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The Advisory Committee on Immunization Practices’ Recommendation for Use of Moderna COVID-19 Vaccine in Adults Aged ≥18 Years and Considerations for Extended Intervals for Administration of Primary Series Doses of mRNA COVID-19 Vaccines — United States, February 2022

2011; Centers for Disease Control and Prevention; Volume: 71; Issue: 11 Linguagem: Inglês

10.15585/mmwr.mm7111a4

1545-861X

Megan Wallace, Danielle Moulia, Amy Blain, Erin K. Ricketts, Faisal S. Minhaj, Ruth Link‐Gelles, Kathryn Curran, Stephen C. Hadler, Amimah Asif, Monica Godfrey, Elisha Hall, a cura di Luciano De Fiore, Sarah Meyer, John R. Su, Eric Weintraub, Matthew E. Oster, Tom T. Shimabukuro, Doug Campos‐Outcalt, Rebecca L. Morgan, Beth P. Bell, Oliver Brooks, H. Keipp Talbot, Grace M. Lee, Matthew F. Daley, Sara E. Oliver,

Vaccine Coverage and Hesitancy

The mRNA-1273 (Moderna) COVID-19 vaccine is a lipid nanoparticle-encapsulated, nucleoside-modified mRNA vaccine encoding the stabilized prefusion spike glycoprotein of SARS-CoV-2, the virus that causes COVID-19.During December 2020, the vaccine was granted Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA), and the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation for use among persons aged ≥18 years (1), which was adopted by CDC.During December 19, 2020-January 30, 2022, approximately 204 million doses of Moderna COVID-19 vaccine were administered in the United States (2) as a primary series of 2 intramuscular doses (100 μg [0.5 mL] each) 4 weeks apart.On January 31, 2022, FDA approved a Biologics License Application (BLA) for use of the Moderna COVID-19 vaccine (Spikevax, ModernaTX, Inc.) in persons aged ≥18 years (3).On February 4, 2022, the ACIP COVID-19 Vaccines Work Group conclusions regarding recommendations for the use of the Moderna COVID-19 vaccine were presented to ACIP at a public meeting.The Work Group's deliberations were based on the Evidence to Recommendation (EtR) Framework,* which incorporates the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach † to rank evidence quality.In addition to initial clinical trial data, ACIP considered new information gathered in the 12 months since issuance of the interim recommendations, including additional follow-up time in the clinical trial, real-world vaccine effectiveness studies, and postauthorization vaccine safety monitoring.ACIP also considered comparisons of mRNA vaccine effectiveness and safety in real-world settings when first doses were administered 8 weeks apart instead of the original intervals used in clinical trials (3 weeks for BNT162b2 [Pfizer-BioNTech] COVID-19 vaccine and 4 weeks for Moderna COVID-19 vaccine).Based on this evidence, CDC has provided guidance * https://www.cdc.