- Approval Id
- 337306e0329dd55f
- Drug Name
- Spikevax Bivalent Original/Omicron BA.4-5 (50 micrograms/50 micrograms)/mL dispersion for injection
- Product Name
- Spikevax Bivalent Original/Omicron BA.4-5 (50 micrograms/50 micrograms)/mL dispersion for injection
- Approval Number
- SIN16881P
- Approval Date
- 2023-10-11
- Registrant
- MODERNA BIOTECH SINGAPORE PTE. LTD.
- Licence Holder
- MODERNA BIOTECH SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INJECTION, SOLUTION
- Dosage
- **4.2 Posology and method of administration**
Posology
The dose of Spikevax bivalent Original/Omicron BA.4–5 is 0.5 mL given intramuscularly.
Spikevax bivalent Original/Omicron BA.4–5 is only indicated for individuals who have previously received at least a primary vaccination course against COVID-19.
For details on the primary vaccination course for ages 12 and above, please refer to the package leaflet for Spikevax 0.2 mg/mL dispersion for injection.
_Paediatric population_
The safety and efficacy of Spikevax bivalent Original/Omicron BA.4–5 in children less than 12 years of age have not yet been established. No data are available.
_Elderly_
No dose adjustment is required in elderly individuals ≥65 years of age.
Method of administration
The vaccine should be administered intramuscularly. The preferred site is the deltoid muscle of the upper arm.
Do not administer this vaccine intravascularly, subcutaneously or intradermally.
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 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**
Spikevax bivalent Original/Omicron BA.4–5 is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older who have previously received at least a primary vaccination course against COVID-19 (see sections 4.2 and 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
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
- MODERNA BIOTECH SINGAPORE PTE. LTD.
- Company Detail Path
- /organization/17bdef34c1b4a1e9/moderna-biotech-singapore-pte-ltd
