Pfizer risk for Myocarditis to be assessed by Oct 2025, risk to infants of pregnant vaccinated by Dec 2025

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    To anyone who thinks the safety profile of these therapies has been determined, please keep this in mind. These are only two in a long list of potential unknown risks.

    https://www.fda.gov/media/151733/download

    "POSTMARKETING REQUIREMENTS UNDER SECTION 505(o)
    1. Study C4591009, entitled “A Non-Interventional Post-Approval Safety Study of the Pfizer-BioNTech COVID-19 mRNA Vaccine in the United States,” to evaluate the occurrence of myocarditis and pericarditis following administration of COMIRNATY
    Final Protocol Submission: August 31, 2021
    Monitoring Report Submission: October 31, 2022
    Interim Report Submission: October 31, 2023
    Study Completion: June 30, 2025
    Final Report Submission: October 31, 2025"

    "POSTMARKETING COMMITMENTS SUBJECT TO REPORTING REQUIREMENTS UNDER SECTION 506B 7.
    Study C4591022, entitled “Pfizer-BioNTech COVID-19 Vaccine Exposure during Pregnancy:
    A Non-Interventional Post-Approval Safety Study of Pregnancy and Infant Outcomes in the Organization of Teratology Information Specialists (OTIS)/MotherToBaby Pregnancy Registry”
    Final Protocol Submission: July 1, 2021
    Study Completion: June 1, 2025
    Final Report Submission: December 1, 2025"
 
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