MedPath

Davesomeran

Generic Name
Davesomeran
Drug Type
Biotech
CAS Number
2798905-80-1
Unique Ingredient Identifier
TYF7YW7ENF

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

Title
Posted
Study ID
Phase
Status
Sponsor

No clinical trials found

No clinical trials found for this drug

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.

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.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
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
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

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.

Help Us Improve

Your feedback helps us provide better drug information and insights.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.