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

FDA CDC COVID-19 vaccines

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.  

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

COVID-19 vaccine facts

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.

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The risk of Guillain-Barré syndrome after COVID mRNA vaccines is low

Guillaine-Barré COVID-19 mRNA vaccines

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.

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New vaccines wishlist — I am looking beyond COVID-19

new vaccines

I once was accused of not being opposed to any vaccine on the market, but little did they know I have a wishlist for new vaccines that goes beyond all that. Believe it or not, there are pathogens out there that still have a deleterious effect on the health of mothers, children, and everyone.

I just wanted to spend a bit of time talking about some of the diseases where new vaccines could improve health outcomes in significant ways. Let’s take a look at some of them.

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Pfizer-Valneva Lyme disease vaccine — phase 2 pediatric trials results

lyme disease vaccine

I have previously discussed a Lyme disease vaccine candidate from Pfizer and Valneva that is starting a phase 3 clinical trial. However, the companies are keeping us updated with their phase 2 results, and there has been exciting news — the pediatric trial (in 5-17-year-olds) showed strong immunogenicity for the new Pfizer-Valneva vaccine.

Of course, dogs have had access to a Lyme disease vaccine, but there has not been a vaccine available for humans for over 20 years. It’s not that dogs are more important than humans (though many of us might argue that point), but about 20 years ago, the anti-vaxxers got the vaccine pulled from the market, one of their few “successes” in getting rid of useful vaccines.

But a small company, Valneva, in partnership with Pfizer, has developed a new vaccine that will be entering Phase 3 clinical trials real soon. Hopefully, we’ll have it in just a few more years.

Let’s first take a look at this disease, and then we will review the vaccine itself along with new results.

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Increased risk of shingles after COVID-19 — time to get both vaccines

shingles COVID-19

A newly published and peer-reviewed study provides evidence that the risk of shingles (herpes zoster) increases after a COVID-19 infection. This supports numerous case reports that have been published that describe shingles in COVID-19 patients.

This post will examine the article. And this should provide you with more evidence that the COVID-19 and shingles vaccines are important to your health.

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mRNA COVID vaccines are not associated with appendicitis

COVID-19 mRNA vaccines appendicitis

I did not know it was a thing, but there were concerns that appendicitis was associated with mRNA COVID-19 vaccines from Moderna and Pfizer. Of course, I wanted to look into it and see if it really was a thing.

Apparently, there was a safety signal for appendicitis that was first seen in Pfizer’s phase 3 clinical trial where a higher number of cases of appendicitis were observed. There were also some observations in Israel that showed an “excess risk of appendicitis of 5.0 episodes per 100,000 individuals after vaccination.

However, a new study carefully looked at new data and found no association between the mRNA COVID-19 vaccines and appendicitis. Let’s look at that study.

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

physician 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.

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I got my Pfizer COVID vaccine booster — Bill Gates didn’t call me

Pfizer COVID-19 vaccine booster

On 14 April 2022, I got my Pfizer COVID-19 vaccine booster shot. As with the first three shots (those were all from Moderna), I felt nothing other than a bit of a sore arm. I decided to with the Pfizer COVID-19 vaccine booster rather than getting a fourth Moderna shot because I kind of wanted to mix up the antigens a bit so that I had better protection. But I could have been just as happy going with the Moderna booster.

Now my immune system is scientifically boosted to handle whatever SARS-CoV-2 has for me. I’m ready to kick its sorry butt for even thinking about infecting me.

Why did I get the booster?

  • Because it’s safe.
  • Because the booster shots protect me against COVID-19 even more.
  • Because there is evidence that the original series of shots have waning immunity.
  • Because it’s the only way to boost my immune system against the coronavirus.
  • Because I know that vaccines are more powerful than pseudoscientific supplements and quackery.
  • Because the CDC recommends it.
  • Because it was free.
  • Because I want to do the right thing for my own health and to protect others.

I don’t know if boosters will be necessary every few months or years. But this virus is so resilient and mutates so frequently, I am willing to bet we will need frequent boosters for any of the COVID-19 vaccines.

In fact, early evidence appears to indicate we might need a second booster for the Omicron variant.

person getting vaccinated
Photo by Gustavo Fring on Pexels.com

Again, I experienced no side effects of any sort other than a tender arm. My 5G iPhone isn’t working any better. My heart is functioning quite well. Everything that was working before getting the booster is still working well now.

The CDC and FDA are recommending a second Pfizer or Moderna COVID-19 vaccine booster for anyone who is over the age of 50 or is immunocompromised. That doesn’t mean all of you should rush to get the second booster, there’s probably no need. The evidence seems to indicate that one booster may be good enough for most people for the time being. But as with everything surrounding this pandemic, something might change next week or next month, or next year. Stay tuned.

But for now, your favorite feathered dinosaur (an avian or non-avian dinosaur to be specific) is protected against COVID-19.

I also got a Shingrix vaccination at the same time. Now begone Herpes zoster.

Now here are some cute pet photos because you spent the time reading about my boosters.

Photo by Sergey Semin on Unsplash
Photo by Mathis Jrdl on Unsplash
Photo by Krista Mangulsone on Unsplash
Avian dinosaurs. Photo by Roi Dimor on Unsplash

Robert Malone did not invent the mRNA vaccine — he now misinforms

Glass vial that held Margaret Keenan’s first Pfizer-BioNTech COVID-19 vaccine, 7th December 2020 (glass vial)

I have been ignoring Robert Malone and his claims that he “invented” the mRNA vaccines. I just thought he would disappear, but now he’s like the other quacks in the COVID-19 vaccine world, spreading misinformation and disinformation about mRNA vaccines.

He’s become the go-to talking head to discredit the COVID-19 mRNA vaccines from Pfizer and Moderna. And he uses his claim that he “invented” the vaccine to become the false authority on the safety and effectiveness of the vaccines. All over the internet, I’m reading COVID-19 vaccine deniers invoke his name as proof that no one should get that vaccine.

Well, I’ve reached my maximum level of annoyance at Robert Malone, so it’s time for the old feathered non-avian dinosaur to tell you what he did with the mRNA vaccines and why he should be ignored.

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