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Clin Infect Dis ; 2021 Nov 03.
Article in English | MEDLINE | ID: covidwho-1501062


BACKGROUND: Myocarditis following COVID-19 mRNA vaccines (Pfizer-BioNTech and Moderna) have been increasingly reported. Incidence rates in the general population are lacking, with pericarditis rather than myocarditis diagnostic codes being used to estimate background rates. This comparison is critical to balance the risk of vaccination with the risk of no vaccination. METHODS: A retrospective case-series was performed utilizing the Mayo Clinic COVID-19 Vaccine Registry. We measured the incidence rate ratio for myocarditis temporally related to COVID-19 mRNA vaccination compared to myocarditis in a comparable population from 2016 through 2020. Clinical characteristics and outcomes of the affected patients was collected. A total of 21 individuals were identified, but ultimately 7 patients met the inclusion criteria for vaccine-associated myocarditis. RESULTS: The overall incidence rate ratio (IRR) of COVID-19 related myocarditis was 4.18 (CI95% 1.63, 8.98) which was entirely attributable to an increased IRR among adult males (IRR 6.69, CI95% 2.35, 15.52) compared to females (IRR 1.41, CI95% 0.03, 8.45).All cases occurred within 2 weeks of a dose of the COVID-19 mRNA vaccine with the majority occurring within 3 days (range 1-13 days) following the second dose (6/7 patients, 86%). Overall, cases were mild, and all patients survived. CONCLUSIONS: Myocarditis is a rare adverse event associated with COVID-19 mRNA vaccines, and in adult males it occurs with significantly higher incidence than the background population rate. Recurrence of myocarditis after a subsequent mRNA vaccine dose is not known at this time.

J Pediatric Infect Dis Soc ; 10(5): 629-634, 2021 May 28.
Article in English | MEDLINE | ID: covidwho-1272968


BACKGROUND: In November 2020, the US Food and Drug Administration (FDA) provided Emergency Use Authorizations (EUA) for 2 novel virus-neutralizing monoclonal antibody therapies, bamlanivimab and REGN-COV2 (casirivimab plus imdevimab), for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adolescents and adults in specified high-risk groups. This has challenged clinicians to determine the best approach to use of these products. METHODS: A panel of experts in pediatric infectious diseases, pediatric infectious diseases pharmacy, pediatric intensive care medicine, and pediatric hematology from 29 geographically diverse North American institutions was convened. Through a series of teleconferences and web-based surveys, a guidance statement was developed and refined based on review of the best available evidence and expert opinion. RESULTS: The course of COVID-19 in children and adolescents is typically mild and there is no high-quality evidence supporting any high-risk groups. There is no evidence for safety and efficacy of monoclonal antibody therapy for treatment of COVID-19 in children or adolescents, limited evidence of modest benefit in adults, and evidence for potential harm associated with infusion reactions or anaphylaxis. CONCLUSIONS: Based on evidence available as of December 20, 2020, the panel suggests against routine administration of monoclonal antibody therapy (bamlanivimab, or casirivimab and imdevimab), for treatment of COVID-19 in children or adolescents, including those designated by the FDA as at high risk of progression to hospitalization or severe disease. Clinicians and health systems choosing to use these agents on an individualized basis should consider risk factors supported by pediatric-specific evidence and ensure the implementation of a system for safe and timely administration that does not exacerbate existing healthcare disparities.

Antibodies, Monoclonal/therapeutic use , Antiviral Agents/therapeutic use , COVID-19/drug therapy , Pneumonia, Viral/drug therapy , Adolescent , Antibodies, Monoclonal, Humanized , COVID-19/epidemiology , Child , Drug Approval , Female , Humans , Male , Pandemics , Pneumonia, Viral/epidemiology , Pneumonia, Viral/virology , SARS-CoV-2 , United States/epidemiology , United States Food and Drug Administration
Mayo Clin Proc ; 96(5): 1250-1261, 2021 05.
Article in English | MEDLINE | ID: covidwho-1219872


The administration of spike monoclonal antibody treatment to patients with mild to moderate COVID-19 is very challenging. This article summarizes essential components and processes in establishing an effective spike monoclonal antibody infusion program. Rapid identification of a dedicated physical infrastructure was essential to circumvent the logistical challenges of caring for infectious patients while maintaining compliance with regulations and ensuring the safety of our personnel and other patients. Our partnerships and collaborations among multiple different specialties and disciplines enabled contributions from personnel with specific expertise in medicine, nursing, pharmacy, infection prevention and control, electronic health record (EHR) informatics, compliance, legal, medical ethics, engineering, administration, and other critical areas. Clear communication and a culture in which all roles are welcomed at the planning and operational tables are critical to the rapid development and refinement needed to adapt and thrive in providing this time-sensitive beneficial therapy. Our partnerships with leaders and providers outside our institutions, including those who care for underserved populations, have promoted equity in the access of monoclonal antibodies in our regions. Strong support from institutional leadership facilitated expedited action when needed, from a physical, personnel, and system infrastructure standpoint. Our ongoing real-time assessment and monitoring of our clinical program allowed us to improve and optimize our processes to ensure that the needs of our patients with COVID-19 in the outpatient setting are met.

Antiviral Agents/administration & dosage , COVID-19 , Critical Pathways , Home Infusion Therapy , SARS-CoV-2 , Spike Glycoprotein, Coronavirus , Antibodies, Monoclonal/administration & dosage , COVID-19/epidemiology , COVID-19/therapy , Clinical Protocols , Critical Pathways/organization & administration , Critical Pathways/trends , Efficiency, Organizational , Home Infusion Therapy/methods , Home Infusion Therapy/standards , Humans , Intersectoral Collaboration , Organizational Culture , Program Development/methods , SARS-CoV-2/immunology , SARS-CoV-2/isolation & purification , Severity of Illness Index , Spike Glycoprotein, Coronavirus/antagonists & inhibitors , Spike Glycoprotein, Coronavirus/immunology , United States/epidemiology