Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid-19 Positive test results; Covid-19 Positive test results; This is a spontaneous report from a contactable consumer. A 26-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6207), dose 1  via intramuscular route in Arm Left on Mar2021 (at 26-years age) as dose 1, single, dose 2 intramuscular, and patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8734) administered in Arm Left on 05Apr2021 (at 26-years age) as dose 2, single for covid-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine The patient medical history and concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test nasal Swab PCR positive on 02Aug2021. Patient visited emergency room/department or urgent care. Since the vaccination, patient was not tested for COVID-19. The outcome of the events was not resolved.  Complaint Inv. Information: Date Opened: 28Apr2021 (Parent) Complaint Priority: High (Parent) Investigation Required? Yes (Root Parent) Related to Potential AE? Yes(Root Parent) Date of Contact: 13Apr2021  (Root Parent) Description of Complaint: Product quality investigation request Lot# EN6207 & EN6199, BNT162B2 Brief Complaint Description: PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE - EN6207 - Lack Of Effect (Root Parent) Triage Location / Country:  Responsible Site Notif. Date : 28Apr2021 Rsnbly Suggest Device Malfunc? No Severity of Harm: N/A Failure Mode: N/A IDC - Level 1: QualitIDC - Level 2: Product Complaint IDC - Level 3: Complaint - Function / Therapeutic Properties (Parent) Complaint Class: Product Use Attributes (Parent) Complaint Sub-Class: Lack Of Effect (Parent) Brand/Trade-Name: PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE (Parent) Product Family-API: BNT162B2 (Parent) Product-Description: COMPOUND BNT 162 COVID-19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML  (Parent) Product-Type: RX (Parent) Product-Category: INJECTABLE (Parent) Sterile-Product: Yes (Parent) Combination-Product: No (Parent) Medical-Device: No (Parent) Combination-Product-Type: N/A (Parent) Lot-#: EN6207 (Parent) UDI- (if appl): N/A(Parent) Batch-Expiry Year: 2021 (Parent) Batch-Expiry Month: Jul (Parent) Batch-Expiry Day: 31 Investigation Decision:(Parent) FPRS Evaluation Comment: Pfizer agrees with investigation decision, classification, priority, and justification. The site assignment grid was reviewed and is accurate for this product. Repeat Investigation?: No Was CAPA Previously Identif'd?: No CAPAs in Place?: N/A CAPA Reference: N/A Full Investigation Required?: Yes Manufactured Post-CAPA: N/A 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 related to lot EN6207 of PFIZER-BIONTECH COVID-19 VACCINE. The initial scope of this investigation is limited to the reported finished goods lot EN6207 pending review of lot genealogy. The investigation will include a include a review of the returned complaint sample (if received) and reserve samples, if necessary. Reviewed On : 25Mar2021 Investigation findings: Summary of Investigation: 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 EN6207, fill lot EN5340, and the formulated drug product lot EN5328. Manufacturing and packaging batch records were reviewed for the reported complaint lot.Root cause/CAPA: Pfizer withheld 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 drug product is stored at controlled refrigeration throughout the manufacturing process and a log is maintained documenting the elapsed time out of refrigeration. A review of the logs discovered segments of the batch exceeded the 46-hour limit. Immediate actions included submitting samples for RNA Integrity analysis, which met the release limits and batch was considered acceptable for release. The product also requires storage in ultra-low temperature freezers following the packaging of the product. A review of the freezer temperature log for the reported batch confirmed that all freezer temperatures were within allowable limits. The results of all analytical tests performed at the time of lot release confirmed that the batch continues to meet potency specifications. Regulatory/Market Assessment:NTM Decision: No-NTM not required NTM Rationale: Other Date NTM Decision Made : This should reflect the most current decision date 28Apr2021 Other NTM Rationale: Not expedited or confirmed Regulatory Impact: No Other Regulatory Notification: N/A Root Cause/CAPA: Process Related? No Final Confirmation Status: Not Confirmed Vendor Related? No Root Cause Analysis/Identif: Pfizer withheld 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 meets potency specifications. It is unknown how the product was handled, stored, or administered after it left the Pfizer withheld site.Impact Analysis: Based on the final scope of the investigation and that there was no probable process related root cause identified the reported complaint is not representative of the overall quality of the lot. No regulatory notification is required.Root Cause Category (Tier 1): Non-assignable (Complaint Not Confirmed) Root Cause Category (Tier 2): Non-assignable (Complaint Not Confirmed) Root Cause Category (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 and Approvals: Additional Approval(s) Req'd?: No Product Quality Impact: NoMarket / Clinical Impact: No Market / Clinical Impact: No SQRT Review Required?: No AQRT Review Req'd?: No Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EN6207 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 and product type. The final scope included the reported finished goods lot EN6207, fill lot EN5340, and the formulated drug product lot EN5328. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. Follow-up attempts are completed. No further  Document Review Summary:DEVIATIONS: Complete - Acceptable There was one deviation investigation initiated related to in-scope lots.QAR 5637107 - The purpose of this investigation was to identify the root cause for exceeding the Time Out of Refrigeration (TOR) limit of 46 hours during the production of the Covid-19 vaccine. Based on the investigation findings detailed below, it was determined that the threshold for when Filling begins a new segment may not provide enough time for the previous segment to reliably complete in Inspection and Packaging within the TOR limit. The worst-case TOR samples for EN6207 came from Segment 1, which had a maximum TOR of 51 hours compared to the limit of 46. The RNA Integrity result for the worst-case TOR sample from EN6207 was 68%. This meets the release limit of >=55%. Additionally, the two validation batches that included a TOR hold time of 46 hours had RNA Integrity results of 65% and 62%. The passing result of the worst-case TOR sample from EN6207 and data comparison against the validation batches show that there was no impact as a result of the TOR excursion experienced during the manufacturing process of the subject batch. Therefore, batch EN6207 is considered to be acceptable for release with regard to QAR# 5637107. 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. 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 except for TOR as discussed above in the deviation section. A log is maintained throughout the manufacturing process of the amount of elapsed time that the product is out of refrigeration. 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. All defective vials were discarded, and alert limits were not exceeded. A review of the audit results for the reported lot confirmed that no quality defects related to the nature of the complaint were observed. LOT HISTORY: Complete - Acceptable The results of all tests and inspections met required specifications at the time of release for distribution on 03Mar2021.  Follow up (05Aug2021): This is a follow-up spontaneous report received from a product quality complaint group providing investigation results. This report included that: investigation summary and conclusion.