Davesomeran

Identification

Summary

Davesomeran is an mRNA vaccine in combination with the Moderna COVID-19 vaccine to prevent infection from the Omicron variant of the SARS-CoV-2 virus in people 6 years old or older.

Generic Name

Davesomeran

DrugBank Accession Number

DB17091

Background

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.^5,6 However, with the addition of davesomeran, Moderna Bivalent vaccine offers protection against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Omicron variants.⁵ 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.⁵

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.⁵ On November 3rd 2022, Health Canada also approved the Moderna Bivalent Vaccine as a booster shot in individuals 18 years of age or older.⁴

Type

Biotech

Groups

Approved, Investigational

Biologic Classification

Vaccines
Other vaccines

Synonyms

Not Available

External IDs

CX-034476 Omicron (BA.4/BA.5)

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Pharmacology

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.⁸

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Associated Conditions

Indication Type	Indication	Combined Product Details	Approval Level	Dose Form
Used in combination to prevent	Coronavirus disease 2019 (covid‑19)	Combination Product in combination with: Moderna COVID-19 Vaccine (DB15654)	••••••••••••	•••••••••• ••••••••••
Used in combination to prevent	Coronavirus disease 2019 (covid‑19)	Combination Product in combination with: Moderna COVID-19 Vaccine (DB15654)	••••••••••••	•••••••••• ••••••••••
Used in combination to prevent	Coronavirus disease 2019 (covid‑19)	Combination Product in combination with: Moderna COVID-19 Vaccine (DB15654)	••••••••••••	•••••••••
Used in combination to prevent	Coronavirus disease 2019 (covid‑19)	Combination Product in combination with: Moderna COVID-19 Vaccine (DB15654)	••••••••••••	•••••••••
Used in combination to prevent	Coronavirus disease 2019 (covid‑19)	Combination Product in combination with: Moderna COVID-19 Vaccine (DB15654)	••••••••••••	•••••••••• ••••••••••

Contraindications & Blackbox Warnings

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Pharmacodynamics

Similar to the previous Moderna COVID-19 Vaccine, the Moderna Bivalent vaccine targets the S spike protein on the membrane of the SARS-CoV-2 virus, with the added immunogenicity against the Omicron variants from davesomeran.⁵ In patients 18 years old or older, Moderna Bivalent vaccine resulted in a 74.9% seroresponse rate compared to 53.1 % seroresponse rate for elasomeran. The seroresponse rate was also higher against the original SARS-CoV-2 strain for Moderna bivalent vaccine compared to that of elasomeran.⁵

Mechanism of action

The Moderna Bivalent vaccine contains 2 ingredients: davesomeran and elasomeran.⁵ They both contains synthetic nucleoside-modified messenger RNA (mRNA) encapsulated in Lipid nanoparticle (LNP) encoding the full-length, pre-fusion stabilized spike protein (S) of SARS-CoV-2, although davesomeran's mRNA specifically targets the BA.4/5 Omicron variants with the L452R and F486V mutations in the S protein.^1,2 The S protein is a major membrane glycoprotein that can bind to the ACE2 receptor in targeted host cells.¹ Due to its location, the S protein is the main target for most mRNA vaccines due to its immunogenicity.³

Absorption