That part is particularly telling.
There are plenty of "concerns or controversial issues" regarding the injection.
For starters, it's clear that the efficacy of pfizer's injection is no where near what their clinical trials state when it comes to Delta, which is the predominant strain now.
Pfizer-BioNTech vaccine recipients have lower antibody levels targeting the Delta variant than other SARS-CoV-2 variants
https://www.crick.ac.uk/news/2021-06-03_pfizer-biontech-vaccine-recipients-have-lower-antibody-levels-targeting-the-delta-variant-than-other-sars-cov-2-variants
Right there in the "approval," they ADMIT there are "concerns or controversial issues." They are REQUIRING them to conduct several studies, over the course of SEVERAL YEARS in order to "assess known serious risks of myocarditis and pericarditis"
POSTMARKETING REQUIREMENTS UNDER SECTION 505(o)
Section 505(o) of the Federal Food, Drug, and Cosmetic Act (FDCA) authorizes FDA to require holders of approved drug and biological product applications to conduct postmarketing studies and clinical trials for certain purposes, if FDA makes certain findings required by the statute (section 505(o)(3)(A), 21 U.S.C. 355(o)(3)(A)).
We have determined that an analysis of spontaneous postmarketing adverse events reported under section 505(k)(1) of the FDCA will not be sufficient to assess known serious risks of myocarditis and pericarditis and identify an unexpected serious risk of subclinical myocarditis.
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:
4. 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.
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
5. Study C4591021, entitled “Post Conditional Approval Active Surveillance Study Among Individuals in Europe Receiving the Pfizer-BioNTech Coronavirus
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
6. Study C4591021 substudy to describe the natural history 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: January 31, 2022
Study Completion: March 31, 2024
Final Report Submission: September 30, 2024
7. Study C4591036, a prospective cohort study with at least 5 years of follow-up for 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
Final Report Submission: May 31, 2027
8. Study C4591007 substudy to prospectively assess the incidence of subclinical 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
9. Study C4591031 substudy to prospectively assess the incidence of subclinical 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
Please submit the protocols to your IND 19736, with a cross-reference letter to this BLA STN BL 125742 explaining that these protocols were submitted to the IND. Please refer to the PMR sequential number for each study/clinical trial and the submission number as shown in this letter.
Please submit final study reports to the BLA. If the information in the final study report supports a change in the label, the final study report must be submitted as a supplement to this BLA STN BL 125742.
More here: https://freerepublic.com/focus/news/3988135/posts
Thank you!