SPIKEVAX BIVALENT ORIGINAL/OMICRON BA.4-5 (elasomeran/davesomeran) COVID-19 VACCINE 0.1 mg/mL suspension for injection pre-filled syringe

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

davesomeran, Quantity: 0.05 mg/mL; elasomeran, Quantity: 0.05 mg/mL

Available from:

Moderna Australia Pty Ltd

Pharmaceutical form:

Injection, suspension

Composition:

Excipient Ingredients: water for injections; cholesterol; glacial acetic acid; heptadecan-9-yl 8-[2-hydroxyethyl-(6-oxo-6-undecoxyhexyl)amino]octanoate; trometamol; sucrose; distearoylphosphatidylcholine; sodium acetate trihydrate; 1,2-dimyristoyl-rac-glycero-3-methoxypolyethylene glycol-2000; trometamol hydrochloride

Administration route:

Intramuscular

Units in package:

10 (5 packs of 2) x 0.5 mL pre-filled syringes

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

SPIKEVAX BIVALENT ORIGINAL/OMICRON BA.4-5 (elasomeran/davesomeran) COVID-19 Vaccine is indicated for:,As a booster dose for active immunisation to prevent coronavirus disease 2019 (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.,The use of this vaccine should be in accordance with official recommendations.

Product summary:

Visual Identification: white to off-white frozen suspension; Container Type: Syringe; Container Material: Other composite material; Container Life Time: 9 Months; Container Temperature: Store between minus 50 - minus 15 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2023-02-20

Patient Information leaflet

SPIKEVAX BIVALENT ORIGINAL/OMICRON BA.4-5_CMI_v2.3_09Jun23
SPIKEVAX BIVALENT ORIGINAL/OMICRON BA.4-5
COVID-19 VACCINE
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about being given this vaccine, speak to your healthcare provider.
This vaccine is new or being used differently. Please report side
effects. See the full CMI for further details.
1.
WHY AM I BEING GIVEN SPIKEVAX BIVALENT ORIGINAL/OMICRON BA.4-5?
SPIKEVAX BIVALENT ORIGINAL/OMICRON BA.4-5 contains the active
ingredients elasomeran and davesomeran. It is a vaccine
used as a booster dose to prevent COVID-19 disease caused by
SARS-CoV-2 in individuals aged 12 years and older.
For more information, see Section 1. Why am I being given SPIKEVAX
BIVALENT ORIGINAL/OMICRON BA.4-5? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN SPIKEVAX BIVALENT
ORIGINAL/OMICRON BA.4-5?
You should not be given SPIKEVAX BIVALENT ORIGINAL/OMICRON BA.4-5 if
you have ever had an allergic reaction to SPIKEVAX
(original), SPIKEVAX BIVALENT ORIGINAL/OMICRON (BA.1), SPIKEVAX
BIVALENT ORIGINAL/OMICRON BA.4-5 or any of the
ingredients listed at the end of the CMI.
Check with your doctor, pharmacist, or nurse before vaccination if
you: have previously had a severe allergic reaction after any
vaccine injection in the past; have a very weak or poorly functioning
immune system; have ever fainted following any needle
injection; have a bleeding disorder; have a high fever or severe
infection; have any serious illness; have anxiety related to
injections.
TALK TO YOUR DOCTOR IF YOU HAVE A WEAKENED IMMUNE SYSTEM, HAVE ANY
OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES,
OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING.
SPIKEVAX BIVALENT ORIGINAL/OMICRON BA.4-5 should not be given to
children under the age of 12 years.
For more information, see Section 2. What should I know before I am
given SPIKEVAX BIVALENT ORIGINAL/OMICRON BA.4-5?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Tell your doctor o

Summary of Product characteristics

SPIKEVAX BIVALENT ORIGINAL/OMICRON BA.4-5_PI_v2.3_09Jun23
1
This vaccine is subject to additional monitoring in Australia. This
will allow quick
identification of new safety information. Healthcare professionals are
asked to report any
suspected adverse events at www.tga.gov.au/reporting-problems
.
AUSTRALIAN PRODUCT INFORMATION – SPIKEVAX BIVALENT
ORIGINAL/OMICRON BA.4-5 (ELASOMERAN/DAVESOMERAN) COVID-
19 VACCINE
1
NAME OF THE MEDICINE
Elasomeran/davesomeran
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
TABLE 1: SPIKEVAX BIVALENT ORIGINAL/OMICRON BA.4-5 QUALITATIVE AND
QUANTITATIVE
COMPOSITION
STRENGTH
PRESENTATION
DOSE(S)
COMPOSITION
0.1 mg/mL
Multidose vial
(blue flip-off cap)
5 doses
of 0.5 mL each
One dose (0.5 mL) contains
25 micrograms of elasomeran and
25 micrograms of davesomeran, a
COVID-19 mRNA Vaccine
(embedded in lipid nanoparticles).
Single-dose vial
(blue flip-off cap)
1 dose
of 0.5 mL
For single use only.
One dose (0.5 mL) contains
25 micrograms of elasomeran and
25 micrograms of davesomeran, a
COVID-19 mRNA Vaccine
(embedded in lipid nanoparticles).
Pre-filled syringe
1 dose of 0.5 mL
For single use only.
Do not use the pre-filled
syringe to deliver a
partial 0.25 mL volume.
One dose (0.5 mL) contains
25 micrograms of elasomeran and
25 micrograms of davesomeran, a
COVID-19 mRNA Vaccine
(embedded in lipid nanoparticles).
Elasomeran is a single-stranded, 5’-capped messenger RNA (mRNA)
produced using a cell-free _in _
_vitro_ transcription from the corresponding DNA templates, encoding
the viral spike (S) protein of
SARS-CoV-2.
Davesomeran is a single-stranded, 5’-capped messenger RNA (mRNA)
produced using a cell-free
_in vitro_ transcription from the corresponding DNA templates,
encoding the viral spike (S) protein of
SARS-CoV-2 (Omicron BA.4-5). The S-proteins of the SARS-CoV-2 Omicron
variant lineages BA.4 and
BA.5 are identical.
▼
SPIKEVAX BIVALENT ORIGINAL/OMICRON BA.4-5_PI_v2.3_09Jun23
2
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Suspension