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. 2022 Aug 5;71(31):988-992.
doi: 10.15585/mmwr.mm7131a2.

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

Evelyn Twentyman, Megan Wallace, Lauren E Roper, Tara C Anderson, Amy B Rubis, Katherine E Fleming-Dutra, Elisha Hall, Joy Hsu, Hannah G Rosenblum, Monica Godfrey, W Roodly Archer, Danielle L Moulia, Laura Daniel, Oliver Brooks, H Keipp Talbot, Grace M Lee, Beth P Bell, Matthew Daley, Sarah Meyer, Sara E Oliver

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

Evelyn Twentyman et al. MMWR Morb Mortal Wkly Rep. .

Abstract

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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Conflict of interest statement

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.

References

    1. Food and Drug Administration. Novavax COVID-19 vaccine, adjuvanted. Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration; 2022. https://www.fda.gov/emergency-preparedness-and-response/coronavirus-dise...
    1. Twentyman E. Evidence to Recommendation Framework: Novavax COVID-19 vaccine in adults. Presented at the Advisory Committee on Immunization Practices meeting, Atlanta, GA; July 19, 2022. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2022-07-19/0...
    1. Food and Drug Administration. Vaccines and Related Biological Products Advisory Committee meeting June 7, 2022: FDA briefing document, Novavax COVID-19 vaccine. Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration; 2022. https://www.fda.gov/media/158912/download
    1. Food and Drug Administration. FDA review of effectiveness and safety of Novavax COVID-19 vaccine in adults ≥18 years of age: Emergency Use Authorization request. Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration; 2022. https://www.fda.gov/media/159004/download
    1. Department of Health and Aged Care, Australian Government. COVID-19 vaccine safety report – 30-06-2022. Woden, Canberra: Australian Government, Department of Health and Aged Care; 2022. https://www.tga.gov.au/periodic/covid-19-vaccine-safety-report-30-06-202...

Supplementary concepts