This document was produced by the Food and Drug Administration (FDA) in response to a Freedom of Information Act (FOIA) request (see https://phmpt.org/wp-content/uploads/2021/10/001-Complaint-101021.pdf).
“1. Introduction: … This document provides an integrated analysis of the cumulative post-authorization safety data, including U.S. and foreign post-authorization adverse event reports received through 28 February 2021…
2. Methodology: … Among adverse event reports received into the Pfizer safety database during the cumulative period, only those having a complete workflow cycle in the safety database (meaning they progressed to Distribution or Closed workflow status) are included in the monthly SMSR. This approach prevents the inclusion of cases that are not fully processed hence not accurately reflecting final information. Due to the large numbers of spontaneous adverse event reports received for the product, the MAH (marketing authorisation holder) has prioritised the processing of serious cases… Pfizer has also taken a multiple actions to help alleviate the large increase of adverse event reports. This includes significant technology enhancements, and process and workflow solutions, as well as increasing the number of data entry and case processing colleagues. To date, Pfizer has onboarded approximately [REDACTED] additional full-time employees (FTEs). More are joining each month with an expected total of more than [REDACTED] additional resources by the end of June 2021…
3. Results, 3.1.1. General Overview: It is estimated that approximately [REDACTED] doses of BNT162b2 were shipped worldwide from the receipt of the first temporary authorisation for emergency supply on 01 December 2020 through 28 February 2021.
Cumulatively, through 28 February 2021, there was 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 (1913), France (1506), Portugal (866) and Spain (756); the remaining 7,324 were distributed among 56 other countries.
Table 1 below presents the main characteristics of the overall cases.
As shown in Figure 1, the 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)...
3.1.2. Summary of Safety Concerns in the US Pharmacovigilance Plan...
Table 6. Description of Missing Information...
Pregnancy cases: 274 cases including:
- 270 mother cases and 4 foetus/baby cases representing 270 unique pregnancies (the 4 foetus/baby cases were linked to 3 mother cases; 1 mother case involved twins).
- Pregnancy outcomes for the 270 pregnancies were reported as spontaneous abortion (23), outcome pending (5), premature birth with neonatal death, spontaneous abortion with intrauterine death (2 each), spontaneous abortion with neonatal death, and normal outcome (1 each). No outcome was provided for 238 pregnancies (note that 2 different outcomes were reported for each twin, and both were counted).”