Approval for use in Australia
Spikevax (Moderna) is approved and available for use as a primary course in people aged 6 months and over.
Moderna is approved and available for use as a booster in people aged 18 years and over.
The TGA provisionally approved it for use in Australia on:
- 9 August 2021 (primary course - for 18 years and over)
- 3 September 2021 (primary course - for 12 years and over)
- 7 December 2021 (booster – for 18 years and over)
- 17 February 2022 (primary course - for 6 years and over) (half the adult dose).
- 19 July 2022 (primary course – for children 6 months and over) (6 month to 5 year formulation)
30 August 2022 (booster – for 18 years and over) (bivalent original/Omicron BA.1 formulation)
The Spikevax (Moderna) original formulation is no longer being manufactured by Moderna, therefore none of the original formulation of the vaccine is being imported and the stock supply within Australia is expected to expire in early 2023. There are more than sufficient supplies of other COVID-19 vaccines available to eligible populations.
Moderna's bivalent COVID-19 vaccine
On 29 August, the TGA provisionally approved Moderna's bivalent COVID-19 vaccine for use as a booster dose in adults 18 years and over, and this vaccine has been available since 10 October 2022.
The Australian Technical Advisory Group on Immunisation (ATAGI) has provided a recommendation that the Moderna bivalent vaccine can be used as an alternative vaccine for any booster dose in people aged 18 years or older, according to the current ATAGI recommendations for booster doses.
The Moderna bivalent COVID-19 vaccine targets the original 2020 strain and the Omicron variant BA.1.
Compared to the original vaccines, ATAGI found it triggers a modest improvement in the immune response against both strains. However, both the bivalent and original vaccines provide significant protection from severe disease against Omicron subvariant infections.
ATAGI has not made any changes to its current third and fourth dose recommendations and is not advising any extra doses at this time.
ATAGI continues to recommend that people who are due for a COVID-19 dose book an appointment, using whichever vaccine is available to them.
For most people the Moderna primary course is 2 doses, 8 weeks apart.
It is preferable to have the first 2 doses 8 weeks apart, but the dose interval between doses can be reduced to 4 weeks. A shorter interval may be recommended for people at higher risk of severe COVID-19 (including older adults and people with underlying medical conditions), or before international travel.
You may not be protected against COVID-19 until 14 days after a vaccine dose.
Some people who are severely immunocompromised are recommended to have a third dose as part of their primary course. Moderna can be used for this third dose. It is usually given 8 weeks after the second dose of the primary course.
Find out more about third doses for people who are severely immunocompromised.
Moderna can also be used as a booster dose in people aged 18 years and older. The booster dose is given 6 months after the last dose or COVID-19 infection, whichever is more recent.
Find out more about booster doses.
If you have had COVID-19, you should wait to be vaccinated with a COVID-19 vaccine 6 months after your confirmed infection.
Moderna vaccine for children
The Therapeutic Goods Administration (TGA) has provisionally approved the Spikevax (Moderna) vaccine for children aged 6 months and over.
Moderna is no longer manufacturing this particular vaccine as it is being gradually replaced by the Moderna bivalent vaccine. However, the Moderna bivalent vaccine is not currently approved for use in this age group.
Children aged 6 months to under 5 years who have an increased risk of getting very sick from COVID-19 will still be able to access the Moderna (original) paediatric COVID-19 vaccine as part of a primary schedule until May 2023.
Vaccinating children can help protect children from getting COVID-19. It can also help prevent children passing the virus onto younger siblings, parents, grandparents and the wider community.
Find out more information on COVID-19 vaccines and children.
What's in the Moderna vaccine
The Moderna vaccine is a messenger RNA (mRNA) vaccine. This type of vaccine uses a genetic code called RNA to make your body's cells produce the coronavirus’ specific spike protein.
Your immune system cells then recognise the spike protein as a threat and begin building an immune response against it. The RNA from the vaccine does not change your DNA in any way, and your body quickly breaks it down.
The Moderna vaccine does not contain any live virus, and it cannot give you COVID-19.
This video from John Hopkins Bloomberg School of Public Health explains how mRNA vaccines work.
You can read the full Spikevax Consumer Medicine Information document on the TGA site for more details.
Benefits of vaccination
The benefits of vaccination with Moderna greatly outweigh the risk of side effects. Very large clinical trials have shown that Moderna is effective in preventing COVID-19 in people aged 12 years and older.
Adults who had 2 doses of Moderna were about 94% less likely to become ill from COVID-19 than people who did not get the vaccine.
The vaccine was also effective in people aged 65 years and in adolescents aged 12 to 17 years.
Common side effects
Moderna is a very safe vaccine. It has been given to millions of people around the world.
As with any vaccine, you may have some temporary side effects after receiving the Moderna vaccine. This shows your immune system is working.
Common side effects after the Moderna vaccine include:
- pain at the injection site
- muscle pain
- fever and chills
- joint pain.
Less common side effects after the Moderna vaccine include:
- redness or swelling at the injection site
- swelling or tenderness in the armpit
- enlarged lymph nodes.
Most side effects are mild and go away within 2 or 3 days.
Rare side effects
Rare side effects after the Moderna vaccine are severe allergic reaction (anaphylaxis), myocarditis and pericarditis.
Myocarditis or pericarditis
In rare cases, myocarditis (inflammation of the heart) and pericarditis (inflammation of the membrane around the heart) can develop after vaccination with the Moderna vaccine.
These rare effects on the heart typically occur:
- within 1 to 5 days of vaccination
- particularly after the second dose
- more often in men aged under 40.
But they can occur in any gender, at any age, and after any dose.
Most cases have mild symptoms and recover well.
Contact a doctor or go to hospital immediately if you develop any of the following symptoms after a Moderna vaccination:
- chest pain
- pressure or discomfort in the chest
- irregular, skipped heartbeats or ‘fluttering’
- shortness of breath
- pain when breathing.
Low risk of developing myocarditis or pericarditis
In the US, reported rates in males were 10 cases per million after first doses, and 67 cases per million after second doses. The TGA is monitoring the risk in the Australian population and publishes weekly COVID-19 vaccine safety reports containing information about the TGA’s monitoring of COVID-19 vaccines.
Find out more about myocarditis and pericarditis.
We have printable guidance on myocarditis and pericarditis after mRNA COVID-19 vaccines for providers.
The Melbourne Vaccine Education Centre has a page on myocarditis and pericarditis that includes an explanatory video.
Use in particular groups
People with certain conditions may need additional precautions such as staying for 30 minutes of observation after having their vaccine or consulting an allergy specialist. Tell your immunisation provider if you have had:
- an allergic reaction to a previous dose or to a component of an mRNA COVID-19 vaccine (Moderna or Pfizer)
- anaphylaxis to other vaccines or to other medications – your provider can check that there are no common components with the Moderna vaccine.
- Confirmed mastocytosis with recurrent anaphylaxis that requires treatment.
If you have a bleeding disorder or you are taking a blood-thinning medication (anticoagulant), tell your immunisation provider. Your immunisation provider can help determine whether it is safe for you to have an injection in your muscle and help decide the best timing for injection.
People with a history of capillary leak syndrome should consider an alternative brand. A few cases of capillary leak syndrome flare-up have been reported after vaccination with Moderna.
People with a history of any of the following can receive Moderna, but talk to your GP, immunisation specialist, or cardiologist about the best timing of vaccination and whether any additional precautions are recommended:
- Recent (i.e. within the past 3 months) myocarditis or pericarditis
- Acute rheumatic fever or acute rheumatic heart disease (with active myocardial inflammation)
- Acute decompensated heart failure.
People who develop myocarditis and/or pericarditis after a COVID-19 vaccine should defer further doses and discuss options for further COVID-19 vaccination with their treating doctor.
Moderna is safe and effective for:
- People who are immunocompromised
- People who are pregnant, breastfeeding or planning pregnancy.
People who should not have the Moderna vaccine
It's not recommended that you have the Moderna vaccine if you have had:
- severe allergic reaction (anaphylaxis) to a previous dose of an mRNA COVID19 vaccine (Moderna or Pfizer)
- anaphylaxis after exposure to any component of the vaccine, including polyethylene glycol (PEG)
- myocarditis and/or pericarditis attributed to a previous dose of a COVID-19 vaccine
- any other serious adverse event, that following review by an experienced immunisation provider or medical specialist was attributed to a previous dose of Moderna or Pfizer vaccine.
After your COVID-19 vaccination
Find out what to do after you are vaccinated for COVID-19, including how to get your vaccination certificate, what you need to do to stay safe, and what to do if you have side effects.
If you have been vaccinated with Moderna, you should still get a COVID-19 test if you have symptoms that meet testing criteria according to your local health authority (such as fever, cough, or sore throat).
Our patient resources include fact sheets about the Moderna vaccine and what to expect after your shot.