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.

Publisher: U.S. Centers for Disease Control Country of Publication: United States NLM ID: 7802429 Publication Model: Electronic Cited Medium: Internet ISSN: 1545-861X (Electronic) Linking ISSN: 01492195 NLM ISO Abbreviation: MMWR Morb Mortal Wkly Rep Subsets: MEDLINE

Publication: Atlanta, GA : U.S. Centers for Disease Control
Original Publication: [Atlanta] U. S. Dept. of Health, Education, and Welfare, Public Health Service, Center for Disease Control.

Advisory Committees* ; Centers for Disease Control and Prevention, U.S.* ; Health Planning Guidelines* ; Immunization Schedule*; 2019-nCoV Vaccine mRNA-1273/*administration & dosage; Adult ; Humans ; Middle Aged ; United States

Competing Interests: All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. No potential conflicts of interest were disclosed.
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 that an 8-week interval might be optimal for some adolescents and adults. The additional information gathered since the issuance of the interim recommendations increased certainty that the benefits of preventing symptomatic and asymptomatic SARS-CoV-2 infection, hospitalization, and death outweigh vaccine-associated risks of the Moderna COVID-19 vaccine. On February 4, 2022, ACIP modified its interim recommendation to a standard recommendation ^§ for use of the fully licensed Moderna COVID-19 vaccine in persons aged ≥18 years.

MMWR Morb Mortal Wkly Rep. 2022 Feb 04;71(5):171-176. (PMID: 35113846)
Nat Commun. 2021 Dec 10;12(1):7217. (PMID: 34893611)
NPJ Vaccines. 2022 Jan 27;7(1):14. (PMID: 35087066)
N Engl J Med. 2020 Nov 12;383(20):1920-1931. (PMID: 32663912)
MMWR Morb Mortal Wkly Rep. 2021 Jul 09;70(27):977-982. (PMID: 34237049)
MMWR Morb Mortal Wkly Rep. 2021 Jan 01;69(5152):1653-1656. (PMID: 33382675)
Cell. 2021 Nov 11;184(23):5699-5714.e11. (PMID: 34735795)
N Engl J Med. 2021 Feb 4;384(5):403-416. (PMID: 33378609)
N Engl J Med. 2020 Dec 17;383(25):2427-2438. (PMID: 32991794)
N Engl J Med. 2021 Nov 4;385(19):1774-1785. (PMID: 34551225)
JAMA Netw Open. 2022 Jun 1;5(6):e2218505. (PMID: 35749115)
Vaccine. 2021 May 12;39(20):2791-2799. (PMID: 33707061)
Clin Infect Dis. 2022 Aug 24;75(1):e888-e891. (PMID: 34849655)
JAMA. 2021 Oct 12;326(14):1390-1399. (PMID: 34477808)
JAMA. 2022 Jan 25;327(4):331-340. (PMID: 35076665)

EPK39PL4R4 (2019-nCoV Vaccine mRNA-1273)

Date Created: 20220317 Date Completed: 20220324 Latest Revision: 20240825

20250114

PMC8942305

10.15585/mmwr.mm7111a4

35298454