Drug updated on 4/18/2024
| Dosage Form | Injection (intramuscular; 5mcg/0.5 mL) |
| Drug Class | Vaccines |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- 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.
Summary
- COVID-19 vaccine (recombinant protein, adjuvanted), also known as Nuvaxovid, is indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) in individuals aged 12 years and older. It has been found to generate a higher level of neutralizing antibodies compared to some vaccines, but less so than top-performing mRNA vaccines.
- Three systematic reviews/meta-analyses provided comparisons among different COVID-19 vaccines, including Nuvaxovid, in terms of safety, effectiveness, and population subgroup considerations.
- The first study focused on the immunogenicity and safety of combining vaccines from various platforms, finding no significant differences in the risk for serious adverse events, suggesting an acceptable safety profile across all types.
- According to the second study's meta-analysis, covering a broad range of vaccines, all demonstrated a statistically significant reduction in contracting symptomatic COVID-19 compared with placebo. Nuvaxovid ranked high among assessed vaccinations, indicating strong efficacy against symptomatic COVID, however, its specific ranking was not detailed beyond this inclusion.
- The third study included data from trials involving both humans and non-human primates, comparing aspects such as reactogenicity, immunogenicity, and overall efficacy. Nuvaxovid produced one of the highest spike neutralizing antibody responses, indicating strong immunogenicity.
- In comparison with other COVID-19 vaccines, Nuvaxovid shows a strong ability to induce an immune response, particularly when considering neutralizing antibody levels, placing it competitively amongst mRNA vaccines.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Nuvaxovid (COVID-19 vaccine (recombinant protein, adjuvanted) Prescribing Information. | 2023 | Novavax, Inc., Gaithersburg, MD |