Overview
The Omicron variant of SARS-CoV-2 is a variant of concern that was first reported in November 2021. It tends to cause less severe disease but is significantly more virulent than both the original virus and earlier variants (e.g. Delta). As of November 2022, it is the primary circulating variant of concern according to the World Health Organization. The Omicron variant comprises several distinct lineages and sublineages (e.g. BA.4, BA.5) which, although similar, may behave differently from one another. Famtozinameran is an mRNA vaccine encoding the S glycoprotein of SARS-CoV-2 Omicron variant lineages BA.4 and BA.5. It is administered in combination with tozinameran for active immunization against COVID-19 caused by SARS-CoV-2, including infection caused by Omicron BA.4/BA.5.
Indication
In the US, famtozinameran in combination with tozinameran (Comirnaty Original & Omicron BA.4/BA.5 Bivalent mRNA vaccine), is indicated as a booster dose for active immunization against COVID-19. It may be given as the third dose of the three-dose primary series with the monovalent Pfizer BioNTech COVID-19 vaccine to patients between 6 months and 4 years of age, and may be used in patients ≥5 years of age as a single booster dose at least two months following the completion of primary vaccination with any COVID-19 vaccine, or following receipt of the most recent booster dose of any approved monovalent COVID-19 vaccine. In Canada, famtozinameran is indicated in combination with tozinameran as a booster dose in patients ≥12 years of age.
Associated Conditions
- Coronavirus Disease 2019 (COVID‑19)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2021/09/02 | N/A | Active, not recruiting |
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. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| COMIRNATY ORIGINAL/OMICRON BA.4-5 CONCENTRATE FOR DISPERSION FOR INJECTION 1.5/1.5 MICROGRAMS/DOSE | SIN17053P | INJECTION | 1.5 μg/dose | 7/25/2024 | |
| COMIRNATY ORIGINAL/OMICRON BA.4-5 CONCENTRATE FOR DISPERSION FOR INJECTION 5/5 MICROGRAMS/DOSE (MDV) | SIN16915P | INJECTION | 5 μg/dose | 12/18/2023 | |
| COMIRNATY ORIGINAL/OMICRON BA.4-5 DISPERSION FOR INJECTION 15/15 MICROGRAMS/DOSE (SINGLE-DOSE VIAL) | SIN16856P | INJECTION | 15 μg/dose | 9/7/2023 | |
| COMIRNATY ORIGINAL/OMICRON BA.4-5 DISPERSION FOR INJECTION 5/5 MICROGRAMS/DOSE (SINGLE-DOSE VIAL) | SIN17058P | INJECTION | 5 μg/dose | 8/1/2024 | |
| COMIRNATY ORIGINAL/OMICRON BA.4-5 DISPERSION FOR INJECTION 15/15 MICROGRAMS/DOSE (MULTI-DOSE VIAL) | SIN16855P | INJECTION | 15 μg/dose | 9/7/2023 |
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 |
|---|---|---|---|---|---|
| COMIRNATY ORIGINAL/OMICRON BA.4-5 DISPERSION FOR INJECTION COVID-19 MRNA VACCINE (NUCLEOSIDE MODIFIED) (15/15 MICROGRAMS)/DOSE | N/A | N/A | N/A | 12/16/2022 |
TGA Drug Approvals
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| COMIRNATY ORIGINAL & OMICRON BA.4/BA.5 | 02541025 | Suspension - Intramuscular | 1.5 MCG / 0.2 ML | N/A | |
| COMIRNATY ORIGINAL & OMICRON BA.4/BA.5 | 02533197 | Suspension - Intramuscular | 5 MCG / 0.2 ML | 12/19/2022 | |
| COMIRNATY ORIGINAL & OMICRON BA.4/BA.5 | 02531461 | Suspension - Intramuscular | 15 MCG / 0.3 ML | 10/11/2022 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| COMIRNATY ORIGINAL/OMICRON BA.4-5 (15/15 MICROGRAMOS)/DOSIS DISPERSION INYECTABLE | 1201528008 | DISPERSIÓN INYECTABLE | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
| COMIRNATY ORIGINAL/OMICRON BA.4-5 (5/5 MICROGRAMOS)/DOSIS CONCENTRADO PARA DISPERSION INYECTABLE | 1201528011 | CONCENTRADO PARA DISPERSION 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. | |||||
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