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

Details

• Journal Article:
  Morbidity and Mortality Weekly Report (MMWR)
• Personal Author:
  Twentyman, Evelyn ; Wallace, Megan ; Roper, Lauren E. ; Anderson, Tara C. ; Rubis, Amy B. ; Fleming-Dutra, Katherine E. ; Hall, Elisha ; Hsu, Joy ; Rosenblum, Hannah G. ; Godfrey, Monica ; Archer, W. Roodly ; Moulia, Danielle L. ; Daniel, Laura ; Brooks, Oliver ; Talbot, H. Keipp ; Lee, Grace M. ; Bell, Beth P. ; Daley, Matthew ; Meyer, Sarah ; Oliver, Sara E.
• Description:
  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.
• Subjects:
  Adolescent Adult Advisory Committees COVID-19 COVID-19 Vaccines Humans Immunization SARS-CoV-2 United States Vaccination Vaccines

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• Source:
  MMWR Morbidity Mortal Weekly Rep. 71(31):988-992
• Series:
  Weekly Report: Morbidity and Mortality Weekly Report (MMWR)
• DOI:
  http://dx.doi.org/10.15585/mmwr.mm7131a2
• ISSN:
  0149-2195 (print) ; 1545-861X (digital)
• Pubmed ID:
  35925807
• Pubmed Central ID:
  PMC9368733
• Document Type:
  Journal Article
• Pages in Document:
  5 pdf pages
• Volume:
  71
• Issue:
  31
• Collection(s):
  Advisory Committee on Immunization Practices (ACIP) Morbidity and Mortality Weekly Report (MMWR)
• Main Document Checksum:
  urn:sha-512:dfba2f35ccbcf1f05ba5662c1a0729a6c54ab3e5ee306a2d6e987f1a52650d14c3d5a54cd068653c85b4b6c5118dbcff210946f072f67748264a312930a6f283
• Download URL:
  https://stacks.cdc.gov/view/cdc/120654/cdc_120654_DS1.pdf
• File Type:
  [PDF - 162.48 KB ]