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.
【초록키워드】 COVID-19, SARS-CoV-2, Efficacy, Vaccine, COVID-19 vaccine, vaccination, variant, vaccine efficacy, drug, RT-PCR, FDA, virus, Emergency use authorization, immunization, EUA, Food and Drug Administration, Protein, polymerase chain reaction, Adults, B.1.1.7, myocarditis, symptomatic, Practice, reverse transcription, Alpha variant, information, Pericarditis, flexibility, association, Reverse transcription-polymerase chain reaction, food, symptomatic COVID-19, dose, Emergency, NVX-CoV2373, Chain Reaction, causal relationship, 95% CI, assessments, efficacy analysis, Novavax, circulating, authorization, Administered, Matrix-M, Committee, PROTECT, reported, provide, cause, predominant, infection with SARS-CoV-2, per-protocol, 【제목키워드】 COVID-19, Practice, United States, Committee, Interim, Person,