- Approval Id
- ead70bf35ef515f1
- Drug Name
- Spikevax 0.2 mg/mL dispersion for injection
- Product Name
- Spikevax 0.2 mg/mL dispersion for injection
- Approval Number
- SIN16834P
- Approval Date
- 2023-08-17
- 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**
Spikevax 0.2 mg/mL is supplied as a multidose vial (red cap) intended for administration to individuals 6 years of age and older and cannot be used for individuals aged 6 months through 5 years old.
Posology
**_Primary series_**
_Individuals 12 years of age and older_
Spikevax is administered as a course of 2 (two) 100 microgram doses (0.5 mL each).
_Children 6 through 11 years of age_
Spikevax is administered as a course of 2 (two) 50 microgram doses (0.25 mL each, containing 50 micrograms mRNA, which is half of the primary dose for individuals 12 years and older).
It is recommended to administer the second dose 28 days after the first dose (see sections 4.4 and 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
_**Booster dose**_
_Individuals 12 years of age and older_
A booster dose (0.25 mL, containing 50 micrograms mRNA, which is half of the primary dose) of Spikevax may be administered intramuscularly. The decision when and for whom to implement a booster dose of Spikevax should be made based on available vaccine safety and effectiveness data, in accordance with official recommendations.
The interchangeability of Spikevax with other COVID-19 vaccines to complete the primary vaccination course has not been established. Individuals who have received one dose of Spikevax (0.5 mL, 100 micrograms) should receive a second dose of Spikevax (0.5 mL, 100 micrograms) to complete the primary vaccination course.
_**Paediatric population**_
The safety and efficacy of Spikevax in children less than 6 years of age have not yet been established. No data are available.
_Elderly population_
No dosage 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 is indicated for active immunisation to prevent COVID-19 disease caused by SARS- CoV-2 in individuals 6 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
- MODERNA BIOTECH SINGAPORE PTE. LTD.
- Company Detail Path
- /organization/17bdef34c1b4a1e9/moderna-biotech-singapore-pte-ltd
