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

FDA approval pfizer COVID-19 vaccine

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.

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Pfizer COVID vaccine received full FDA approval – expect new mandates

pfizer COVID-19 vaccine FDA

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.

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Hospital COVID vaccine mandate – Texas Federal District court rejects challenge

Hospital COVID vaccine mandate

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 disease. 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). 

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COVID vaccine mandate lawsuit filed in Texas by Methodist Hospital employees

pexels-photo-6074971.jpeg

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. 

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JNJ seeking emergency use authorization for its COVID-19 vaccine

JNJ 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.

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