Drug updated on 9/12/2024
Dosage Form | Injection (intramuscular; 0.5 mL) |
Drug Class | Vaccines |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.
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Summary
- Nuvaxovid (COVID-19 vaccine (recombinant protein, adjuvanted)) is indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.
- This summary is based on the review of eight systematic review(s)/meta-analysis(es). [1-8]
- A third dose of BNT162b2 following two doses of CoronaVac resulted in the highest geometric mean ratio (GMR) of neutralizing antibodies (GMR = 15.24, 95% CI: 9.53-24.39). mRNA-1273 also induced higher antibody levels compared to BNT162b2 alone (GMR = 1.32, 95% CI: 1.06-1.64), NVX-CoV2373 (GMR = 1.60, 95% CI: 1.16-2.21), or ChAdOx1 (GMR = 1.80, 95% CI: 1.25-2.59).
- BNT162b2 showed the highest protection against symptomatic SARS-CoV-2 infection (RR 0.05) in a network meta-analysis, while mRNA-1273 was second in efficacy. NVX-CoV2373 demonstrated a vaccine efficacy (VE) of 82.91% (95% CI: 50.49%-94.10%), with significant but lower reductions in symptomatic COVID-19.
- High-certainty evidence supports substantial reductions in severe or critical COVID-19 incidence with BNT162b2, mRNA-1273, Ad26.COV2.S, and BBV152 vaccines, with NVX-CoV2373 showing moderate-certainty evidence for similar outcomes.
- Most vaccines were generally well-tolerated, with mild and self-limiting adverse events. No significant differences in serious adverse events (SAEs) were observed among participants receiving different vaccine regimens, with uncertain evidence for SAEs specifically for BNT162b2, CoronaVac, BBIBP-CorV, and NVX-CoV2373.
- Local and systemic adverse events were relatively more common with mRNA vaccines.
- Studies included participants aged 18 years or older, with specific attention to younger age groups (12-17 years), older adults (over 60 years), and immunocompromised patients; findings highlight higher seroprevalence in children from minority ethnic backgrounds and underprivileged regions, and elevated hospitalization rates in children post-Omicron variant emergence, emphasizing the need for improved vaccination strategies in these subgroups.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Nuvaxovid (COVID-19 vaccine (recombinant protein, adjuvanted)) Prescribing Information. | 2023 | Novavax, Inc., Gaithersburg, MD |