Consumer medicine information

SPIKEVAX COVID-19 VACCINE

 This vaccine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems.

SPIKEVAX COVID-19 VACCINE

Active ingredient: Elasomeran

This vaccine has provisional approval in Australia to prevent COVID-19 disease caused by SARS-CoV-2 virus in individuals 6 months of age and older. This approval has been granted on the basis of short term efficacy and safety data. Evidence of longer term efficacy and safety from ongoing clinical trials and vaccination in the community continues to be gathered and assessed.


Consumer Medicine Information (CMI)

This leaflet provides important information about using SPIKEVAX. You should also speak to your doctor, pharmacist, or nurse if you would like further information or if you have any concerns or questions about using SPIKEVAX.

Where to find information in this leaflet:

1. Why am I being given SPIKEVAX?
2. What should I know before I am given SPIKEVAX?
3. What if I am taking other medicines?
4. How will I be given SPIKEVAX?
5. What should I know about being given SPIKEVAX?
6. Are there any side effects?
7. Product details

1. Why am I being given SPIKEVAX?

SPIKEVAX contains the active ingredient Elasomeran. SPIKEVAX is a vaccine which stimulates the body’s natural defences (immune system). The vaccine works by causing the body to produce protection (antibodies) against the virus that causes COVID-19 disease. SPIKEVAX uses a substance called messenger ribonucleic acid (mRNA) to carry instructions to cells in the body that are used to make the spike protein that is also on the virus. The cells then make antibodies against the spike protein to help fight off the virus. This will help to protect you against COVID-19 disease.

SPIKEVAX is used to prevent COVID-19 disease caused by SARS-CoV-2. It is given to individuals aged 6 months and older.

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

Warnings

You should not be given SPIKEVAX if:

  • you are allergic to Elasomeran or any of the ingredients listed at the end of this leaflet.

Always check the ingredients to make sure you can be given this vaccine.

Check with your doctor, pharmacist, or nurse before vaccination if you:

  • Have previously had a severe, life-threatening 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; however, you can have your vaccination if you have a mild fever or upper airway infection like a cold.
  • Have any serious illness.
  • Have anxiety related to injections. Anxiety and stress related reactions can occur, however, they will be temporary.
  • Take any medicines for any other condition.

There is an increased risk for myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) after vaccination with SPIKEVAX. These conditions can develop within just a few days after vaccination, and have primarily occurred within two weeks. They are seen more often after the second vaccination, and more often occurred in younger men; however, they are also seen in a number of women. Following vaccination, you should be alert to signs of myocarditis and pericarditis, such as breathlessness, a noticeably rapid, strong, or irregular heartbeat and chest pain. Additionally, non-specific signs such as feeling very tired, nausea and vomiting, stomach pain, dizziness or fainting, fluid retention and cough have been reported in some recipients with myocarditis or pericarditis. Seek immediate medical attention should these occur.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Capillary leak syndrome (CLS) flare-ups

A few cases of capillary leak syndrome flare-ups (causing fluid leakage from small blood vessels (capillaries) resulting in rapid swelling of the arms and legs, sudden weight gain and feeling faint, low blood pressure) have been reported following vaccination with SPIKEVAX. If you have previously had episodes of CLS, talk to a doctor before you are given SPIKEVAX.

If you have a weakened immune system (immunocompromised)

If you have a weakened immune system, you may receive a third dose of SPIKEVAX. The efficacy of SPIKEVAX even after a third dose may be lower in people who have weaker immune systems. In these cases, you should continue to maintain physical precautions such as mask wearing and social distancing to help prevent COVID-19. In addition, your close contacts should be vaccinated as appropriate. Discuss appropriate individual recommendations with your doctor.

Pregnancy and breastfeeding

SPIKEVAX can be used during pregnancy. A large amount of information from pregnant women vaccinated with SPIKEVAX during the second and third trimester has not shown negative effects on the pregnancy or the newborn baby. While information on effects on pregnancy or the newborn baby after vaccination during the first trimester is limited, no change to the risk for miscarriage has been seen.

Check with your doctor, pharmacist, or nurse if you are pregnant or intend to become pregnant.

SPIKEVAX can be given during breastfeeding. A large amount of information from breastfeeding women vaccinated with SPIKEVAX has not shown negative effects in breastfed babies.

Talk to your doctor, pharmacist, or nurse if you are breastfeeding or intend to breastfeed.

Use in Children

SPIKEVAX is not recommended for children aged under 6 months.

3. What if I am taking other medicines?

Tell your doctor, pharmacist, or nurse if you are taking any other medicines, including any medicines, vitamins, or supplements that you buy without a prescription from your pharmacy, supermarket, or health food shop.

Tell your doctor or pharmacist if you have recently received any other vaccine.

Check with your doctor, pharmacist, or nurse if you are not sure about what medicines, vitamins or supplements you are taking and if these affect SPIKEVAX.

4. How will I be given SPIKEVAX?

How much SPIKEVAX is given.

  • SPIKEVAX will be given to you as two injections. It is recommended to administer the second dose of SPIKEVAX 28 days after the first dose to complete the vaccination course.
  • If you have a weakened immune system, you may receive a third dose of SPIKEVAX at least 28 days after the second dose, as a third full dose will help your immune system get a better response.
  • A single booster dose of SPIKEVAX may be given at least 6 months after the second dose in individuals aged 18 years and above.
  • A single booster dose of SPIKEVAX may be given to you if you have completed your full course of your first vaccination (usually two doses) with another approved COVID-19 vaccine.
  • Your doctor, pharmacist or nurse will inject the vaccine into a muscle (intramuscular injection) in your upper arm or your thigh.
  • After each injection of the vaccine, your doctor, pharmacist, or nurse will watch over you for at least 15 minutes to monitor for signs of an allergic reaction.

If you miss an appointment for your 2nd or 3rd dose of SPIKEVAX

If you miss an appointment, arrange another visit as soon as possible with your doctor, pharmacist, or nurse.

If you miss a scheduled injection, you may not be fully protected against COVID-19 disease.

If you use too much SPIKEVAX

  • As SPIKEVAX is given under the close supervision of a doctor, pharmacist, or nurse it is unlikely that you will be given too much.
  • If you are concerned that you have been given too much SPIKEVAX, tell your doctor, pharmacist, or nurse immediately.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know about being given SPIKEVAX?

As with any vaccine, the 2-dose vaccination course of SPIKEVAX may not completely protect all those who receive it and it is not known how long you will be protected.

Things you should know

You may not be fully protected against COVID-19 disease until fourteen days after your second dose.

You may not be protected if you only receive one dose, so a second dose is important.

Driving or using machines

Do not drive or use machines if you are feeling unwell after vaccination. Wait until any effects of the vaccine have worn off before you drive or use machines.

Looking after your vaccine

Your doctor, pharmacist or nurse is responsible for storing this vaccine and disposing of any unused product correctly.

6. Are there any side effects?

All vaccines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor, pharmacist, or nurse if you have any further questions about side effects.

Less serious side effects

Less serious side effects What to do
  • Swelling in the underarm
  • Decreased appetite (observed in 6 month to 3 year olds)
  • Irritability/crying (observed in 6 month to 3 year olds)
  • Headache
  • Sleepiness (observed in 6 month to 3 year olds)
  • Nausea
  • Vomiting
  • Muscle ache, joint aches, and stiffness
  • Pain or swelling at the injection site
  • Feeling very tired
  • Chills
  • Fever
  • Rash
  • Rash, redness, or hives at the injection site (some of which may occur sometime after the injection)
Speak to your doctor, pharmacist, or nurse if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects What to do
  • Feeling faint or light-headed
  • Changes in your heartbeat
  • Shortness of breath
  • Wheezing
  • Swelling of your lips, face, or throat
  • Hives or rash
  • Nausea or vomiting
  • Stomach pain
  • A skin reaction that causes red spots or patches on the skin that may look like a target or “bulls eye” with a dark red centre surrounded by paler red rings (erythema multiforme)
  • Decreased sense of touch or sensation
  • Tingling, pricking or pins and needles feeling
  • Seizures with a fever (observed in 6 month to 2 year olds)
Call your doctor, pharmacist, or nurse straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor, pharmacist, or nurse if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this vaccine.

7. Product details

What SPIKEVAX contains

Active ingredient Elasomeran
Other ingredients
(Inactive ingredients)
  • Heptadecan-9-yl 8-[2-hydroxyethyl-(6-oxo-6-undecoxyhexyl)amino]octanoate
  • Cholesterol
  • Distearoylphosphatidylcholine
  • 1,2-Dimyristoyl-rac-glycero-3-methoxypolyethylene glycol-2000
  • Trometamol
  • Trometamol hydrochloride
  • Acetic acid
  • Sodium acetate trihydrate
  • Sucrose
  • Water for injections

Do not take this vaccine if you are allergic to any of these ingredients.

What SPIKEVAX looks like

SPIKEVAX is a white to off white suspension supplied in a glass vial with a rubber stopper and aluminum seal or a pre-filled syringe:

0.2 mg/ml vial (AUST R 370599)

0.1 mg/ml vial (AUST R 388244)

0.1 mg/ml pre-filled syringe (AUST R 388245)

Not all presentations may be marketed.

Sponsor

Moderna Australia Pty Ltd
Level 6, 60 Martin Place
Sydney,
NSW, 2000
www.modernacovid19global.com/au/
Phone: 1800 344 018
Email address: apacmedinfo@modernatx.com

This leaflet was prepared in October 2022.