Interim Recommendation of the Advisory Committee on Immunization Practices for Use of the Novavax COVID-19 Vaccine in Persons Aged ≥18 years - United States, July 2022
The NVX-CoV2373 (Novavax) COVID-19 vaccine is a recombinant spike (rS) protein nanoparticle vaccine with Matrix-M adjuvant to protect against infection with SARS-CoV-2, the virus that causes COVID-19. On July 13, 2022, the Food and Drug Administration (FDA) issued Emergency Use Authorization (EUA) for the Novavax vaccine for primary COVID-19 immunization of unvaccinated adults aged ≥18 years, administered as 2 doses (5 μg rS and 50 μg Matrix-M adjuvant in each dose) 3 weeks apart (1). On July 19, 2022, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation for use of the Novavax vaccine in persons aged ≥18 years for the prevention of COVID-19.* In the per-protocol† efficacy analysis, vaccine efficacy (VE) against reverse transcription-polymerase chain reaction (RT-PCR)-confirmed symptomatic COVID-19 was 89.6% (95% CI = 82.4%-93.8%). The Alpha variant (B.1.1.7) of SARS-CoV-2 was the predominant circulating variant during the period of case accrual for VE assessments. Cases of myocarditis or pericarditis were reported in temporal association with vaccination, suggesting a possible causal relationship. The ACIP recommendation for the use of the Novavax COVID-19 vaccine is interim and will be updated as additional information becomes available. The adjuvanted, protein subunit-based Novavax COVID-19 vaccine provides an additional option for unvaccinated adults, increasing flexibility for the public and for vaccine providers. Vaccination is important for protection against COVID-19.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:71 |
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| Enthalten in: |
MMWR. Morbidity and mortality weekly report - 71(2022), 31 vom: 05. Aug., Seite 988-992 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Twentyman, Evelyn [VerfasserIn] |
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| Links: |
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| Themen: |
2SCD8Q63PF |
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| Anmerkungen: |
Date Completed 08.08.2022 Date Revised 26.08.2022 published: Electronic Citation Status MEDLINE |
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| doi: |
10.15585/mmwr.mm7131a2 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM344453553 |
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| 520 | |a The NVX-CoV2373 (Novavax) COVID-19 vaccine is a recombinant spike (rS) protein nanoparticle vaccine with Matrix-M adjuvant to protect against infection with SARS-CoV-2, the virus that causes COVID-19. On July 13, 2022, the Food and Drug Administration (FDA) issued Emergency Use Authorization (EUA) for the Novavax vaccine for primary COVID-19 immunization of unvaccinated adults aged ≥18 years, administered as 2 doses (5 μg rS and 50 μg Matrix-M adjuvant in each dose) 3 weeks apart (1). On July 19, 2022, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation for use of the Novavax vaccine in persons aged ≥18 years for the prevention of COVID-19.* In the per-protocol† efficacy analysis, vaccine efficacy (VE) against reverse transcription-polymerase chain reaction (RT-PCR)-confirmed symptomatic COVID-19 was 89.6% (95% CI = 82.4%-93.8%). The Alpha variant (B.1.1.7) of SARS-CoV-2 was the predominant circulating variant during the period of case accrual for VE assessments. Cases of myocarditis or pericarditis were reported in temporal association with vaccination, suggesting a possible causal relationship. The ACIP recommendation for the use of the Novavax COVID-19 vaccine is interim and will be updated as additional information becomes available. The adjuvanted, protein subunit-based Novavax COVID-19 vaccine provides an additional option for unvaccinated adults, increasing flexibility for the public and for vaccine providers. Vaccination is important for protection against COVID-19 | ||
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| 700 | 1 | |a Rubis, Amy B |e verfasserin |4 aut | |
| 700 | 1 | |a Fleming-Dutra, Katherine E |e verfasserin |4 aut | |
| 700 | 1 | |a Hall, Elisha |e verfasserin |4 aut | |
| 700 | 1 | |a Hsu, Joy |e verfasserin |4 aut | |
| 700 | 1 | |a Rosenblum, Hannah G |e verfasserin |4 aut | |
| 700 | 1 | |a Godfrey, Monica |e verfasserin |4 aut | |
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| 700 | 1 | |a Oliver, Sara E |e verfasserin |4 aut | |
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