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5.3.6 CUMULATIVE ANALYSIS OF POST-AUTHORIZATION ADVERSE EVENT REPORTS OF PF-07302048 (BNT162B2) RECEIVED THROUGH 28-FEB-2021
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)
Portugal (866) and
the remaining 7,324 were distributed among 56 other countries.
Since Dec. 11, 2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under EUA
(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).
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
“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine.
We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness,
and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities,”
“….. the public is counting on safe and effective vaccines. The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S."
the law, passed in January, in force since early February,
not proportionate, relatively mild symptoms experienced by most people who contract Omicron