The Pfizer documents - Freedom of Information Act | Dr. John Campbell

  • letztes Jahr
(9 Mar 2022)
Public Health and Medical Professionals for Transparency, Pfizer / FDA FOI

https://phmpt.org

Request, Freedom of Information Act (FOIA)

https://phmpt.org/wp-content/uploads/2021/10/IR0546-FDA-Pfizer-Approval-FINAL.pdf

Against FDA

https://phmpt.org/wp-content/uploads/2021/10/001-Complaint-101021.pdf

The court order

https://phmpt.org/wp-content/uploads/2022/02/056-ORDER-GRANTING-IN-PART-THE-MOTION-TO-MODIFY-THE-PRODUCTION-SCHEDULE-AND-ADDOPTS-THE-JOINT-STATUS-REPORT-MODIFIED-AGREED-PRODUCTION-SCHEDULE.pdf

List of downloadable documents

https://phmpt.org/pfizers-documents/

5.3.6 CUMULATIVE ANALYSIS OF POST-AUTHORIZATION ADVERSE EVENT REPORTS OF PF-07302048 (BNT162B2) RECEIVED THROUGH 28-FEB-2021

https://phmpt.org/wp-content/uploads/2021/11/5.3.6-postmarketing-experience.pdf

Adverse event reports
01 December 2020 through 28 February 2021
Cumulatively, through 28 February 2021,
a total of 42,086 case reports (25,379 medically confirmed and 16,707 non-medically confirmed)
containing 158,893 events.
Most cases (34,762) were received from United States (13,739),
United Kingdom (13,404)
Italy (2,578),
Germany (1,913),
France (1,506),
Portugal (866) and
Spain (756)
the remaining 7,324 were distributed among 56 other countries.
Fatal, 1,223
Since Dec. 11, 2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under EUA

https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine

(Approval, 21st August 2021)
Acting FDA Commissioner Janet Woodcock, M.D.
While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated.
Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.
System Organ Classes (SOCs)
that contained the greatest number (≥2%) of events, in the overall dataset,
were General disorders and administration site conditions (51,335 AEs),
Nervous system disorders (25,957),
Musculoskeletal and connective tissue disorders (17,283),
Gastrointestinal disorders (14,096),
Skin and subcutaneous tissue disorders (8,476),
Respiratory, thoracic and mediastinal disorders (8,848),
Infections and infestations (4,610),
Injury, poisoning and procedural complications (5,590), and Investigations (3,693).
Cardiovascular AESIs
Number of cases: 1403 (3.3% of the total PM dataset),
of which 241 are medically confirmed and 1162 are non-medically confirmed;

5. SUMMARY AND CONCLUSION
Review of the available data for this cumulative PM experience, confirms a favorable benefit: risk balance for BNT162b2.
Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research..

Rest of Text at;
https://youtu.be/7YOD9drZasM

Dr. John Campbell;
https://www.youtube.com/@Campbellteaching

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