Abstract
On December 18, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the Moderna COVID-19 (mRNA-1273) vaccine (ModernaTX, Inc; Cambridge, Massachusetts), a lipid nanoparticle-encapsulated, nucleoside-modified mRNA vaccine encoding the stabilized prefusion spike glycoprotein of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19) (1). This vaccine is the second COVID-19 vaccine authorized under an EUA for the prevention of COVID-19 in the United States (2). Vaccination with the Moderna COVID-19 vaccine consists of 2 doses (100 μg, 0.5 mL each) administered intramuscularly, 1 month (4 weeks) apart. On December 19, 2020, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation* for use of the Moderna COVID-19 vaccine in persons aged ≥18 years for the prevention of COVID-19. To guide its deliberations regarding the vaccine, ACIP employed the Evidence to Recommendation (EtR) Framework, † using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. § Use of all COVID-19 vaccines authorized under an EUA, including the Moderna COVID-19 vaccine, should be implemented in conjunction with ACIP’s interim recommendations for allocating initial supplies of COVID-19 vaccines (3). The ACIP recommendation for the use of the Moderna COVID-19 vaccine under EUA is interim and will be updated as additional information becomes available.
【초록키워드】 COVID-19, coronavirus disease, SARS-CoV-2, Coronavirus disease 2019, Vaccine, COVID-19 vaccine, mRNA-1273, spike glycoprotein, drug, FDA, virus, Emergency use authorization, EUA, Food and Drug Administration, COVID-19 vaccines, mRNA, Practice, United States, assessment, information, development, Massachusetts, Moderna, food, dose, Emergency, framework, conjunction, nucleoside, prefusion, authorization, Cambridge, Administered, recommendation, approach, Committee, prevention of COVID-19, initial, the United State, cause, the vaccine, intramuscularly, nucleoside-modified mRNA, 【제목키워드】 COVID-19, Practice, Moderna, Committee, Interim,