Overview
SARS-CoV-2, the causative agent of COVID-19, relies on the interaction between its trimeric spike (S) glycoprotein and angiotensin-converting enzyme 2 (hACE2) expressed on host cells in order to establish a productive infection in humans. Antibodies directed against the S protein are capable of blocking S-hACE2 interactions and neutralizing viral particles and are present in convalescent patients and those who have been inoculated against COVID-19. Nuvaxovid (NVX-CoV2373) contains a recombinant mutant S protein that is codon-optimized for baculovirus-mediated expression in Sf9 cells derived from Spodoptera frugiperda together with a Matrix-M adjuvant (Fractions A and C from Quillaja saponaria extract). The resulting stable perfusion S protein nanoparticles are thermostable and capable of inducing productive cellular and humoral immune responses in humans and across a wide range of animal models. The European Commission granted Novavax conditional marketing authorization for nuvaxovid for active immunization to prevent COVID-19 caused by SARS-CoV-2 on December 20, 2021 and full marketing authorization on Jul 06, 2023. On February 17, 2022, nuvaxovid was approved by Health Canada. On July 13, 2022, nuvaxovid was granted an emergency use authorization by the FDA for the prevention of COVID-19 in adults, which was expanded to include patients ≥12 years of age in August 2022.
Background
SARS-CoV-2, the causative agent of COVID-19, relies on the interaction between its trimeric spike (S) glycoprotein and angiotensin-converting enzyme 2 (hACE2) expressed on host cells in order to establish a productive infection in humans. Antibodies directed against the S protein are capable of blocking S-hACE2 interactions and neutralizing viral particles and are present in convalescent patients and those who have been inoculated against COVID-19. Nuvaxovid (NVX-CoV2373) contains a recombinant mutant S protein that is codon-optimized for baculovirus-mediated expression in Sf9 cells derived from Spodoptera frugiperda together with a Matrix-M adjuvant (Fractions A and C from Quillaja saponaria extract). The resulting stable perfusion S protein nanoparticles are thermostable and capable of inducing productive cellular and humoral immune responses in humans and across a wide range of animal models. The European Commission granted Novavax conditional marketing authorization for nuvaxovid for active immunization to prevent COVID-19 caused by SARS-CoV-2 on December 20, 2021 and full marketing authorization on Jul 06, 2023. On February 17, 2022, nuvaxovid was approved by Health Canada. On July 13, 2022, nuvaxovid was granted an emergency use authorization by the FDA for the prevention of COVID-19 in adults, which was expanded to include patients ≥12 years of age in August 2022.
Indication
Nuvaxovid is indicated for active immunization to prevent COVID-19 caused by SARS-CoV-2 in patients 12 years of age and older. Nuvaxovid is also available in the US under an emergency use authorization (EUA) for the prevention of COVID-19 in patients ≥12 years of age.
Associated Conditions
- Coronavirus Disease 2019 (COVID‑19)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/05/10 | Phase 3 | Active, not recruiting | |||
2024/03/04 | Phase 3 | Active, not recruiting | |||
2023/09/07 | Phase 2 | Completed | |||
2023/06/29 | Phase 2 | Completed | |||
2023/05/25 | Phase 3 | Completed | |||
2022/07/18 | Phase 3 | Completed | |||
2022/05/12 | Phase 3 | Completed | |||
2022/03/29 | Phase 3 | Completed | |||
2021/12/02 | Phase 4 | Completed | Tan Tock Seng Hospital |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||