Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Colleague became COVID positive on 17Jul2021; Colleague became COVID positive on 17Jul2021; This is a spontaneous report from a contactable other hcp. A 40-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot No: EK5730; Expiration Date: 31Mar2021), via intramuscular in right arm on 24Mar2021 (at the age of 40-years-old) as second dose, single for COVID-19 immunization. Patient received first dose of (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot No: EJ1685), via intramuscular in left arm on 03Mar2021 as first dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. It was unknown if the patient had known allergies. It was unknown if patient experienced COVID prior vaccination. It was unknown if patient received other vaccine in four weeks. It was reported that on 14Jul2021, the colleague (patient) became COVID positive on 17Jul2021. Event resulted in doctor or other healthcare professional office/clinic visit. Treatment for the event was given as antibiotic and steroids. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 17Jul2021. Report received from a Product Complaint Group included that this is a notification generated from the gQTS system. As part of the LOE simplification process, the following Complaint Records were classified as Product Use Attributes // Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the 'One and Done' business process according to in PQS Q1215 and/or Q1252. Refer to the below table (Parent) Brand/Trade - Name: COMPOUND BNT162 COVID-19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1, Lot-# (CR): ER8737, Conclusion of Previously Completed Investigation. The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot ER8737 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 ER8737, fill lot EW3426, and the formulated drug 5861480 5857105 product lot EP8586. A complaint sample was not returned, and photographs were not received. No related quality issues were id. When more than one investigation is found in the family, the Conclusion field could result in repeating rows in the table. If the Conclusion is blank in the table above, then the investigation record is likely an Offline Contractor Investigation and the conclusion must be obtained directly from the child investigation record(s) of the linked Complaint Record. 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 pfizer 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. 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 EK5730 of the PFIZER-BIONTECH COVID-19 VACCINE. The initial scope of this investigation is limited to the reported finished goods lot EK5730 pending review of lot genealogy. The investigation will include a review of the returned complaint sample (if received) and reserve samples, if necessary. Reviewed On (GMT): 26Jan2021. 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 EK5730, fill lot EK3313, and the formulated drug product lot EK3312. Manufacturing and packaging batch records were reviewed for the reported complaint lot. Pfizer 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 associate 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 confirmed that all times were within allowable limits. 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. Root Cause Analysis/Identify pfizer Kalamazoo 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 Pfizer Kalamazoo site. 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. 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. The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EK5730 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 EK5730, fill lot EK3313, and the formulated drug product lot EK3312. 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. Manufacturing batch records complete acceptable. The bulk manufacturing batch record for the complaint batch was reviewed as part of this investigation and 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 materials, 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 greater than the expected temperature, supervision is notified. A review of the log for the reported batch confirmed that all freezer temperatures were acceptable. Samples are then stored until the product is released for distribution. There were no issues recorded during the packaging or storage process which may have impacted the quality of the batch and potency of the drug product. Reserve sample testing result: 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. Lot trend assmt. And rationale the complaint history for the reported PFIZER-BIONTECH COVID-19 VACCINE lot EK5730 was reviewed. As of 11Feb2021, there were a total of five complaints for this lot and classification. No lot specific trend was identified that would require additional investigation. Lot Trend Actions Taken was not applicable. Outcome of the event was recovering.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure cannot be ruled out.