Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test, Vaccination failure
Clinical narrative: severe COVID-19 symptoms; severe covid-19 symptoms; This is a literature report from a regulatory authority. The reporter reported similar events for five patients. This is the first of five reports. This is a report to notify that the case 202101329133 and 202101360380 are duplicates. All subsequent follow-up information will be reported under manufacturer report number 202101360380.  A 68-year-old patient of an unspecified gender received BNT162B2, dose 2 via an unspecified route of administration on 12Feb2021 (Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 22Jan2021 (Batch/Lot number was not reported), both as single dose for COVID-19 immunisation. Medical history included kidney transplant on 06Feb2015. Concomitant medication included mycophenolate mofetil (MYCOPHENOLATE) taken for immunosuppression, start and stop date were not reported. The patient experienced severe COVID-19 symptoms requiring supplemental oxygenation, in Mar2021 with outcome of unknown (Time from vaccine completion to diagnosis: 28 days). The patient underwent lab tests and procedures in 2021 which included Nucleocapsid proteina IgG titer detection positive, Spike protein IgG titer detection positive. COVID-19 treatment received Remdesivir, dexamethasone. The hospital admission was required for the event. Here authors present their early single-center experience with vaccine breakthrough and symptomatic COVID-19 (Coronavirus Disease-2019) disease hospitalization rates in fully vaccinated kidney transplant recipients. A total of 166 kidney transplant recipients were diagnosed with symptomatic COVID-19 at their health system from Mar2020 to Apr2021. Of these 107 (64%) required inpatient admission and overall mortality was 11% (18/166). Three hundred and eighty (mostly age > 65 years) completed both doses of the Pfizer-BioNTech or Moderna vaccine by Apr2021. From February to April there were 17/166 (10%) new positive documented COVID-19 cases. Among them 7/17 patients developed symptomatic disease despite being fully vaccinated suggesting an early breakthrough rate of 1.8% (7/380). Four out of seven were hospitalized; however only two developed severe COVID-19 symptoms requiring supplemental oxygenation redemsivir and dexamethasone. These patients were predominately male (5/7) with a median age of 53 who received a de-ceased donor with a median time of 3 years from transplant. Majority (6/7) were maintained on triple immunosuppression with one patient taken off of anti-metabolite due to persistent BK viremia. Median time from vaccine completion to time to diagnosis was 33 days. Interestingly 3/7 patients had detectable Sars-CoV- 2 spike IgG antibody while 2/7 had both spike and nucleocapsid protein IgG at the time of COVID-19 diagnosis. Unfortunately quantitative antibody levels as well as SARs-CoV- 2 variant data was not available. Their early experience suggests limited early breakthrough COVID-19 in kidney trans-plant recipients who completed the two-dose SARs-CoV- 2 mRNA vaccine series despite a reported 54% antibody response. In patients who did experience vaccine breakthrough the majority did not develop severe symptoms that required inpatient admission. This may reflect a need for quantitative antibody disease protection threshold measurements as well as the importance of continued vaccine efforts among immunosuppressive patients despite the reported lower antibody response. Their results are further strengthened by a significant decline in the diagnosis of new COVID-19 cases since vaccinations started. Future studies are needed to assess newer strategies in vaccination to better protect immunosuppressed patients from preventable morbidity and mortality.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded,Linked Report(s) : US-PFIZER INC-202101327226 Same article/drug/event; different patient;US-PFIZER INC-202101352709 Same article/drug/event; different patient;US-PFIZER INC-202101352771 Same article/drug/event; different patient;US-PFIZER INC-202101352772 Same article/drug/event; different patient