NOVAVAX COVID-19 Vaccination

Approval for use in Australia

Nuvaxovid (Novavax) is approved and available for use as a primary course in people aged 12 years and over.  

Novavax is approved and available for use as a booster in people aged 18 years and over.

The TGA provisionally approved Novavax for use as a primary course in Australia on 20 January 2022. The TGA provisionally approved Novavax for use as a booster on 9 June 2022.

Dose schedule

Primary course

For most people the Novavax primary course is 2 doses, given 8 weeks apart. It is preferable to have the first 2 doses 8 weeks apart, but the dose interval can be reduced to 3 weeks. This 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 fully protected against COVID-19 until 7 to 14 days after your second dose.

Some people who are severely immunocompromised are recommended to have a third dose as part of their primary course. Novavax can be used for this third dose. It is usually given 8 weeks after the second dose of the primary course.

Booster doses

Novavax 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.

mRNA vaccines (Pfizer or Moderna) are preferred as COVID-19 booster doses. Although not preferred, Novavax can be used as a booster dose for:

• people who have a contraindication to mRNA vaccines (including those who have had a serious adverse event following mRNA vaccines, such as a history of anaphylaxis or myocarditis attributed to an mRNA vaccine)
• people who do not prefer an mRNA vaccine.

What's in the Novavax vaccine

Novavax is a protein-based vaccine. This type of vaccine contains part of the coronavirus spike protein.  

Your immune system cells recognise the spike protein as a threat and begin building an immune response against it.  

The Novavax vaccine also has an ingredient called the Matrix-M adjuvant. This helps create a stronger immune response to the vaccine. 

Novavax does not contain any live virus and it cannot give you COVID-19.  

You can read the full Nuvaxovid (Novavax) Consumer Medicine Information document on the TGA site for more details (click 'I accept' to see the PDF).  

Benefits of vaccination

The benefits of vaccination with Novavax greatly outweigh the risk of side effects. Three large clinical trials showed that Novavax is effective in preventing and protecting against serious illness from COVID-19 in people aged 12 years and older. People who had 2 doses of Novavax were about 80-90% less likely to have COVID-19 with symptoms than people who did not get the vaccine. It is equally effective in people over the age of 65 years, as well as in people with some stable pre-existing medical conditions.  

Common side effects

Novavax has been safely given to thousands of people around the world. This is a relatively small number of people compared with other COVID-19 vaccines. As with all COVID-19 vaccines, we are continuing to monitor for side effects.

As with any vaccine, you may have some temporary side effects after receiving the Novavax vaccine. This shows your immune system is working. 

Common side effects after Novavax include: 

• injection site pain, tenderness, or swelling 
• tiredness 
• headache 
• muscle or joint pain
• fever and chills 

Less common side effects after Novavax include:

• redness at the injection site
• nausea
• enlarged lymph nodes
• feeling generally unwell
• pain in arm or leg
• insomnia
• itching at the injection site.

Rare side effects

Rare side effects after the Novavax vaccine are severe allergic reaction (anaphylaxis), and myocarditis and pericarditis. We don’t yet know if there are any other rare side effects after Novavax vaccine. This is because only relatively small numbers of people have received this vaccine worldwide. More information will be available over time. 

The TGA and the Australian Technical Advisory Group on Immunisation (ATAGI) are monitoring the safety of COVID-19 vaccines closely.

Myocarditis and pericarditis

Myocarditis (inflammation of the heart) and pericarditis (inflammation of the membrane around the heart) can occur after Novavax. Cases have been reported in the clinical trial and in post-licensure use in Australia.

These rare effects on the heart typically occur:

• within 1 to 5 days of vaccination
• predominantly after the second dose
• more often in men under 40 years

But they can occur in any gender, at any age, and after any dose.

Contact a doctor or go to hospital immediately if you develop any of the following symptoms after a Novavax vaccination: 

• chest pain
• pressure or discomfort in the chest
• irregular, skipped heartbeats or ‘fluttering’
• fainting
• shortness of breath
• pain when breathing

Low risk of developing myocarditis or pericarditis 

The risk of developing myocarditis or pericarditis is very low. 

Up to 30 June 2022, 3 cases of myocarditis and 12 cases of pericarditis from 160,000 doses administered had been reported to the TGA and assessed as being likely to be related to the vaccine. The small number of total doses globally prevents the calculation of a precise rate currently.

Fact sheets 

Find out more about myocarditis and pericarditis.

We also have a 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 the Novavax COVID-19 vaccine
• anaphylaxis to other vaccines or to other medications – your provider can check that there are no common components with the Novavax 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 any of the following can receive Novavax, 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.

Novavax is safe and effective for:

• People who are immunocompromised
• People who are pregnant, breastfeeding or planning pregnancy.

People who should not have the Novavax vaccine

It's not recommended that you have the Novavax vaccine if you have had: 

• a severe allergic reaction (anaphylaxis) to a previous dose of the vaccine 
• anaphylaxis after exposure to any component of the vaccine, including polysorbate 80 
• any other serious adverse event attributed to a previous dose of the vaccine. 

Find out more information on precautions and who should not have the Novavax 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 Novavax, 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). 

 

The above information was sourced from https://www.health.gov.au/our-work/covid-19-vaccines/our-vaccines/novavax