From:
ATAGI COVID19 WG
To:
s 22
Cc:
s 22
KELLY, Paul; MURPHY, Brendan; EDWARDS, Caroline;
SCHOFIELD, Lisa; DE TOCA, Lucas; s 22
BALMANNO, Rachel; s 22
Subject:
ATAGI Statement on TTS - 17 June 2021 [SEC=OFFICIAL]
Date:
Thursday, 17 June 2021 12:49:40 PM
Attachments:
image001.png
ATAGI Statement on TTS - 17 June 2021 final.docx
Dear s 22
As you’re aware, the Australian Government has asked that the Australian Technical Advisory
Group on Immunisation (ATAGI) monitor the rates of TTS cases in the Australian context and
update its recommendations should it be required on the basis of this data.
To this end, ATAGI has met today and provides the updated advice to Government from its
deliberations.
Kind regards,
ATAGI COVID-19 WG Secretariat
Vaccine Policy Branch | COVID-19 Vaccine Taskforce Division
Australian Government Department of Health
s 22
E: xxxxx.xxxxxxxxx@xxxxxx.xxx.xx
GPO Box 9848, Canberra ACT 2601, Australia
The Department of Health acknowledges the Traditional Custodians of Australia and their continued connection to land,
sea and community. We pay our respects to all Elders past and present. ACT 1982 (CTH)
HEALTH
INFORMATION
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THEBY THE DEPARTMENT OF
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17th June 2021
The Hon Greg Hunt MP
Minister for Health
Parliament House
CANBERRA ACT 2600
Dear Minister Hunt,
Re: Revised recommendations on the use of COVID-19 Vaccine AstraZeneca
Following a review of the risk and benefits, the Australian Technical Advisory Group on Immunisation
(ATAGI) has today revised its recommendations for use of COVID-19 Vaccine AstraZeneca in the Australian
context. ATAGI now recommends:
• COVID-19 Pfizer vaccine (Comirnaty) is the preferred vaccine for those under 60 years of age. The
recommendation was revised due to a higher risk and observed severity of thrombosis and
thrombocytopenia syndrome (TTS) in the 50-59 year old age group than reported internationally and
initially estimated in Australia.
ACT 1982 (CTH)
• For those aged 60 years or above, the benefits of receiving a COVID-19 vaccine are greater 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 COVID-
19 Vaccine AstraZeneca outweighs the risk of TTS in this age grou
HEALTHp.
•
People of any age without contraindications who have had th
INFORMATION eir first dose of COVID-19 Vaccine
AstraZeneca without any serious adverse events should receive the second dose.
ATAGI reinforces that due to the ongoing risk of COVID-19, maximising vaccine coverage is a priority.
ATAGI acknowledges that this recommendation a
FREEDOM OF nd ongoing supply constraints of the COVID-19 Pfizer
vaccine are likely to have an impact on the overall program, yet believes emergin
THIS DOCUMENT HAS BEEN RELEASED UNDER g data on the risks of TTS
with COVID-19 Vaccine AstraZe
THEneca vaccine warrant this important step.
BY THE DEPARTMENT OF
s 47C
ATAGI remains committed to reviewing the emerging data on risks and benefits of COVID vaccines and, if
required, providing additional technical advice to government on the safety and use of COVID vaccines.
Yours sincerely
Chris Blyth and Allen Cheng on behalf of the Australian Technical Advisory Group on Immunisation
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ATAGI revised recommendations on the use of COVID-19 Vaccine AstraZeneca, 17 June 2021
Summary
The Australian Technical Advisory Group on Immunisation (ATAGI) recommends the COVID-19 Pfizer
vaccine (Comirnaty) as the preferred vaccine for those aged 16 to under 60 years. This updates the
previous preferential recommendation for Comirnaty over COVID-19 Vaccine AstraZeneca in those aged
16 to under 50 years. The recommendation is revised due to a higher risk and observed severity of
thrombosis and thrombocytopenia syndrome (TTS) related to the use of AstraZeneca COVID-19 vaccine
observed in Australia in the 50-59 year old age group than reported internationally and initially estimated
in Australia.
For those aged 60 years and above, the individual benefits of receiving a COVID-19 vaccine are greater
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
COVID-19 Vaccine AstraZeneca outweighs the risk of TTS in this age group and underpins its ongoing use
in this age group.
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. This is
supported by data indicating a substantially lower rate of TTS following a second COV
ACT 1982 (CTH) ID-19 Vaccine
AstraZeneca dose in the United Kingdom (UK).
Background
HEALTH
The Australian COVID-19 vaccination program has the overarching
INFORMATION goal of protecting all people in
Australia from the harm caused by the novel coronavirus SARS-CoV-2.
On 8 April 2021, ATAGI recommended that Comirnaty was the preferred vaccine for people under the age
of 50 years due to local and international reports of thrombosis and thrombocytopenia syndrome (TTS)
following COVID-19 Vaccine AstraZeneca.
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Based on available internatiTona
HE l data at that time, the estimated risk of TTS was 4-6 per million cases
following a first dose of COVID-19 Vaccine AstraZeneca. Give
BY THE DEPARTMENT OF n the ongoing risk of COVID-19 outbreaks,
low vaccine coverage, and increasing rate of severe COVID-19 outcomes in older individuals, it was
considered that the benefits of COVID-19 Vaccine AstraZeneca outweighed the risk in those over 50 years.
As such, no preferential recommendation for either vaccine was made in this age group. This advice was
reinforced on 23 April 2021 and has been reviewed weekly by ATAGI since then.
Principles underpinning the revised recommendations
In making the decision to revise the previous recommendation, ATAGI has considered several factors that
have been monitored closely, including:
• The potential risk of severe illness and death from COVID-19 over the coming months
• Minimising harms to people due to adverse events following immunisation
• Australian data on the age-specific risks and severity of TTS following COVID-19 Vaccine AstraZeneca
• The expected vaccine supply over the months ahead
• The impacts of any change in recommendation on the COVID-19 vaccine program.
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The benefits of vaccination to prevent COVID-19
There is an ever-present risk of COVID-19 in Australia while the population remains largely susceptible to
infection. Recent events in Victoria have demonstrated how rapidly outbreaks can spread despite
intensive contact tracing and public health action. As at 16 June 2021, 63% of people aged 70 years and
older and 25% of those aged 18 years and older have received at least one dose of a COVID-19 vaccine.
The risk of severe COVID-19 is strongly related to increasing age. In 2020, for every 100 people with
COVID-19 aged between 50-59 years, around 14 were hospitalised and 3 required admission to an
intensive care unit (ICU). One in every 600 people with COVID-19 in this age group died. In contrast, for
every 100 people aged 70-79 years with COVID-19, around 38 were hospitalised, 7 were admitted to ICU
and 4 died (ie. 24 deaths in 600). Therefore, the benefit of vaccination in preventing COVID-19 is greater
in older people. If an outbreak occurred comparable to the first wave in Australia, the benefits in
preventing severe COVID-19 would outweigh the risks of TTS due to COVID-19 Vaccine AstraZeneca in
older adults, as illustrated in Weighing up the potential benefits against the risk of harm from COVID-19
Vaccine AstraZeneca.
ATAGI acknowledges the difficulty in balancing the small risk of a clinically significant adverse event
related to vaccination with COVID-19 Vaccine AstraZeneca against the need to pr
UNDER otec
(CTH) t individuals and the
community against the ongoing threat of COVID-19, together with ongoing limitations and uncertainties
about the supply of alternative COVID-19 vaccines. ATAGI emphasises that thi
1982 s advice is specific to the
context that there is currently no or limited community transmission in most of Australia and would be
ACT
different in other countries.
RELEASED
The risks of TTS after COVID-19 Vaccine AstraZeneca
BEEN HEALTH
From early April to 16 June 2021, 60 cases of confir
HAS med or p
OF robable TTS have been reported in Australia.
INFORMATION
This includes an additional seven cases reported in the past week in people between 50-59 years,
increasing the rate in this age group from 1.9 to 2.
OF 7 per 100,000 AstraZeneca vaccine doses. The revised
estimates of risk associated with first doses of COVID-19 Vaccine AstraZeneca are listed in the table
below.
DOCUMENT
FREEDOM
DEPARTMENT
Estimated risk of TTS per
THIS
Age
100,000 AstraZeneca
THE THE
vaccine doses (first dose)
<50 ye
BY ars
3.1
50-59 years
2.7
60-69 years
1.4
70-79 years
1.8
80+ years
1.9
TTS is a serious condition in a proportion of individuals who develop it. The overall case fatality rate in
Australia (3%; 2 deaths among 60 cases) is lower than has been reported internationally. This is likely to
reflect increased detection due to heightened awareness, as well as early diagnosis and treatment. A
spectrum of severity of illness has been reported in Australia, from fatal cases and those with significant
morbidity, to relatively milder cases. TTS appears to be more severe in younger people.
There are different ways in which the severity of TTS can be measured. The US Centers for Disease
Control and Prevention (CDC) defines “tier 1” cases as clots involving unusual sites, such as the veins of
the brain (cerebral venous sinus thrombosis) or abdomen (splanchnic thrombosis); these are general y
more severe and may potential y lead to long term health complications. In those under 60 years, 52% of
TTS episodes are occurring in tier 1 sites compared with 28% in those 60 years and older. Other markers
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of severity include the requirement for intensive care (33% of TTS in those under 60 years; 15% of TTS
cases in those 60 years and older), and fatal cases (both occurring in those < 60 years).
Second dose recommendations for COVID-19 Vaccine AstraZeneca
ATAGI supports completion of a two-dose schedule with COVID-19 Vaccine AstraZeneca, based on current
evidence. The risk of TTS following a second dose of COVID-19 Vaccine AstraZeneca is much lower than
the risk following a first dose. The UK has reported 23 TTS cases in 15.7 million people after receiving a
second dose, an estimated rate of 1.5 per million second doses (compared to a reported risk of 14.2 per
million first doses in the UK).
People of any age without contraindications who have had their first dose of COVID-19 Vaccine
AstraZeneca without any serious adverse events should receive the second dose.
Recommendations
UNDER
(CTH)
• ATAGI advises that Comirnaty is preferred over COVID-19 Vaccine AstraZeneca from the age of 16 to
under 60 years. This is based on recent data regarding TTS cases in Australia an
1982
d a reassessment of
current age-specific risks and benefits of vaccination.
ACT
• ATAGI considers the benefit of vaccination in preventing COVID-19 with COVID-19 Vaccine
RELEASED
AstraZeneca outweighs the risk of TTS in people aged 60 and above. For this age group, the benefits
of receiving a COVID-19 vaccine are greater than in younger people. The risks of severe outcomes
with COVID-19 increase with age and are particularly h
BEEN igh in older unvaccinated individuals.
HEALTH
• COVID-19 Vaccine AstraZeneca can be used in adults aged under 60 years for whom Comirnaty is not
HAS
OF
available, the benefits are likely to outweigh the risks for that in
INFORMATION dividual and the person has made an
informed decision based on an understanding of the risks and benefits.
OF
• People of any age without contraindications who have had their first dose of COVID-19 Vaccine
AstraZeneca without any serious adverse events should receive the second dose.
• ATAGI reinforces the importance of providing clear communications to people who have received or
DOCUMENT
are considering COVID-19 Vaccine AstraZeneca, and
DEPARTMENT notes guidance documents for consumers, for
FREEDOM
primary care and for hospitals are being continual y revised to accommodate this new
THIS
recommendation.
THE THE
BY
Next steps
ATAGI is continuing to monitor the evidence regarding the risks of TTS and the epidemiology of COVID-19,
and wil continue to review recommendations. Further modifications may be recommended as additional
COVID-19 vaccine supply and emerging evidence become available. ATAGI reinforces that due to the
ongoing risk of COVID-19, maximising vaccine coverage is a priority, particularly in those at greatest risk of
severe COVID-19.
ATAGI is currently working with general practitioners, emergency physicians and haematologists to
update clinical advice on TTS for consumers and primary care.
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