Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cardiac index, Cytomegalovirus test, Drug ineffective, Immunophenotyping
Clinical narrative: Two participants died because of COVID-19 infection/and 1 developed infection after receiving 3 doses of the BNT162b2 vaccine; Two participants died because of COVID-19 infection/and 1 developed infection after receiving 3 doses of the BNT162b2 vaccine; This is a literature report for the following literature source(s)  A female patient (unknown if pregnant) received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (death, hospitalization, medically significant), COVID-19 (death, hospitalization, medically significant), outcome "fatal" and all described as "Two participants in study died because of COVID-19 infection/and 1 developed infection after receiving 3 doses of the BNT162b2 vaccine". The patient underwent the following laboratory tests and procedures: Antibody test: Unknown result; Biopsy lung: Unknown result; Blood creatinine: Unknown result; Body mass index: Unknown result, notes: KG/M2; Bronchoscopy: Unknown result; Cardiac index: Unknown result, notes: L/min/m2; Cytomegalovirus test: Unknown result; Immunophenotyping: Unknown result; Pulmonary arterial pressure: Unknown result. The patient date of death was unknown. Reported cause of death: "died because of COVID-19 infection".  Additional information: There was no significant difference in the incidence of infection between the 2 arms. Three participants in each arm developed COVID-19 infection. Two participants in each arm developed COVID-19 infection before the availability of vaccines, and 1 in each arm had been vaccinated but developed a breakthrough infection. Two participants in the study died because of COVID-19 infection; 1 developed infection before the availability of vaccines, and 1 developed infection after receiving 3 doses of the BNT162b2 vaccine. Both had prolonged, refractory hypoxemic respiratory failure that led to death. One of these participants developed COVID-19 and hypoxemic respiratory failure that required hospitalization during study follow-up. She remained hospitalized with persistent respiratory failure and died after completing the study follow-up.  Five participants in the study died during the study period, and a sixth participant died after completing the study follow-up but had been hospitalized with prolonged respiratory failure after a COVID-19 infection that occurred during the study period. In contrast, none of the participants in the control study died. Causes of death included COVID-19 infection in 2 participants, CLAD in 1 participant, PTLD in 1 participant, hemothorax in 1 participant, and a suspected pulmonary embolism in 1 participant.  Although there were different causes of death, it is notable that 4 of 6 deaths were associated with viruses; 2 deaths were due to COVID-19 infection, 1 was due to progressive RAS 6 wk after rhinovirus/enterovirus infection, and 1 was due to EBY-associated PTLD in an EBV seropositive recipient.  However, inhibition by belatacept of naive T-cell responses may explain the observed 2 deaths related to COVID-19 and the death due to progressive RAS after rhinovirus/enterovirus infection in the study. Of the 6 total study participants who developed COVID-19, only 2 were vaccinated because most infections occurred before the availability of vaccines.  The authors conclude that the investigational immunosuppressive regimen used in this pilot RCT is associated with increased mortality after lung transplantation. These findings emphasize the need to examine novel immunosuppressive treatments in lung transplantation in the context of carefully designed and monitored clinical trials rather than incorporating these into clinical practice based on findings in other solid organ transplant settings.; Sender's Comments: Based on the compatible time association, the lack of efficacy cannot be excluded for suspect vaccine BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-202200000005 Same article and different patient/drug/event;; Reported Cause(s) of Death: died because of COVID-19 infection; died because of COVID-19 infection