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Original
Message As pilots needing medicals it is very important that we learn to understand this stuff.
The FDA approved the Biologics License Application (BLA) ONLY, not the vaccine and reissued the Emergency use Authorization and expanded the EUA to 12 to 16 y/o's. Here is that document. https://www.fda.gov/media/151710/download
The FDA then goes on to describe what the company needed to get full approval and gave a timeline to finish in 2027.
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Furthermore, the pharmacovigilance system that FDA is required to maintain under section 505(k)(3) of the FDCA is not sufficient to assess these serious risks.
Therefore, based on appropriate scientific data, we have determined that you are required to conduct the following studies:
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StudyC4591009,entitled“ANon-InterventionalPost-ApprovalSafetyStudyof the Pfizer-BioNTech COVID-19 mRNA Vaccine in the United States,” to evaluate the occurrence of myocarditis and pericarditis following administration of COMIRNATY.
We acknowledge the timetable you submitted on August 21, 2021, which states that you will conduct this study according to the following schedule:
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
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StudyC4591021,entitled“PostConditionalApprovalActiveSurveillanceStudy Among Individuals in Europe Receiving the Pfizer-BioNTech Coronavirus
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Disease 2019 (COVID-19) Vaccine,” to evaluate the occurrence of myocarditis and pericarditis following administration of COMIRNATY.
We acknowledge the timetable you submitted on August 21, 2021, which states that you will conduct this study according to the following schedule:
Final Protocol Submission: August 11, 2021 Progress Report Submission: September 30, 2021 Interim Report 1 Submission: March 31, 2022 Interim Report 2 Submission: September 30, 2022 Interim Report 3 Submission: March 31, 2023 Interim Report 4 Submission: September 30, 2023 Interim Report 5 Submission: March 31, 2024 Study Completion: March 31, 2024
Final Report Submission: September 30, 2024
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StudyC4591021substudytodescribethenaturalhistoryofmyocarditisand pericarditis following administration of COMIRNATY.
We acknowledge the timetable you submitted on August 21, 2021, which states that you will conduct this study according to the following schedule:
Final Protocol Submission: January 31, 2022 Study Completion: March 31, 2024
Final Report Submission: September 30, 2024
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StudyC4591036,aprospectivecohortstudywithatleast5yearsoffollow-upfor potential long-term sequelae of myocarditis after vaccination (in collaboration with Pediatric Heart Network).
We acknowledge the timetable you submitted on August 21, 2021, which states that you will conduct this study according to the following schedule:
Final Protocol Submission: November 30, 2021 Study Completion: December 31, 2026
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Final Report Submission: May 31, 2027
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StudyC4591007substudytoprospectivelyassesstheincidenceofsubclinical myocarditis following administration of the second dose of COMIRNATY in a subset of participants 5 through 15 years of age.
We acknowledge the timetable you submitted on August 21, 2021, which states that you will conduct this assessment according to the following schedule:
Final Protocol Submission: September 30, 2021 Study Completion: November 30, 2023
Final Report Submission: May 31, 2024
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StudyC4591031substudytoprospectivelyassesstheincidenceofsubclinical myocarditis following administration of a third dose of COMIRNATY in a subset of participants 16 to 30 years of age.
We acknowledge the timetable you submitted on August 21, 2021, which states that you will conduct this study according to the following schedule:
Final Protocol Submission: November 30, 2021 Study Completion: June 30, 2022
Final Report Submission: December 31, 2022
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