Overview
Developed by Sinopharm's Wuhan Institute of Biological Products co., this vaccine consists of the WIV04 strain of SARS-CoV-2. This strain was isolated from a patient in Wuhan, cultivated in a Vero cell line, and then subsequently inactivated using B-propiolactone. Double-blind, randomized, placebo-controlled phase 1 (96 participants) and phase 2 (224 participants) were carried out in healthy adults between 18-59 years. Results from these trials showed low rates of adverse reactions and demonstrated immunogenicity. Currently, the vaccine is being tested in Phase 3 clinical trial in Abu Dhabi (ChiCTR2000034780).
Indication
No indication information available.
Associated Conditions
No associated conditions information available.
Research Report
Comprehensive Report on the Inactivated SARS-CoV-2 Vaccine (WIBP-CorV, WIV04 Strain, DB15862)
1. Introduction and Background
1.1. Vaccine Identification and Developer
The Inactivated SARS-CoV-2 Vaccine, known scientifically as WIBP-CorV, utilizes the WIV04 strain of the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and is cataloged under DrugBank ID DB15862.[1] This vaccine was developed by the Wuhan Institute of Biological Products Co., Ltd., a subsidiary of the China National Biotec Group (CNBG), which is part of the state-owned Sinopharm conglomerate.[1]
A crucial aspect of discussing this vaccine is the consistent and careful differentiation between WIBP-CorV (WIV04 strain, developed by the Wuhan Institute) and Sinopharm's other prominent inactivated COVID-19 vaccine, BBIBP-CorV (HB02 strain, developed by the Beijing Institute of Biological Products). Although both are inactivated whole-virus vaccines originating from Sinopharm, they are distinct products. This distinction is particularly important because pivotal Phase 3 clinical trials, such as the one registered under NCT04510207 and ChiCTR2000034780, evaluated both vaccine strains in parallel against a common placebo group, revealing different efficacy point estimates.[5] Furthermore, their international regulatory pathways and subsequent global uptake have diverged significantly, most notably concerning the World Health Organization (WHO) Emergency Use Listing (EUL), which was granted to BBIBP-CorV but not to WIBP-CorV.[7] Failure to maintain this specificity would lead to inaccuracies in attributing efficacy, safety, and regulatory data, thereby compromising the integrity of this report.
1.2. Vaccine Type and Rationale
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2022/01/24 | Phase 3 | Completed |
FDA Drug Approvals
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No FDA approvals found for this drug. |
EMA Drug Approvals
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No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
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No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
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No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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No TGA approvals found for this drug. |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
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No Health Canada approvals found for this drug. |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
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No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
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No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
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No UK EMC drug information found for this drug. |
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