Overview
SARS-CoV-2 mRNA vaccine (ARCoV) is a novel mRNA coronavirus vaccine that consists of a lipid nanoparticle-encapsulated mRNA encoding the receptor binding domain of SARS-CoV-2. It is the first COVID-19 mRNA vaccine to be approved for clinical trials in China, and was co-developed by Abogen Biosciences, Walvax Biotechnolgoy Co., Ltd. and the People’s Liberation Army (PLA) Academy of Military Sciences. Preclinical studies in mice and non-human primates has shown that intramuscular administration of ARCoV elicited a Th1-biased cellular response and robust antibodies against SARS-CoV-2. Manufactured as a liquid, ARCoV is thermostable at room temperature for at least 1 week. As of July 2020, the vaccine candidate is set for Phase 1 clinical trials to investigate for safety, tolerance, and immunogenicity (ChiCTR2000034112).
Indication
No indication information available.
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2021/04/14 | N/A | Completed |
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 | 1/6/2021 | ||
Authorised | 1/6/2021 | ||
Authorised | 1/6/2021 |
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 |
|---|---|---|---|---|---|
| SPIKEVAX JN.1 DISPERSION FOR INJECTION IN PRE-FILLED SYRINGE COVID-19 MRNA VACCINE 50 MICROGRAMS/DOSE 0.5ML | N/A | N/A | N/A | 10/7/2024 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| SPIKEVAX JN.1 (SARS-CoV-2 JN.1 mRNA) COVID-19 VACCINE 0.1 mg/mL suspension for injection pre-filled syringe | 458805 | Medicine | A | 11/15/2024 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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