Consumer medicine information

1. Why am I being given SPIKEVAX?

SPIKEVAX contains the active ingredient Elasomeran. SPIKEVAX is a vaccine used to prevent COVID-19 disease caused by SARS-CoV-2 in individuals aged 6 months and older.
For more information, see Section 1. Why am I being given SPIKEVAX? in the full CMI.

2. What should I know before I am given SPIKEVAX?

You should not be given SPIKEVAX if you have ever had an allergic reaction to SPIKEVAX 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 other vaccine injection or after you were given SPIKEVAX 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; have previously had episodes of capillary leak syndrome.
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 should not be given to children under the age of 6 months.
For more information, see Section 2. What should I know before I am given SPIKEVAX? in the full CMI.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription. Tell your doctor or pharmacist if you have recently received any other vaccine. For more information, see Section 3. What if I am taking other medicines? in the full CMI.

4. How will I be given SPIKEVAX?

Your doctor, pharmacist or nurse will inject the vaccine into a muscle (intramuscular injection) in your upper arm or your thigh. You will be given one dose, followed by a second dose 28 days later to complete the vaccination course. It is very important that you receive your second dose. If you have a weakened immune system, you may receive a third dose at least 28 days after the second dose. A booster dose may be given at least 5 months after the second dose in individuals aged 12 years to 17 years and at least 6 months after the second dose in individuals aged 18 years and above. This booster may be given to you if you have completed your full course of your first vaccination with another approved COVID-19 vaccine. A doctor, pharmacist or nurse will observe you for at least 15 minutes after being given SPIKEVAX.
More instructions can be found in Section 4. How will I be given SPIKEVAX? in the full CMI.

5. What should I know about being given SPIKEVAX?

6. Are there any side effects?

Common side effects include swelling in the underarm, headache (including migraine), nausea, vomiting, muscle aches, joint aches, and stiffness, pain or swelling at the injection site, feeling very tired, chills, fever, rash, redness, or hives at the injection site. Decreased appetite, irritability/crying and sleepiness are also common side effects in 6 month to 3 year olds.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Elasomeran.

2 Qualitative and Quantitative Composition

See Table 1.
https://stagingapi.mims.com/au/public/v2/images/fulltablegif/SPIKEV01.gif 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.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Suspension for injection.
White to off white suspension.

4 Clinical Particulars

4.9 Overdose

No case of overdose has been reported.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Non-clinical data reveal no special hazard for humans based on conventional studies of repeat dose toxicity and reproductive and developmental toxicity. The full relevance of animal studies to human risk with vaccines for COVID-19 remains to be established.
Genotoxicity. The novel lipid components SM-102 and PEG-2000-DMG of the vaccine were negative in the bacterial reverse mutation Ames test and in vitro micronucleus test in human peripheral blood lymphocytes. A luciferase mRNA in SM102-containing lipid nanoparticles was negative in a rat bone marrow micronucleus assay (IV dose of SM-102 28.5 mg/kg, PEG-2000-DMG 2.8 mg/kg), whilst a surrogate Zika mRNA-based vaccine formulated in SM-102-containing lipid nanoparticles induced micronuclei in male rats, but not in females (IV dose of SM-102 60 mg/kg, PEG-2000-DMG 6 mg/kg). The weight of evidence suggests the genotoxicity potential of the novel lipid components SM-102 and PEG-2000-DMG is very low. The other components of Spikevax (other lipids and mRNA) are not expected to be genotoxic.
Carcinogenicity. Carcinogenicity studies were not performed. The components of the vaccine (lipids and mRNA) are not expected to have carcinogenic potential.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

CAS number. 2457298-05-2.

7 Medicine Schedule (Poisons Standard)

Prescription only medicine (Schedule 4).

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/SPIKEVST.gif