- Approval Id
- 78994e15d6a30e94
- Drug Name
- COMIRNATY ORIGINAL/OMICRON BA.4-5 DISPERSION FOR INJECTION 15/15 MICROGRAMS/DOSE (MULTI-DOSE VIAL)
- Product Name
- COMIRNATY ORIGINAL/OMICRON BA.4-5 DISPERSION FOR INJECTION 15/15 MICROGRAMS/DOSE (MULTI-DOSE VIAL)
- Approval Number
- SIN16855P
- Approval Date
- 2023-09-07
- 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 12 years of age and older_
A booster dose of COMIRNATY (Bivalent) may be administered intramuscularly after completing the primary series of COMIRNATY or after a previous booster dose of COMIRNATY or COMIRNATY (Bivalent).
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 12 years has not yet been established.
_Elderly population_
No dosage adjustment is required in elderly individuals ≥ 65 years of age. The safety of a booster dose of COMIRNATY in individuals 65 years of age and older is based on safety data in 12 booster dose recipients 65 through 85 years of age in Study 2, 306 booster dose recipients 18 through 55 years of age in Study 2, and 1,175 booster dose recipients 65 years of age and older in Study 4. The effectiveness of a booster dose of COMIRNATY in individuals 65 years of age and older is based on effectiveness data in 306 booster dose recipients 18 through 55 years of age in Study 2, and an efficacy analysis from participants 16 years of age and older in 9,945 participants in Study 4.
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.
Vials of COMIRNATY (Bivalent) contain 6 doses of 0.3 mL of vaccine.
Low dead-volume syringes and/or needles can be used to extract 6 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 a sixth dose from a single vial. Irrespective of the type of syringe and needle:
- Each dose must contain 0.3 mL of vaccine.
- If the amount of vaccine remaining in the vial cannot provide a full dose of 0.3 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, 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) is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 12 years of age and older.
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
