Rare diseases
Investigational molecules
Locations
Famtozinameran is a nucleic acid substance classified under ATC code J07BN01.[1] It is a component of a bivalent COVID-19 mRNA vaccine that encodes the viral spike protein of Omicron variant lineages BA.4 and BA.5.[4] The substance is also known by the development code BNT162B2 Omicron (BA.4/BA.5).[4] In the product records, famtozinameran appears together with tozinameran as part of the Comirnaty Original/Omicron BA.4-5 (15/15 micrograms)/dose dispersion for injection, a product authorised in the European Union with authorisation records EU/1/20/1528/002 and EU/1/20/1528/008.[1] The authorisation holder is BioNTech Manufacturing GmbH.[1] Famtozinameran was first approved in Canada in 2022.[4]
Famtozinameran comprises a nucleoside-modified messenger RNA (mRNA) encapsulated in lipid nanoparticles that deliver the mRNA into host cells.[4] Once inside these cells, the mRNA is translated by host machinery to produce a modified SARS-CoV-2 spike (S) protein — specifically the S protein of the Omicron BA.4/BA.5 variant lineages — which is subsequently recognised by the host immune system.[4] The vaccine has been shown to elicit both neutralising antibody and cellular immune responses to the S protein, which helps protect against subsequent SARS-CoV-2 infection.[4] Tozinameran, the other component of the bivalent vaccine, was originally known as BNT162b2 and was the first messenger RNA vaccine approved in Australia for the prevention of COVID-19, based on the ancestral strain of SARS-CoV-2.[5]
Famtozinameran is formulated as a dispersion for injection and is given by the intramuscular route.[1] The bivalent vaccine containing famtozinameran is available as multidose vials containing doses of 15+15 micrograms/0.3 mL suspension for injection.[5] In the Phase 2 trial, an intradermal route of administration using silicon microneedles was also investigated for a 20 microgram dose of the mRNA vaccine.[2]
Two clinical trials involving famtozinameran-containing products are registered, both completed.[1][2] The larger study is a Phase 3 trial with 4,000 participants that evaluated immune responses after COVID-19 vaccination with different vaccine formulations, including Comirnaty Original/Omicron BA.4-5 (15/15 micrograms)/dose.[1] The primary outcome measured the proportion of seropositive subjects with an antibody level above the target level in groups of vaccine recipients receiving different vaccine products at 6 months after two doses against the prevailing virus variant.[1] The smaller study is a Phase 2 trial with 120 participants aged 75 years or older who were healthy or had stable disease.[2] This trial investigated the immunogenicity of a 20 microgram dose of the COVID-19 mRNA Comirnaty vaccine through intradermal administration with silicon microneedles, compared with intramuscular administration of a 20 microgram dose and a 30 microgram dose, the latter being the standard intramuscular dose.[2] The primary outcome was anti-S IgG levels in serum 28 days after vaccination, expressed in geometric mean concentrations (GMC).[2]
The supplementary sources provided do not include detailed side effect information for famtozinameran specifically. The Australian Prescriber article notes that the bivalent vaccines combining tozinameran with famtozinameran are provisionally approved for use as booster doses.[5] The DrugBank entry lists one contraindication for the substance, but the specific contraindication is not described in the available content.[4]
Each condition opens its own overview and trial list
Recruiting trials first
Tell us about your condition – we search every trial in Europe and connect you with the right site.
