Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I got Covid two weeks after my first shot; I got Covid two weeks after my first shot; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EK9231, first dose) solution for injection intramuscular on an unknown date (at the age of 39-years-old) at single dose for COVID-19 vaccination. Medical history included high blood pressure and prediabetic. Concomitant medication included losartan. The patient stated, "I got Covid two weeks after my first shot." The outcome of the event got Covid two weeks after my first shot was unknown.  Note: In Material Information (CI grid), Material # and Material Description fields are applicable to non-SAP sites and will be blank on the report for investigation records created under SAP sites. Material # (SAP) and Material Description (SAP) fields are applicable to SAP sites and will be blank on the report for investigation records created under non-SAP sites. Investigation Decision: (Parent) FPRS Evaluation Comment: (Site name), reviewed this complaint and agrees with the site assignment, investigation decision, classification, sub-classification, and priority. The reported lot number is valid and an investigation will be performed. Repeat Investigation?: No. Was CAPA Previously Identif'd?: No. Full Investigation Required?: Yes. CAPAs in Place?: N/A. CAPA Reference: N/A. Manufactured Post-CAPA: N/A. Reviewed By: (name). Reviewed On (GMT): 23Feb2021. QA Review & Rationale: The complaint and its classification have been reviewed. No immediate containment action is required. The complaint, its priority, and its classification have been reviewed and determined to be appropriate. A full investigation will be performed. This is a complaint for lack of effect of lot EL9266 of the PFIZER-BIONTECH COVID-19 VACCINE. The initial scope of this investigation is limited to the reported finished goods lot EL9266 pending review of lot genealogy. The investigation will include a review of the returned complaint sample (if received) and reserve samples, if necessary. Investigation findings: The initial scope of the investigation was limited to the reported finished goods lot. The final scope was expanded to include the reported finished goods lot EL9266, fill lot EL9257, and the formulated drug product lot EL9248. Manufacturing and packaging batch records were reviewed for the reported complaint lot. (Site name) QO did not receive photographs or a complaint sample for examination. The complaint was not confirmed.  There were no planned or unplanned deviations recorded during the manufacture of the complaint lot and associated manufacturing lots that may have caused a complaint of this nature. A review of the manufacturing records confirmed processing steps were performed within pre-established parameters. All raw materials and amounts used in the manufacture of the batch were of the correct weight and identity. The results of all analytical tests performed at the time of lot release confirmed that the batch continues to meet potency specifications. The product requires storage in ultra-low temperature freezers. A review of the temperature log for the reported batch confirmed that all freezer temperatures were within allowable limits.  Regulatory / Market Assessment: NTM Decision: No-NTM not required. NTM Rationale: Other. Date NTM Decision Made (GMT): This should reflect the most current decision date 26Feb2021. Other NTM Rationale: This complaint is not confirmed or considered process related. Regulatory Impact: No. Other Regulatory Notification: N/A. AQRT/MACC Ref Number: N/A. Root Cause / CAPA: Process Related?: No. Final Confirmation Status: Not Confirmed. Vendor Related?: No. Root Cause Analysis/Identif: (Site name) Quality Operations could not indicate a probable root cause for the complaint to be related to the production process of the involved batch. Review of the manufacturing and packaging batch records and release test results confirmed that the batch continues to meet potency specifications. It is unknown how the product was handled, stored, or administered after it left the (Site name). Impact Analysis: Based on the results of this investigation, the manufacturing and packaging batches remain acceptable and the reported complaint is not representative of the lot. No regulatory notification is needed.  Root Cause Category (Tier 1): Non-assignable (Complaint Not Confirmed). Contributing Factor (Tier 1): Non-assignable (Complaint Not Confirmed). Root Cause Category (Tier 2): Non-assignable (Complaint Not Confirmed). Contributing Factor (Tier 2): Non-assignable (Complaint Not Confirmed). Root Cause Category (Tier 3): N/A. Contributing Factor (Tier 3): N/A. Special or Common Cause: Common Cause Root Cause is always present to some degree in the process. Special Cause Root Cause is something different happening at a certain time or place in the process. Improve / control: Corrective / Preventive Action: There were no corrective actions as a result of this complaint investigation. The results of all tests, inspections, and in-process controls have been reviewed and all results met the established requirements prior to the release of the reported batch for distribution. Conclusion & Approvals: Additional Approval(s) Req'd?: No. Product Quality Impact: No. Market / Clinical Impact: No. SQRT Review Required?: No. Stability Impact: No. AQRT Review Req'd?: No. Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EL9266 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EL9266, fill lot EL9257, and the formulated drug product lot EL9248. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. Scope of Compl. Investigation: The scope of this investigation included the reported finished goods lot EL9266, fill lot EL9257, and the bulk formulated drug product EL9248. Acceptable review of related documentation, including manufacturing batch records and review of release test results at the time of lot release confirmed that there were no issues which may have resulted in a complaint of this nature. Vendor Investigation?: No. Action Title / Short Descript.: N/A. Design Related?: Document Review Summary:  DEVIATIONS: Complete - Acceptable There were no planned or unplanned deviations recorded during the manufacturing of the reported lot or associated batches that may have caused a complaint of this nature. MANUFACTURING BATCH RECORDS: Complete -Acceptable. The bulk manufacturing batch records for the complaint batch were reviewed as part of this investigation and were found to be acceptable. All processing steps were performed within pre-established parameters. The review of the manufacturing record confirmed that all in process checks, all line startup and end of batch challenges, and all line clearance and cleaning activities were completed satisfactorily. All raw materials used in the complaint batch were of the correct weight and identity. All the manufacturing temperatures mix speeds and mixing times were within acceptable ranges. In-process appearance and specific gravity test results were all within acceptable ranges. A review of the solution filtration documentation confirmed that all filters and Water for Injection (WFI) were used within their expiration dates, and that all the filtration times, pH results, and pressure specifications were met. The manufacturing processes of raw material usage, solution formulation and filtration were all found to be acceptable. All manufacturing parameters met established requirements. A log is maintained throughout the manufacturing process of the amount of elapsed time that the product is out of refrigeration. A review of the elapsed time tracking logs confirmed that all times were within allowable limits. PACKAGING BATCH RECORDS: Complete -Acceptable. The review of the packaging record confirmed that all in process checks, all line startup and end of batch challenges, and all line clearance and cleaning activities were completed satisfactorily. Audits are performed on the finished packaged units by Packaging Operations personnel at regular intervals throughout the final packaging process. This is done in order to ensure that all required labeling and packaging is present, complete, and meets all establishments requirements. During the audits, inspectors visually check the appearance of the finished product for defects. The Pfizer-BioNTech COVID-19 Vaccine vials are loaded into trays containing 195 vials each. Five trays are then banded together into a bundle. The vaccine requires ultra-low temperature freezer storage. Prior to loading, freezer temperatures were verified to between -67°C and -73°C. Freezer shelves were then loaded with bundles of product. During the freezing phase, which occurs 60 hours after loading, the temperature of the freezers is monitored. If the temperature is warmer than the previously recorded temperature, supervision is notified. Additionally, after the freezer temperature drops below -60°C, the temperature recorded may be warmer due to the freezer operation caused by the freezer cycling. This is acceptable. A review of the log for the reported batch confirmed that all freezer temperatures acceptable. Samples are then stored until the product is released for distribution.  LOT HISTORY: Complete - Acceptable. The results of all tests and inspections met required specifications at the time of release for distribution on 31Jan2021 Reserve Sample Evaluation: Rsrv. Sample Evaluation Reqd?: No. Rsrv. Sample Eval. Rationale: Visual examination of a reserve sample would not be expected to indicate the potency of the drug product. A reserve sample was not sent to the QC-lab to determine the amount of active ingredient since the complaint was received within six months of the release date of the involved batch. The results of all analytical tests performed at the time of lot release were confirmed to be within registered specifications. All available stability results for this product were within registered specification and stability studies (including accelerated studies) are ongoing for this product. Confirmed Reserve Defect?: No. The complaint history for the reported PFIZER-BIONTECH COVID-19 VACCINE lot EL9266 was reviewed. As of 26Feb2021, there are a total of two complaints for this lot and classification. No lot specific trend was identified that would require additional investigation. Lot Trend Actions Taken: There were no lot trend actions taken as a result of this investigation.