Help protect your patients from
circulating COVID‑19 variants1

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Primary series
11-month follow-up

The effectiveness of the Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) is based on the effectiveness of the Novavax COVID-19 vaccine (original monovalent) and the immunogenicity of the monovalent vaccine (Omicron BA.1) and the monovalent vaccine (Omicron BA.5).1

Primary series

In a phase 3 clinical trial, the vaccine met the primary endpoint and demonstrated efficacy in preventing symptomatic mild, moderate, or severe COVID‑19 from 7 days after dose 21

The Novavax COVID‑19 vaccine was studied globally in approximately 45,000 participants.1

Primary endpoint: vaccine efficacy against COVID‑19
Adults 18 years of age or older1

(95% CI: 83.8, 94.3)
N=25,657

Adolescents 12 to 17 years of age1

(95% CI: 37.6, 92.5)
N=1,799

Note: Data based on strains circulating at the time of the study.1

Secondary outcomes among adult clinical trial participants
Protection against COVID‑19 in
high-risk patients2*

(95% CI: 83.6, 95.0)
N=24,230

Protection against moderate-to-severe
disease from then-circulating strains of virus2†

(95% CI: 87.0, 100.0)
N=25,452

The Novavax COVID‑19 vaccine may not protect all vaccine recipients1

*Participants at overall high risk for COVID-19 included those 65 years of age or older and those of any age with chronic health conditions or an increased risk for COVID‑19 because of work or living conditions.2
†Moderate COVID‑19 was defined as high fever and objective evidence of lower respiratory tract infection. Severe disease was defined as clinically significant tachypnea, tachycardia, or hypoxia; receipt of intensive respiratory support; major dysfunction of one or more organ systems; admission to an intensive care unit; or death.2

Post hoc analysis

In a phase 3 trial, 4 hospitalizations were identified—0 among Novavax COVID‑19 vaccine recipients and 4 among placebo—resulting in a vaccine efficacy against hospitalization of 100% (95% Cl: 28.8, 100.0).3

  • Limitations include vaccine efficacy estimates impacted by a low number of events (ie, hospitalizations), pandemic-era restrictions successfully reducing infections and hospitalizations during the study, and the exclusion of key demographics, such as participants with certain underlying health conditions3
  • Vaccine effectiveness against hospitalization is under review in ongoing real-world evidence studies; cases of COVID-19–related postvaccination hospitalizations have been observed4,5
100%

(95% Cl: 28.8, 100.0)
N=25,482

Efficacy against hospitalization due to then-circulating strains of virus3

Study design

The phase 3 clinical study is a multicenter, randomized, observer-blinded, placebo-controlled study conducted in the United States and Mexico. Upon enrollment, participants were stratified by age (18 to 64 years; ≥65 years) and randomized in a 2:1 ratio to receive the Novavax COVID‑19 vaccine or placebo. Participants 12 to 17 years of age were included in the expansion trial.1

Exclusion criteria: Participants were excluded if they were significantly immunocompromised due to immunodeficiency disease or on chemotherapy for active cancer, had received chronic immunosuppressive therapy or received immunoglobulin or blood-derived products within 90 days, were pregnant or breastfeeding, and/or had a history of laboratory-confirmed, diagnosed COVID‑19. Participants with clinically stable underlying comorbidities were included, as well as those with well-controlled HIV.1

11-month follow-up

In a follow-up to the phase 3 trial, participants who completed the primary vaccination series had antibodies that remained elevated at 11 months6

Anti-S (WT) IgG GMT=anti-spike (wild type) immunoglobulin G geometric mean titer.

In this follow-up evaluation before the booster dose, it was predetermined that participants who received the primary vaccination series pre-crossover would receive a Novavax COVID‑19 Vaccine, Adjuvanted booster at the 11-month mark. Those who received placebo pre-crossover were not included in this analysis. The 11-month antibody levels were based on evaluation of anti-prototype spike antibodies to the Novavax COVID‑19 vaccine.6

While you can't predict how COVID-19 will impact your patients, you can help prevent COVID-19 with the protein-based Novavax COVID-19 vaccine1
Explore the
safety profile

References: 1. Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) EUA Fact Sheet for Healthcare Providers. Novavax Inc.; September 2024. 2. Dunkle LM, Kotloff CL, et al. Efficacy and safety of NVX-CoV2373 in adults in the United States and Mexico. N Engl J Med. 2022;386(6):531-543. 3. Marchese AM, Zhou X, et al. NVX-CoV2373 vaccine efficacy against hospitalization: a post hoc analysis of the PREVENT-19 phase 3, randomized, placebo-controlled trial. Vaccine. 2023;41(22):3461-3466. 4. Data on file. Novavax, Inc. 2024. 5. Gwak E, Choe SA, et al. Short-term relative effectiveness of homologous NVX-CoV2373 and BNT162b2 COVID-19 vaccinations in South Korea. medRxiv. Published online July 5, 2024. doi:10.1101/2024.07.02.24309830. 6. Añez G, Bennett C. Paving the way for protein: Novavax’s COVID-19 vaccine as a booster and variant-adapted. Presented at: World Vaccine Congress Europe; October 12, 2022; Barcelona, Spain.