FDA-Approved COVID-19 Vaccine Comirnaty’s Availability in Tennessee Unclear

 

A Tennessee Department of Health (TDOH) official did not say Friday whether his agency currently offers the Food and Drug Administration’s (FDA’s) fully approved COVID-19 vaccine, which the manufacturer, Pfizer, calls Comirnaty.

TDOH officials did, however, comment on the matter in October.

The Tennessee Star on Friday asked the TDOH whether it is shipping Pfizer’s FDA fully approved Comirnaty COVID-19 vaccine or Pfizer’s EUA vaccine, which is not FDA fully approved.

TDOH spokesman Bill Christian responded via email Friday and said he was looking into the matter, but he did not respond again before Friday’s stated deadline.

TDOH officials tweeted in October that the FDA had approved a Pfizer COVID-19 vaccine.

Twitter user @RockyTopSaint that month replied to the TDOH with the following tweet:

Yes, Every Kid

“Is the FDA approved Comirnaty available in Tennessee?”

And TDOH officials responded.

“The federal gov has a large amount of the originally-labeled vaccine to be distributed before the branded product is released. The vaccine has not changed. It is the same formulation as the EUA vaccine, but for marketing purposes under the BLA is now referred to as Comirnaty,” TDOH officials tweeted.

The FDA first approved Comirnaty in August, according to that agency’s website.

“The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty, for the prevention of COVID-19 in individuals 16 years of age and older,” according to the FDA’s website.

“Pfizer-BioNTech COVID-19 Vaccine is authorized for emergency use and is available under the EUA as a two-dose primary series for individuals 5 years of age and older, as a third primary series dose for individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise, and as a single booster dose for individuals 16 years of age and older at least six months after completing a primary series of the vaccine.”

Whether Pfizer distributes Comirnaty is unknown, but the company told The Ohio Star this week that it is still shipping the EUA version of the vaccine.

“The Pfizer-BioNTech COVID-19 Vaccine (EUA labeled product) is currently being shipped; however, please be advised that the COMIRNATY and the Pfizer-BioNTech COVID-19 Vaccine have the same formulation and can be used interchangeably,” company officials said via email.

“They are made using the same processes, and there are no differences between them in safety or effectiveness.”

Pfizer did not respond when asked multiple times if Comirnaty is in use anywhere.

Though Pfizer says the vaccines are interchangeable, the FDA concedes that the products are “legally distinct.”

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Chris Butler is an investigative journalist at The Tennessee Star. Follow Chris on Facebook. Email tips to [email protected].
Photo “Pfizer Vaccine” by U.S. Secretary of Defense. CC BY 2.0.

 

 

 

 

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8 Thoughts to “FDA-Approved COVID-19 Vaccine Comirnaty’s Availability in Tennessee Unclear”

  1. […] The Star News Network reported this week in The Ohio Star, The Tennessee Star, and The Georgia Star News, the Pfizer COVID-19 vaccine with the brand name Comirnaty that was […]

  2. Jane

    According to rules of EUA, if an FDA approved treatment is available, the EUA products can no longer be distributed. Are the other “vaccines” still available? (Yes) Are proven therapeutics suppressed? (Yes)

  3. John

    Stop referring to this shot as a vaccine. IT IS A FLU SHOT! It does not prevent you from getting COVID. At best, it might help an at risk patient fight it off….just like the regular flu shot.

  4. Truthy McTruthFace

    it’s not available anywhere that anyone knows of.

    so your company is trying to force you to get an UNAPPROVED JAB

    1. 83ragtop50

      Exactly. Pfizer and the lobby-loving politicians need to sell off (at taxpayer expense) those millions of emergency approved doses. Heck, making money is the most important job next to keep an elected office. Public healt be damned.

      My wife and I took the first 2 rounds of the Pfizer Kool-Aide because my wife has a severe autoimmune disorder. No more jabs for us.

  5. David Blackwell RN, BSN, CCM

    You would be doing yourself a huge favor by staying away from any and all of these products. Eat right and exercise. Coca-Cola is killing Americans. Cheeseburgers are killing Americans. Potato chips are killing Americans. Donuts are killing Americans. Junk food is killing Americans. Gluttony is killing Americans. Slothfulness is killing Americans. This virus, like the other 199 cold viruses all have a 99% recovery rate.

  6. Faithy

    Let me help you out. They have NOT created Comirnaty and is next schedule to due so only three years from 2021. All of the government and pharma held hands worldwide to bring the result you have today. I can’t wait to see their response now the the CDC released Pfizer myocarditis death and injuries and releasing damaging side effects like they have been all year in tiny bits by bits. Remember, Governor Lee, McNally, and the Establishment TN “We don’t pass laws, we pass lawsuits” Republicans accepted campaign donations from Pfizer and still actively pushed the vaccine.

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