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.

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.

COVID-19*/epidemiology ; COVID-19*/prevention & control ; Vaccines*; Adolescent ; Adult ; Advisory Committees ; COVID-19 Vaccines ; Humans ; Immunization ; SARS-CoV-2 ; United States/epidemiology ; Vaccination

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 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.

0 (COVID-19 Vaccines)
0 (Vaccines)
2SCD8Q63PF (NVX-CoV2373 adjuvated lipid nanoparticle)

SARS-CoV-2 variants

Date Created: 20220804 Date Completed: 20220808 Latest Revision: 20220826

20250114

PMC9368733

10.15585/mmwr.mm7131a2

35925807