Overview
Davesomeran is a mRNA vaccine used in conjunction with elasomeran as part of the Moderna Bivalent COVID-19 vaccine. Similar to the previous Moderna COVID-19 vaccine, Moderna Bivalent vaccine encodes the full-length pre-fusion stabilized spike (S) protein to elicit an immune response. However, with the addition of davesomeran, Moderna Bivalent vaccine offers protection against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Omicron variants. A phase 2 and 3 open-label study in participants 18 years or older who had previously received a two-dose primary series and one booster dose of Moderna COVID-19 Vaccine demonstrated that the Moderna Bivalent vaccine elicit a higher seroresponse both against the original SARS-CoV-2 strain and the BA.4/5 strain compared to that of the Moderna COVID-19 Vaccine. In October 22nd 2022, the FDA approved the Moderna Bivalent Vaccine as a booster in patients 6 years or older, administered at least 2 months after completion of primary vaccination or receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. On November 3rd 2022, Health Canada also approved the Moderna Bivalent Vaccine as a booster shot in individuals 18 years of age or older.
Indication
Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) is a mixture of 2 mRNA vaccines, davesomeran and elasomeran, and is indicated for active immunization against COVID-19. It may be used in patients between 6 months and 5 years of age as a single booster dose at least 2 months following completion of a primary vaccination series with the monovalent Moderna COVID-19 vaccine. It is also indicated for use in patients ≥6 years of age as a single booster dose following completion of either primary vaccination with any authorized COVID-19 vaccine, or following receipt of the most recent booster dose with any authorized monovalent COVID-19 vaccine.
Associated Conditions
- Coronavirus Disease 2019 (COVID‑19)
Clinical Trials
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No clinical trials found
No clinical trials found for this drug
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
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No FDA approvals found for this drug. |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
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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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Spikevax Bivalent Original/Omicron BA.4-5 (50 micrograms/50 micrograms)/mL dispersion for injection | SIN16881P | INJECTION, SOLUTION | 50mcg/mL | 10/11/2023 |
NMPA Drug Approvals
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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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SPIKEVAX BIVALENT ORIGINAL/OMICRON BA.4-5 (elasomeran/davesomeran) COVID-19 VACCINE 0.1 mg/mL suspension for injection vial | 399552 | Medicine | A | 2/20/2023 | |
SPIKEVAX BIVALENT ORIGINAL/OMICRON BA.4-5 (elasomeran/davesomeran) COVID-19 VACCINE 0.1 mg/mL suspension for injection pre-filled syringe | 399553 | Medicine | A | 2/20/2023 | |
SPIKEVAX BIVALENT ORIGINAL/OMICRON BA.4-5 (elasomeran/davesomeran) COVID-19 VACCINE 0.1 mg/mL suspension for injection vial-single dose | 406730 | Medicine | A | 6/8/2023 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
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SPIKEVAX BIVALENT (ORIGINAL / OMICRON BA.4/5) | moderna biopharma canada corporation | 02532352 | Dispersion - Intramuscular | 0.05 MG / ML | 11/25/2022 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
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SPIKEVAX BIVALENTE ORIGINAL/OMICRON BA.4-5 (50 MICROGRAMOS/50 MICROGRAMOS)/ML DISPERSION INYECTABLE | Moderna Biotech Spain S.L. | 1201507006 | DISPERSIÓN INYECTABLE | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
Philippines FDA Drug Approvals
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No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
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No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
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No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
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No UK EMC drug information found for this drug. |
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