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Famtozinameran

Generic Name
Famtozinameran
Drug Type
Biotech

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.

Background

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

Active, not recruiting
Posted: 2021/09/02
Sponsor:Pfizer

FDA Approved Products

No FDA products found for this drug

Singapore Approved Products

COMIRNATY ORIGINAL/OMICRON BA.4-5 CONCENTRATE FOR DISPERSION FOR INJECTION 1.5/1.5 MICROGRAMS/DOSE
Manufacturer:Pfizer Manufacturing Belgium NV
Form:INJECTION
Strength:1.5 μg/dose
Online:Yes
Approved: 2024/07/25
Approval:SIN17053P
COMIRNATY ORIGINAL/OMICRON BA.4-5 CONCENTRATE FOR DISPERSION FOR INJECTION 5/5 MICROGRAMS/DOSE (MDV)
Manufacturer:Pfizer Manufacturing Belgium NV
Form:INJECTION
Strength:5 μg/dose
Online:Yes
Approved: 2023/12/18
Approval:SIN16915P
COMIRNATY ORIGINAL/OMICRON BA.4-5 DISPERSION FOR INJECTION 15/15 MICROGRAMS/DOSE (SINGLE-DOSE VIAL)
Manufacturer:Pfizer Manufacturing Belgium NV, Sanofi-Aventis Deutschland GmbH, mibe GmbH Arzneimittel, Allergopharma GmbH & Co. KG, Patheon Italia S.p.A, BioNTech Manufacturing Marburg GmbH
Form:INJECTION
Strength:15 μg/dose
Online:Yes
Approved: 2023/09/07
Approval:SIN16856P
COMIRNATY ORIGINAL/OMICRON BA.4-5 DISPERSION FOR INJECTION 5/5 MICROGRAMS/DOSE (SINGLE-DOSE VIAL)
Manufacturer:Pfizer Manufacturing Belgium NV
Form:INJECTION
Strength:5 μg/dose
Online:Yes
Approved: 2024/08/01
Approval:SIN17058P
COMIRNATY ORIGINAL/OMICRON BA.4-5 DISPERSION FOR INJECTION 15/15 MICROGRAMS/DOSE (MULTI-DOSE VIAL)
Manufacturer:Pfizer Manufacturing Belgium NV, Sanofi-Aventis Deutschland GmbH, mibe GmbH Arzneimittel, Allergopharma GmbH & Co. KG, Patheon Italia S.p.A, BioNTech Manufacturing Marburg GmbH
Form:INJECTION
Strength:15 μg/dose
Online:Yes
Approved: 2023/09/07
Approval:SIN16855P

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