Introduction Evidence-based clinical data on coronavirus disease 2019 (COVID-19) pharmacotherapies are scarce . Objective This study documented and characterized COVID-19 cases reported in individuals receiving treatment with Pfizer pharmaceutical products and cases that reported use of Pfizer pharmaceutical products for COVID-19 treatment. Methods This retrospective observational review leveraged the Pfizer safety database containing adverse event data collected in association with use of Pfizer products between 1 October, 2019, and 25 June, 2020; the database includes worldwide adverse event data from various sources. Selected Medical Dictionary for Drug Regulatory Activities (MedDRA ® ) Preferred Terms and subsequent clinical review were used to characterize COVID-19 cases. Results Over 1500 relevant cases were identified over an 8-month period. In cases that reported COVID-19, immunosuppressant/immunomodulating agents, followed by anticoagulant/antithrombic agents and corticosteroids, were the most frequently reported agents. The frequent reporting of immunosuppressant/immunomodulating agents among cases of COVID-19 suggests increased vulnerability to infection among treated patients, either because of immunosuppressive effects of certain agents or the nature of the underlying treated condition. In cases involving off-label pharmacotherapy use for the treatment of COVID-19-related conditions, the most frequently reported therapeutic classes included antibiotics, antimalarial agents, antivirals/antiretroviral agents, immunosuppressant/immunomodulating agents, corticosteroids, anticoagulants, and immunoglobulin/interferons. The most frequently reported pharmacotherapeutic agents were azithromycin and chloroquine/hydroxychloroquine, followed by lopinavir-ritonavir, ceftriaxone, and tofacitinib. The most frequently reported clinical adverse events associated with azithromycin (as sole therapy or combined with chloroquine/hydroxychloroquine) include electrocardiogram QT prolonged, drug interaction, hepatitis, diarrhea, and hepatitis acute. Regarding cardiac-related events, 19% (120/645) of azithromycin cases reported events associated with QT prolongation/torsade de pointes (which included seven fatal cardiac events). The most frequently reported clinical adverse events associated with other commonly used agents are also presented. Conclusions This pharmacovigilance surveillance study provides a unique characterization of cases in which a broad range of pharmaceutical products was reported in relation to COVID-19.

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Purpose To characterize the inpatient use of filgrastim in cancer patients hospitalized for management of post-chemotherapy fever after receiving either outpatient filgrastim or pegfilgrastim. Method Retrospective review of chart records in a single-center, tertiary-care, teaching hospital and outpatient oncology center of cancer patients hospitalized for fever after outpatient chemotherapy and proactive administration of filgrastim or pegfilgrastim. Patients with the following tumor types were included: breast cancer, cervical cancer, colon cancer, Hodgkin disease, intermediate- or high-grade non-Hodgkin lymphoma, small cell or non-small cell lung cancer, and ovarian cancer. Result Billing data identified 1,438 outpatient chemotherapy patients treated with filgrastim or pegfilgrastim; 261 (18.2%) of whom were hospitalized for fever. All patients in the filgrastim groups, and 78% of those in the pegfilgrastim group, were given inpatient filgrastim. Duration of filgrastim administration in the inpatient setting was significantly shorter (P < 0.001) for the pegfilgrastim group. Conclusions Filgrastim was frequently administered to cancer patients hospitalized for fever, even after outpatient pegfilgrastim was administered as an adjunct to chemotherapy. Patients treated with once-per-cycle pegfilgrastim in an outpatient setting do not require filgrastim if they are hospitalized for fever before neutrophil recovery. Thus, hospitals could realize immediate cost savings by not treating those patients with filgrastim. This study illustrates the need to develop operational procedures in institutions to rapidly identify prior outpatient pegfilgrastim administration as a patient is admitted for post-chemotherapy fever.

Background The enduring presence of COVID-19 and subsequent increasing incidence of COVID-19 reinfection has prompted evaluation of associated risk factors, particularly the role of immunosuppression. Objective The objective of this study was to characterize cases indicative of COVID-19 reinfection with respect to their reported use of immunosuppressant/immunomodulating agents. Methods This cross-sectional observational study leveraged the Pfizer global safety database (SDB) containing adverse event data collected in association with use of Pfizer products between 1 October 2019, and 30 June 2022. Selected Medical Dictionary for Drug Regulatory Activities (MedDRA ® ) Preferred Terms were used to identify COVID-19 cases; the search was further refined to comprise cases that subsequently reported events potentially indicative of COVID-19 reinfection. Results Of the cumulative total of 218,242 COVID-19 cases reported into the SDB, 4590 cases (2.1%) involving potential COVID-19 reinfection were identified. Of these 4590 cases of potential Covid-19 reinfection, a total of 134 cases reported COVID-19 specifically during treatment with pharmaceutical products, of which approximately 16% (21/134) of cases reported use of immunosuppressant/immunomodulating agents. Likewise, in the overall dataset (213,652 cases; excluding the 4590 cases involving potential COVID-19 recurrence), the percentage of reported immunosuppressant/immunomodulating agents was low (12%). In applying similar parameters to a dataset that excludes COVID-19 vaccine cases, 18% of cases reported use of immunosuppressant/immunomodulating agents (similar to the aforementioned 16% of cases reported from the overall total dataset that was inclusive of vaccine cases). Conclusion This pharmacovigilance study provides a characterization of cases indicative of COVID-19 reinfection with respect to reported use of immunosuppressant/immunomodulating agents. The observations generated from this cross-sectional observational analysis may prompt further research into the role of immunosuppression in COVID-19 reinfection, in an effort to better inform clinical practice and patient management.