FOI 25-0034 - Document 1
Australian Technical
Advisory Group on
Immunisation (ATAGI)
Clinical guidance on use of the
COVID-19 vaccine in Australia
under
in 2021 (v6.0)
(CTH) Care.
1982 Aged
Version 6.0
released
30 July 2021
Act and
This clinical guidance is for COVID-19 immunisation providers and program staff and is updated based on
currently available data. It provides recommendations on the use of the Comirnaty (Pfizer) COVID-19 vaccine
been
and COVID-19 Vaccine AstraZeneca. Recent changes from previous versions of ATAGI Clinical guidance on
COVID-19 vaccines in Australia include: has
Health
-
Comirnaty is recommended for children aged 12-15 years with medical conditions that increase
of
their risk of severe il ness; all Aboriginal and Torres Strait Islander children aged 12-15 and al
Information
children aged 12-15 years in remote communities as part of outreach vaccination programs.
-
Additional medical conditions relevant to adolescents have been added to the list of ‘Conditions
of
associated with increased risk of severe COVID-19'.
- Mixed vaccination schedules are recommended in special circumstances, including in some
document
returned travellers and in those who have had a serious vaccine-attributed adverse event
following a first dose.
-
Myocarditis and pericarditis have been rarely
Department reported after Comirnaty. People who develop
This
myocarditis or pericarditis a
Freedom fter having Comirnaty should defer further doses of Comirnaty and
discuss this with their treating doctor.
the
-
People with a past history of inflammatory cardiac il ness e.g., myocarditis, pericarditis,
endocarditis; acute rheumatic fever; complex or severe congenital heart disease; acute
by
decompensated heart failure or a history of cardiac transplant can receive Comirnaty, however
consultation with a cardiologist is recommended as a precaution prior to vaccination.
-
A history of capil ary leak syndrome is a new contraindication to COVID-19 Vaccine AstraZeneca
-
Immune thrombocytopenia, Guillain Barré Syndrome and capil ary leak syndrome have been
reported after COVID-19 Vaccine AstraZeneca.
-
Precautions are required for people with a history of confirmed mastocytosis with recurrent
anaphylaxis. Patients with other mast cell disorders can be vaccinated without special
precautions.
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Key points
•  The overarching goal of Australia’s COVID-19 vaccination program is to protect al  people in
Australia from the harm caused by SARS-CoV-2, through preventing serious il ness and death,
and, as much as possible, disease transmission.
•  Delivery of vaccine has been prioritised initial y for population groups at increased risk of
exposure to SARS-CoV-2 or of severe COVID-19, or occupational groups critical to societal
functioning. These are: quarantine and border workers; frontline healthcare workers; aged care
and disability care staff and residents; older adults (initially ≥80 years with progression to lower
age brackets); people aged ≥12 years with underlying medical conditions associated with an
increased risk of severe COVID-19; Aboriginal and Torres Strait Islander adults and critical and
high-risk workers, including defence, police, fire, emergency services and others.
•  COVID-19 vaccine is current recommended for al  people aged ≥ 16 years, and for the fol owing
groups:
the
•  Children aged 12-15 years with specified medical conditions that increase their risk of
severe COVID-19
•  Aboriginal and Torres Strait Islander children aged 12-15 years
•  Al  children aged 12-15 in remote communities, as part of broader community outreach
under
vaccination programs.
(CTH) Care.
•  Comirnaty (Pfizer Australia Pty Ltd) is provisionally registered by the TGA in people aged ≥12
years and is given in a two-dose schedule. Efficacy against symptomatic COVID-19 is about 95%
after two doses.
1982 Aged
•  COVID-19 Vaccine AstraZeneca (AstraZeneca Pty Ltd) is provisional y registered in people aged
released
≥18 years and is given in a two-dose schedule. Efficacy against symptomatic COVID-19 ranges
Act  and
from about 62% to 73%, with the higher efficacy seen after a longer interval (12 weeks) between
doses. Efficacy from day 22 after the first dose up until 12 weeks is about 73%.
been
•  The effectiveness of both vaccines against symptomatic infection with the Delta strain of SARS-
CoV-2 is reduced compared with earlier strains, however protection against hospitalisation is
Health
maintained.
has
of
•  ATAGI recommends completing the vaccination course with the same vaccine. Mixed schedules
are only recommended in special circumstances suc
Information h as for those with serious vaccine-attributed
adverse events after the first dose, or in those who were partially vaccinated overseas with a
of
brand not available in Australia.
•  COVID-19 Vaccine AstraZeneca is associated with a rare risk of thrombosis with
document
thrombocytopenia syndrome (TTS). The risk of TTS appears higher in younger adults than in
older adults, and is higher after the first dose than the second. Comirnaty is not associated with a
risk of TTS.
This Freedom
Department
•  Comirnaty is the preferred brand over COVID-19 Vaccine AstraZeneca in people aged <60
the
years, and in pregnant people. COVID-19 Vaccine AstraZeneca continues to be recommended in
people aged 18 to <60 years when the benefits outweigh risks, including in outbreak settings
by
•  Comirnaty should be routinely offered to pregnant people at any stage of pregnancy, and to
women who are breastfeeding or planning pregnancy.
•  Comirnaty is recommended in people with a past history of certain precautionary conditions for
COVID-19 Vaccine AstraZeneca; cerebral venous sinus thrombosis (CVST), heparin induced
thrombocytopenia (HIT), idiopathic splanchnic (mesenteric, portal, splenic) vein thrombosis, and
antiphospholipid syndrome with thrombosis. Comirnaty is recommended for the second dose for
people in these groups who have received a first dose of COVID-19 Vaccine AstraZeneca
•  Precautions to the use of both Comirnaty and COVID-19 Vaccine AstraZeneca include a history
of generalised (non-anaphylactic) reaction to a prior dose or an ingredient, past anaphylaxis to
medications/vaccines which may contain polyethylene glycol or polysorbate 80, and a history of
confirmed mastocytosis with recurrent anaphylaxis which requires treatment
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•  Precautionary conditions specific to Comirnaty include a past history of inflammatory cardiac
il ness e.g., myocarditis, pericarditis, endocarditis; acute rheumatic fever; complex or severe
congenital heart disease; acute decompensated heart failure or a history of cardiac transplant.
People with these conditions can stil  receive Comirnaty, however consultation with a
cardiologist is recommended prior to vaccination.
•  Contraindications to COVID-19 Vaccine AstraZeneca include anaphylaxis to a previous dose or
to an ingredient; thrombosis with thrombocytopenia after a previous dose; capil ary leak
syndrome, or any other serious adverse event attributed to a previous dose.
•  Contraindications to Comirnaty include anaphylaxis to a previous dose or to an ingredient;
myocarditis and/or pericarditis attributed to a previous dose, or any other serious adverse event
attributed to a previous dose.
•  Co-administration of a COVID-19 vaccine with other vaccines is not routinely recommended. A
minimum 7-day interval is advised between administration of a COVID-19 vaccine and any other
vaccine, including influenza vaccine. This interval can be shortened (including to same day
administration) in special circumstances.
the
•  Recording of COVID-19 vaccine administration in the Australian Immunisation Register (AIR)
is mandatory.
•  Notification of adverse events following immunisation should be made to the Therapeutic Goods
under
Association (TGA) and through the specified reporting mechanisms for your state or te
Care.rritory.
(CTH)
Aged
released 1982
Act  and
been
has
Health
Information
of
of
document
This Freedom
Department
the
by
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Date: 30 July 2021
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The virus: SARS-CoV-2
The pandemic of coronavirus disease (COVID-19) is caused by the severe acute respiratory coronavirus 2
(SARS-CoV-2), a virus first identified in December 2019. Bats appear to be the reservoir of SARS-CoV-2.1
SARS-CoV-2 is a single-stranded RNA betacoronavirus in the same subgenus as the severe acute respiratory
virus syndrome (SARS) virus, and is more distantly related to the Middle East respiratory syndrome (MERS)
virus.2
SARS-CoV-2 contains four main structural proteins: spike (S) glycoprotein, small envelope (E) glycoprotein,
membrane (M) glycoprotein and nucleocapsid (N) protein.3 Most COVID-19 vaccines target the spike protein,
which contains two subunits: S1 and S2. S1 contains the receptor binding domain, which binds to the
angiotensin converting enzyme 2 receptor on host cells, facilitating entry.4
Several SARS-CoV-2 variant strains have been identified. Some variants are associated with higher
transmissibility and increased severity or duration of disease. These variants are classified as a Variant of
the
Concern (VOC) or Variant of Interest depending on their at ributes.5
As of July 2021, four VOCs have been identified: Alpha, first identified in the United Kingdom; Beta, first identified
in South Africa; Gamma, first identified in Brazil, and Delta, first identified in India.5 These variants are more
under
transmissible than the wild type of SARS-CoV-2, and they have become the predominant strains in their
(CTH) Care.
countries of origin and in other settings.6 The Delta variant has been shown to be more transmissible than other
variants. In many countries, it has replaced Alpha as the dominant variant of SARS-CoV-2.7 Some early
surveil ance data also suggests that it causes a higher rate of severe outcomes compared to other variants.8,9
1982 Aged
Immunogenicity and efficacy/effectiveness of current COVID-19 vaccines against some variant strains of SARS-
released
CoV-2 is reduced compared to the ancestral strain. For the Delta variant, vaccine effectiveness of both
Act  and
Comirnaty and COVID-19 Vaccine AstraZeneca against symptomatic infection has been reduced compared to
Alpha but is maintained against hospitalisation.10 Refer to the Vaccine Information section for further
been
information.
Clinically significant variations in the ef icacy/effectiveness of dif erent vacc
Health  ines against these emerging strains
has
wil  continue to be monitored to determine if any changes to vaccines or to vaccine policy are needed.
Information
of
The disease: COVID-19 of
SARS-CoV-2 causes asymptomatic or mild disease in 81% of cases; severe il ness (with dyspnoea, hypoxia or
>50% lung involvement on imaging within 48 hours) in 14%; and critical il ness in 5%.11 The most common
document
symptoms are fever and cough.12 Other common symptoms include myalgia, headache, dyspnoea, sore throat,
diarrhoea and nausea/vomiting. Loss of smell or taste and rhinorrhoea occur in fewer than 10% of cases.
This
Department
Older age is an important risk factor for
Freedom   severe COVID-19, as shown in several international systematic reviews.
In comparison with those aged <5
the  0 years, the risk of death from COVID-19 progressively increases throughout
each decade of age, from about 2 times high for those aged 50–59 years to >10 times higher for those aged ≥80
by
years.13 Findings were similar when results were adjusted for other risk factors.14 In Australia, prior to the
implementation of the COVID-19 vaccination program, the COVID-19 case fatality ratio increased substantially
with age, from 0.6% in those aged 50–64 years, to 7.0% in those aged 65–79 years and 33.8% in those aged
≥80 years.15
Certain medical conditions are associated with an increased risk of severe il ness from COVID-19. Refer to Box
1 for a list of specified medical conditions.
There are certain occupational and environmental settings that may place individuals at higher risk of COVID-19
exposure either because of a higher risk of infected individuals being present and/or because the conditions
enable rapid spread of the virus. These include healthcare facilities; aged care and disability care facilities; border
and quarantine facilities; and some industries such as meat processing. Refer to the Recommendations section
for further information.
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Further information about COVID-19 is available in the COVID-19 CDNA National Guideline for Public Health
Units. Information about Australian epidemiology is available on the Department of Health website, including
regular epidemiological reports.
The COVID-19 vaccination program
The aim of the COVID-19 vaccination program in Australia is to reduce COVID-19 related harm by preventing
serious il ness and death, and, as much as possible, disease transmission. Information on COVID-19 vaccination
program implementation in Australia is available on the Department of Health website.
The epidemiology of COVID-19 is a key determinant informing the most appropriate use of COVID-19 vaccines,
in addition to the characteristics and availability of COVID-19 vaccines.
In Australia, outbreak control measures (including contract tracing, testing and isolation; border control and
quarantine; and physical distancing) have been successful in limiting the spread of COVID-19 in the
the
community.16 However, sporadic disease outbreaks continue to occur following virus introduction from
international travellers.
In set ings where there is no sustained SARS-CoV-2 community transmission, the initial focus of a vaccine
program is to prevent importation of cases and demonstrate reciprocity to critical (partic
under ularly frontline) workers at
(CTH) Care.
highest risk of exposure to SARS-CoV-2.17 Subsequent priority groups include older adults, particularly those
living in residential aged care or disability care facilities, and those with medical risk factors for severe il ness or
death from COVID-19.
1982 Aged

released
Act and
been
has
Health
Information
of
of
document
This Freedom
Department
the
by
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Vaccine, doses and administration
The following COVID-19 vaccines have been provisionally approved for use in Australia. The TGA website
provides access to the TGA-approved product information for each vaccine. Refer also to Vaccine information
section for more details.
Comirnaty (generic name BNT162b2)
Sponsor:
Pfizer Australia Pty Ltd
Approved age for use:
≥12 years
Presentation:
Multi-dose vial without preservative, each vial containing 6 doses in 0.45 mL.

Requires dilution with 1.8 mL of sterile 0.9% NaCl without preservative into each
multi-dose vial.
Volume/strength:
0.3 mL (30 µg) per dose
the
Schedule:
  2 doses, at least 21 days apart
Administration route:
Intramuscular injection into deltoid muscle
Ingredients:
Each 0.3mL dose contains 30 mcg mRNA encoding the SARS-CoV-2 spike
under  Care.
glycoprotein
(CTH)

List of excipients:
o  ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-
hexyldecanoate) (ALC-0315) 1982 Aged
o  2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide (ALC-
released
0159)
Act
o  Distearoylphosphatidylcholine (DSPC)
and
o  Cholesterol
o  Potassium chloride
been
o  Monobasic potassium phosphate
o  Sodium chloride  Health
o  Dibasic
has  sodium phosphate dihydrate
o  Sucrose
of
o  Water for injections
Information
COVID-19 Vaccine AstraZeneca  of
Sponsor:
AstraZeneca Pty Ltd
Approved age for use:
≥18 years
document
Presentation:
Multi-dose vial without preservative, each vial containing either 8 doses in 4 mL or
10 doses in 5 mL.
This
Department
Volume/strength:
0.5 mL pe
Freedom  r dose
Schedule:
  2 do
the ses, 12 weeks apart (minimum interval 4 weeks apart)
Administration route:
Intramuscular injection into deltoid muscle
by
Ingredients:
Each 0.5 mL dose contains 5x1010 viral particles of ChAdOx1-Sa

List of excipients:
o  Histidine
o  Histidine hydrochloride monohydrate
o  Sodium chloride
o  Magnesium chloride hexahydrate
o  Disodium edetate (EDTA)
o  Sucrose
o  Ethanol absolute
o  Polysorbate 80
o  Water for injection
a. Recombinant, non-replicating chimpanzee adenovirus vector encoding the SARS-CoV-2 Spike glycoprotein
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Recommendations
COVID-19 vaccination is recommended for all people aged ≥16 years to protect against COVID-19.
Additionally, ATAGI currently recommends that the following children aged 12-15 years be prioritised for
vaccination:
•  Children with specified medical conditions that increase their risk of severe COVID-19 [Box 1]
•  All Aboriginal and Torres Strait Islander children aged 12-15 years
•  Al  children aged 12-15 in remote communities, as part of broader community outreach
vaccination programs that provide vaccines for all ages (≥12 years).
Recommendations for use in all other children aged 12-15 years wil  be made in updated advice within the
coming months.
There is a limited supply of COVID-19 vaccines in the initial phases of the COVID-19 vaccination
program. Therefore, vaccine allocation is being determined based on several factors, such as timing of
the
supply, priority target groups and logistical considerations. The following population groups are prioritised
initially:
People with occupational risk of exposure to SARS-CoV-2
under
People in certain occupations are at increased risk of being infected with SARS-CoV-2 and/or
(CTH) Care.
transmitting the virus to vulnerable people who have risk factors for severe il ness. These include:
•  frontline healthcare workers, who have a seven-fold increased risk of severe COVID-19
compared with non-essential workers (RR 7.42; 95% CI: 5.52–10.00)18
1982 Aged
•  quarantine and border workers
released
•  aged care and disability care staff
Act  and
•  critical and high-risk workers including defence, police, fire and emergency services; certain
laboratory staff; meat processing workers; and select others.
been
Residents of aged care and disability care facilities
Aged care facilities have been the setting for a number of serious COVID-19 outbreaks in Australia.19
has
Health
Older adults
of
Older age is by far the strongest risk factor associated with morbidity and mortality from COVID-19.11,14,20
Information
All Aboriginal and Torres Strait Islander people aged ≥ 12
of
Aboriginal and Torres Strait Islander people are at increased risk of severe il ness and death from
COVID-19 due to multiple factors, including a high prevalence of underlying chronic health conditions
document
associated with severe COVID-19 and a greater likelihood of living in communities where social
distancing cannot be practised.21
Department
While the impact of
This  COVID-19 on Aboriginal and Torres Strait Islander people to date has been mitigated
Freedom
by existing control measures (especially restriction of movement into communities), the factors above
the
warrant prioritisation for vaccination.
by
People aged ≥ 12 with medical conditions that increase their risk of severe COVID-19
People aged ≥ 12 years with certain underlying chronic medical conditions, outlined in Box 1, are at
increased risk of severe il ness with COVID-19 and should be prioritised for vaccination, particularly older
adults and those who have multiple comorbidities.
Pregnant people
Compared to non-pregnant women, pregnant women who contract COVID-19 have an increased risk of
severe il ness, including increased odds of intensive care admission (OR 2.13, 1.53 – 2.95; I2 71.2%),
need for invasive ventilation (OR 2.59, 2.28 – 2.94, I2 0%) and need for extracorporeal membrane
oxygenation (OR 2.02, 1.22 – 3.34, 12 0%).23  Compared to pregnant women who did not have COVID-19,
women who had COVID-19 during pregnancy may have a higher risk of stil birth (OR 2.84, 95% CI 1.25 to 6.45),
neonatal death (OR 2.77, 95% CI 0.92 to 8.37), need for admission to the neonatal intensive care unit (odds ratio
4.89, 95% CI 1.87 to 12.81, I2=96.2%).23
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Box 1: Conditions associated with increased risk of severe COVID-19
Conditions
Notes
Immunocompromising conditions
Haematological diseases or
Including leukaemia, lymphoma or myeloma resulting in
cancers
immunocompromise
Recommend discussion with specialist regarding optimal timing of
vaccination
Solid organ transplant recipients
Recommend discussion with specialist regarding optimal timing of
who are on immune suppressive  vaccination
therapy
Bone marrow transplant recipients  Recommend discussion with specialist regarding optimal timing of
or chimeric antigen receptor T-cell  vaccination
(CAR-T) therapy recipients or those
with graft host disease
the
Non-haematological cancer
Diagnosed within the past 5 years or on chemotherapy, radiotherapy,
immunotherapy or targeted anti-cancer therapy (active treatment or
recently completed) or with advanced disease regardless of
treatment
under  Care.
Survivors of childhood cancers
Nil
(CTH)
Chronic inflammatory conditions
Including: systemic lupus erythematosus, rheumatoid arthritis,
requiring medical treatments
Crohn’s disease, ulcerative colitis, and similar who are being treated
with disease modifying anti-rheumatic drugs (DMARDs) or immune-
1982 Aged
suppressive or immunomodulatory therapies.
released
Generally not inclusive of peo
Act  ple living with osteoarthritis,
and
fibromyalgia, myalgic encephalomyelitis/chronic fatigue syndrome or
similar non-immunocompromising inflammatory conditions.
been
Primary or acquired
Including congenital causes of immunodeficiency and HIV/AIDS
immunodeficiency
Health
Other underlying conditions
has
Chronic renal (kidney) failure with a Does not include m
of  ild-moderate chronic kidney disease
eGFR of <44mL/min
Information
Heart disease
Including ischaemic heart disease, valvular heart disease,
cardi
of  omyopathies and pulmonary hypertension, and complex
congenital heart disease
Chronic lung disease
Including chronic obstructive pulmonary disease, cystic fibrosis,
document interstitial lung disease and severe asthma (defined as requiring
frequent hospital visits or the use of multiple medications).
This Freedom
Department
Does not include Mild or moderate asthma
Diabetes
the  Nil
Obesity
Defined for adults as severe obesity with BMI ≥ 40kg/m2; and for
by
children as BMI ≥ 95th percentile for age
Chronic liver disease
Nil
Chronic neurological conditions
Including stroke, dementia, multiple sclerosis, motor neurone
disease, Parkinson’s disease, cerebral palsy and epilepsy. Generally
not inclusive of migraine or cluster headaches Generally not
inclusive of migraine or cluster headaches
Poorly control ed blood pressure  Nil
(defined as two or more
pharmacologic agents for blood
pressure control, regardless of
readings)
Those living with significant
Including Down syndrome, muscular dystrophy, traumatic brain and
disability requiring frequent
spinal cord injury, severe intellectual disability
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assistance with activities of daily
living
Those with severe mental health  Including schizophrenia and bi-polar disorder
conditions
Children with complex chronic

disease
Pregnant people
Nil
Vaccine preference recommendations
Comirnaty is preferred over COVID-19 Vaccine AstraZeneca in people aged < 60 years.  This is based on the
higher risk and observed severity of thrombosis and thrombocytopenia syndrome (TTS) in people < 60 years
compared to those ≥ 60. However, COVID-19 Vaccine AstraZeneca can be used in adults aged < 60 years if
Comirnaty if the person has made an informed decision based on an understanding of the risks and benefits. In
outbreak settings, adults <60 years of age should strongly consider COVID-19 Vaccine AstraZeneca if they are
the
unable to access Comirnaty.
People of any age who have received their first dose of COVID-19 Vaccine AstraZeneca without any serious
adverse events at ributable to the first dose and without any new contraindications should receive a second dose
of COVID-19 Vaccine AstraZeneca. This is supported by data indicating a substantially
under  lower rate of TTS
Care.
following a second COVID-19 Vaccine AstraZeneca dose in the United Kingdom (UK).
(CTH)
Comirnaty is also the recommended vaccine for pregnant women. Pregnant women who have already received
a first dose of COVID-19 Vaccine AstraZeneca can receive either Comirnaty or COVID-19 Vaccine AstraZeneca
1982 Aged
for their second dose, although Comirnaty is preferred.   released
For those aged 60 years and above, the individual benefits of receiving a COVID-19 vaccine are greater
Act  and
than in younger people. The risks of severe outcomes with COVID-19 increase with age and are
particularly high in older unvaccinated individuals. The benefit of vaccination in preventing COVID-19 with
been
COVID-19 Vaccine AstraZeneca outweighs the risk of TTS in this age group and underpins its ongoing
use in this age group.
has
Health
Considerations for special populations of
People who are immunocompromised
Information
of
COVID-19 vaccine is recommended for people who are immunocompromised because of their increased risk of
severe il ness with COVID-19.24 There are many causes and varying degrees of immunocompromise, and the
risk of COVID-19 wil  vary according to t
document he number and type of underlying conditions, medical management and
other factors.
Department
Currently, there are limited data on the safety and ef icacy of COVID-19 vaccination for people who are
This Freedom
immunocompromised. In principle there are no theoretical safety concerns for Comirnaty (a non-live vaccine) or
the
COVID-19 Vaccine AstraZeneca (a non-replicating viral vector vaccine) in people who are immunocompromised,
based on a general understanding of vaccine characteristics.
by
Early (preprint) evidence suggests a reduced immune response to vaccination with Comirnaty in people with
cancer and solid organ transplant recipients.25-29 A small preprint study of 26 patients on biologic
immunomodulatory medications for inflammatory bowel disease who received two doses of an mRNA COVID-
19 vaccine showed that 22/26 patients achieved levels of antibody against the receptor binding domain (RBD) of
the S-protein of SARS-CoV-2 that are comparable to convalescent plasma from recovered COVID-19 patients.30
COVID-19 vaccine is also recommended for people with HIV. A small number of people (n=120) with stable HIV
infection were recruited into the phase I /I I trial for Comirnaty, and a cohort of people with stable HIV infection
were recruited into a phase I/I  trial of COVID-19 Vaccine AstraZeneca. Immunogenicity and safety data for these
cohorts group are anticipated.31,32
Before vaccination, people with immunocompromise should be counselled about the safety and efficacy of
COVID-19 vaccine, and the limited available data in immunocompromised recipients. People with
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immunocompromise who have been vaccinated should be advised to continue taking other protective measures
against SARS-CoV-2.
For further information refer to the COVID-19 vaccination decision guide for people with immunocompromise and
Provider guide to COVID-19 vaccination in people with immunocompromise.
Children
COVID-19 vaccine is currently recommended for children aged 12-15 in the fol owing groups:
•  Those with specified medical conditions that increase their risk of severe COVID-19 [Box 1]
•  All Aboriginal and Torres Strait Islander children aged 12-15 years
•  Al  children aged 12-15 in remote communities, as part of broader community outreach
vaccination programs that provide vaccines for all ages (≥12 years).
Recommendations for use in all other children in this age group wil  be made in updated advice within the coming
months.
the
Preliminary evidence suggests that children and adolescents have a lower susceptibility to SARS-CoV-2
compared to adults and play a lesser role in transmission at a population level.33 Children and adolescents with
COVID-19 are commonly asymptomatic or have mild or moderate symptoms. A systematic review that included
under
data on il ness severity in 1,475 children with COVID-19 reported asymptomatic infection in 15%, mild il ness in
(CTH) Care.
42%, moderate illness in 39%, severe illness in 2% and critical illness in 0.7%.34
A rare but serious condition associated with COVID-19 in children is Paediatric Inflammatory Multisystem
Syndrome Temporally associated with SARS-CoV-2 (PIMS-TS), which can present
1982   with feat
Aged ures similar to those
of Kawasaki disease or toxic shock syndrome.36
released
Act
Severe il ness from COVID-19 in children is uncommon but is more likely in those w
and  ith certain pre-existing
medical conditions.37-39 A phase II-I I trial of Comirnaty which included 2260 adolescents aged 12 to 15 years
been
found a vaccine efficacy against symptomatic COVID-19 in this age cohort of 100% (95% CI 75.3 – 100) from 7
days after the second dose, and an acceptable safety profile.40 The most common adverse event was injection
Health
site pain (79-86%), followed by fatigue (60-66%) and headache (55-65%). Fever occurred in 20% of participants
has
who received Comirnaty, and was slightly more frequent in those aged 12-15 (37%) than in those aged 16-25
of
(32%). Systemic adverse events were more common after the second dose. No vaccine-related serious adverse
Information
events were reported. Trials of Comirnaty and other COVID-19 vaccines in younger cohorts are underway.
of
People who are pregnant, breastfeeding or planning pregnancy
document
Pregnant people should be routinely offered Comirnaty at any stage of pregnancy. Pregnant women with
COVID-19 have an increased risk of severe il ness and adverse pregnancy outcomes. Women who are
Department
breastfeeding or who are planning pregnancy are also recommended to receive Comirnaty.
This Freedom
Comirnaty is the preferred COVID-19 vaccine for people who are pregnant, breastfeeding or planning
the
pregnancy. There is a growing body of evidence supporting the safety of mRNA COVID-19 vaccines in
pregnancy. There are stil  v
by  ery limited data on the safety of viral vector vaccines (such as COVID-19 Vaccine
AstraZeneca) in pregnancy. Pregnant women who received a first dose of COVID-19 Vaccine AstraZeneca can
receive either Comirnaty or COVID-19 Vaccine AstraZeneca for their second dose, although Comirnaty is
preferred.
Pregnant women with COVID-19 have a higher risk of intensive care admission (OR 2.13, 95% CI 1.53 - 2.95),
invasive ventilation (2.59, 95% CI 2.28 - 2.94), need for extra corporeal membrane oxygenation (OR 2.02, 95%
CI 1.22 - 3.34) and preterm birth (OR 1.47, 95% CI 1.14 – 1.91) compared to non-pregnant reproductive aged
women23 with COVID-19. Factors which increase the risk of severe il ness and death from COVID-19 during
pregnancy include increased maternal age, high body mass index and pre-existing co-morbidities. Infants born to
mothers with COVID-19 are more likely to require admission to the neonatal intensive care unit (OR 4.89, 95%
CI 1.87 – 12.81) versus those without COVID-19.
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In a prospective cohort study of over 35,000 pregnant women who received an mRNA COVID-19 vaccine, the
adverse event profile was similar to that of non-pregnant women.41,42 Pregnant women were slightly more likely
to report injection site pain, and less likely to report generalised symptoms such as fever or tiredness. Fever of
38°C or above was reported by fewer than 1% of pregnant women after the first dose of Comirnaty, and fewer
than 5% after the second dose. The findings from this large study are supported by other smaller observational
studies.41,42
The same study reported on pregnancy and neonatal outcomes in 827 women who received an mRNA COVID-
19 vaccine in pregnancy, and did not identify any safety concerns.43 Complications such as preterm delivery,
stil birth, small for gestational age infants and congenital anomalies occurred at a similar rate to what is seen in
the general population. In the clinical trial for Comirnaty, 23 women became pregnant during the study period, of
which 11 had received Comirnaty. Information about the outcomes of their pregnancies is awaited.44 Animal
studies of Comirnaty have not shown any negative effects on fertility or pregnancy. A phase 2/3 randomised
controlled trial of Comirnaty in pregnant women is underway in the US.45
the
For further information refer to the Shared decision making guide for women who are pregnant, breastfeeding or
planning pregnancy
People with a past SARS-CoV-2 infection
under
(CTH) Care.
Past infection with SARS-CoV-2 is not a contraindication to vaccination; however, it is recommended that
vaccination be deferred for up to six months after the acute il ness in those who have had PCR-confirmed SARS-
CoV-2 infection. Evidence suggests that past infection reduces the risk of reinfection for at least 6 months.46
1982 Aged
Individuals who have prolonged symptoms from COVID-19 beyond six months can be vaccinated on a case-by-
released
case basis.
Act  and
In the phase II/I I trial of Comirnaty, the vaccine was administered to a small number of people with serological
evidence of previous SARS-CoV-2 infection. There were no specific safety issues reported among these
been
individuals. A similarly high overall ef icacy was shown when participants who had had previous SARS-CoV-2
infection were also included for analysis, but a separate estimate of ef icacy for these individuals was not
has
Health
reported.
of
In the pooled analysis of phase I /I I trials of COVID-19 Vaccine AstraZeneca, 718 participants (3%) were found
Information
to be seropositive, and the safety profile was consistent across participants with or without prior evidence of
of
SARS-CoV-2 infection at baseline. Seropositive participants had increased anti-spike antibody responses after
the first dose, but no further increase after the second.47
document
Serological testing or other testing to detect current or previous infection with SARS-CoV-2 before vaccination is
neither necessary nor recommended before vaccination.
This
Department
Timing of administration o
Freedom f other vaccines, including influenza vaccine
the
The preferred minimum interval between receipt of a COVID-19 vaccine and any other vaccine, including
influenza vaccine, is 7 day
by s. A shorter interval (i.e., less than 7 days, including co-administration) is acceptable in
the following settings:
•  Increased risk of COVID-19 or another vaccine-preventable disease (e.g., COVID-19 outbreak,
influenza outbreak, tetanus-prone wound)
•  Logistical issues e.g., difficulty scheduling visits to maintain the 7-day interval
This also means that a person may be able to receive another vaccine in between their two doses of Comirnaty
vaccine, if appropriate.
As with any other vaccine, vaccination should be deferred if the recipient is acutely unwell. If a person
experiences a short term expected adverse event such as fever fol owing vaccination, other vaccines should not
be administered until the adverse event has resolved.
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Co-administration or near administration (e.g. within days) of two or more vaccines can sometimes lead to a
higher frequency of mild to moderate adverse events or make the attribution of potential adverse events to
vaccination more challenging.
This advice is based on the current absence of data on the immunogenicity and safety of these vaccines when
co-administered, and may change as further information becomes available.
If co-administration of an influenza vaccine and COVID-19 vaccine occurs, revaccination is not required for either
vaccine. The patient should be informed of the possibility of an increased likelihood of common adverse ef ects
and be asked to report any untoward adverse events.
Co-administration of antipyretics/analgesics
Prophylactic use of paracetamol or ibuprofen is not recommended before receiving a COVID-19 vaccine.
Antipyretics and analgesics can be taken after vaccination for management of vaccine-related side effects such
as fever and myalgia, if required.
the
Variation of schedule
Comirnaty
under
(CTH) Care.
The recommended interval between two doses of Comirnaty is at least 21 days. The minimum acceptable
interval between the two doses is 19 days. It is recommended to complete the two-dose course within 6 weeks.
This allows time for logistical considerations, including supply and timing of access to vaccine at the individual
1982 Aged
and clinic levels. These limits are based on the intervals between doses studied in clinical trials.
released
Shortening of the minimum acceptable interval may result in a sub-optimal
Act   immune
and  response. If two doses have
inadvertently been given at a shorter than the minimum acceptable interval, it is not currently recommended that
a vaccine dose is repeated. This is because there are no dat
been  a on administration of more than two vaccine doses
given in close proximity in time, and there is stil  a likelihood of good protection in that individual.
Health
Longer intervals between first and second dose
has s may need to be recommended during program rollout if
epidemiological considerations warrant a change (e.g. during
of  an outbreak response to ensure available doses
are provided as first doses to as many people as possible).
Information
If the second dose of Comirnaty is adminis
of tered later than the recommended interval, no further doses are
required.
document
Although Comirnaty may provide partial protection against COVID-19 as soon as 12 days after the first dose, this
protection is likely to be short lived. A two-dose course is recommended for optimal protection.
This
Department
COVID-19 Vaccine AstraZe
Freedom neca
the
The recommended interval between two doses of COVID-19 Vaccine AstraZeneca is 12 weeks. The minimum
interval between doses is 4 weeks. Shortening the interval from 12 weeks to no less than 4 weeks between
by
doses is acceptable and may be appropriate in certain circumstances, for example, imminent travel or anticipated
risk of COVID-19 exposure. In an outbreak setting, ATAGI recommends an interval of 4 to 8 weeks between
doses. If a dose has been inadvertently given before the minimum 4-week interval, it is not currently
recommended that the vaccine dose be repeated.
In clinical trials, the timing of administration of COVID-19 Vaccine AstraZeneca ranged from approximately 4
weeks up to 26 weeks. In a post-hoc analysis, vaccine ef icacy following the second dose of COVID-19 Vaccine
AstraZeneca progressively increased with a longer interval between doses and appeared to be greatest when
the interval was ≥12 weeks. Short-term efficacy from 3 weeks after the first dose, before the second dose and up
to 12 weeks post vaccination was about 73% (95% CI: 48.79–85.76).48 Also refer to the Vaccine information
section for further information. Short term efficacy from 22 days until 90 days after a single dose was 76% (95%
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FOI 25-0034 - Document 1
CI: 59·3–85·9). The duration of protection after a single dose has not yet been established, and a second dose is
recommended for optimal protection.
If the second dose of COVID-19 Vaccine AstraZeneca is administered later than the recommended interval, no
further doses are required.
Mixed (heterologous) schedules
Based on current evidence, ATAGI recommends using the same COVID-19 vaccine for the two doses of the
primary course. Emerging (preprint) data demonstrating that mixed schedules of Comirnaty and COVID-19
Vaccine AstraZeneca are immunogenic and have an acceptable safety profile in the small cohorts
vaccinated.49,50 Larger studies and longer term follow up are required to confirm the safety of this approach.
In the following special circumstances, an alternate brand may be recommended for the second dose:
•  People with serious vaccine-attributable adverse events after dose 1 that warrant the use of an
the
alternate vaccine brand for dose 2:
o  anaphylaxis to the first dose of a COVID-19 vaccine
o  thrombosis with thrombocytopenia following the first dose of COVID-19 Vaccine
AstraZeneca
under
o  any other serious adverse event attributed to the first dose of a COVID-19
(CTH)   vacci
Care.ne (and
without another cause identified) fol owing expert review (typically by a jurisdictional
immunisation specialist service or a relevant medical specialist).
•  People with a precautionary condition for which the use of Comirnaty
1982  is recomm
Aged  ended instead of
COVID-19 Vaccine AstraZeneca:
released
Act
o  history of cerebral venous sinus thrombosis (CVST) and
o  history of heparin-induced thrombocytopenia
o  history of idiopathic splanchnic (mesenteric, portal, splenic) venous thrombosis
been
o  history of anti-phospholipid syndrome (APLS) with thrombosis.
Health
•  People given an incomplete course of a COVID-19 vaccine brand not available in Australia.
has
of
The recommended interval for administration of a second COVID-19 vaccine dose using an alternative brand is 4
Information
to 12 weeks after the first dose. A longer interval is acceptable if the second dose cannot be administered during
this time window. Further advice is available in ATAGI clinical advice on use of a dif erent COVID-19 vaccine as
of
the second dose in special circumstances
document
Repeat vaccination
Additional or booster doses beyond the two-dose course are not currently recommended.
This Freedom
Department
Data on the real-world effectiveness and duration of protection from Comirnaty and COVID-19 Vaccine
the
AstraZeneca are anticipated, including against current and emerging strains (variants) of SARS-CoV-2, and will
inform future recommendations regarding the need for and timing of booster doses.
by
In the same way that the influenza vaccines are modified to protect against newly circulating strains each
season, COVID-19 vaccines may in future be adapted to protect against SARS-CoV-2 variant strains.
Contraindications
Contraindications to COVID-19 Vaccine AstraZeneca are:
•  anaphylaxis after a previous dose
•  anaphylaxis to any component of the vaccine, including polysorbate 80
•  history of capil ary leak syndrome
•  thrombosis with thrombocytopenia occurring after a previous dose
•  any other serious adverse event attributed to a previous dose .
Contraindications to Comirnaty are:
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•  anaphylaxis after a previous dose
•  anaphylaxis to any component of the vaccine, including polyethylene glycol (PEG)
•  myocarditis and/or pericarditis attributed to a previous dose
•  any other serious adverse event attributed to a previous dose.
Anaphylaxis after COVID-19 vaccines
The observed rate of anaphylaxis after Comirnaty administration in the United States in early 2021 was 4.7
cases per mil ion doses administered.51 89% of cases occurred within 30 minutes of vaccination.51 Comirnaty
contains polyethylene glycol (PEG), and it is possible that this component is implicated in anaphylaxis.52,53
However, anaphylaxis following PEG is reported to be extremely rare (37 case reports between 1977 and
2016).52
Anaphylaxis to polysorbate 80, which is an excipient in COVID-19 Vaccine AstraZeneca and is also included in
many other vaccines, is rare.54 Anaphylaxis to COVID-19 Vaccine AstraZeneca is rare. The rate of reported
the
anaphylaxis after COVID-19 Vaccine AstraZeneca in Australia appears similar to the overall rate for other
vaccines.
Precautions
under
(CTH) Care.
Specific allergies
The following individuals should be assessed for suitability for vaccination, if necessary in consultation with an
1982 Aged
allergist/immunologist or specialist immunisation clinic:  released
•  people with immediate (within 4 hours) and generalised symptoms of a possible al ergic reaction
Act  and
(e.g. urticaria/hives), without anaphylaxis, to a previous dose of a COVID-19 vaccine
•  people with a generalised al ergic reaction (without anaphylaxis) to any component of the
been
COVID-19 vaccine to be administered (e.g. PEG in Comirnaty or polysorbate 80 in COVID-19
Vaccine AstraZeneca)
•  people with a history of anaphylaxis to previous vaccines and/
Health  or multiple drugs (injectable and/or
has
oral) where ingredients such as PEG or polysorbate 80 may conceivably be the cause
of
people with a history of confirmed mastocytosis with recurrent anaphylaxis that requires treatment.
Information
People in these categories may require vaccination in a facility with medical staf  in attendance, observation for at
of
least 30 minutes following administration of a COVID-19 vaccine dose, or vaccination with an alternate brand of
COVID-19 vaccine. Refer to ASCIA Guide: Al ergy and COVID-19 Vaccination for more information.
document
Al  other vaccine recipients, including those with a history of allergy; anaphylaxis to food, drugs, venom or latex;
or allergic conditions, including asthma, atopic dermatitis (eczema) or allergic rhinitis (hay fever), should be
Department
observed for at least 15 minutes following administration of the vaccine at the clinic site in accordance with the
This Freedom
current recommendations in the Australian Immunisation Handbook. It is important that all providers are trained
the
in anaphylaxis management.
by
For individuals suspected to have had an allergic reaction to their first dose of a COVID-19 vaccine, seek advice
from the state/territory specialist immunisation service or a specialist allergist/immunologist. These individuals
may need a clinical assessment prior to the second vaccine dose. Before and during each vaccination session,
providers should check that up-to-date protocols, equipment, medicines and trained staff to manage anaphylaxis
are available. Refer to the Preparing for vaccination section of the Australian Immunisation Handbook.
Precautionary conditions for COVID-19 Vaccine AstraZeneca
Comirnaty is recommended instead of COVID-19 Vaccine AstraZeneca in people of any age with:
•  a history of cerebral venous sinus thrombosis (CVST)
•  a history of heparin-induced thrombocytopenia (HIT)
•  a history of idiopathic splanchnic (mesenteric, portal, splenic) thrombosis
•  a history of antiphospholipid syndrome with thrombosis.
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For people in the above groups who have received a first dose of COVID-19 Vaccine AstraZeneca,
Comirnaty is recommended for the second dose.
People who develop immune thrombocytopenia (ITP) within 42 days after receiving COVID-19 Vaccine
AstraZeneca should consult a haematologist regarding whether to proceed with the second dose using
the same or an alternate vaccine, and the timing of the second dose.
Precautionary conditions for Comirnaty
People with a history of any of the fol owing conditions can receive Comirnaty but advice should be
sought from a cardiologist about the best timing of vaccination and whether any additional precautions
are recommended:
•  Inflammatory cardiac il ness e.g., myocarditis, pericarditis, endocarditis
•  Acute rheumatic fever
•  People aged 12-29 years with dilated cardiomyopathy
•  Complex or severe congenital heart disease including single ventricle (Fontan) circulation
the
•  Decompensated heart failure
•  Cardiac transplant recipients.
Vaccination should be deferred in people with ongoing cardiac inflammation, or an alternative vaccine
under
(e.g. COVID-19 Vaccine AstraZeneca) considered in people aged ≥ 60 years. People who develop
(CTH) Care.
myocarditis and/or pericarditis after receiving Comirnaty should defer further doses and discuss this with
their treating doctor.
For further information, refer to the Joint ATAGI-CSANZ Guidance on Myocarditis and/or Pericarditis after
1982 Aged
mRNA COVID-19 Vaccines
released
Acute il ness
Act  and
Vaccination should be deferred in people with an acute il ness, including febrile il ness (axil ary temperature
been
≥38.5°C). This is a general precaution for all vaccines and wil  avoid potential misattribution of symptoms from the
acute il ness as being due to the vaccine or vice-versa.
has
Health
People with bleeding disorders
Information
of
People with bleeding disorders and people who are receiving anticoagulant therapy may develop haematomas
at intramuscular injection sites. Before vaccination, the recipient should be informed about this risk. Comirnaty
of
and COVID-19 Vaccine AstraZeneca should be administered by intramuscular injection. Subcutaneous
administration is not recommended, as no data are available on the safety or immunogenicity of COVID-19
document
vaccines given via this route.
When administering an intramuscular injection to an individual with a bleeding disorder, a 23 or 25 gauge needle
This
Department
should be used, and firm pressure appl
Freedom  ied to the site without rubbing for at least 2 minutes.55
the
For further information on how to safely administer vaccines intramuscularly to people with bleeding disorders,
refer to the Vaccination for people with bleeding disorders section in the Australian Immunisation Handbook.
by
Adverse events
Comirnaty
In the phase II/III trial of Comirnaty, adverse events within 7 days following vaccination were very common but
generally mild to moderate and well tolerated.
Injection site reactions were very common (refer to Table 1). Injection site pain was reported with similar
frequency after dose 1 and dose 2, and was more common in people aged 16 to 55 years (83% post dose 1 and
78% post dose 2) than in people aged >55 years (71% and 66 %, respectively). It also occurred at similar rates in
people aged 12 to 15 years (86% post dose 1 and 79% post dose 2), and those aged 16-25 (83% and 78%
respectively).40 Injection site redness and swelling occurred in <10% of all participants. These local reactions
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were generally mild to moderate, had a median onset on the day following vaccination, and resolved within 1 to 2
days.
Systemic adverse events were more common following the second dose of Comirnaty than the first dose (refer
to Table 1). The median onset of systemic adverse events was 1–2 days after vaccine receipt, with resolution in
a median of 1 day.56 Adverse events were generally milder and less frequent in adults aged >55 years than in
those aged 16–55 years. It also occurred at similar rates in people aged 12 to 15 years (e.g. fatigue 60% post
dose 1 and 66% post dose 2; headache 55% post dose 1 and 65% post dose 2), and those aged 16-25 (fatigue
60% and 66%, respectively; headache 54% and 61% respectively).40 Most adverse events were mild to
moderate severity and did not affect daily activities. The reported rates of diarrhoea and vomiting did not dif er
between vaccine and placebo recipients.
The median duration of follow-up for adverse events was 2 months after the second dose. Lymphadenopathy,
though uncommon (<1%), was more common in vaccine recipients than in placebo recipients (64 cases [0.3%]
versus 6 cases [<0.1%]) and is likely related to the expected immune response to the vaccine. The cases of
the
lymphadenopathy were generally mild to moderate and resolved after a median time of 10 days. There were four
cases of Bell’s palsy (acute peripheral facial paralysis) in the vaccination group (with onset at 3, 9, 37 and 48
days after a dose respectively), and no cases in the placebo group.56 However, this observed frequency was
consistent with the expected background rate of Bell’s palsy in the general population a
under nd thus may not have a
(CTH) Care.
causal relationship to vaccination.
Rarely, myocarditis and pericarditis have been reported following vaccination with Comirnaty and other mRNA
COVID-19 vaccines.57,58 Most reported cases have been mild, self-limiting and recovered quickly, although
1982 Aged
longer-term fol ow-up of these cases is ongoing. Cases have been reported predominantly after the second dose
released
and predominantly in younger males (aged < 30 years).
Act  and
There were no substantive dif erences in the frequency of adverse events overall observed in the clinical trial by
age, sex, race, ethnicity or baseline SARS-CoV-2 status. There was no evidence of enhanced COVID-19
been
disease in vaccinated individuals who developed SARS-CoV-2 infection after completing vaccination, with only
one severe case in the eight vaccine failures.59
has
Health
Anaphylaxis after Comirnaty has been reported rarely. Refer to Contraindications for further information.
Information
of
Table 1: Frequency of select common adverse events reported within 7 days following
of
each dose of Comirnaty in phase II/II  trial56

12 – 15 years of age
16–55 years of age  >55 years of age
document

Dose 1
Dose 2
Dose 1
Dose 2
This
Department
Injection site
86%
Freedom  79%
83%
78%
71%
66%
pain
the
Fever
10%
by
20%
4%
16%
1%
11%
Fatigue
60%
66%
47%
59%
23%
51%
Headache
55%
65%
42%
52%
25%
39%
Chills
28%
42%
14%
35%
6%
23%
Muscle pain
24%
32%
21%
37%
14%
28%
Joint pain
10%
16%
11%
22%
9%
19%
Required
37%
51%
28%
45%
20%
38%
paracetamol
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COVID-19 Vaccine AstraZeneca
Thrombosis with thrombocytopenia syndrome
A newly identified, rare condition called thrombosis with thrombocytopenia syndrome (TTS) has been reported
after COVID-19 Vaccine AstraZeneca in several countries including Australia, and appears to be causally linked
to vaccination. TTS involves thrombosis with thrombocytopenia. The onset of symptoms is around 4 to 42 days
post vaccination. The site of thrombosis varies, and reported presentations include cerebral venous sinus
thrombosis (CVST), thrombosis in the splanchnic (mesenteric, portal, splanchnic) circulations, deep vein
thrombosis, pulmonary embolism and arterial thrombosis. Although very rare, TTS can cause disability and even
death, with a fatal outcome in about one fifth of the cases reported in the UK to date.60
The overal  estimated rate of TTS is around 1-2 cases per 100,000 doses administered, however this estimate is
based on a relatively small number of cases, especially in young adults, reported in Australia to date and is
therefore imprecise.61 The estimated rate is higher in younger adults (<60 years of age), therefore younger age
the
appears to be a risk factor for TTS. No other specific risk factors have been identified. While some case series
report more cases in women, others have found no dif erence by sex. There is no evidence that a past history of
clots or of any clotting tendencies increases the risk of TTS, and people with the following conditions can receive
COVID-19 Vaccine AstraZeneca:
under
(CTH) Care.
•  History of blood clots in typical sites
•  Increased clotting tendency that is not immune-mediated
•  Family history of blood clots
1982 Aged
•  History of ischaemic heart disease or stroke  released
•  Current or past thrombocytopenia (low platelet count)
Act
•  Those receiving anticoagulation therapy
and
There is a theoretical concern that certain rare conditions may increase the risk of TTS, and therefore Comirnaty
been
is recommended for people with a history of these conditions:
•  Cerebral venous sinus thrombosis (CVST)
has
Health
•  Heparin-induced thrombocytopenia (HIT)
of
•  Idiopathic splanchnic (mesenteric, portal, splenic) vein thrombosis
Information
•  Antiphospholipid syndrome with thrombosis.
of
The great majority of reported cases of TTS have been after the first vaccine dose. As of July 2021, 44 cases
were reported out of 22.8 mil ion second doses administered in the UK. This translates to a rate of 1.9 cases per
document
million doses60
TTS requires specific haematological investigations as part of the diagnostic workup.62 Antibodies to platelet
Department
factor 4 are reported
This  in most, but not all, cases.  For further information about TTS, refer to Information for
Freedom
Immunisation Providers on Thrombosis with Thrombocytopenia Syndrome (TTS) following COVID-19
the
vaccination.
by
Other adverse events reported after COVID-19 Vaccine AstraZeneca
In the phase II/III trials of COVID-19 Vaccine AstraZeneca, adverse events reported within 7 days following
vaccination were very common (86%) but the majority were mild or moderate.47 Injection site tenderness (63.7%)
and pain (54.2%) were the most commonly reported. Fatigue (53.2%) and headache (52.6%) were the most
frequently reported systemic adverse events47 (refer to Table 2).
Local or systemic solicited adverse events were most commonly reported on day 1 following vaccination. These
reactions were generally mild to moderate and resolved within a few days. The most common systemic solicited
adverse effects at day 7 were fatigue, headache and malaise.
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Adults aged ≥65 years reported fewer local or systemic solicited adverse events, and fewer ≥grade 3 solicited
adverse events, than younger adults.47,59 Most adverse events did not affect daily activities. Adverse events
reported after the second dose were milder and less frequent than those after the first dose.
Reports on unsolicited adverse events were col ected through to 28 days following a dose of the COVID-19
Vaccine AstraZeneca. Most of the unsolicited adverse events were mild to moderate in severity and consistent
with adverse events commonly observed following vaccination with other vaccines.47
In a combined interim analysis of four clinical trials, one case of transverse myelitis was reported in the vaccine
arm, which occurred 14 days after dose 2.48 This case was reviewed by an independent neurological commit ee
and the likely diagnosis was revised to be idiopathic short segment spinal cold demyelination. Two additional
cases of transverse myelitis were considered unlikely to be related to vaccination, with one case subsequently
attributed to pre-existing but previously unrecognised multiple sclerosis, and the other case reported in the
control group.
The first dose of COVID-19 Vaccine AstraZeneca has been found to be associated with a smal
the  l risk of immune
thrombocytopenia (ITP).63 Two other serious but rare adverse events have been reported after COVID-19
Vaccine AstraZeneca, for which a causal association has not yet been confirmed. These are Guil ain Barre
syndrome and capil ary leak syndrome.64,65
under  Care.
Anaphylaxis after COVID-19 Vaccine AstraZeneca has been reported rarely. Refer to Contrain
(CTH)  dications for
further information.
Table 2: Frequency of select common adverse events reported w
1982  ithin 7
Aged days following
at least one dose of COVID-19 Vaccine AstraZeneca in phase II/III trial in people aged
released
>18 years66
Act  and

18–55 years
56–69 years
≥70 years
been

Dose 1
Dose 2
Dose 1
Dose 2
Dose 1
Dose 2
has
Health
Injection site  61%
49%
43%
34%
20%
10%
of
pain
Information
Injection site
76%
61%
67%
59%
49%
47%
of
tenderness
Fatigue
76%
55%
50%
41%
41%
33%
document
Headache
65%
31%
50%
34%
41%
20%
Muscle pain
53%
35%
37%
Department
24%
18%
18%
This Freedom
Fever
24%
0%
0%
0%
0%
0%
the
Reporting advers
by  e events
Al  notifications of adverse events following immunisation should be made through the usual reporting
mechanisms.
The safety of COVID-19 vaccines wil  be actively monitored by the TGA as well as state and territory
governments.

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Vaccine information
Vaccine efficacy in clinical trials
Comirnaty
A phase I /I I trial of Comirnaty is ongoing with >43,000 individuals aged ≥12 years enrolled. An interim analysis,
with an observation period of 2 months post dose 2, reported vaccine efficacy (VE) of 95.0% (95% CI: 90.3–97.6)
in preventing symptomatic laboratory-confirmed COVID-19 in people aged ≥16 years (median age 52 years,
range 16–89 years for vaccine recipients) without evidence of prior infection with SARS-CoV-2.48 There is also
evidence of VE against severe il ness, although the estimate is imprecise due to the lower number of people
overall who developed severe disease (VE 88.9% after first dose [95% CI: 20.1–99.7]).59
No data are currently available to assess ef icacy for prevention of asymptomatic infection, although serological
data are awaited. The duration of protection has not been determined.
the
In this interim analysis, short-term VE after a single dose was 52.4% (95% CI: 29.5–68.4), with protective effect
observed starting 12 days after dose 1.
People aged ≥ 65 years
under
(CTH) Care.
Sub-group analyses demonstrated similarly high efficacy in adults aged ≥65 years (VE 94.7% [95% CI: 66.7–
99.9]) and in adults with at least one medical comorbidity or obesity (VE 95.3% [95% CI: 87.7–98.8]).49
Children aged <16 years
1982 Aged
Preliminary results of an ongoing study involving more than 2000 adolescent
released  s aged 12–15 years showed that VE
against COVID-19 occurrence at least 7 days after dose 2 in participant
Act s with or without evidence of previous
and
infection was 100% (95%CI 78.1-100) with no cases in the vaccine arm. After dose 1 and before dose 2, 3
COVID-19 cases were noted (within 11 days after dose 1) among vaccine recipients, compared with 12 cases
been
among placebo recipients (VE:75% (95% CI: 7.6 to 95.5)). No cases of severe COVID-19 were observed in this
age cohort. The neutralising antibody response after 2 doses was higher among those aged 12–15 years
has
Health
compared with those aged 16–25 years. 40
of
People with specified medical conditions
Information
This ongoing phase II/I I trial also includes pa
of  rticipants with well-controlled chronic medical conditions. An interim
sub-analysis of data on those with some specified medical conditions showed a similar VE to those without such
conditions (95.3% [95% CI: 87.7–98.8] versus 94.7% [95% CI: 85.9–98.6]59).
document
Data on safety, immunogenicity or efficacy of Comirnaty in people living with stable HIV have not yet been
published.  This Freedom
Department
COVID-19 Vaccine AstraZeneca
the
Phase II/III trials of COVID-19 Vaccine AstraZeneca are ongoing with >57,000 individuals aged ≥18 years enrolled.
by
An interim analysis of pooled data was conducted as of 4 November 2020 from two ongoing randomised, blinded,
controlled trials: a phase II/I I study, COV002, in adults aged ≥18 years in the UK and a phase I I study, COV003,
in adults aged ≥18 years  in  Brazil. This analysis showed the overall VE was 70.4% (95% CI:  54.8–80.6)  in
preventing symptomatic laboratory-confirmed COVID-19 in people aged ≥18 years 15 or more days after the
second dose in the primary efficacy study population.48 The median duration of follow up from 15 or more days
after the second dose was 48 days. This was based on 131 cases (30 among 5,807 who received COVID-19
Vaccine AstraZeneca versus 101 among 5,829 who received the control vaccine).48
COVID-19 Vaccine AstraZeneca was demonstrated to have reduced neutralisation activity against the B.1.1.7
variant than against a canonical (Victoria) lineage, however vaccine efficacy against B.1.1.7 was preserved with
VE 70.4% (95% CI 43.6 – 84.5), compared to VE 81.5% (95% CI 67.9 – 89.4) for the Victoria lineage.67 No
efficacy data has been published on the VE against the Delta variant. Sera neutralisation studies show 4.3-fold
ATAGI Clinical Guidance on COVID-19 Vaccine in Australia_v6.0
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FOI 25-0034 - Document 1
reduction in neutralisation of Delta after 2 doses of COVID-19 Vaccine AstraZeneca compared to wild type. After
1 dose COVID-19 Vaccine AstraZeneca, the sera barely inhibited Delta.
Number of doses and interval between the 2 doses
Updated analysis of pooled data as of 7 December 2020 reported a VE of 63.09% (95% CI: 51.81–71.73) in
preventing symptomatic laboratory-confirmed COVID-19 in people aged ≥18 years who received two standard
doses.68 This was based on 271 cases (74 among 7,201 who received COVID-19 Vaccine AstraZeneca versus
197 among 7,178 who received the control vaccine).48 Ef icacy from day 22 after the first dose until up to 12 weeks
post vaccination was 76·0% (59·3–85·9).48
In clinical trials, the interval between the two doses of COVID-19 Vaccine AstraZeneca ranged from approximately
4 weeks up to 26 weeks. Among participants who received two standard recommended doses at an interval of 4
to 12 weeks, the overal  VE for prevention of symptomatic laboratory-confirmed COVID-19 was 59.5% (95% CI:
45.8–69.7), based on 218 cases.69 The VE varies with dose interval. The VEs for prevention of symptomatic
laboratory-confirmed COVID-19 more than 14 days after the second dose with intervals of <6 w
the  eeks, 6–8 weeks,
9–11 weeks and ≥12 weeks between the first and second dose were 55.1% (95% CI 33.0 – 69.9), 59.9% (95%
CI 32.0 – 76.4), 63.7% (95% CI 28.0 – 81.7) and 81.3% (95% CI 60.3 – 91.2) respectively.70
There were very few people with severe disease and hospitalisation in the interim analy
under  sis of clinical trials to
Care.
assess VE against these outcomes. In the population who received two standard doses, there w
(CTH)  ere 0 out of
4,440 participants who received COVID-19 Vaccine AstraZeneca who were hospitalised, and 4 out of 4,455 in
the control group.71
1982 Aged
People aged ≥65 years
released
Fewer than 6% of participants included in the interim analysis were aged ≥65 years.48 In this cohort there were
Act  and
only four and eight cases of COVID-19 in recipients of COVID-19 Vaccine AstraZeneca and of control vaccine,
respectively. However, there were no cases of COVID-19 hospitalisation, severe disease or COVID-19 deaths
been
among  trial  participants  aged ≥65 years.68 These small numbers preclude the assessment of the efficacy of
COVID-19 Vaccine AstraZeneca in this age group at this time. Participants aged ≥65 years who received two
has
Health
doses showed SARS-CoV-2 specific neutralising antibody levels comparable with those in serum samples from
of
people who had recovered from COVID-19 (convalescent sera).
Information
Additional information on the efficacy of COVID-19 Vaccine AstraZeneca in adults aged ≥65 years is anticipated
of
from a  phase  I I clinical trial underway in the USA and South America (NCT04516746) with over  30,000
participants, including at least 25% of participants aged ≥65 years.72,73
document
People with specified medical conditions
An interim sub-analysis of data on people with specified medical conditions in the Phase II/I I trials showed VE in
This
Department
this group was similar to that in people
Freedom  without such conditions. A total of 2,068 (39.3%) participants had at least
one pre-existing comorbidity (defined as a BMI ≥30 kg/m2, cardiovascular disorder, respiratory disease or
the
diabetes). A pooled data analysis (as of 7 December 2020) showed that participants who had one or more
by
comorbidities had a VE of 58.3% (95% CI: 33.6–73.9).69
Vaccine effectiveness in post-licensure studies
Comirnaty
The ef ectiveness of Comirnaty has been studied in vaccination programs in countries such as Israel, USA,
Canada and the UK.
In a study in Israel that included over 1.1 mil ion people aged ≥16 years, effectiveness of Comirnaty from 7 days
after 2 doses was 87% (95% CI: 55–100) against COVID-19 hospitalisations and 92% (95% CI: 75–100) against
severe disease.74 Data on the duration of protection from the vaccine are not available yet.
In a large population-based cohort study in the UK that included about 375,000 participants aged ≥16 years,
overall ef ectiveness of Comirnaty against PCR-positive SARS-CoV-2 infection was 67% (95% CI: 61–72) 21
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FOI 25-0034 - Document 1
days after dose 1 and 72% (95% CI: 64–79) after dose 2. When assessed against asymptomatic and
symptomatic infection, two-dose effectiveness estimates were 52% (95% CI: 34–64) and 91% (95% CI: 83–95),
respectively. During the period of this study, the, Alpha (B.1.1.7) variant of SARS-CoV-2 predominated in the UK.
Large population studies have also been done in the UK in period when the Delta variant has become dominant.
Overall effectiveness of Comirnaty against PCR-positive SARS-CoV-2 infection irrespective of symptoms at the
swab test was 30% (95% CI: 17-41) ≥28 days after dose 1 and 79% (95% CI: 75-82) ≥14 days after dose 2.
When assessed against symptomatic infection, ef ectiveness estimates were 33% (95% CI: 15-47) and 83%
(95% CI: 78-87) respectively.8 Another study examined hospitalisation caused by Delta in the UK, vaccine
effectives estimates were 94% (95% CI: 46-99) after dose 1 and 96% (95% CI: 86-99) ≥ after dose 2.10
COVID-19 Vaccine AstraZeneca
Ef ectiveness data for COVID-19 Vaccine AstraZeneca are available from studies mainly in the UK. In a
population-based cohort study in the UK, COVID-19 Vaccine AstraZeneca had 64% (95% CI: 55–70)
the
effectiveness against PCR-positive SARS-CoV-2 infection 21 days after the first dose.75 Ef ectiveness against
symptomatic infection was marginally higher than against asymptomatic infection.
A prospective cohort study in Scotland found ef ectiveness of COVID-19 Vaccine AstraZeneca against COVID-
under
19 hospitalisations was 94% for the first dose in 28 to 34 days after vaccination.76 (CTH) Care.
Large population studies have also been done in the UK in period when the Delta variant has become dominant.
Overall effectiveness of COVID-19 Vaccine AstraZeneca against PCR-positive SARS-CoV-2 infection
irrespective of symptoms at the swab test was 18% (95% CI: 9-25) ≥28 days after
1982  dose 1 and
Aged   60% (95% CI: 53-
66) ≥14 days after dose 2. When assessed against symptomatic infection, effectiveness estimates were 33%
released
(95% CI: 23-41) and 61% (95% CI: 51-70) respectively.8 Another study examined hospitalisation caused by
Act  and
Delta in the UK, vaccine effectives estimates were 71% (95% CI: 51-83) after dose 1 and 92% (95% CI: 78-97) ≥
after dose 2.10
been
Vaccine effectiveness against SARS-CoV-2 transmission
has
Health
Data from studies in the UK shows that both Comirnaty and COVID-19 Vaccine AstraZeneca are ef ective in
of
preventing onward transmission of the virus to close contacts in case of breakthrough infections.  In one study
Information
among the UK general population the ef ectiveness against transmission from breakthrough infections to
of
household contacts from 21 days after the first dose was 47% (95% CI :37-57%) for COVID-19 Vaccine
AstraZeneca and 49% (95%CI:41-56%) for Comirnaty.77 Another UK study reported that among healthcare
workers, who predominantly had received C
document  omirnaty, vaccination was associated with a 30% (95% CI: 22–37)
reduction in transmission of SARS-CoV-2 to household contacts.78
Department
Vaccine effect
This iveness in ol
Freedom der adults
In a single-centre case–control stud
the  y in Bristol in the UK,79 vaccine efectiveness against hospitalisation among
adults aged ≥80 years from 14 days after dose 1 was 71% (95% CI: 36–95) for COVID-19 Vaccine AstraZeneca
by
79% (95% CI: 47– 93) for Comirnaty 79 .
Other UK studies have reported effectiveness of first dose of either Comirnaty or COVID-19 Vaccine
AstraZeneca of 76% (95% CI: 68–82) against overall SARS-CoV-2 infection in people aged ≥75 years and 81%
(95% CI: 65–90) against COVID-19 hospitalisation in people aged ≥80 years.75,76
VE data available for two doses of COVID-19 Vaccine AstraZeneca are stil  limited because of the 12-week
interval between the two doses used in vaccination programs.75

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FOI 25-0034 - Document 1
Transporting, storing and handling vaccines
Comirnaty
Comirnaty vaccine vials have a shelf life of 6 months at -90ºC to -60ºC. Vials can be stored at domestic freezer
temperatures (-25°C to -15°C) for up to 2 weeks and can be returned to -90ºC to -60ºC within the original shelf
life. Frozen vials should be thawed at 2ºC to 8ºC. A carton of 195 vials would require 3 hours to thaw. Frozen
vials can also be thawed at room temperature (up to 30ºC) for 30 minutes, for immediate use. Once thawed, the
vaccine should not be re-frozen. Refer to the product information for more detailed guidance regarding thawing of
vials.
After thawing, the shelf life is 31 days at 2ºC to 8ºC. Undiluted vaccine vials can be stored at up to 30°C for 2
hours (including thawing time). After dilution, vials must be kept at 2ºC to 30ºC and used within 6 hours from the
time of dilution (not including the 2-hour maximum window for storage of an undiluted vial at up to 30°C). Do not
freeze the diluted vaccine. ATAGI recommends that, when possible, pre-drawn doses kept at room temperature
the
be used within an hour to minimise any remote potential risk of infection.
Comirnaty is presented in a multi-dose vial containing 0.45 mL of undiluted vaccine and must be reconstituted by
diluting with 1.8 mL of sterile 0.9% sodium chloride. The vaccine does not contain a preservative. Do not use
under
bacteriostatic 0.9% sodium chloride. The total quantity after dilution wil  be 2.25 mL. Do not shake the v
Care.ial. It is
(CTH)
preferable to administer vaccine doses immediately after dilution.
During storage, minimise exposure to room light, and avoid exposure to direct sunlight and ultraviolet light.
1982 Aged
For additional information refer to the National Vaccine Storage Guidelines Strive for 5.
released
COVID-19 Vaccine AstraZeneca
Act  and
The shelf life of COVID-19 Vaccine AstraZeneca is 6 months at 2ºC to 8ºC.
been
In Australia, COVID-19 Vaccine AstraZeneca is supplied in multi-dose vials, with either 8 doses in 4 mL or 10
doses in 5 mL. Dilution is NOT required. has
Health
Unopened multi-dose vials are to be stored at 2°C to 8°C and
of   in the outer carton, to protect from light.
Information
After first opening, chemical and physical in-use stability has been demonstrated from the time of vial puncture to
administration for no more than 6 hours at r
of oom temperature up to 30°C, or no more than 48 hours in a
refrigerator at 2°C to 8°C. The vial can be re-refrigerated, but after first opening the cumulative storage time at
room temperature must not exceed 6 hours, and the total cumulative storage time must not exceed 48 hours.
document
Although there are data supporting stability of vaccine doses after withdrawal into a syringe for up to 6 hours at
Department
room temperature (as reflected in the Astra Zeneca vaccine product information [PI], ATAGI recommends that,
This Freedom
when possible, pre-drawn doses kept at room temperature be used within an hour to minimise any remote
potential risk of infection.  the
For additional information r
by efer to the National Vaccine Storage Guidelines Strive for 5.
Transporting doses for home visits
When transporting COVID-19 Vaccine AstraZeneca or Comirnaty for a home visit, there are two options:
1. Where possible, transport the vial at 2-8°C and not exceeding the total maximum storage period of 6 hours
and draw up the dose at the site of administration
2. A pre-drawn dose in a syringe can be transported if it can be appropriately stored (protecting from light and
maintaining the cold chain) and can be administered as soon as practicable and not exceeding the total
maximum storage period of 1 hour if at room temperature, and within 6 hours if at 2-8°C).

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FOI 25-0034 - Document 1
Recording vaccination
It is mandatory to record every administered dose of COVID-19 vaccine on AIR.
This wil  assist in ensuring that the correct vaccine and interval are used for the second dose, and in identifying
patients who are due for a second dose. This wil  also allow verification or provision of evidence of completion of
COVID-19 vaccination, if required.
For more information, refer to the Services Australia website: AIR for health professionals.
Serological testing for immunity
Testing for anti-spike antibodies or neutralising antibodies to demonstrate immunity against SARS-CoV-2 in
vaccinated individuals is not recommended. An immune correlate of protection has not yet been established for
SARS-CoV-2 infection.80
the
Impact of vaccination on future COVID-19 testing
Receipt of a COVID-19 vaccine wil  not affect the results of nucleic acid (PCR) testing or rapid antigen testing for
diagnosis of SARS-CoV-2 infection.
under
(CTH) Care.
Since both Comirnaty and COVID-19 Vaccine AstraZeneca encode the spike protein of SARS-CoV-2,
vaccination may af ect any subsequent serological diagnostic testing and result in detection of antibody to the
spike protein, but wil  not af ect the results of anti-nucleocapsid antibody testing.  Aged
released 1982
Isolation or testing for COVID-19 fol owing adverse events
Act  and
Testing for SARS-CoV-2 infection or implementing (non-medically recommended) isolation of someone who
develops symptoms of fever, headache, fatigue or other s
been ystemic symptoms within and lasting for <48 hours
after receipt of a COVID-19 vaccine is not necessarily required. If a vaccine recipient develops typical vaccine-
related adverse events (refer to Adverse events section) and there is compl
Health  ete absence of respiratory
has
symptoms (including loss of smell), it is more likely that they have an expected vaccine response. However,
of
vaccine-induced protection is not immediate, and it is possible that SARS-CoV-2 could be contracted within
Information
several days before or after vaccination (this would not constitute vaccine failure).
of
Local public health guidance should be followed irrespective of a history of vaccination. Criteria for SARS-CoV-2
testing vary and depend, in part, on local epidemiology and outbreak management.
document
For Comirnaty, the median time of onset of systemic adverse events was 1–2 days after vaccine receipt,
with resolution in a median of 1 day. For COVID-19 Vaccine AstraZeneca, local or systemic solicited adverse
This
Department
events were most commonly reported on
Freedom   day 1 following vaccination, and generally resolved within a few days.
the
Post-exposure prophylaxis
by
COVID-19 vaccines are not recommended for post-exposure prophylaxis use, as no data are available to
support such use. The median incubation period for SARS-CoV-2 is 5–6 days (with a range of 1 to 14 days in
most people) and vaccination after exposure is unlikely to generate suf icient immunity within this period to
prevent infection in a previously unvaccinated exposed individual.
However, local public health authorities may recommend prioritising COVID-19 vaccination for certain
populations related to local outbreaks or settings with community transmission of COVID-19. For latest
information refer to the CDNA National guidelines for public health units on COVID-19.

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FOI 25-0034 - Document 1
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Ward JL, Harwood R, Smith C, et al. Risk factors for intensive care admission and death amongst
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