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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.
MMWR Morb Mortal Wkly Rep. 2022 Mar 18; 71(11):416-421.MM

Abstract

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.

Authors

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Pub Type(s)

Technical Report

Language

eng

PubMed ID

35298454

Citation

Wallace, Megan, et al. "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." MMWR. Morbidity and Mortality Weekly Report, vol. 71, no. 11, 2022, pp. 416-421.
Wallace M, Moulia D, Blain AE, et al. 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. MMWR Morb Mortal Wkly Rep. 2022;71(11):416-421.
Wallace, M., Moulia, D., Blain, A. E., Ricketts, E. K., Minhaj, F. S., Link-Gelles, R., Curran, K. G., Hadler, S. C., Asif, A., Godfrey, M., Hall, E., Fiore, A., Meyer, S., Su, J. R., Weintraub, E., Oster, M. E., Shimabukuro, T. T., Campos-Outcalt, D., Morgan, R. L., ... Oliver, S. E. (2022). 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. MMWR. Morbidity and Mortality Weekly Report, 71(11), 416-421. https://doi.org/10.15585/mmwr.mm7111a4
Wallace M, et al. 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. MMWR Morb Mortal Wkly Rep. 2022 Mar 18;71(11):416-421. PubMed PMID: 35298454.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Wallace,Megan, AU - Moulia,Danielle, AU - Blain,Amy E, AU - Ricketts,Erin K, AU - Minhaj,Faisal S, AU - Link-Gelles,Ruth, AU - Curran,Kathryn G, AU - Hadler,Stephen C, AU - Asif,Amimah, AU - Godfrey,Monica, AU - Hall,Elisha, AU - Fiore,Anthony, AU - Meyer,Sarah, AU - Su,John R, AU - Weintraub,Eric, AU - Oster,Matthew E, AU - Shimabukuro,Tom T, AU - Campos-Outcalt,Doug, AU - Morgan,Rebecca L, AU - Bell,Beth P, AU - Brooks,Oliver, AU - Talbot,H Keipp, AU - Lee,Grace M, AU - Daley,Matthew F, AU - Oliver,Sara E, Y1 - 2022/03/18/ PY - 2022/3/17/entrez PY - 2022/3/18/pubmed PY - 2022/3/25/medline SP - 416 EP - 421 JF - MMWR. Morbidity and mortality weekly report JO - MMWR Morb Mortal Wkly Rep VL - 71 IS - 11 N2 - 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. SN - 1545-861X UR - https://www.unboundmedicine.com/medline/citation/35298454/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_ L2 - https://doi.org/10.15585/mmwr.mm7111a4 DB - PRIME DP - Unbound Medicine ER -