VRBPAC

FDA, CDC, and COVID-19 vaccines — who does what?

This article about the role of the CDC and FDA concerning COVID-19 vaccines 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.

I write this right after the FDA expert advisory committee, Vaccines and Related Biological Products Advisory Committee (VRBPAC), voted unanimously that the benefits of both Moderna and Pfizer-BioNTech’s COVID-19 vaccines for children 6 months to 5 years of age outweigh their risks, clearing a smooth path for FDA to grant emergency use authorization (EUA) to these vaccines. I was asked about the division of labor between CDC and FDA on COVID-19 vaccines, and it seems like something worth setting out.

So this is a short post about the relative roles of the FDA and CDC in getting COVID-19 vaccines to people in the USA. It is not a full picture of how vaccines get to us; there is a lot more to that. I am not even going into the full requirement for approving or authorizing a vaccine; just who does what. But this piece of the puzzle can be useful by itself.

For those looking for a full description of the vaccine approval process, I recommend either the Skeptical Raptor’s post on that topic or the description by the Vaccine Education Center of the Children’s Hospital of Philadelphia.

COVID vaccine development process – how it compares to “normal”

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 COVID-19 vaccine development process, along with the independent controls that make sure that all vaccines are safe and effective.

COVID-19 vaccine boosters FAQs – what you should know

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

Following the advice of the Vaccine and Related Products Advisory Committee (VRBPAC), the FDA announced that COVID-19 vaccine boosters can be given to those individuals who received the Moderna and JNJ vaccines. This follows a previous announcement about the Pfizer vaccine booster shots. The FDA also stated that all eligible individuals could mix and match vaccines for their booster dose.

There is a lot of information about these boosters out there, so I thought I would take a moment to try to provide some facts and clarity about what the recommendations are about these COVID-19 vaccine boosters. Also, this is related to a US FDA set of decisions and recommendations from the CDC, so this article is going to only apply to the USA. However, don’t be surprised if the EU and other regulatory agencies across the world do the same thing.

COVID vaccine effectiveness against Delta variant –

During the 17 September 2021 FDA vaccine expert committee meeting, the COVID-19 vaccine effectiveness against the Delta variant was reviewed. I want to assess some of the results so that we have a better understanding of how the vaccines are working against the Delta variant.

I have read all kinds of comments and reports about the COVID-19 vaccine effectiveness against the Delta variant, but it will be good to see what data was presented to the top vaccine experts in the country. Let’s take a peek at the data.

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.

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.

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.

Johnson and Johnson COVID-19 vaccine scientific facts

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. This vote by the vaccine experts is the last step in advance of FDA clearance for an Emergency Use Authorization (EUA).

This article will review the key points about the Johnson and Johnson COVID-19 vaccine’s safety, effectiveness, ingredients, and other critical information. This scientific information should answer a lot of questions about the vaccine that will inevitably arise over the next few weeks.

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.

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.

Moderna COVID-19 vaccine – FDA approves emergency use authorization

On 17 December 2020, the Moderna COVID-19 mRNA vaccine was reviewed by the Vaccines and Related Biological Products Advisory Committee (VRBPAC) in advance of an emergency use authorization (EUA). VRBPAC gave an overwhelming recommendation for the vaccine, and the FDA issued the EUA today.

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 Moderna COVID-19 mRNA vaccine.