Letter to the FDA: COVID-19 ‘Vaccines’ and COVID-19 Infection Linked to Myocarditis – What Do They Have in Common?
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
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.
- 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
- 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/media/159897/download
Thus, all three vaccines causally linked to myocarditis have one thing in common…spike protein exposure.
- We understand that COVID-19, infection, itself, can lead to myocarditis.
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/vaccine-benefits.html
- 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.
- 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://pubmed.ncbi.nlm.nih.gov/35222350/
My question is:
- 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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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?
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!