Letter to Dr. Peter Marks, Director of the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA).
"Dr Taccetta is a U.S. licensed physician, board-certified in pathology, with a career in drug development spanning 25 years."
"1. What is 'VITT'?
Vaccine-induced Immune Thrombotic Thrombocytopenia (VITT) is 'a newly described syndrome' 'characterized by new onset thrombocytopenia [i.e., low blood platelet count] and acute venous or arterial thrombosis [i.e., blood clot], including at unusual sites such as the cerebral venous sinus, with onset of symptoms approximately one to two weeks following receipt of the [certain COVID-19] vaccine[s]...
Dr. Taccetta's Letter to Dr. Peter Marks, Director of the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA)
Dear Dr. Marks,
... My concerns with comparing rates of TTS (or cerebral venous sinus thrombosis (CVST) as an indicator for TTS) with 'background rates' of other conditions (as suggested by others) are multiple: https://www.acpjournals.org/doi/10.7326/M21-4502...
1. Regardless of the reporting rates of TTS/CVST following the mRNA vaccines, there is clearly a strong temporal association: in approximately half the TTS or CVST reports observed in VAERS, there is ‘clustering’ within 14 days of vaccination...
As of 07 OCT 2022:
There are 611 total CVST events reported for Pfizer’s vaccine... 309/611 had an onset within 14 days post-vaccination...
There are 169 total CVST events reported for Moderna’s vaccine... 73/169 had an onset within 14 days post-vaccination...
One death due to this elusive syndrome is one too many. At this point, a temporary pause of the mRNA vaccines for thorough evaluation of the available safety data is justified.
I await your response to this critical concern."