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DailyClout Letters Opinion
Opinion

Letter to the FDA: COVID-19 ‘Vaccines’ and COVID-19 Infection Linked to Myocarditis – What Do They Have in Common?

December 27, 2022 • by Carol Taccetta, MD, FCAP

Peter Marks, MD, PhD

Director, Center for Biologics Evaluation and Research

U.S. Food and Drug Administration

10903 New Hampshire Avenue

WO71-7232

Silver Spring, MD 20993

Peter.Marks@fda.hhs.gov

 

December 18, 2022

 

Dear Dr. Marks,

I am troubled by the following, and look forward to your studied response on my single question at the bottom of this letter.

  1. Both approved mRNA COVID-19 vaccines have a causal link to ‘rare’ myocarditis. The “mRNA vaccine[s] can direct human cells to make a viral spike protein.”

https://www.fda.gov/media/155675/download

https://www.fda.gov/media/151707/download

https://www.genome.gov/about-genomics/fact-sheets/Understanding-COVID-19-mRNA-Vaccines

 

  1. The currently authorized Novavax COVID-19 Vaccine, Adjuvanted, contains the SARS-CoV-2 spike protein and Matrix-M adjuvant, and also has a causal link to myocarditis. Neither approved mRNA vaccine contains the Matrix-M adjuvant.

https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/novavax-covid-19-vaccine-adjuvanted – additional

https://www.fda.gov/media/159897/download

 

Thus, all three vaccines causally linked to myocarditis have one thing in common…spike protein exposure.

  1. We understand that COVID-19, infection, itself, can lead to myocarditis.

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/vaccine-benefits.html

 

  1. We also understand that, unlike a live, attenuated vaccine, there is no current evidence that COVID-19 vaccines carry any risk of infection.

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/facts.html


Thus, there is logically some non-infectious toxicity that the three COVID-19 vaccines and the COVID-19 infection, itself, have in common. Something they share.

  1. One theory for vaccine-induced myocarditis, offered by Ofer Levy, director of the Precision Vaccines Program at Boston Children’s Hospital and site of NIH-supported COVID-19-related projects, and as stated by NBC News, is the following: “That condition, he said, may also be related to the immune response generated by the shots.”

https://www.nbcnews.com/health/health-news/pots-debilitating-heart-condition-linked-covid-lesser-degree-vaccines-rcna61226

https://www.childrenshospitals.org/news/childrens-hospitals-today/2021/07/pediatric-vaccine-researcher-talks-covid19

https://pubmed.ncbi.nlm.nih.gov/35222350/

 

My question is:

  1. Regarding myocarditis, what non-infectious toxic entity, whether related to an immune response or not, do the three covid-19 vaccines and the covid-19 infection share?

 

In my opinion, the common denominator appears to be exposure to spike protein. I greatly look forward to your response, Dr. Marks.

 

Appreciatively,

Carol Taccetta, MD, FCAP

 

Sent: December 18, 2022

Receipt acknowledged by Dr. Marks: December 18, 2022

 

Please note: The views expressed are Dr. Taccetta’s personal opinions and do not reflect the views of former or current employers or any professional organizations to which she belongs.

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Dr. Carol Taccetta is a U.S.-licensed physician, board-certified in pathology, with a career in drug development spanning 25 years. Key agency interactions include Dr. Taccetta’s co-drafting of a chapter in the 1989 U.S. Surgeon General’s Report (CDC), as well as serving as Sponsor’s Responsible Medical Officer for a successful New Drug Application (NDA) to the FDA.

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#FDA #Pfizer CBER comirnaty Covid COVID-19 covid19 moderna moderna vaccine mrna mrna vaccines novavax peter marks pfizer vaccine spike protein spikevax
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2 replies added

  1. Grateful warrior December 29, 2022 Reply

    Agreed. From the jump, I could not understand how they said the spike protein was toxic and damaging to the vessels,, arteries, and organs. Then when the jab comes along they say well the mRNA tech will have your body produce the said “toxic” spike protein??? This was baffling to me. I’m not a scientist or doctor but it certainly did not make any sense to me? What day you?

    • Carol Taccetta December 29, 2022 Reply

      As a physician with a quarter century career in drug safety, I join you in being baffled by the choice of spike protein for a vaccine!

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