and harm people – and goes again the majority preferences. In any way, shape, and form it is a failure to fill the judicial role. 

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Increased risk of diabetes in children who have recovered from COVID

children diabetes covid

A new study from the CDC shows that children who have recovered from COVID-19 are at a significantly higher risk of type 1 or type 2 diabetes. I have written previously that COVID-19 might be linked to diabetes, but those studies were in adults. But this study shows that the risk of diabetes might be greater for children who had COVID-19.

This should be more reason for parents to make certain that their children are fully vaccinated against the disease. Diabetes is a lifetime disease that must be closely managed with insulin and, in the case of type 2 diabetes, various medications.

This post will review the research on children who have had COVID-19 and the risk of type 1 or type 2 diabetes.

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COVID vaccine safety and effectiveness for 5-11-year-olds

woman holding sign

On 30 December 2021, the Centers for Disease Protection and Control (CDC) released two studies on COVID-19 vaccine safety for 5-11-year-olds that showed that there were few serious safety issues and showed that the vaccines prevented serious illness and hospitalization.

These two studies provide strong evidence for COVID-19 vaccine safety and effectiveness for children and should provide confidence for parents to make sure their children get the vaccine.

This post will examine these peer-reviewed articles and pull out the key data for the reader.

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I got my Moderna COVID vaccine booster – my immune system is powerful

Moderna booster

On 25 October 2021, I got my Moderna COVID-19 vaccine booster shot. As with the first two shots, I felt nothing other than a bit of a sore arm.

Now my immune system is scientifically boosted to handle whatever SARS-CoV-2 has for me. I’m ready to kick its sorry butt for even thinking about infecting me.

Why did I get the booster?

  • Because it’s safe.
  • Because the Moderna booster protects me against COVID-19 even more.
  • Because there is evidence that the original series of shots have waning immunity.
  • Because it’s the only way to boost my immune system against the coronavirus.
  • Because I know that vaccines are more powerful than pseudoscientific supplements and quackery.
  • Because the CDC recommends it.
  • Because it was free.
  • Because I want to do the right thing for my own health and to protect others.

I don’t know if boosters will be necessary every few months or years. But this virus is so resilient and mutates so frequently, I am willing to bet we will need frequent boosters for any of the COVID-19 vaccines.

In fact, early evidence appears to indicate we might need a second booster for the Omicron variant.

person getting vaccinated
Photo by Gustavo Fring on Pexels.com

Any of you who are pregnant, obese, or immunocompromised, especially if you’re older than 50 should get the booster. Anyone with the following health conditions should get COVID-19 vaccine boosters:

  • Alcoholism
  • Cancer
  • Chronic kidney, liver, or lung diseases (such as moderate or severe asthma)
  • Dementia
  • Diabetes
  • Down syndrome
  • Genetic conditions, such as sickle cell disease or thalassemia
  • Cardiovascular diseases
  • HIV
  • Hypertension
  • Mental health conditions such as depression or schizophrenia
  • Smokers or former smokers
  • Stroke
  • Substance abuse
  • Tuberculosis

Anyone who works in certain occupations that are at high risk of COVID-19 should get the booster shot:

  • Healthcare workers
  • Firefighters
  • Police
  • Educators, such as teachers, daycare workers, and support staff
  • US postal workers
  • Public transit workers
  • Food and agriculture workers
  • Those who work in grocery stores, corrections, or manufacturing

Those were the original recommendations. However, now everyone should get a booster, and as I said above, we might need a second booster.

Update

Nothing to update. No adverse events. No breakthrough infections. No flu (because I also got my flu vaccine). I must be the one boring boosted individual.

Moderna booster
Cute kittens to make you happy before you get your booster shot. Photo by Ilse Orsel on Unsplash.
Cute puppies for dog lovers. Photo by Jametlene Reskp on Unsplash