About the vaccine

Comirnaty (Pfizer Australia Pty Ltd) is a vaccine that can prevent people from becoming ill from COVID-19. Comirnaty does not contain any live virus, and it cannot give you COVID-19. It contains the genetic code for an important part of the SARS-CoV-2 virus called the spike protein. After getting the vaccine, your body makes copies of the spike protein. Your immune system will then learn to recognise and fight against the SARS-CoV-2 virus, which causes COVID-19. The genetic code is then broken down quickly by the body.

To prevent COVID-19, everyone aged 16 years and older should get vaccinated, with a few exceptions specified in this information sheet. Vaccination is voluntary.

You can discuss any concerns or questions you have about COVID-19 vaccination with your immunisation provider and/or your GP before you receive the vaccine.

Benefits of the vaccine

A very large clinical trial showed that Comirnaty is effective in preventing COVID-19 in people aged 16 years and older. People who had two doses of Comirnaty were about 95 per cent less likely to get COVID-19 than people who did not get the vaccine. It was equally effective in people over the age of 65 years, as well as people with some stable pre-existing medical conditions.

Protection against COVID-19 starts from about 2–3 weeks after the first dose. While one dose may give some protection, it may only last for the short-term. Two doses will give optimal protection. No vaccine is 100 per cent effective, so it is possible that you can
still get sick from COVID-19 after vaccination. We do not know how long
the protection from Comirnaty will last. We will learn more about this
over time.

We currently do not know how effective COVID-19 vaccines are at preventing spread of the virus. This means that SARS-CoV-2 could potentially still infect a vaccinated person. Even if they have no symptoms or only mild symptoms they could still pass it on to others.

This is why it is important to continue other preventative measures like:

• physical distancing
• hand washing
• wearing a face mask
• COVID-19 testing and quarantine/isolation as required by your state/territory.

If you have been vaccinated with two doses of Comirnaty, you should still get a COVID-19 test if you have symptoms that meet testing criteria according to your local health authority (e.g. fever, cough, sore throat).

Who can receive this vaccine

People aged 16 years and older can receive this COVID-19 vaccination.

Certain groups of people are prioritised to receive vaccines first because they are at higher risk of:

• exposure to the COVID-19 virus, for example workers in border or quarantine facilities, a healthcare facility or aged-care facility, or
• severe illness and death from COVID-19, for example are older or have underlying medical conditions.

Who should not receive this vaccine

You should not receive this vaccine if you have had:

• anaphylaxis (a type of severe allergic reaction) to a previous dose of the same
  COVID-19 vaccine, or
• anaphylaxis after exposure to any component of a COVID-19 vaccine.

Precautions for vaccination

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 of a COVID-19 vaccine or to an ingredient of the vaccine
• anaphylaxis to other vaccines or to other medicines. Your provider can check to ensure there are no common ingredients with the COVID-19 vaccine you are receiving
• a mast cell disorder.

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 intramuscular injection, and help decide the best timing for injection.

Special circumstances to discuss before vaccination

People with weakened immune systems (immunocompromise)

People with immunocompromise includes those who have a medical condition that weakens their immune system. It also includes those who may be taking medications that suppress their immune system.

The Australian Government strongly recommends people with immunocompromise receive COVID-19 vaccination. Comirnaty is not a live vaccine. It is safe in people with immunocompromise.

People with immunocompromise, including those living with HIV, have a higher risk of severe illness from COVID-19, including a higher risk of death.

Clinical trials for Comirnaty did not include people with immunocompromise, except for a small group of people with stable HIV. We do not know if Comirnaty is as effective in people with immunocompromise compared to the rest of the population. It is possible that Comirnaty might not be as effective in people with immunocompromise as it is in the general population. It is important to continue other preventative measures such as physical distancing after vaccination.

Women who are pregnant or breastfeeding

If you are breastfeeding, you can have Comirnaty. You do not need to stop breastfeeding after vaccination.

Pregnant women are not routinely recommended to have Comirnaty, but can consider vaccination:

• if they are at higher risk of getting COVID-19, for example due to their occupation, or
• if they have risk factors for severe illness, for example due to pre-existing medical conditions.

If you are pregnant, your healthcare provider can help you to assess the benefits and risks of vaccination.

People with a history of COVID-19

If you have had COVID-19 in the past, tell your immunisation provider. Your provider may advise to wait for up to six months after recovery before having a COVID-19 vaccine. If you have ongoing illness from COVID-19, discuss the best timing of vaccination with your treating doctor.

Comirnaty and children

Comirnaty has only been provisionally approved for use in people aged 16 years or older, and cannot be given to younger people. Clinical trials are currently testing Comirnaty in older children but we do not yet have the results of this trial. The risk of COVID-19, especially severe disease, in children is lower than in older adolescents and adults.

Ensuring the safety of Comirnaty

Comirnaty and other COVID-19 vaccines have been developed quickly due to increased funding for vaccine research, and access to very large numbers of volunteers for research studies. A large clinical trial involving around 44,000 people confirmed Comirnaty to be safe and effective.

The Therapeutic Goods Administration (TGA) assesses all vaccines in Australia. This ensures that, in order for a vaccine to be approved, it is safe, effective and manufactured to a very high quality standard. A description of the process for approval of COVID-19 vaccines is available on the TGA website.

The safety of COVID-19 vaccines will be monitored continuously throughout the COVID-19 vaccination program.

There are reports of a very rare side effect involving blood clotting with low blood platelet count after receiving the COVID-19 Vaccine AstraZeneca. The COVID-19 Vaccine AstraZeneca vaccine is made in a different way. There is no evidence of this condition being linked to the Comirnaty COVID-19 vaccine.

You can report suspected side effects to your vaccination provider or other healthcare professional. They will then make a formal report on your behalf to your state or territory health department or directly to the Therapeutic Goods Administration (TGA).

If you would prefer to report it yourself, please visit the TGA website for information on how to report suspected side effects associated with COVID-19 vaccines.

After your COVID-19 vaccination

About the vaccine

Today you have received the Comirnaty (Pfizer Australia Pty Ltd) vaccine.

This vaccine can prevent people from becoming ill from COVID-19. Comirnaty does not contain any live virus, and it cannot give you COVID-19. It contains the genetic code for an important part of the SARS-CoV-2 virus called the spike protein. After getting the vaccine, your body makes copies of the spike protein. Your immune system will then learn to recognise and fight against the SARS-CoV-2 virus. The genetic code is broken down quickly by the body.

What to expect after vaccination

As with any vaccine, you may have some side effects after receiving a COVID-19 vaccine.

Common side effects after Comirnaty include:

• pain or swelling at the injection site
• tiredness
• headache
• muscle pain
• fever and chills
• joint pain.

Less common side effects after Comirnaty include:

• redness at the injection site
• nausea
• enlarged lymph nodes
• feeling unwell
• pain in limb
• insomnia
• itching at the injection site.

These side effects are usually mild and usually go away within one or two days. Some recipients will experience more significant flu-like symptoms from this vaccination compared to other common vaccinations and may require time away from normal activities. These symptoms may occur after either dose but are more common after the second dose.

If you experience pain at the injection site or fever, headaches or body aches after vaccination, you can take paracetamol or ibuprofen. These help to reduce some of the above symptoms (you do not need to take paracetamol or ibuprofen before vaccination). If there is swelling at the injection site, you can use a cold compress.

Rare side effects that have been reported after Comirnaty are:

• severe allergic reaction (anaphylaxis).

You should seek medical attention after vaccination if:

• you think you are having an allergic reaction. Call 000 if you experience severe symptoms, such as difficulty breathing, wheezing, a fast heartbeat or collapsing
• you are worried about a potential side effect or have new or unexpected symptoms
• you have an expected side effect of the vaccine which has not gone away after a few days.

For symptoms which are not urgent, you can see your regular healthcare provider (usually your GP).

Vaccine safety monitoring and reporting side effects

You can report suspected side effects to your vaccination provider or other healthcare professional. They will then make a formal report on your behalf to your state or territory health department or directly to the Therapeutic Goods Administration (TGA).

If you would prefer to report it yourself, please visit the reporting suspected side effects associated with a COVID-19 vaccine webpage on the TGA website and follow the directions on the page.

COVID-19 testing after vaccination

Some side effects from COVID-19 vaccination might be similar to symptoms of COVID-19 (e.g. fever). However, Comirnaty does not contain any live virus and cannot cause COVID-19. You may not need to get a COVID-19 test or isolate:

• if you develop general symptoms like fever, headache or tiredness in the first two days after vaccination, and
• if you are sure that you don’t have any respiratory symptoms (e.g. runny nose, cough, sore throat, loss of smell or loss of taste).

However, you should check the current guidelines in your state/territory for the most up-to-date information. This advice may change in the event of a COVID-19 outbreak in your local area. You may still need to get a COVID-19 test if you meet other criteria, for example if you are a close contact of a known COVID-19 case. If in doubt, seek medical assessment.

Remember your second appointment

It is important that you receive two doses of Comirnaty (Pfizer), at least three weeks apart. The second dose is likely to prolong the duration of protection against COVID-19.

How is the information you provide at your appointment used

For information on how your personal details are collected, stored and used visit https://www.health.gov.au/using-our-websites/privacy/privacy-notice-for-covid-19-vaccinations

Information received from Australian Government Health Department

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