- Approval Id
- a1d436c759465470
- Drug Name
- COMIRNATY ORIGINAL/OMICRON BA.4-5 CONCENTRATE FOR DISPERSION FOR INJECTION 5/5 MICROGRAMS/DOSE (MDV)
- Product Name
- COMIRNATY ORIGINAL/OMICRON BA.4-5 CONCENTRATE FOR DISPERSION FOR INJECTION 5/5 MICROGRAMS/DOSE (MDV)
- Approval Number
- SIN16915P
- Approval Date
- 2023-12-18
- Registrant
- BIONTECH PHARMACEUTICALS ASIA PACIFIC PTE. LTD.
- Licence Holder
- BIONTECH PHARMACEUTICALS ASIA PACIFIC PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INJECTION
- Dosage
- **4.2 Posology and method of administration**
Posology
_Booster dose in individuals 5 through <12 years of age_
A booster dose of COMIRNATY (Bivalent) (For Age 5 Years to <12 Years) (Vials with Orange Cap) may be administered intramuscularly in individuals 5 years through <12 years of age who have previously received at least a primary vaccination course against COVID-19.
COMIRNATY (Bivalent) (For Age 5 Years to <12 Years) (Vials with Orange Cap) cannot be used in individuals 12 years of age and older.
For further information on efficacy, see section 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.
_Paediatric population_
The safety and efficacy of COMIRNATY (Bivalent) in children aged less than 5 years has not yet been established.
Method of administration
COMIRNATY (Bivalent) should be administered intramuscularly (see section 6.6 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). The preferred site is the deltoid muscle of the upper arm.
Do not inject the vaccine intravascularly, subcutaneously or intradermally.
After dilution, vials of COMIRNATY (Bivalent) (For Age 5 Years to <12 Years) (Vials with Orange Cap) contain 10 doses of 0.2 mL of vaccine.
Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. The low dead-volume syringe and needle combination should have a dead volume of no more than 35 microlitres. If standard syringes and needles are used, there may not be sufficient volume to extract 10 doses from a single vial. Irrespective of the type of syringe and needle:
- Each dose must contain 0.2 mL of vaccine.
- If the amount of vaccine remaining in the vial cannot provide a full dose of 0.2 mL, discard the vial and any excess volume.
- Do not pool excess vaccine from multiple vials.
The vaccine should not be mixed in the same syringe with any other vaccines or medicinal products.
For precautions to be taken before administering the vaccine, see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.
For instructions regarding thawing, handling, dilution, dose preparation of vaccine before administration, and disposal of the vaccine, see section 6.6 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.
- Route Of Administration
- INTRAMUSCULAR
- Indication Info
- **4.1 Therapeutic indications**
COMIRNATY (Bivalent) (For Age 5 Years to <12 Years) (Vials with Orange Cap) is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 5 to <12 years of age.
The use of this vaccine should be in accordance with official recommendations.
- Contraindications
- **4.3 Contraindications**
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.
- Atc Code
- J07BN01
- Atc Item Name
- covid-19, RNA-based vaccine
- Pharma Manufacturer Name
- BIONTECH PHARMACEUTICALS ASIA PACIFIC PTE. LTD.
- Company Detail Path
- /organization/3a9ceb985c446dc7/biontech-pharmaceuticals-asia-pacific-pte-ltd
