Vaccine Safety Datalink

The risk of Guillain-Barré syndrome after COVID mRNA vaccines is low

I keep reading anti-vaccine commentary that Guillain-Barré syndrome had been linked to the COVID-19 vaccines according to a deep dive into the VAERS database. Those of you who read my works know that I am apt to dismiss almost any claim that is based on VAERS. it is not built to show correlation let alone causation between Guillain-Barré syndrome and COVID-19 vaccines.

However, as I have said before VAERS can send a safety signal that should be investigated more thoroughly. And that’s what a vaccine research team did — they went to a better vaccine safety database and performed a thorough study. And what they found is that the COVID-19 mRNA vaccines, from Pfizer and Moderna, were not linked to Guillain-Barré syndrome. However, they did find a link to the JNJ COVID-19 vaccine, which confirms what was being discussed a few months ago.

Let’s take a look at this study so that we can at least partially debunk anti-COVID-19 vaccine claims.

No evidence of post-vaccine mortality – a systematic review

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.

VAERS once more with science — how to use it and how to abuse it

I have written numerous times about the Vaccine Adverse Event Reporting System (VAERS) because it is the database of choice for the anti-vaccine world to “prove” that a vaccine is dangerous. It is misused even though it does not tell scientists whether a vaccine is harmless or harmful.

Even though I’ve discussed it many times, I’ve usually critiqued VAERS here and there in different ways, so I wanted to write down, in easy-to-consume, bullet points. I love bullet points since if you have a limited amount of time to read through thousands of words, you can find the information you need easily.

So here we go, let’s take a look at the dumpster-diving into the VAERS database.

Adverse events surveillance after 11.8 million COVID mRNA vaccine doses

A paper was just published that reviewed adverse events after 11.8 million COVID-19 mRNA vaccine doses were administered in the USA. Because it is the topic of discussion these days, I felt it was important to review this paper.

Even though anti-vaxxers love to claim excess adverse events after people receive the COVID-19 mRNA vaccine, there are excellent methods that the CDC has developed to monitor these issues in vaccines, and this new paper looks at one of them.

The news is good, in case you’re wondering.

The childhood vaccines schedule is not linked to type 1 diabetes

I have debunked a lot of anti-vax claims that childhood vaccines, including the COVID-19 vaccines, are linked to type 1 diabetes. Of course, there is no evidence of a link between vaccines and diabetes — in fact, there is lots of evidence that some vaccines can actually reduce the risk of diabetes.

Of course, there is a continuing effort to stop this particular anti-vax myth (as if anti-vaxxers actually care about science and evidence), so another peer-reviewed study has been published that once again discredits these claims. And once again, for those who just want the tl;dr version, this research team found no link between vaccines and diabetes.

Anti-vaxxers misuse VAERS against COVID-19 vaccines – bad science

Recently, a poorly written pre-print article uses VAERS “data” to show that the COVID-19 vaccines cause myocarditis in children 12-17 years old. Although we do have some data that the COVID-19 mRNA vaccines may be linked to myocarditis in some age groups.

I, and many others, have frequently criticized the use of VAERS, and I will do it again in this article, so just hang on. It cannot be used for anything by gross observations, and it certainly cannot be used as the basis for an article that condemns a vaccine.

So, let’s once again go down the rabbit hole of misusing VAERS to evaluate the safety of COVID-19 vaccines.

COVID-19 vaccines are not related to spontaneous abortions – new research

Newly published research supports the fact that COVID-19 vaccines are not linked to spontaneous abortions in pregnant women. This data supports the CDC’s and other health authorities’ recommendations that pregnant women receive the vaccine to protect themselves and their developing fetus.

However, there was little research that supported the actual safety and effectiveness of the vaccines during pregnancy. Pregnant women were excluded from the early clinical trials, although a few may have been enrolled prior to diagnosis of pregnancy.

A new peer-reviewed research letter provides evidence that the COVID-19 vaccines are not linked to spontaneous abortions or miscarriages.

Flu vaccine unrelated to miscarriages – getting the facts right

A while ago, the Washington Post dropped this provocative headline, “Researchers find a hint of a link between flu vaccine and miscarriages.” Add this to the long list of anti-vaccine tropes, which include the HPV and COVID-19 vaccines, that somehow, in some magical way, these vaccines cause something bad to fertility or pregnancy.

Of course, a more thorough review of the research shows that the flu vaccine does not miscarriages. A careful reading of the Washington Post article shows that it is filled with nuance and hedging because the underlying published article does not actually provide robust evidence that any flu vaccine increases the risk of miscarriages.

The Washington Post made several points that are important to consider, and we’ll examine the underlying research in more depth. But the most important point they made is that,

The findings suggest an association, not a causal link, and the research is too weak and preliminary, experts said, to change the advice, which is based on a multitude of previous studies, that pregnant women should get a flu vaccine to protect them from influenza, a deadly disease that may cause serious birth defects and miscarriage.

I wonder how many anti-vaccine radicals will fail to make that point, instead, screaming that “vaccines are dangerous and the worthless flu vaccine causes miscarriages.”

Tough breaking news for @ChelseaClinton @DrPanMD @doritmi FLU SHOT linked to MISCARRIAGE! #endvaxinjury https://t.co/6JwjnsAviY
— Del Bigtree (@delbigtree) September 13, 2017

Well, of course. Del Bigtree isn’t known for his scientific knowledge.

Well, we don’t cherry-pick our evidence here, so we’re going to look at the broad body of evidence with respect to the flu, flu vaccines, and pregnancy. Because that’s how we roll here. And because we think pregnant women deserve the best information possible to protect themselves and their developing babies. Because that’s also how we roll here.

Do not use VAERS to evaluate vaccine adverse events

The Vaccine Adverse Event Reporting System (VAERS) is one of the systems employed by the US Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) to monitor vaccine safety. VAERS is a post-marketing surveillance program, collecting information about adverse events (including death) that occur after the administration of vaccines to ascertain whether the risk-benefit ratio is high enough to justify the continued use of any particular vaccine.

VAERS, the Vaccine Safety Datalink (VSD), and the Clinical Immunization Safety Assessment Network (CISA) are the major tools used by the CDC and FDA to monitor vaccine safety. These are powerful tools that contradict the trope from anti-vaccine activists that regulatory agencies do not monitor vaccine safety – they do.

This article will review how VAERS works along with its strengths and limitations. However, one thing we will focus on how dumpster diving into the VAERS database without context is a very bad use of statistics.

Improving Vaccine Policy Making: A Dose of Reality – Dorit R Reiss and Paul A Offit

This post is a preprint of an article to be published in Vaccine entitled “Improving Vaccine Policy Making: A Dose of Reality.” The authors are Dorit Rubinstein Reiss, Ph.D., Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), and Paul A. Offit, MD, Professor of Pediatrics, Division of Infectious Disease, The Children’s Hospital of Philadelphia, The Perelman School at the University of Pennsylvania.

This article’s full citation is:

Reiss DR, Offit PA. Improving Vaccine Policy Making: A Dose of Reality. Vaccine. 2020 February 5. doi: 10.1016/j.vaccine.2020.01.036.

This preprint (see Note 1) is being published here, with permission from Professors Reiss and Offit, as a public service because it is an important part of the discussion on vaccine policy. Read More »Improving Vaccine Policy Making: A Dose of Reality – Dorit R Reiss and Paul A Offit