JNJ

VAERS facts — contradicting anti-vaccine claims and beliefs

by Dorit Rubinstein Reiss
2022-08-18
COVID-19 vaccine, JNJ, Meningitis vaccine, Rotavirus vaccine, Vaccines

This article about VAERS facts, literally a FAQ, 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.

Some of the new generation of anti-vaccine activists appear to have built their careers on misrepresentation of VAERS. One example is Dr. Jessica Rose, who apparently started her career as a legitimate young scientist, but at some point became a devoted anti-vaccine activist. Dr. Rose’s background is described by Orac thus:

Her background is more in the sort of computational biology that looks at protein structures and bioinformatics related to DNA sequences than it is to the sort of mathematical and statistical skill set necessary to delve into VAERS with any credibility. A perusal of her curriculum vitae, which is included on the profile, confirms my assessment, particularly her publication record, which includes a lot of molecular biology and virology, but nothing in the way of epidemiology.

In 2021, Dr. Rose joined the anti-vaccine organization IPAK as a research fellow, and she has published several papers in IPAK’s own publication, named Science, Public Health Policy, and the Law, whose editorial board is comprised of leading anti-vaccine activists.

Dr. Rose’s specialty appears to be doing bad analyses of VAERS and claiming, based on them, that COVID-19 vaccines are dangerous.

On August 9, 2022, Dr. Rose published a “Question and Answer” “facts” about VAERS, titled “A question and answer document on the subject of VAERS as a pharmacovigilance tool”. It is highly misleading. But it gave me an opportunity to provide information based on actual facts about VAERS.

If you want to see how it’s misleading, jump ahead to question 3 (and I hope you then go back and read the long discussion in questions 1 and 2).

I will repeat each question, answer it, shortly summarize Dr. Rose’s claims, and explain why they are misleading. Note that this discussion is limited to the mRNA vaccines and the J&J vaccine, which are the ones used in the United States and subject to reporting to VAERS – Novavax is newer and is not the subject of most of the misinformation from the anti-vaccine activists misleading people about VAERS.

Second COVID vaccine booster now or wait for the new vaccine?

Someone asked me the other day whether she should get the extremely safe second COVID-19 vaccine booster now or wait for the new Omicron-adapted vaccines that are coming in the fall from Pfizer and Moderna. I didn’t know the answer, so I thought I would investigate. Maybe it will help you or someone you know with that decision too.

The actual answer is a bit complicated, but there appear to be some good, solid recommendations coming from people who are experts in containing this pandemic. Let’s take a look.

By the way, this old dinosaur got his first Moderna booster in October 2021 and received his second booster (this time Pfizer) in April 2022. I do practice what I rant about here!

COVID-19 vaccine facts and debunking myths — the semi-complete list

by Michael Simpson
2022-11-27
AstraZeneca, COVID-19, JNJ, Moderna, Novavax, Pfizer, Pinned, Vaccines

There are so many myths about the COVID-19 vaccine, I wanted to post some facts about the new vaccines which we can use for debunking purposes. I used to think that the HPV vaccine brought the most hatred and misinformation from the anti-vaccine world, but it’s clear that the new COVID-19 vaccines are their new targets.

This article will only focus on the five vaccines that I believe will eventually receive FDA or European Medicines Agency (EMA) approval – Pfizer, Moderna, AstraZeneca, Johnson & Johnson (JNJ Janssen), and Novavax vaccines. I remain unconvinced that any vaccine made in China or the Russian Sputnik V vaccine will ever get approved by countries with robust drug regulatory agencies. However, if they are, I will certainly add them to a future iteration of this list.

I’m going to make this in a basic chart form for ease of use in finding COVID-19 vaccine facts and myths. I will link to supporting evidence wherever relevant.

COVID vaccines are not responsible for mysterious hepatitis outbreak

by Michael Simpson
2022-05-31
AstraZeneca, COVID-19, COVID-19 vaccine, Infectious disease, JNJ

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.

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.

Physician vaccine hesitancy — new polling shows about 10% are anti-vaccine

A new poll published in Vaccine showed that physician acceptance of vaccine safety, effectiveness, and importance was extremely high. However, physician vaccine hesitancy seemed to be higher than expected, with about 1 in 10 primary care physicians not believing that vaccines are safe.

I want to examine this poll about physician vaccine hesitancy and give my opinions on what was found.

COVID vaccines slightly affect menstrual cycles but do not affect menses

by Michael Simpson
2022-01-10
COVID-19, JNJ, Moderna, Pfizer, Vaccines, Women's health

A new peer-reviewed paper showed that COVID-19 vaccines slightly and temporarily increased the length of menstrual cycles. The research also showed that the vaccine did not change the number of days of menses. The effects are so minor as to not warrant concerns about these vaccines.

This brief post is just going to lay out the data from the article and try to show that if you are a woman considering the vaccine, this shouldn’t be a concern.

COVID-19 vaccine facts and myths – UPDATED info about the new vaccines

I’m going to make this in a basic chart form for ease of use. I will link to supporting evidence wherever relevant.

FDA rejects ICAN petition to revoke of EUAs issued for COVID vaccines

by Viridiana Ordonez
2021-11-03
COVID-19, Del Bigtree, JNJ, Moderna, Pfizer, Vaccines

This article about the FDA’s actions on a petition from ICAN to revoke EUAs for COVID-19 vaccines was written by Viridiana Ordonez. Ms. Ordonez has contributed other articles to this website and is a J.D. candidate at the University of California, Hastings College of Law.

Del Bigtree‘s Informed Consent Action Network (ICAN) submitted a Citizen Petition to the Food and Drug Administration (FDA) on September 27, 2021. In its petition, ICAN requested that the FDA revoke the Emergency Use Authorization (EUA) granted to ModernaTX, Inc. (Moderna) and JNJ Jansen Biotech, Inc. (Janssen) for their COVID-19 vaccines.

ICAN argued that because the FDA has now approved Comirnaty – the COVID-19 vaccine created by Pfizer-BioNTech – the requirements for issuance of the EUA for the other vaccines are no longer met.

The FDA replied to the petition on October 20, 2021, and rejected the request, explaining that ICAN’s petition did not contain facts demonstrating any reasonable grounds for its request. This post summarizes FDA’s response.

COVID-19 vaccine mortality risk is lower than in an unvaccinated group

by Michael Simpson
2021-10-22
COVID-19, JNJ, Moderna, Pfizer, Vaccines

The COVID-19 vaccine mortality risk has been a subject of a lot of myths and misinformation ever since the vaccines were released. Too much of the false information relies upon dumpster diving into the Vaccine Adverse Event Reporting System (VAERS) rather than good science that might show causality.

The CDC published a study in the peer-reviewed Morbidity and Mortality Weekly Report on 22 October 2021 which examined the risk of non-COVID mortality in a COVID-19 vaccine group compared to an unvaccinated group. So that I don’t bury the lede, the risk of death from non-COVID causes was much higher in the unvaccinated group compared to the vaccinated one.

Let’s look at the details.