EUA

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).

Novavax COVID vaccine — we should not ignore it, since it might be useful

For the past year, we have ignored the Novavax COVID-19 vaccine while focusing on the ones from AstraZeneca, Moderna, Pfizer, and JNJ. However, Novavax will soon be requesting an Emergency Use Authorization (EUA) in the USA for its vaccine, known as Nuvaxovid or Covovax, bringing another weapon in the war against COVID-19. The vaccine received an emergency use authorization in the EU in December 2021.

The Novavax COVID-19 vaccine is completely different than the mRNA vaccines from Moderna and Pfizer and the adenovirus vector vaccines from JNJ and AstraZeneca. It uses a technology that is similar to what is used with other common vaccines.

Unfortunately, Novavax ran into several manufacturing issues which delayed its availability across the world. But over the past few months, they fixed those issues with their contractors and now appear to be ready to launch the vaccine widely across the world.

I just wanted to make sure that we remain aware of it, and I wanted to toss out some ideas that I have about the vaccine. I think it might be much more important than the other vaccines in fighting against the variants that keep hitting us.

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.

Merck seeking emergency us authorization for molnupiravir, new COVID-19 drug

Pharmaceutical giant Merck announced a new drug to treat COVID-19, called molnupiravir, which appeared to cut the risk of hospitalization and death by nearly half for at-risk patients. Furthermore, Merck will be seeking an emergency use authorization for it immediately.

Although this may sound like good news, and if you are reading the news about this drug, you’d think it was a miracle, I want to make sure that everyone understands several important factors about this drug’s safety and effectiveness profile. It is not a miracle, but it may be an important addition to the treatment protocols for COVID-19 patients, especially those at the highest risk of hospitalization or death.

This is not a worthless drug, at least for COVID-19, such as the horse dewormer, ivermectin, that has become popular with the pseudoscience crowd. Molnupiravir was designed from the beginning as an anti-viral drug.

Vaccine licensing primer – correcting anti-vaccine misinformation

by Dorit Rubinstein Reiss
2021-09-25
COVID-19, Pfizer, Robert F Kennedy Jr, Vaccines

This article about vaccine licensing 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.

Anti-vaccine activists want to claim the Pfizer vaccine is still experimental despite FDA licensing. They base that claim on a footnote in a document reauthorizing Pfizer’s Emergency Use Authorization (EUA). FDA is clear that the now fully-licensed vaccine is identical to the EUA vaccine (except of course for the labeling: the EUA vaccine still bears its EUA label), and that both can legally be marketed. The anti-vaccine claim is being made because the full licensure of the Pfizer vaccine renders moot their claim (not yet decided by a court) that you cannot mandate a vaccine licensed under the EUA.

FDA approval of Pfizer COVID vaccine – why did it take so long?

One of the questions I keep seeing is why did it take so long for FDA approval of the Pfizer/BioNTech COVID-19 vaccine, Comirnaty? The answer is complicated, but the basic issue is that the FDA is very conservative in approving drugs – I bet that will surprise everyone.

I’m going to delve into a couple of issues with the FDA and its approval of the Pfizer COVID-19 vaccine. Even though some people argue that it took too long to go from the Emergency Use Authorization (EUA) to full approval, it was, in fact, fairly rapid. Remember, clinical trials only commenced maybe 15 months ago, so this is warp speed compared to the usual vaccine timeline that may be nearly 10 years.

Many of us thought that it would take up to three years before we had COVID-19 vaccines available – I’m willing to eat humble pie on blowing that prediction, but it’s amazing what happens when governments, scientists, and pharmaceutical companies can do when they are all focused on a common goal. Not for nothing, but why can’t we do the same thing with climate change – a lot more of us are at risk of that than COVID-19, but I’ll leave that for another day.

Let’s take a brief look at why some of you are wondering why it took so long for the FDA approval of the Pfizer COVID-19 vaccine.

Pfizer COVID vaccine received full FDA approval – expect new mandates

Today, 23 August 2021, the Pfizer/BioNTech COVID-19 mRNA vaccine received full FDA approval for individuals 16 years and older. This should stop the claim by anti-vaxxers claimed that these vaccines were “experimental,” because they had an Emergency Use Authorization (EUA) in the USA and other countries, despite the fact that the EUAs required just as rigorous analysis as a typical New Drug Application.

Let’s examine what this Pfizer COVID-19 vaccine FDA approval means practically.

COVID vaccine mandate lawsuit filed in Texas by Methodist Hospital employees

This article about the employee lawsuit against the Texas Methodist 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 disease. She is also a member of the Vaccines Working Group on Ethics and Policy.

In June 2021, employees of Methodist Hospital filed a lawsuit in a Texas court challenging the hospital’s decision to mandate the COVID-19 vaccine. Although the lawsuit does raise one issue of legal uncertainty – whether you can mandate a vaccine under an Emergency Use Authorization (EUA) – its claim there is weak, and its other claims are a combination of incorrect factual claims and implausible legal claims.

The suit should have little chance of success – but because of the timing, this may be the first legal decision we have on the question of mandating EUA vaccines. The hospital’s mandate has a deadline of June 7, 2021. It seems like most of the plaintiffs – as far as I can tell from the complaint – have already been dismissed, so the deadline may not require fast handling, but the fact that there is a very near deadline may affect scheduling.

JNJ seeking emergency use authorization for its COVID-19 vaccine

Pharmaceutical giant Johnson and Johnson (JNJ) has submitted an application for an emergency use authorization (EUA) for its COVID-19 vaccine. In phase 3 clinical trials, results showed that it was effective against the illness, and it was especially robust in preventing severe cases of COVID-19 along with death.

The COVID-19 vaccine, which was developed by JNJ subsidiary Janssen Biotech, will be reviewed by an FDA advisory committee on 26 February 2021. If that review goes well, the FDA Commissioner could issue the EUA within a few days.