Bridge Medical Centre COVID Vaccination Consent Form
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About COVID-19 vaccination
People who have a COVID-19 vaccination course have a much lower chance of getting sick from COVID-19.
There are four brands of vaccine in use in Australia. All are effective and safe.
You can have:
AstraZeneca or Novavax if you are 18 years or over
Moderna if you are 12 years or over
Pfizer if you are 5 years or over*
Pfizer, Moderna, or Novavax are preferred over AstraZeneca for adults under 60 years of age.
Most people require two doses initially. This is called the primary course.
People with severe immunocompromise may require a third primary dose to bring their immune response up to optimal levels.
People aged 16 years or over, including people with severe immunocompromise and pregnant women, should have a booster dose three months or more after their primary course, to prolong their protection against COVID-19.
People aged 16 and over can have a booster dose of Pfizer.
People aged 18 and over can have Pfizer or Moderna as a booster.
AstraZeneca is not preferred but can be used in some instances in people over 18 years.
For more information visit the Department of Health COVID-19 vaccine website: www.health.gov.au/covid-19-vaccines
Medical experts have studied COVID-19 vaccines to make sure they are safe. Most side effects are mild. They may start on the day of vaccination and last for one or two days. As with any vaccine or medicine, there may be rare or unknown side effects.
A very rare side effect after AstraZeneca is called thrombosis with thrombocytopenia syndrome, or TTS. This means blood clotting (thrombosis) with low blood platelet levels (thrombocytopenia). TTS does not happen after Pfizer or Moderna.
Myocarditis and pericarditis (heart inflammation) have been reported following Pfizer and Moderna. Most cases have been mild and people have recovered quickly.
Tell your health care provider if you have any side effects after vaccination that you are worried about.
You may be contacted by SMS or email in the week after you have the vaccine to see how you are feeling.
Some people may get COVID-19 after vaccination. You must still follow all public health advice in your state or territory to stop the spread of COVID-19, including:
keep your distance – stay at least 1.5 metres away from other people
wash your hands often with soap and water, or use hand sanitiser
wear a mask
stay home if you are unwell with cold or flu-like symptoms and arrange to get a COVID-19 test.
By law, the person giving your vaccination must record it on the Australian Immunisation Register. You can view your vaccination record online through your:
Medicare account
MyGov account
My Health Record account (you can register for this with a Medicare number or an Individual Healthcare Identifier).
How your information is used
For information on how your personal details are collected, stored and used, visit www.health.gov.au/using-our-websites/privacy/privacy-notice-for-covid-19-vaccinations.
If you are getting your vaccination in a pharmacy, the pharmacy must share some of your personal information with the Pharmacy Programs Administrator. This is so the pharmacy can claim payment from the Australian Government. More information about why this is needed and what information is shared is provided at the link above.
On the day you have your vaccine
Before you get vaccinated, tell the person giving you the vaccination if you:
have had an allergic reaction, particularly a severe allergic reaction (anaphylaxis), to:
a previous dose of a COVID-19 vaccine
an ingredient of a COVID-19 vaccine
other vaccines or medications
are immunocompromised. This means that you have a weakened immune system that makes it harder for you to fight diseases. You can still have a COVID-19 vaccine but talk to your doctor about when is the best time to get your vaccine. This will depend on your condition and your treatment.
Available Factsheets
About the vaccine
The Comirnaty (Pfizer) COVID-19 vaccine can prevent children from becoming ill from COVID-19. The vaccine schedule for children is 2 doses, given 8 weeks apart. This interval can be shortened in special circumstances to a minimum of 3 weeks.
The Pfizer COVID-19 vaccine does not contain any live virus and cannot cause 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 child’s body makes copies of the spike protein. Your child’s immune system will then learn to recognise and fight against the SARS-CoV-2 virus, which causes COVID-19. The body breaks down the genetic code quickly.
Vaccination is voluntary and free. You can discuss any concerns or questions you have about COVID-19 vaccination for your child with your immunisation provider or your GP before they receive the vaccine.
Benefits of the vaccine
Although most children who get COVID-19 have a mild illness, some children, including those with no history of health conditions, can become very unwell with COVID-19. Children with some medical conditions (including chronic lung disease, congenital heart disease, neurological disease, obesity and immunocompromise) have a higher risk of becoming seriously ill or needing to be admitted to hospital if they get COVID-19.
In the United States, almost 6,000 cases have been reported of a rare but serious condition associated with COVID‑19 called paediatric inflammatory multisystem syndrome temporally associated with SARS-CoV-2 (PIMS-TS). This is also known as multisystem inflammatory syndrome in children (MIS‑C). Most children with PIMS-TS/MIS-C need to be treated in hospital and a small proportion of children with PIMS-TS/MIS-C have died. Most people who contracted PIMS‑TS/MIS-C were aged between 5 and 11 years.
A clinical trial showed that the Pfizer COVID-19 vaccine is effective in preventing COVID-19 in children aged 5 to 11 years. Children who had 2 doses were about 91 percent less likely to get sick from COVID-19 than children who did not get the vaccine.
Children can transmit the virus to others, including older family members who are at higher risk of becoming seriously ill. Infected children often miss out on school and other activities.
When children are vaccinated, the risk that they will become infected and spread COVID-19 to family members, friends and others around them is reduced. Reducing the spread of COVID-19 may help to minimise school closures and other disruptions to extra-curricular and social activities which significantly impact on the wellbeing of children and their families.
Getting your child vaccinated will also help with the return to normal activities without disruptions, like needing to isolate after contact with someone with COVID-19, and will support the safe enjoyment of other activities, like overseas travel.
Protection against COVID-19 starts from about 2 to 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 improved protection.
No vaccine is 100 per cent effective, so it is possible that your child could still get sick from COVID-19 after vaccination. Evidence shows, however, that people who are vaccinated are much less likely to get seriously ill from COVID-19 or need to go to hospital.
Safety of the vaccine
The safety of the Pfizer COVID-19 vaccine has been tested in more than 3,500 children aged 5 to 11 years in the clinical trial and a safety expansion group. The trial showed that the vaccine is safe in children and most side effects were mild.
The Pfizer COVID-19 vaccine for children aged 5 to 11 years is a smaller dose (one third of the active component of the vaccine) than the vaccine for people aged 12 years and over.
In the United States, vaccination of children aged 5 to 11 years with the Pfizer COVID-19 vaccine started on 4 November 2021. As at 9 December 2021, more than 5 million children in this age group have received at least one dose and more than 2 million have received both doses of the Pfizer COVID-19 vaccine. No specific safety concerns have been identified in this age group in this large, real-world population, where the number of children vaccinated is already greater than the approximately 2.3 million children aged 5–11 years in Australia.
Expected side effects in the first one to two days after vaccination are less common in children than in teenagers and young adults. The most common side effects include a sore arm, headache and fatigue. These usually go away on their own or are treated with over the counter medication like paracetamol or ibuprofen. Children don’t usually need to see a doctor for these mild side effects after receiving a COVID-19 vaccine.
The Pfizer COVID-19 vaccine has a very rare risk of heart inflammation (called myocarditis or pericarditis). Myocarditis and/or pericarditis occurs very rarely in younger people, including adolescents and children 12 years of age and older, who have had the Pfizer Comirnaty vaccine or the Moderna Spikevax vaccine. It is more common after dose 2 and in males. In the USA, from data reported through to 11 June 2021, the rate of myocarditis/pericarditis in female adolescents aged 12-17 years was 9.1 per million doses, and in male adolescents aged 12-17 years 66.7 per million doses of an mRNA COVID-19 vaccine given. The rate and severity of myocarditis in children is expected to be lower than that in adolescents, and more mild. Myocarditis is more commonly seen in males under 30 years of age after the second dose. Most people who have had these conditions after their vaccine have recovered fully.
The clinical trial in children aged 5 to 11 years did not have enough participants to assess rates of myocarditis or pericarditis following vaccination with the Pfizer COVID-19 vaccine, but no specific safety concerns have been identified so far from millions of doses of this vaccine administered overseas to children aged 5 to 11 years. The benefits of vaccination outweigh this very rare risk, and vaccination is still recommended for all eligible age groups.
The Therapeutic Goods Administration (TGA) assesses all vaccines in Australia. For a vaccine to be approved, the TGA must assess that 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 at: www.tga.gov.au.
The safety of COVID-19 vaccines has been, and will continue to be, monitored throughout the COVID-19 vaccination program, including for children.
For current information on the frequency and severity of myocarditis and pericarditis after the Pfizer COVID-19 vaccine, see the Australian Technical Advisory Group on Immunisation (ATAGI) weekly COVID-19 meeting updates, available at: www.health.gov.au/committees-and-groups/australian-technical-advisory-group-on-immunisation-atagi#statements.
Who should not receive this vaccine?
Your child should not receive the Pfizer COVID-19 vaccine if they have had:
anaphylaxis (a type of severe allergic reaction) to a previous dose of the Pfizer COVID-19 vaccine
anaphylaxis after exposure to any component of the vaccine, including polyethylene glycol (PEG)
any other serious adverse event that an experienced immunisation provider or medical specialist has confirmed was caused by a previous dose of the Pfizer COVID-19 vaccine, without another cause identified.
Precautions for vaccination
Children 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 your child has had:
an allergic reaction to a previous dose or to a component of the Pfizer COVID-19 vaccine
anaphylaxis to other vaccines or to other medicines – your provider can check to ensure there are no common components with the COVID-19 vaccine your child is receiving
confirmed mastocytosis with recurrent anaphylaxis that requires treatment.
Tell your immunisation provider if your child has ableeding disorder or is taking a blood-thinning medication (anticoagulant). This will help them determine whether it is safe for your child to have an intramuscular injection and help decide the best timing for injection.
Special circumstances to discuss before vaccination
Children with heart conditions Children with a history of any of the following conditions can receive the Pfizer COVID-19 vaccine. You should seek advice, however, from a GP, immunisation specialist or cardiologist about the best timing of vaccination and whether any additional precautions are recommended.
Recent (within the past 3 months) myocarditis or pericarditis (heart inflammation)
Acute rheumatic fever (with active heart inflammation) or acute rheumatic heart disease
Acute decompensated heart failure.
Tell your doctor if your child has had myocarditis or pericarditis diagnosed after a previous dose of the Pfizer COVID-19 vaccine.
Children with weakened immune systems (immunocompromise) It is strongly recommended that children with immunocompromise receive COVID-19 vaccination. The Pfizer COVID-19 vaccine is not a live vaccine. It is safe in children with immunocompromise.
Children with immunocompromise, including those living with HIV, have a higher risk of severe illness from COVID-19, including a higher risk of death.
Some children with immunocompromise may have a reduced immune response to the vaccine, so it is important to consider other preventative measures, such as physical distancing, after vaccination.
Children with a history of COVID-19 If your child has had COVID-19 in the past, tell your doctor or immunisation provider. COVID-19 vaccination is still strongly recommended in children who have already had COVID-19 infection. COVID-19 vaccination can be given after recovery from the infection, or can be deferred for up to six months after the acute illness (confirmed with a COVID-19 test). This is because evidence suggests that past infection reduces the risk of reinfection for at least six months.
Children who have recently received another vaccine Children can safely receive other vaccines any time before, after or at the same time as their COVID-19 vaccine. If your child has recently received another vaccine (within the last 7 days), it is best to let your immunisation provider know so they can correctly assess any side effects.
Children who turn 12 before their second dose The Pfizer COVID-19 vaccine for children aged 5 to 11 years contains a smaller dose of the active vaccine component compared with the dose for people aged 12 years and over. It is important that your child gets the correct vaccine for their age. If they received their first dose when they were 11 years old, and had their 12th birthday before their second dose, it is safe for them to receive the Pfizer COVID-19 vaccine for people aged 12 years and over for their second dose. This is also the usual practice for other types of vaccines where there are different dose strengths for different age groups.
What to expect after vaccination
As with any vaccine, your child may have some side effects after receiving a COVID-19 vaccine.
Common side effects after the Pfizer COVID-19 vaccine in children include:
pain, redness or swelling at the injection site
tiredness
headache
fever and chills.
Less common side effects after the Pfizer COVID-19 vaccine in children include:
joint pain
muscle pain
vomiting.
These side effects are usually mild and go away within one or two days.
If your child experiences pain at the injection site or fever, headaches or body aches after vaccination, they can take paracetamol or ibuprofen. These help to reduce some of the above symptoms (paracetamol or ibuprofen does not need to be taken before vaccination). If there is swelling at the injection site, a cold compress can be applied.
Rare side effects reported after the Pfizer COVID-19 vaccine include:
severe allergic reaction (anaphylaxis)
myocarditis (inflammation of the heart muscle)
pericarditis (inflammation of the outer lining of the heart).
You should seek medical attention after vaccination if your child has:
symptoms of a severe allergic reaction, such as difficulty breathing, wheezing, a fast heartbeat, or if your child collapses
chest pain, pressure or discomfort, irregular heartbeat, skipped beats or ‘fluttering’, fainting, shortness of breath, pain with breathing
new or unexpected symptoms, or if you are worried about a potential side effect
an expected side effect of the vaccine that has not gone away after a few days, like headache, fever or chills.
For non-urgent symptoms, you can see your regular healthcare provider (e.g. your GP).
Vaccinated people can still get COVID-19. Even if they have no symptoms, or only mild symptoms, they could still pass the virus on to others. This is why it is important after vaccination to continue other preventative measures, such as:
physical distancing
hand washing
wearing a face mask (depending on age)
COVID-19 testing and quarantine/isolation as required by your state/territory.
If your child has been vaccinated, they should still get a COVID-19 test if they have symptoms that meet your local health authority’s testing criteria.
Vaccine safety monitoring and reporting side effects
You may be contacted by SMS or email in the week after your child has received each dose of the vaccine to see how they are feeling. This is part of our ongoing monitoring of the safety of COVID-19 vaccines.
You can report suspected side effects that your child experiences to your vaccination provider or other healthcare professional. They will then make a formal report on your child’s behalf to your state or territory health department and/or the TGA.
If you would prefer to report it yourself, please visit www.tga.gov.au/reporting-suspected-side-effects-associated-covid-19-vaccine and follow the directions on the webpage.
COVID-19 testing after vaccination Some side effects from COVID-19 vaccination might be similar to symptoms of COVID-19 (e.g. fever). However, the Pfizer COVID-19 vaccine does not contain any live virus and cannot cause COVID-19.
Your child may notneed to get a COVID-19 test or isolate if:
they develop general symptoms like fever, headache or tiredness in the first 2 days after vaccination
you are sure that they 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 if there is a COVID-19 outbreak in your local area. Your child may need to get a COVID-19 test if they meet other criteria, e.g. if they are a close contact of a known COVID-19 case. If in doubt, seek medical assessment.
Remember your next appointment
It is important that your child receives 2 doses of the Pfizer COVID-19 vaccine, 8 weeks apart, for their primary course. The dosing interval can be shortened to a minimum of 3 weeks in certain situations, e.g. as part of a local outbreak response or before your child starts any immunosuppressive treatment. Your provider will advise if your child’s second dose should be given earlier.
The second dose is likely to prolong the duration of protection against COVID-19. Unless there are special circumstances, it is better for your child to get their second dose 8 weeks after the first (rather than a shorter interval) because better immune responses are more likely after a longer interval.
Staying up to date
To be considered up to date with COVID-19 vaccination, you must have completed all the doses recommended for your age and health status.
Find out about how to stay up to date with COVID-19 vaccines - https://www.health.gov.au/initiatives-and-programs/covid-19-vaccines/getting-your-vaccination/stay-up-to-date.
How your information is used and recorded For information on how your child’s personal details are collected, stored and used visit www.health.gov.au/using-our-websites/privacy/privacy-notice-for-covid-19-vaccinations.
If your child is getting their vaccination in a pharmacy, the pharmacy must share some of your child’s personal information with the Pharmacy Programs Administrator so they can claim payment from the Australian Government. More information about why this is needed and what information is shared is provided at the link above.
By law, the person giving your child’s vaccination must record it on the Australian Immunisation Register. You can view your child’s vaccination record online through your:
Medicare account
MyGov account
My Health Record account (you can register for this with a Medicare number or an Individual Healthcare Identifier).
Further information
If you would like more detailed information about vaccinating your child against COVID-19, the following websites have some useful information:
Is it true? Get the facts on COVID-19 vaccines: www.health.gov.au/initiatives-and-programs/covid-19-vaccines/is-it-true
FAQs about COVID-19 and COVID-19 vaccination in children: www.ncirs.org.au/covid-19/covid-19-and-children-frequently-asked-questions
Information about COVID-19 vaccination in children: https://mvec.mcri.edu.au/references/covid-19-vaccination-in-children/
COVID-19 vaccines for children and teens (CDC): www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/children-teens.html
Information on COVID-19 Vaccine AstraZeneca
About the vaccine
COVID-19 Vaccine AstraZeneca can prevent people from becoming ill from COVID-19. This vaccine does not contain any live SARS-CoV-2 virus, and cannot give you COVID-19. It contains the genetic code for an important part of the SARS-CoV-2 virus called the spike protein. This code is inserted into a harmless common cold virus (an adenovirus), which brings it into your cells. Your body then makes copies of the spike protein, and your immune system learns to recognise and fight the SARS-CoV-2 virus. The adenovirus has been modified so that it cannot replicate once it is inside cells. This means it cannot spread to other cells and cause infection.
Vaccination is voluntary and free. 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.
COVID-19 Vaccine AstraZeneca can be used in people aged 18 and above, and is safe and effective. A very rare side effect reported after the AstraZeneca vaccine is ‘thrombosis with thrombocytopenia syndrome’ (TTS), which involves blood clotting and low blood platelet levels. The benefits of vaccination greatly outweigh the risk of this condition. However, to minimise this risk, Comirnaty (Pfizer) is the preferred COVID-19 vaccine for adults under 50 years of age, and for people with a past history of cerebral venous sinus thrombosis (a type of brain clot) or heparin induced thrombocytopenia (a rare reaction to heparin treatment).
Benefits of vaccination
COVID-19 Vaccine AstraZeneca protects people from becoming ill from COVID-19. It particularly prevents severe illness, hospitalisation and death. The vaccine has been shown to be highly effective in both clinical trials (before it was registered for use) and in studies of people vaccinated in the ‘real world’ in England and Scotland.
COVID-19 is a very serious disease which can cause serious illness in people of all ages. It has caused millions of deaths and hundreds of millions of infections worldwide.
Vaccination helps protect both individual people and also benefits all people in the community by reducing the spread of COVID-19.
Risks of vaccination
As with any vaccine, you may have some temporary side effects after receiving a COVID-19 vaccine. Common side effects after COVID-19 Vaccine AstraZeneca include: injection site pain or tenderness, tiredness, headache, muscle pain, and fever and chills Most side effects are mild and temporary, going away within 1-2 days. As with any medicine or vaccine, there may be rare and/or unknown side effects.
As with any medicine or vaccine, there may be rare and/or unknown side effects.
COVID-19 Vaccine AstraZeneca appears to be associated with a rare side effect called thrombosis with thrombocytopenia syndrome (TTS), which has been reported in several countries overseas.
What is TTS?
TTS involves blood clots (thrombosis) and low levels of blood platelets (thrombocytopenia), and occurs about 4-20 days after vaccination. The blood clots can occur in different parts of the body, such as the brain (called cerebral venous sinus thrombosis or CVST) or in the abdomen.
The mechanism that causes TTS is not fully understood, but it appears similar to heparin-induced thrombocytopenia (or HIT), a rare reaction to heparin treatment.
How common is TTS?
TTS is very rare (4-6 cases per million doses), but it can make people very unwell and in about 1 in 4 cases has led to death. As at 8 April one case and one probable (likely) case has been reported in Australia on 1 April 2020, following administration of approximately 400,000 doses of COVID-19 Vaccine AstraZeneca.
Are any groups more at risk of TTS?
No specific risk factors have been confirmed for TTS.
In the countries that have reported TTS, more cases have occurred in adults under 60 years of age compared to older adults, and in women compared to men. However it is not yet clear if age and sex are risk factors, since the AstraZeneca vaccine was preferentially given to younger people in some countries, and since women make up a large proportion of the healthcare workers that were prioritised for vaccination.
As a precaution, in Australia Comirnaty (Pfizer) vaccine is preferred for adults under 50 years of age, since their risk of TTS may be slightly higher than older people, and since they have a lower risk of severe outcomes from COVID-19 compared to older adults.
Is the AstraZeneca vaccine safe in people who have had blood clots in the past?
Comirnaty (Pfizer) vaccine is preferred in people who have a past history of cerebral venous sinus thrombosis or heparin-induced thrombocytopenia, given the similarities between these conditions at TTS.
If you have had other types of blood clots in the past, or if you have risk factors for blood clots, you can still have the AstraZeneca vaccine. There is no evidence that people who have had a past history of other types of blood clots have an increased risk of TTS. The overall rate of blood clots has not risen in countries which have extensively used the AstraZeneca vaccine.
What if I have had my first dose of AstraZeneca vaccine?
All of the cases of TTS reported to date have occurred after the first dose of the vaccine. People who have had their first dose without any serious side effects can be confident in getting their second dose.
What symptoms does thrombosis with thrombocytopenia syndrome usually cause?
TTS is very rare and occurs around 4-20 days after vaccination. Symptoms can include abdominal pain and/or severe headache that does not settle with pain relief.
People should seek medical attention immediately if they experience these symptoms:
a severe persistent headache with additional features:
appears at least 4 days after vaccination
does not improve with simple painkillers
may be worse when lying down or accompanied by nausea and vomiting
neurological symptoms such as:
blurred vision
difficulty with speech
drowsiness
seizures
shortness of breath or chest pain
a swollen leg
persistent abdominal (belly) pain
tiny blood spots under the skin away from the site of injection together with symptoms above.
Things to consider before vaccination
Precautions
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 provider can help determine whether it is safe for you to have an intramuscular injection, and help to decide the best timing for injection.
People with weakened immune systems (immunocompromise)
People with immunocompromise includes those who have a medical condition or are taking medications that weaken their immune system. People with immunocompromise, including those living with HIV, have a higher risk of severe illness from COVID-19, including a higher risk of severe illness and death.
The Australian Government strongly recommends people with immunocompromise receive a COVID-19 vaccine. COVID-19 Vaccine AstraZeneca does not behave like a ‘live vaccine’. The adenovirus carrier has been modified so that it cannot replicate or spread to other cells, and it cannot cause infection. It is safe in people with immunocompromise.
Clinical trials for COVID-19 Vaccine AstraZeneca did not include people with immunocompromised but many people with such conditions have now been vaccinated worldwide. A clinical trial is being conducted of COVID-19 Vaccine AstraZeneca given to people with stable HIV infection, with results expected in a few months.
We do not know if COVID-19 Vaccine AstraZeneca is as effective in people with immunocompromise compared to the rest of the population. It is possible that it might be less effective, and so it is important to continue other preventative measures such as physical distancing after vaccination.
For more information on use of the vaccine in immunocompromised see:
Women who are pregnant or breastfeeding
If you are breastfeeding, it is preferable for you to have the Pfizer (Comirnaty) COVID-19 vaccine. This is the preferred vaccine in young adults. However, you can still have the COVID-19 Vaccine AstraZeneca if the benefits of vaccination outweigh the risks for you. You do not need to stop breastfeeding after vaccination.
Pregnant women are not routinely recommended to have COVID-19 vaccination. They 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. The Pfizer (Comirnaty) COVID-19 vaccine is preferred over the COVID-19 Vaccine AstraZeneca for pregnant women due to their age.
For more information on use of the vaccine in pregnancy and breastfeeding see:
People with a history of COVID-19
If you have ever 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.
Either COVID-19 vaccine brand can be used in people with a past history of COVID-19
COVID-19 Vaccine AstraZeneca and children
COVID-19 Vaccine AstraZeneca has only been provisionally approved for use in people aged 18 years or older, and cannot be given to younger people. The risk of COVID-19, especially severe disease, in children is lower than in older adolescents and adults.
Vaccine safety and reporting adverse events
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. Suspected side effects can be reported 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.
Information on COVID-19 Pfizer (Comirnaty) vaccine
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 vaccination
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.
COVID-19 vaccination decision guide for people with immunocompromise
This guide is for people with a weakened immune system (which is called immunocompromise), including people taking immune-weakening medicines, who are considering COVID-19 vaccination. This guide includes information about two vaccines:
COVID-19 vaccines Comirnaty (Pfizer)
COVID-19 Vaccine AstraZeneca.
The Department of Health will publish updated versions of this guide as more information and new vaccines become available.
What is immunocompromise?
Being ‘immunocompromised’ means having a weakened immune system due to a medical condition or treatment. Many conditions can cause immunocompromise, including:
Cancer, especially blood cancer (leukemia or lymphoma).
Treatments for cancer (e.g. chemotherapy, targeted therapies, radiotherapy and CAR-T cell therapy) can also weaken the immune system.
Having a bone marrow, stem cell or solid organ transplant.
Immune deficiencies.
HIV infection (particularly if the CD4 count is low).
Taking medications that weaken your immune system. These medications are called immunosuppressants or immunomodulators.
Should I have a COVID-19 vaccine if I am immunocompromised?
You should have a COVID-19 vaccine if you are 16 years or older and have immunocompromise or are taking immune-weakening treatments. There are no COVID-19 vaccines currently available for people aged under 16 years.
The two COVID-19 vaccines currently available in Australia are suitable for people with immunocompromise. They are
Comirnaty (Pfizer), which is for people aged 16 and older
COVID-19 Vaccine AstraZeneca, which is for people aged 18 and older
Many immunocompromising conditions can cause a higher risk of severe illness and complications from COVID-19 including:
solid organ transplantation
blood and solid organ cancers or their treatments including immune therapy
chemotherapy
radiotherapy
blood/marrow stem cell transplant, and
CAR-T cell therapy.
Vaccination protects you from having severe illness and needing to go to hospital as a result of getting COVID-19.
Is the COVID-19 vaccine safe for me if I am immunocompromised?
Comirnaty (Pfizer), is not a live vaccine. COVID-19 Vaccine AstraZeneca contains a virus which cannot replicate or spread to other cells. It does not behave like a live vaccine and cannot cause infection. There is no reason to expect any higher risk of safety issues with either Comirnaty or COVID-19 Vaccine AstraZeneca in people with immunocompromise.
Will COVID-19 vaccine be effective for me if I am immunocompromised?
People with immunocompromise can have reduced responses to vaccines, meaning they may not be as well protected as people whose immune system is normal. After your vaccination continue to follow other protective measures against COVID-19 including:
physical distancing
hand washing
wearing a face mask, and
COVID-19 testing and self-isolation or quarantine according to instructions of your local public health authority.
The effectiveness of COVID-19 vaccines in people with immunocompromise is not yet known because detailed studies have not yet been conducted on this group. These studies will be available in the coming months and years. However, as there are a lot of risks associated with COVID-19, immunocompromised people should get vaccinated as soon as possible.
When should I get the vaccine?
There is a limit of initial supplies of COVID-19 vaccines. Those at the highest risk of exposure to COVID-19, or those at the highest risk of severe illness or death from COVID-19, will be offered the vaccines first. As a result, you may have to wait some time before you can get a COVID-19 vaccine. However, people with immunocompromise have been prioritised over younger healthy adults to receive COVID-19 vaccine.
Chemotherapy
If you are having chemotherapy, discuss the best timing of vaccination with your treating doctor. Some types of chemotherapy can cause a fall in your body’s immune (white) cells or platelets and during these times it is better to avoid vaccination. There are no specific safety concerns with Comirnaty or COVID-19 Vaccine AstraZeneca in people with low immune (white) cells but both vaccines can cause fever. This may lead to extra investigations to look for other causes of fever. People with very low platelet counts may have increased bleeding at the injection site following vaccination.
Immune-weakening treatment
If you are taking an immune-weakening treatment, discuss the best timing of vaccination with your treating doctor. Most people taking immune-weakening treatment will need to continue their treatment before and after vaccination. If you have regular infusions (i.e. you receive your treatment by a drip), it would be best not to have your vaccine on the same day as an infusion. This would avoid any confusion about whether the medication or the vaccine was responsible for any side effects, if you have them
It would be best to have both vaccine doses before you start a new immune-weakening treatment (also called immunosuppressive or immunomodulatory treatment). Vaccination would ideally be at least 2 weeks before, if possible. This helps to ensure your immune system responds properly to the vaccine doses. If you can’t delay the start of your new immune-weakening treatment, you can still be vaccinated. If you are having COVID-19 Vaccine AstraZeneca, your doctor can reduce the time interval between the two doses, before you start your new treatment.
If you are taking an immune checkpoint inhibitor, discuss the best timing of vaccination with your treating doctor.
COVID-19 vaccination decision guide for women who are pregnant, breastfeeding or planning pregnancy
This decision guide is for you if you are considering COVID-19 vaccination and you are pregnant, breastfeeding or planning pregnancy. It contains information about the COVID-19 vaccines Comirnaty (Pfizer) and COVID-19 Vaccine AstraZeneca. This information will be updated when other vaccines become available.
Introduction
The information below will help you to decide whether you should have a COVID-19 vaccine. If you have any questions, ask your immunisation provider, doctor or midwife.
This document will help you to learn about:
COVID-19 vaccine.
COVID-19 in pregnant women.
The possible benefits and possible risks of having a COVID-19 vaccine.
What is most relevant to you in deciding if and when to have a COVID-19 vaccine.
The COVID-19 vaccines
Australia is likely to receive different COVID-19 vaccines over time. The vaccines currently available are Comirnaty (Pfizer) and COVID-19 Vaccine AstraZeneca.
Both vaccines contain the genetic code for an important part of the COVID-19 virus called the spike protein. When the vaccine injection is given, your body reads the genetic code and makes copies of the spike protein. This then trains your immune system to recognise and fight against the COVID-19 virus.
The vaccines work in different ways. Comirnaty (Pfizer) has the piece of genetic code in a form called mRNA, and is not a live vaccine. COVID-19 Vaccine AstraZeneca has the piece of genetic code in a harmless common cold ‘carrier’ virus (an adenovirus). The carrier virus has been modified so that it cannot replicate and spread to other cells or cause infection, and does not behave like a live vaccine.
Both vaccines require two doses to be given. For Comirnaty, the doses are given at least 3 weeks apart. For COVID-19 Vaccine AstraZeneca, the doses are given 12 weeks apart.
If you are breastfeeding
Recommendation
If you are breastfeeding you can receive Comirnaty or COVID-19 Vaccine AstraZeneca at any time. You do not need to stop breastfeeding before or after vaccination.
Are there complications of COVID-19 in breastfeeding women?
There is no evidence that breastfeeding women have any increased risk of complications from COVID-19 compared to women who are not breastfeeding.
Current knowledge about COVID-19 vaccine in breastfeeding women
COVID-19 vaccines have not yet been studied in detail in breastfeeding women. However there are no concerns about their safety in breastfeeding women or their babies.
Breastfeeding women can safely receive almost all other vaccines. There is only caution with one vaccine against yellow fever, which is a live vaccine. Comirnaty is not a live vaccine. The mRNA in Comirnaty is rapidly broken down in the body and we do not think that it passes into breastmilk. Even if it did, it would be quickly destroyed in the baby’s gut and is therefore extremely unlikely to have any effect on your baby. COVID-19 Vaccine AstraZeneca contains a carrier virus that does not behave like a live vaccine. It has been modified so that it cannot replicate or spread to other cells, and it cannot cause infection.
If you are planning pregnancy
Recommendations:
If you are planning a pregnancy, you can receive Comirnaty or COVID-19 Vaccine AstraZeneca. You do not need to avoid becoming pregnant before or after vaccination. Getting vaccinated before conceiving means you will have some protection against COVID-19 throughout your pregnancy. Vaccination does not affect fertility. You are not required to have a pregnancy test before getting vaccinated. If you become pregnant after your first dose, you might choose to have the second dose during pregnancy (see below) or wait until after your pregnancy. It is important to note that the first dose may only provide partial protection against COVID-19, and this protection may be short-lived. You will only have optimal protection after two doses.
Current knowledge about COVID-19 vaccine in women who are planning pregnancy
There is no evidence that women who become pregnant after being vaccinated against COVID-19 have an increased risk of developing complications that affect their pregnancy or their baby’s health.
If you are pregnant
Recommendations:
Although we do not routinely recommend COVID-19 vaccine in pregnancy, you and your treating health professional may consider vaccination if the potential benefits outweigh any potential risks.
You should consider having a COVID-19 vaccine during your pregnancy if:
you have medical risk factors for severe COVID-19 (refer to the Medical conditions that increase the risk of severe COVID-19 section of this information sheet)
you are at high risk of exposure to the virus that causes COVID-19 or very likely to be in contact with people with COVID-19.
You may prefer to wait until after your pregnancy to be vaccinated if:
you have no risk factors for severe COVID-19
you are not at high risk of exposure to COVID-19.
What factors might increase your risk of getting COVID-19 or its complications?
If you work in an occupation or environment where you are more likely to be in contact with people with COVID-19, including in:
border/quarantine services
healthcare
aged care
disability care.
If you live in an area where COVID-19 cases are occurring.
If you have pre-existing (pre-pregnancy) medical risk factors for severe COVID-19, for example:
diabetes
high blood pressure
heart disease
obesity (medical conditions section in this information sheet).
If you are an Aboriginal or Torres Strait Islander person.
If you are unable to maintain protective measures such as social distancing and use of masks.
What factors might reduce your risk of exposure to COVID-19, or your risk of severe disease?
If you don’t have any additional risk factors for severe COVID-19.
If you live in an area where there is no community transmission. However, this can change rapidly and it takes about 14-21 days for protection after vaccination to develop.
If you can maintain protective measures such as social distancing and use of masks.
Possible complications of COVID-19 in pregnant women and their babies
Pregnant women with COVID-19 have a higher risk of certain complications compared to non-pregnant women with COVID-19 of the same age, including:
An increased risk (about 5 times higher) of needing admission to hospital
An increased risk (about 1.5 times higher) of needing admission to an intensive care unit.
An increased risk (about 2 times higher) of needing invasive ventilation (breathing life support).
COVID-19 also increases the risk of certain pregnancy complications including:
A slightly increased risk (about 1.3 times higher) of having their baby born prematurely (before 37 weeks of pregnancy).
An increased risk (about 3 times higher) of their baby needing admission to a hospital newborn care unit
Pregnant women with certain underlying medical conditions are more likely to have severe illness from COVID-19 compared to pregnant women without these conditions. The conditions are:
Being older than 35 years
Overweight or obese (body mass index above 30 kg/m2)
Pre-existing (pre-pregnancy) high blood pressure
Pre-existing (pre-pregnancy) diabetes (type 1 or type 2)
What do we know about COVID-19 vaccines in pregnancy?
There is very little information from clinical trials on COVID-19 vaccines in pregnant women. A clinical trial of Comirnaty in pregnant women is currently underway in the United States. There is also no available information on other types of mRNA or viral vector vaccines in pregnant women.
In the clinical trial for Comirnaty, 23 women became pregnant while enrolled in the trial. Of these, 11 women received Comirnaty. As of 14 November 2020, their pregnancies are ongoing, and medical experts continue to follow their pregnancies.
In the clinical trials for COVID-19 Vaccine AstraZeneca, 21 women became pregnant while enrolled in the trial. Of these, 12 received COVID-19 Vaccine AstraZeneca. Further information about the outcomes of their pregnancies is awaited.
There is emerging information about the safety of COVID-19 vaccines from other countries where the vaccine is being rolled out. In the United States, over 1800 pregnant women who received an mRNA-based COVID-19 vaccine (such as Comirnaty) have been enrolled in a registry as of 19th February 2021. Side effects after vaccination were similar in pregnant women compared to non-pregnant women. As of early March 2021, over 16,000 women in the United States have received Comirnaty while pregnant or shortly before becoming pregnant and information about vaccine safety and effectiveness in this group will become available over time.
One study which included 84 pregnant women showed that they had similar side effects after vaccination with an mRNA COVID-19 vaccine, compared to non-pregnant women. The immune system response to the vaccine was also similar in pregnant women compared to non-pregnant women.
Animal studies of Comirnaty have not shown evidence of any harmful effects on fertility, in pregnancy or in the developing fetus.
Preliminary animal studies of COVID-19 Vaccine AstraZeneca have not shown any harmful effects in pregnancy or in the developing fetus. Definitive studies are underway.
Possible benefits of COVID-19 vaccination during pregnancy
It is likely that the vaccine protects you against COVID-19 and its complications.
Having two doses reduces your likelihood of being ill with COVID-19.
For both vaccines, if you are vaccinated and later get infected with COVID-19, you are much less likely to have severe illness or need admission to hospital.
Possible harms from COVID-19 vaccination during pregnancy
You may experience side effects after vaccination. Common side effects reported after Comirnaty in its clinical trial in people aged 18-55 include:
pain at the injection site (in about 84%)
tiredness (in about 62%)
headache (in about 52%)
muscle pain (in about 37%)
chills (in about 35%)
joint pain (in about 22%)
fever (in about 16%)
diarrhoea (in 10%)
Common side effects after COVID-19 Vaccine AstraZeneca (in people aged 18 and above) include:
tenderness at the injection site (in about 64%)
pain at the injection site (in about 54%)
headache (in about 53%)
tiredness (in about 53%)
muscle pain (in about 44%)
feeling unwell, also called malaise (in about 44%)
chills (in about 32%)
nausea (in about 22%)
fever (in about 8%)
Fever is considered undesirable in early pregnancy, but most people who have a COVID-19 vaccine will not have a fever. If you experience the following side effects, you can take paracetamol to reduce these symptoms:
fever
pain at the injection site
headache
muscle pain
joint pain
chills
Paracetamol is safe in pregnancy. It is not recommended to take paracetamol before having a COVID-19 vaccine.
COVID-19 may cause side effects in pregnant women or their babies that we do not yet know about:
We do not yet have results from studies of COVID-19 vaccines in pregnant women, though these studies are underway. We do not yet know if there are extra side effects from this vaccine in pregnant women or in their babies, although this is very unlikely. Based on our understanding of these vaccines, we do not expect any serious problems in pregnant women or their babies.
Other vaccines given during pregnancy such as influenza vaccine or whooping cough vaccine, do not cause more side effects in pregnant women or their babies. They do protect newborn babies from these diseases.
COVID-19 vaccines may be less effective in pregnant women and may not protect their babies from COVID-19
We do not know how effective Comirnaty or COVID-19 Vaccine AstraZeneca are in pregnant women. They could be less effective than in non-pregnant women, but this is unlikely. Other vaccines routinely given during pregnancy (such as flu or whooping cough vaccine) are equally effective in pregnant women compared to non-pregnant women.
We do not know whether receiving Comirnaty or COVID-19 Vaccine AstraZeneca during pregnancy will provide protection to your baby against COVID-19, because this has not been studied.
Factors to consider when deciding the timing of COVID-19 vaccination during pregnancy
If you choose to delay the second dose
The two doses of Comirnaty should be at least 3 weeks apart. The two doses of COVID-19 Vaccine AstraZeneca should be 12 weeks apart.
Having one dose of a COVID-19 vaccine before or during pregnancy, and waiting until after your baby is born to have the second dose, will still be effective in boosting your protection. You will not need to repeat the first dose.
Having one dose only provides partial protection against COVID-19. We do not know how long or great protection from one dose will be, so it is still important to get the second dose.
Timing in relation to other vaccines
There should be an interval of at least 14 days between a dose of a COVID-19 vaccine and any other vaccine. This applies to both doses of COVID-19 vaccine.
This may affect the timing of the two vaccines medical professionals routinely recommend during pregnancy:
Influenza vaccine, which can be given at any time.
Whooping cough vaccine, which is ideally given between 20 and 32 weeks of pregnancy. The influenza and the whooping cough vaccines can be given together on the same day.
If you want to get a COVID-19 vaccine during your pregnancy, talk to your immunisation provider about making a schedule for each vaccine dose. This will avoid any unnecessary delays.
Making the decision – a summary
If you have any questions about this information, ask your immunisation provider, doctor or midwife.
If you are breastfeeding, you can receive Comirnaty or COVID-19 Vaccine AstraZeneca at any time, and do not need to stop breastfeeding after vaccination.
If you are planning a pregnancy, you can receive Comirnaty or COVID-19 Vaccine AstraZeneca at any time.
If you have an increased risk of being exposed to COVID-19, or of having severe illness, you should consider having a COVID-19 vaccine during pregnancy.
You can choose to have a COVID-19 vaccine at any time during pregnancy; your immunisation provider can help you to decide the best time.
Ensure there is a 14 day gap between having a dose of a COVID-19 vaccine and any other vaccine (including influenza or whooping cough vaccines).
Medical conditions that increase the risk of severe COVID-19
The risk of severe COVID-19 is higher in people with certain medical conditions.
Individuals at high risk of severe COVID-19 illness
Organ transplant recipients who are on immune suppressive therapy.
Those who have had a bone marrow transplant in the last 24 months.
Those on immune suppressive therapy for graft versus host disease.
Those who have haematological cancers, for example, leukaemia, lymphoma or myelodysplastic syndrome (diagnosed within the last 5 years).
Those having chemotherapy or radiotherapy.
Individuals at moderate risk of severe COVID-19 illness
Those with chronic renal (kidney) failure.
Those with heart disease (coronary heart disease or failure).
Those with chronic lung disease (excludes mild or moderate asthma).
Those who have a non-haematological cancer (diagnosed in the last 12 months).
Those who have diabetes.
Severe obesity with a BMI ≥40 kg/m2.
Those with chronic liver disease.
Those with some neurological conditions (stroke, dementia, other).
Those with some chronic inflammatory conditions and treatments.
Those with other primary or acquired immunodeficiency.
Those with poorly controlled blood pressure.
Patient Information on thrombosis with thrombocytopenia syndrome
17 June 2021 – Version 3.1
What has been updated:
Updated vaccine recommendations: COVID-19 Pfizer vaccine (Comirnaty)
preferred over COVID-19 Vaccine AstraZeneca for people under 60 years
of age
AstraZeneca Vaccine and the COVID-19 vaccination program
The Australian Government receives advice and recommendations from the
Australian Technical Advisory Group on Immunisation (ATAGI) about the
AstraZeneca vaccine.
There has been a link between the AstraZeneca COVID-19 vaccine and a rare
condition called thrombosis with thrombocytopenia syndrome (TTS). This
condition appears to be more common in younger adults.
Comirnaty is the preferred COVID-19 vaccine for adults under 60 years of
age at this time. However, adults under 60 years of age may still choose to
receive the AstraZeneca COVID-19 vaccine if they have weighed up the
benefits and the risks. Talk to your doctor or immunisation provider to
help inform your decision.
All adults are recommended to be vaccinated against COVID-19. The risk of
severe illness and death from COVID-19 progressively increases with age in
older adults. This means that older adults will have a higher benefit from
vaccination.
More information on what this means can be found at www.health.gov.au/covid19-vaccines
What is thrombosis with thrombocytopenia syndrome (TTS)?
This is a rare side effect of the AstraZeneca COVID-19 vaccine. It can be
very serious and can cause long-term disability and death. Comirnaty
(Pfizer) is not associated with a risk of TTS.
The condition causes thrombosis (blood clotting) and thrombocytopenia (low
blood platelet counts). It is different from general clotting disorders
such as deep vein thrombosis (DVT) or pulmonary embolism (PE). TTS can
occur at different parts of the body, including the brain (called cerebral
venous sinus thrombosis) and in the abdomen (idiopathic splanchnic vein
thrombosis). The low level of blood platelets can potentially cause
bleeding.
Thrombosis is the formation of a blood clot, which prevents blood flowing
normally through the body. While thrombosis is usually a normal response to
prevent bleeding (e.g. following injury), in this case this process is
abnormal.
Thrombocytopenia is a condition in which you have a low blood platelet
count. Platelets (thrombocytes) are blood cells that help blood clot.
Platelets stop bleeding by clumping and forming plugs in injured blood
vessels.
When does TTS typically occur?
TTS typically occurs around 4 to 28 days after vaccination with AstraZeneca
COVID-19 vaccine.
How common is TTS?
TTS is rare. It is currently estimated to affect about 1-2 per 100,000
people who receive the AstraZeneca COVID-19 vaccine. But for those under 60
years of age, the rate is currently estimated to be higher. These estimates
will be updated as further information become available.
Are any groups more at risk of TTS?
The rate of TTS reported in Australia and overseas is higher in younger
adults and it may be more common in women. However cases have also been
reported in men and in older people. It is not yet clear if women are at
higher risk. More women than men have been vaccinated in some countries as
they are a large proportion of frontline healthcare workers and have been
prioritised for vaccination.
Based on current information, we do not know if there are any pre-existing
medical conditions that may contribute to developing TTS or make it worse
if it occurs.
What symptoms does TTS usually cause?
If you experience the following symptoms after vaccination you should seek
medical attention immediately:
A severe persistent headache with additional features:
appears at least 4 days after vaccination
does not improve with simple painkillers
may be worse when lying down
may be accompanied by nausea and vomiting
Neurological symptoms such as:
blurred vision
difficulty with speech
drowsiness
seizures
Shortness of breath
Chest pain
Swelling in your leg
Persistent abdominal (belly) pain
Tiny blood spots under the skin away from the site of injection.
Do the benefits of the AstraZeneca vaccine outweigh the risk?
Yes. The benefits of vaccination clearly outweigh the risks in many
circumstances. This is particularly so for older people who have a higher
risk of severe illness or death from COVID-19.
Cases of TTS have occurred in people of all ages. However, the risk of TTS
appears to be lower in those aged 60 years and older than in younger
adults.
For people under 60 years of age, Comirnaty (the Pfizer COVID-19 vaccine)
is preferred. However, adults under 60 may still choose to have AstraZeneca
vaccine after considering the benefits and risks of vaccination. The risks
of dying or having severe disease from COVID-19 are generally lower in
healthy younger adults and they have a higher (although still rare) risk of
TTS after vaccination compared with older adults.
What if you are aged 60 and under and are booked in to receive your first
dose of AstraZeneca?
If you are under the age of 60, Comirnaty (the Pfizer vaccine) is preferred
for you. If you are booked in to receive your first dose of the AstraZeneca
COVID-19 vaccine and you are younger than 60 years old, please talk to your
health professional
How do people aged under 60 years book an appointment for the Pfizer
vaccine? Where is it available?
The COVID-19 vaccination program has been modified in light of the ATAGI
advice. More Pfizer vaccination sites will become available around the
country in line with increasing supplies. You can check your eligibility
and where to get a vaccine using the
eligibility checker
.
What if you have received your first dose of AstraZeneca and are due for
your second dose?
People of any age without contraindications who have had their first dose
of COVID-19 Vaccine AstraZeneca without any serious adverse events should
receive a second dose of the same vaccine. UK data suggests that the risk
of TTS is much lower after the second dose, with 23 cases reported to date
out of 15.7 million second doses of the AstraZeneca COVID-19 vaccine given.
This translates into an estimated rate of 1.5 cases per million second
doses (compared to a reported risk of 14.2 cases per million first doses in
the UK).
Are there any conditions which increase the risk of TTS?
There is a theoretical concern that a few rare conditions might increase
the risk of TTS. These conditions are:
Cerebral venous sinus thrombosis (a type of blood clot in the brain)
Heparin-induced thrombocytopenia (a reaction to a medication called
heparin)
Idiopathic splanchnic thrombosis (blood clot in abdominal veins)
Antiphospholipid syndrome with thrombosis
TTS is different to these certain rare conditions, although there are
similarities between TTS and each of these conditions. As a precaution,
people with a past history of any of these conditions are recommended to
receive the Pfizer (Comirnaty) vaccine over the AstraZeneca COVID-19
vaccination at this time. The Pfizer (Comirnaty) vaccine is not associated
with TTS.
Is the AstraZeneca vaccine safe in people who have had blood clots in the
past?
If you have had other types of blood clots in the past, or if you have risk
factors for blood clots, you can still have the AstraZeneca vaccine. There
is no evidence that people who have had a past history of other types of
blood clots have an increased risk of developing TTS or becoming more ill
from it if it occurs.
People with the following conditions can receive the AstraZeneca
COVID-19 Vaccine:
History of blood clots in typical sites
Increased clotting tendency that is not immune-mediated
Family history of blood clots
History of ischaemic heart disease or stroke
Current or past thrombocytopenia (low platelet count)
Those receiving anticoagulation therapy
The overall rate of blood clots has not risen in countries which have
extensively used the AstraZeneca vaccine with millions of doses
administered. Blood clots occur commonly in the population, and not all
blood clots that occur after AstraZeneca COVID-19 will be caused by the
vaccine. If you develop a blood clot after vaccination, your doctor can do
blood tests to determine the cause.
For more information
Speak to your healthcare professional or vaccination provider if you have
further questions about the AstraZeneca vaccine.