COVID-19 vaccine weekly safety report - 09-09-2021

Release date

Thursday, 9 September 2021

Previous reports

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Vaccination against COVID-19 is the most effective way to reduce deaths and severe illness from infection. Two COVID-19 vaccines are currently in use in Australia – Vaxzevria (AstraZeneca) and Comirnaty (Pfizer). The Therapeutic Goods Administration (TGA) has also granted provisional approval for another vaccine called Spikevax (Moderna).

Like all medicines, COVID-19 vaccines have some side effects. These need to be continuously balanced against the expected benefits in preventing illness and death from COVID-19 disease. The overwhelming majority of side effects are mild and resolve within a few days.

The TGA closely monitors reports of suspected side effects (also known as adverse events). Importantly, adverse events reported to the TGA are often not caused by the vaccine itself. Learn more about causality and the TGA’s COVID-19 vaccine safety monitoring and reporting activities.

Report a suspected side effect.

Summary

To 5 September 2021, approximately 21 million vaccine doses have been given in Australia – 13.1 million first doses and 7.9 million second doses.
The TGA is continually monitoring the safety of the COVID-19 vaccines. The most frequently reported side effects suspected to be associated with the vaccines reflect what was seen in the clinical trials and include injection-site reactions such as a sore arm, and more general symptoms such as headache, muscle pain, fever and chills.
We are closely monitoring rare reports of blood clots with low blood platelets (also called thrombosis with thrombocytopenia syndrome or TTS) which have been found to be linked to the Vaxzevria (AstraZeneca) vaccine. Early detection of this syndrome may help to prevent more serious complications developing and guidance for health professionals is now available.
In the last week, an additional 7 reports of blood clots and low blood platelets have been assessed as confirmed or probable TTS. None of these cases was fatal.
The protective benefits of vaccination against COVID-19 far outweigh the potential risks of vaccination.

Reported side effects for COVID-19 vaccines

Gathering reports of adverse events following immunisation (AEFI) is just the first step in determining whether the effect is related to the vaccine and whether a significant safety issue is involved. Learn more about how the TGA identifies and responds to safety issues.

In the week of 30 August – 5 September 2021, staff at the TGA have accepted an additional 2,145 AEFI reports into our database for COVID-19 vaccines.

The most common adverse effects reported to the TGA following immunisation are predictable and have been observed with many vaccines. They include headache, muscle pain, fever, chills and injection site reactions for both vaccines.

Large scale vaccination means that coincidentally some people will experience a new illness or die within a few days or weeks of vaccination.

The TGA reviews all deaths reported in people who have received the vaccination. We also monitor reports for signals that may relate to vaccine safety to distinguish between coincidental events and possible side effects of the vaccine. As the number of vaccinated people has increased, so has reporting of fatal events with a coincidental association with vaccination. This does not indicate a link between vaccination and the fatalities reported. Review of individual reports and patterns of reporting does not suggest the vaccines played a role in these deaths.

Since the beginning of the vaccine rollout to 5 September 2021, approximately 21 million doses of COVID-19 vaccines have been given. So far, the TGA has found that 9 reports of deaths were linked to immunisation from 516 reports received and reviewed. These deaths occurred after the first dose of the Vaxzevria (AstraZeneca) vaccine – 8 were TTS cases and 1 was a case of immune thrombocytopenia (ITP). The overwhelming majority of deaths reported to the TGA following vaccination occurred in people aged 65 years and older.

Total adverse event reports to 5 September 2021

2.7

Reporting rate per 1000 doses

57,161

Total AEFI reports received

20,985,989

Total doses administered

34,659

Total reports for Vaxzevria

22,180

Total reports for Comirnaty

347

Total reports for brand not specified

Reporting rates per 1000 doses by jurisdiction

1.9

Australian Capital Territory

1.8

New South Wales

2.5

Northern Territory

2.6

Queensland

2.7

South Australia

4.7

Tasmania

4.0

Victoria

2.6

Western Australia

Interpreting information on vaccine adverse event reports

The Database of Adverse Event Notifications (DAEN) is the publicly available part of our adverse event database, but it is separate to the internal database that we use to monitor vaccine safety. Importantly, the recent problems with the DAEN have not affected our ability to receive and analyse adverse event reports.

We are aware that false claims are being circulated based on misinterpretation of adverse event information published in the DAEN. Publication of an adverse event report in the DAEN does not mean that the vaccine caused the event, but simply reflect the observations of the person (consumer or healthcare professional) who has them. It is important to remember that many unrelated medical events occur by chance after immunisation. This is especially the case when hundreds of thousands of people are being vaccinated each week.

In some states and territories the reporting of specific outcomes, such as death, that occur closely following a vaccination is mandatory for health professionals. For this reason, the number of adverse events and deaths reported in the DAEN is not an indication of the safety of the vaccines. Expert review and investigation is needed to work out which events were caused by the vaccine. The outcomes of our analysis of adverse event reports are communicated in the weekly report.

The most authoritative safety information on the COVID-19 vaccines is included in the Product Information (PI) and Consumer Medicine Information (CMI) which can be found on the TGA website.

When looking for information about COVID-19 vaccines, consider whether the source of the information is credible. Useful websites such as ‘COVID vaccines – is it true?’ and RMIT ABC Fact Check can help to address false claims and misleading rumours. Other reliable resources are listed at the end of this report.

Vaxzevria (AstraZeneca) vaccine

To 5 September 2021, approximately 10.2 million doses of the Vaxzevria (AstraZeneca) vaccine have been administered in Australia. The reports of suspected side effects we receive for this vaccine are consistent with what is being observed internationally. Most are expected side effects that resolve within a few days.

Thrombosis with thrombocytopenia syndrome (TTS)

TTS is a rare event involving serious blood clots with a low blood platelet count. It is triggered by the immune system’s response to Vaxzevria (AstraZeneca) and is different from other clotting conditions.

Early detection and appropriate treatment of TTS helps to prevent more serious complications developing. Guidance for health professionals is now available which outlines when to suspect TTS, initial tests that can be performed in primary care and when to refer people for emergency care. Patients presenting with low platelets and a headache should be thoroughly investigated for blood clots in the brain, including careful review of imaging results to identify early, small clots. The Royal Australian and New Zealand College of Radiologists have published imaging recommendations for patients with suspected TTS.

People should seek immediate medical attention if they develop any of the following symptoms after vaccination:

severe or persistent headache, blurred vision, confusion or seizures
shortness of breath, chest pain, leg swelling or persistent abdominal pain
unusual skin bruising and/or pinpoint round spots beyond the site of vaccination.

The most common time period for onset of TTS symptoms is 4–30 days after vaccination.

To date, there have been 132 cases of TTS assessed as related to the Vaxzevria (AstraZeneca) vaccine from approximately 10.2 million vaccine doses. These cases most often occurred about 2 weeks after vaccination. So far in Australia, almost all of the TTS cases have occurred after a first dose of the vaccine. Women in younger age groups seem to be slightly more likely to develop clots in unusual locations, such as the brain or abdomen, which have more serious outcomes. Eight people have died as a result of TTS – 6 of these were women. In Australia, the risk of dying from TTS after vaccination is less than 1 in a million (people receiving a first dose).

While TTS is very rare, some people may have concerns that they can discuss with their doctor. ‘Weighing up the potential benefits against risk of harm from COVID-19 Vaccine AstraZeneca’ includes information to help people make informed decisions about vaccination.

Details of TTS cases to date

Since last week’s report, a further 7 reports of blood clots and low blood platelets have been assessed as confirmed or probable TTS likely to be linked to the first dose of Vaxzevria (AstraZeneca). Five of the 7 new cases of TTS reported this week were in individuals aged under 60 years (Table 1). We continue to closely monitor cases of TTS as Vaxzevria (AstraZeneca) is now being used more frequently in people aged under 60 years. To date, we have not observed a significant change in the rate of TTS in this age group.

Table 1: Newly confirmed and probable TTS cases for the week of 3-9 September 2021‡
New confirmed TTS	New probable TTS
Four new cases: 25-year-old man from Victoria 48-year-old woman from NSW 58-year-old man from NSW 89-year-old man from Queensland	Three new cases: 44 and 50-year-old men from NSW 65-year-old woman from Victoria

‡As previously reported, the TGA determines whether a report is likely to represent TTS by assessing cases against accepted criteria established by the UK’s Medicines and Healthcare products Regulatory Agency.

In addition to the new cases reported today, 1 case previously reported as probable TTS has been reclassified as confirmed TTS. This takes the total Australian reports assessed as TTS following the Vaxzevria (AstraZeneca) vaccine to 132 cases (74 confirmed, 58 probable) from approximately 10.2 million vaccine doses.

We continue to investigate suspected cases of TTS following the second dose of Vaxzevria (AstraZeneca). To date, only one of these cases have been definitively linked to vaccination. Investigations overseas have shown that the risk of TTS after the second dose is extremely low (for example, 1.8 cases per million based on data from the UK).

When assessed against the criteria used by the US Centers for Disease Control and Prevention (CDC), fewer than half of the cases reported to the TGA are classified as Tier 1 cases which tend to have more serious outcomes. Tier 1 cases involve clots in an unusual location, such as the brain or abdomen (Table 2). Australian data indicates that patients aged under 50 years of age are more likely to be classified as Tier 1 and/or require treatment in intensive care. However, more than one third of these younger patients have not required treatment in intensive care.

Table 2: Total confirmed and probable TTS cases to date by age and CDC classification
Age	Total cases	Reports per 100,000 doses‡	CDC classification†
Age	Total cases	Reports per 100,000 doses‡				Tier 1	Tier 2	Not classified
<30 years	6	2.0 (<50 years)	2	2	2
30-39	3		3	-	-
40-49	8		6	1	1
50-59	31	2.9	16	10	5
60-69	32	1.6	10	9	13
70-79	34	2.0	9	10	15
80+	18	1.7	4	7	7
All ages	132 (60 men, 72 women)	2.0	50 (16 men, 34 women)	39 (23 men, 16 women)	43 (22 men, 21 women)

‡ Rates of TTS are calculated based on first doses of the Vaxzevria (AstraZeneca) vaccine as of 19 August to account for the time to onset of TTS. These rates are estimates of risk based on small numbers of cases so far.

† The US CDC classification is defined as:

Tier 1 = clots in an unusual location (such as the brain or abdomen) and a low platelet count with or without antibodies that activate platelets (anti-PF4 antibodies)
Tier 2 = clots found in common locations (such as the leg or lungs) and a low platelet count and anti-PF4 antibodies
Not classified = case does not meet the criteria for Tier 1 or Tier 2 (for example clots in common locations with low platelet count but no evidence of anti-PF4 antibodies).

Cases have most often occurred about 2 weeks after vaccination, although the time to onset (or diagnosis) has ranged from one to 83 days (Table 3). To date, cases presenting with a longer time to onset (over 50 days) have been designated as probable cases and have presented with common forms of clots. It can be difficult to distinguish between normal clots and TTS for these cases and they remain under investigation. As more is learnt about TTS internationally, we are considering modifying our case criteria, such as including the time to onset of symptoms as part of the criteria for confirming TTS. If the criteria are updated, it may result in some cases being reclassified as unlikely to be TTS because they present such a long time after vaccination and/or are likely to be due to other causes.

Table 3: Time to onset, treatment and outcomes for TTS cases*
Time to onset/ diagnosis (days)	Median (range)	13 (1-83)
Treated in ICU	At any point	38
	Currently	0
Outcome	Discharged	117
	In hospital	7
	Fatal	8

*Data is based on the most recent medical information available to the TGA

Other safety signals with the Vaxzevria (AstraZeneca) vaccine

Guillain-Barre Syndrome (GBS)

GBS is a rare immune disorder affecting the nerves and can result in pain, numbness, muscle weakness and difficulty walking. It has been associated with COVID-19 infection as well as other infectious diseases. Following rigorous investigations by the TGA and other international drug regulators, a clear link between GBS and the Vaxzevria (AstraZeneca) vaccine has not been established. However as a precautionary measure, a warning statement about GBS has been added to the Product Information in response to rare cases following vaccination.

To 5 September 2021, the TGA has received 110 reports mentioning GBS occurring after vaccination with Vaxzevria (AstraZeneca). These cases will be considered as part of our ongoing monitoring of this safety signal. It is expected that some suspected cases may not be related to vaccination, as GBS can also be caused by other common causes of GBS such as viral infections and some types of gastroenteritis.

We encourage people to seek medical attention if they experience symptoms that could suggest GBS as early medical care can reduce severity and improve outcomes. Symptoms to look out for include weakness and paralysis in the hands or feet that can progress to the chest and face over a few days or weeks. These tend to affect both sides of the body.

Immune thrombocytopenia (ITP)

The TGA continues to monitor and investigate reports of suspected ITP, a type of thrombocytopenia or low platelet count. We will communicate the outcomes of this investigation, including any regulatory actions, when it is complete. To 5 September 2021, the TGA has received 66 reports of suspected ITP following vaccination. These patients had an extremely low platelet count, and signs of thrombocytopenia which may include unusual bruising, a nosebleed and/or blood blisters in the mouth. Their symptoms occurred in a timeframe that suggested they could be linked to vaccination and no other obvious cause was identified based on the information provided to TGA. Apart from one fatal case that was assessed by an expert Vaccine Safety Investigation Group as being likely to be vaccine related, suspected cases of ITP have not been definitively linked to vaccination.

ITP can occur when the immune system is activated, for example by a viral infection or vaccination, and mistakenly destroys platelets which help blood to clot. In many cases it is mild with up to a third of people having no symptoms at all, or only minor bruising. However, about 5% develop severe bleeding.

We encourage people to seek medical attention if they experience signs and symptoms that could suggest ITP, such as unusual skin bruising or clusters of small red or purple spots that do not lose their colour when pressed. Unusual bleeding is another sign, for example bleeding from the nose or mouth that is hard to stop, or blood in the urine or stools.

Up-to-date information about the expected side effects of Vaxzevria (AstraZeneca) can be found in the Consumer Medicine Information (for consumers) and Product Information (for health professionals).

Comirnaty (Pfizer) vaccine

To 5 September 2021, approximately 10.7 million doses of Comirnaty (Pfizer) have been administered in Australia. Reports of suspected side effects of the Comirnaty (Pfizer) vaccine received by the TGA are consistent with what has been observed in the clinical trials and by other medicine regulators overseas.

Myocarditis and pericarditis

Following investigations by the TGA and international drug regulators, a warning statement about myocarditis (inflammation of the heart) and pericarditis (inflammation of the membrane around the heart) has been included in the Consumer Medicine Information and Product Information for Comirnaty (Pfizer).

These rare effects on the heart typically occur within 10 days of vaccination, particularly after the second dose of Comirnaty (Pfizer) and more often in younger men. While cases are usually transient and resolve following rest, some patients require treatment in hospital.

We know that myocarditis and pericarditis are much more common with COVID-19 infection and damage to the heart is frequently severe after infection. ATAGI, in collaboration with Cardiac Society of Australia and New Zealand (CSANZ), have emphasised that the protective benefits of the Comirnaty (Pfizer) vaccine greatly outweigh the risk of these rare side effects.

To 5 September 2021, we have received 370 reports of suspected myocarditis and/or pericarditis following vaccination with Comirnaty (Pfizer). Twelve of these reports were in children – 10 boys and 2 girls aged 15–17 years old. Five cases occurred after the first dose and 7 after the second dose. Reports of suspected myocarditis and/or pericarditis are reviewed to assess the relationship with vaccination. Myocarditis and pericarditis can occur due to other causes, including common viral infections, so it is expected that many reported cases may not be related to vaccination. We continue to monitor and review reports of suspected myocarditis/pericarditis occurring after vaccination and will communicate new information identified from our ongoing surveillance activities.

We encourage people to seek medical attention if they experience symptoms that could suggest myocarditis or pericarditis. This includes chest pain, palpitations (irregular heartbeat) fainting or shortness of breath after receiving the vaccine, particularly if they occur within 1–5 days. Initial tests for those presenting with symptoms include ECG, troponin and chest X-ray.

Up-to-date information about Comirnaty (Pfizer) can be found in the Consumer Medicine Information (for consumers) and Product Information (for health professionals).