Overview
SARS-CoV-2 vaccine is an adjuvanted recombinant protein-based COVID-19 vaccine candidate being developed collaboratively by GlaxoSmithKline (GSK) and Sanofi. This vaccine candidate is composed of a spike protein antigen which aims to stimulate immune system production of antibodies against SARS-CoV-2; it uses technology previously employed for a recombinant influenza vaccine.
Background
SARS-CoV-2 vaccine is an adjuvanted recombinant protein-based COVID-19 vaccine candidate being developed collaboratively by GlaxoSmithKline (GSK) and Sanofi. This vaccine candidate is composed of a spike protein antigen which aims to stimulate immune system production of antibodies against SARS-CoV-2; it uses technology previously employed for a recombinant influenza vaccine.
Indication
No indication information available.
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/11/19 | Phase 3 | Active, not recruiting | |||
2024/10/10 | N/A | Not yet recruiting | |||
2024/09/20 | N/A | Recruiting | |||
2022/12/01 | N/A | Completed | Hospitales Universitarios Virgen del Rocío | ||
2022/02/10 | N/A | Completed | |||
2021/02/10 | N/A | Active, not recruiting | Oslo University 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 |
|---|---|---|---|
Authorised | 12/20/2021 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| NUVAXOVID DISPERSION FOR INJECTION COVID-19 VACCINE 5 µg/dose (RECOMBINANT, ADJUVANTED) | SIN16886P | INJECTION, SUSPENSION | 5 µg/dose | 10/17/2023 |
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. | |||||