Emergency use authorization

Hospital COVID vaccine mandate – Texas Federal District court rejects challenge

This article about a Texas Federal District Court that rejected a challenge to a hospital COVID vaccine 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 June 12, 2021 (yes, a Saturday), a Texas federal district judge dismissed a lawsuit brought by employees of the Houston Methodist Hospital against the hospital’s COVID vaccine mandate which required employees to be vaccinated unless they qualify for a medical or religious exemption.

I wrote about the lawsuit here. It is a badly argued lawsuit, with multiple extreme claims, and it does a bad job in setting out the one somewhat plausible argument it has, the argument that you cannot mandate a vaccine under an Emergency Use Authorization (EUA).

Vaccine development process – how it’s usually done

Back before the world of the COVID-19 pandemic, the vaccine development process took a long time. Despite the nonsensical claims of the anti-vaccine zealots, the vaccine development process is robust and thorough. The safety and effectiveness of all of the pre-pandemic vaccines are settled science (read the article before you jump up and down screaming about “settled science”).

However, the world of the COVID-19 pandemic meant that if we can save a few months or even years off the development timeline on a new COVID-19 vaccine, it could save hundreds of thousands, maybe millions, of lives.

Of course, much of the optimism comes from experts like Dr. Anthony Fauci, one of the few rational public health experts who are willing to speak up in Washington DC. Maybe he has seen some secret data only available only to him and Bill Gates that supports this optimism. Maybe he just is trying to be the national cheerleader for healthcare.

I don’t know the real answer, but a lot of vaccine experts who have spent their lifetime studying vaccines, like Dr. Peter Hotez, MD Ph.D., have expressed dismay at how politics may “trump” good science.

So, this article will try to lay out the development process, along with the independent controls that make sure that all vaccines are safe and effective.

Experimental COVID vaccines? Another anti-vaxxer trope to be debunked

by Michael Simpson
2021-08-12
COVID-19, JNJ, Moderna, Pfizer, Vaccines

And here we go with another one of those silly anti-vaxxers tropes – the COVID-19 vaccines are experimental, and the government/Big Pharma/Bill Gates are conspiring to test the vaccine on innocent people. Nothing could be further from the truth.

The claim that the COVID-19 vaccines are experimental probably arises from the fact that most of them received an Emergency Use Authorization (EUA) in the USA and other countries. The anti-vaxxers what to use the EUA to make a strawman argument that EUA is equivalent to “a risky, experimental drug that will cause great harm to you.”

But if these anti-vaccine activists spent just a little bit of time to understand the high-quality science behind these vaccines and the Emergency Use Authorizations, they might move on to some other topic. But in case someone finds this article among all of the nonsense on the internet, looking to find out if COVID-19 vaccines are, in fact, experimental, let’s debunk that with actual facts.

COVID vaccine mandates update – what a week of news

This article, which is an update about COVID-19 vaccine mandates, 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.

It has been an intense week for the discussion of COVID vaccine mandates, and a lot has happened. This post is simply a very short overview of developments. So here is what is going on this week.

COVID-19 vaccine mandate challenge from a corrections officer

This article about a challenge to a COVID-19 vaccine 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 disease. She is also a member of the Vaccines Working Group on Ethics and Policy.

In late February, a lawsuit challenging an employment mandate, that county officers in New Mexico receive a COVID-19 vaccine, was filed in a district federal court. Although there is some uncertainty on whether an Emergency Use Authorization (EUA) vaccine mandate is legal, this lawsuit is not well-founded, and the county’s response very well-argued. Hopefully, the court will reject this claim.

JNJ COVID-19 vaccine receives FDA emergency use authorization – great news

On 26 February 2020, the Johnson and Johnson (JNJ) COVID-19 vaccine underwent an FDA expert review, similar to the ones for the Pfizer and Moderna COVID-19 vaccines. The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of the third vaccine in the USA to prevent COVID-19. On 27 February 2020, the USFDA gave clearance for an Emergency Use Authorization (EUA).

VRBPAC agreed that the vaccine was very effective, especially in preventing death and serious COVID-19 disease. They also found no serious safety signals, with the incidence serious adverse events were no higher compared to the placebo group or what would be expected in the general population.

The EUA approved the vaccine for use in adults 18 and older. Before JNJ can ship the vaccine, the CDC’s Advisory Committee on Immunization Practices (ACIP) will meet tomorrow to make recommendations on who can receive this vaccine.

COVID-19 vaccines pipeline – potential next emergency use authorizations

by Michael Simpson
2021-01-06
AstraZeneca, COVID-19, Janssen, Moderna, Novavax, Pfizer, Vaccines

After the emergency use authorizations (EUA) were given for the Moderna and Pfizer COVID-19 vaccines, what is next in the pipeline? There are three vaccines that could be reviewed by the Vaccines and Related Biological Products Advisory Committee (VRBPAC) during the next few weeks that would provide recommendations to the FDA (and other national drug regulatory bodies) for EUAs.

The three vaccines I’m going to discuss are ones that have a reasonable chance of getting approved for use in the USA or Europe. This excludes COVID-19 vaccines from Russia, China, and other countries that rarely, if ever, get FDA approval for vaccines (see Note 1).

So, let’s take a look at what are probably the next three COVID-19 vaccines in the pipeline.

COVID-19 vaccine EUA is unrelated to hydroxychloroquine

This article about how “cures” should prevent a COVID-19 vaccine emergency use authorization (EUA) 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.

I have seen this myth around but haven’t had a chance to respond to it, so I will do it quickly here. No, there is no conspiracy to hide the benefits of things like hydroxychloroquine (HCQ) and vitamin D, and no, if they were shown effective, it would not prevent a COVID-19 vaccine EUA.

Pfizer COVID-19 vaccine facts – scientific evidence to deal with misinformation

Because the Pfizer COVID-19 vaccine is ready to launch in many countries, it is time that we provide the facts about the vaccine. This will be different than my myth debunking article (which will be constantly updated as the anti-vaxxers get going with their lies and disinformation), as this article will try to make sure that everyone is on the same page with what this vaccine is.

Almost all of the information will come from the Pfizer/BioNTech COVID-19 mRNA vaccine documents that were submitted for review by the Vaccines and Related Biological Products Advisory Committee (VRBPAC) in advance of an emergency use authorization (EUA) that was issued by the FDA on the evening of 11 December 2020. I read through most of the material to save you all time during this holiday season (so please like this article and share it across the planet).

I’m going to just hit what I think will be the most important points about the vaccine’s safety, effectiveness, ingredients, and other related information. Because these Pfizer COVID-19 vaccine facts will be most useful in debunking wild claims that you might read on the internet. I am planning to do the same with the Moderna vaccine, so stay tuned once VRBPAC reviews their data and the FDA issues an EUA.

Pfizer COVID-19 mRNA vaccine – FDA approves emergency use authorization

On 10 December 2020, the Pfizer/BioNTech COVID-19 mRNA vaccine was reviewed by the Vaccines and Related Biological Products Advisory Committee (VRBPAC) in advance of an emergency use authorization (EUA). Unless you were avoiding the internet (and hence, you wouldn’t be reading this), you would know that the review went well, and VRBPAC “approved” the vaccine. On the evening of 11 December, the FDA gave approval for the EUA, the first COVID-19 vaccine available in the USA.

This article will quickly review the major points about the VRBPAC discussion, a review of some of the data, and finally a summary of what we know and don’t know about the Pfizer COVID-19 mRNA vaccine.