COVID-19 vaccine weekly safety report - 16-09-2021

Published

16 September 2021

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Vaccination against COVID-19 is the most effective way to reduce deaths and severe illness from infection. Millions of people have received COVID-19 vaccines under the most intense safety monitoring ever conducted in Australia.

Two COVID-19 vaccines are currently in use in Australia – Vaxzevria (AstraZeneca) and Comirnaty (Pfizer). The Spikevax (Moderna) vaccine will also be available shortly. To be registered for use, these vaccines have met the TGA’s high standards for quality, safety and effectiveness.

Like all medicines, COVID-19 vaccines may have some side effects (also known as adverse events). The overwhelming majority of these side effects are mild and resolve within a few days. More serious side effects can occur after vaccination but are very rare.

The TGA closely monitors reports of suspected side effects and provides regular updates on vaccine safety in this report. Find out how the TGA identifies and responds to a safety concern.

Importantly, suspected adverse events reported to the TGA are often not caused by the vaccines. Learn more about causality and the TGA’s COVID-19 vaccine safety monitoring and reporting activities.

Report a suspected side effect.

Summary

The protective benefits of vaccination against COVID-19 continue to far outweigh the potential risks of vaccination.
To 12 September 2021, approximately 22.8 million vaccine doses have been given in Australia – 14 million first doses and 8.8 million second doses.
The most frequently reported side effects suspected to be associated with the vaccines reflect what was seen in the clinical trials. They 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) linked to the Vaxzevria (AstraZeneca) vaccine.
In the last week, an additional 5 reports of blood clots and low blood platelets have been assessed as confirmed or probable TTS. None of these cases were fatal.

Reported side effects for COVID-19 vaccines

The most frequently reported side effects suspected to be associated with the vaccines reflect what was seen in the clinical trials. They include injection-site reactions such as a sore arm, and more general symptoms such as headache, muscle pain, fever and chills.

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 been vaccinated. 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 12 September 2021, over 22.8 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 535 reports received and reviewed. These deaths occurred after the first dose of the Vaxzevria (AstraZeneca) vaccine – 8 were TTS cases and one 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 12 September 2021

2.6
Reporting rate per 1000 doses
59199
Total AEFI reports received
22802573
Total doses administered
35441
Total reports for Vaxzevria
23434
Total reports for Comirnaty
352
Total reports for brand not specified

Reporting rates per 1000 doses by jurisdiction

1.8
Australian Capital Territory
1.7
New South Wales
2.4
Northern Territory
2.5
Queensland
2.6
South Australia
4.5
Tasmania
3.7
Victoria
2.5
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. Intense public interest in the DAEN has caused intermittent problems with access and the search function. We have now upgraded the DAEN and full functionality is currently being restored. We apologise for any inconvenience and would like to reassure the public that these issues have not affected our ability to receive and analyse adverse event reports.

We are aware that false claims have been circulating based on misinterpretation of information published in the DAEN. Publication of a report in the DAEN does not mean that the vaccine caused the adverse event, but simply reflects the observations of the person who reported the event. 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 determine which events were caused by the vaccine. The outcomes of our analysis of adverse event reports are communicated in this report each week.

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 12 September 2021, approximately 10.8 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 has been observed in the clinical trials and by other medicine regulators overseas. Most side effects resolve within a few days.

Thrombosis with thrombocytopenia syndrome (TTS)

We are closely monitoring rare reports of blood clots with low blood platelets (also called thrombosis with thrombocytopenia syndrome or TTS) linked to the Vaxzevria (AstraZeneca) vaccine.

Early detection of TTS may help 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 134 cases of TTS assessed as related to Vaxzevria (AstraZeneca) from approximately 10.8 million vaccine doses. These cases most often occurred about 2 weeks after vaccination. So far in Australia, almost all of the confirmed 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 approximately 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 5 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). Only one of the new cases of TTS reported this week was in an individual 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 10-16 September 2021‡
New confirmed TTS	New probable TTS
Two new cases: 78 and 91-year-old men from NSW	Three new cases: 58 and 69-year-old men from NSW 85-year-old woman from NSW

‡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.

Three cases previously reported as probable or confirmed TTS have been reclassified to unlikely following further review which found the medical evidence did not support a causal link with the vaccine. This takes the total Australian reports assessed as TTS following Vaxzevria (AstraZeneca) to 134 cases (75 confirmed, 59 probable) from approximately 10.8 million vaccine doses.

To date, 11 cases of TTS have occurred after the second dose. Nine cases have been classified as probable TTS, with two cases meeting the criteria for confirmed TTS. All cases have occurred in individuals older than 50 years, with 8 of the cases in people over 60-years of age. Eight of the patients had clots in common locations, such as the lungs or legs, with only 2 cases classified as Tier 1 (see below). The information available to us indicates that only one of these patients required treatment in the intensive care unit, and 7 individuals have been discharged from hospital. Our preliminary analysis is consistent with overseas investigations which have shown that the risk of TTS after the second dose is extremely low (for example, 1.9 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	1.8 (<50 years)	2	2	2
30-39	3		3	-	-
40-49	8		6	1	1
50-59	32	2.8	17	10	5
60-69	33	1.6	10	9	14
70-79	35	2.0	9	11	15
80+	17	1.9	4	7	6
All ages	134 (63 men, 71 women)	2.0	51 (17 men, 34 women)	40 (24 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	39
	Currently	1
Outcome	Discharged	116
	In hospital	10
	Fatal	8

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

Other safety signals with Vaxzevria (AstraZeneca)

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 Vaxzevria (AstraZeneca) 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 12 September 2021, the TGA has received 115 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 conditions, such as a viral infection or 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 12 September 2021, the TGA has received 71 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 COVID-19 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 12 September 2021, approximately 12million doses of Comirnaty (Pfizer) have been administered in Australia. The reports of suspected side effects we receive for this vaccine are consistent with what has been observed in the clinical trials and by other medicine regulators overseas. Most side effects resolve within a few days.

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 are rare effects on the heart that typically occur within 10 days of vaccination with the mRNA vaccines Comirnaty (Pfizer) and Spikevax (Moderna). They occur more commonly after the second dose and more often in younger men. Cases are usually transient and resolve following treatment and rest.

The TGA is actively monitoring this safety signal, particularly now the Comirnaty (Pfizer) vaccine is being rolled out in younger age groups. Our analysis of Australian cases after first and second doses has identified similar findings to those seen in other countries.

To 12 September 2021, we have received 457 reports of suspected myocarditis and/or pericarditis following vaccination with the Comirnaty (Pfizer) vaccine. 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.

Of the reports received, 128 reported suspected myocarditis. We have reviewed these cases against an internationally accepted case definition for myocarditis to classify how certain it is that these cases reflect myocarditis. This assessment does not determine whether cases have been caused by vaccination.

Cases considered to be highly likely to be myocarditis, based on strong clinical evidence, are classified as level 1. In contrast, level 2 or 3 cases have less information and may be supported only by the symptoms and limited test results and/or the treating doctor’s view. Of the 128 suspected cases:

90 were classified as likely to be myocarditis (3 were level 1, 35 were level 2 and 52 reports were level 3)
11 were deemed unlikely to be myocarditis
27 could not be classified because they did not contain enough information

For the cases classified as likely to be myocarditis patients were between 16 and 60 years-old. When reported, most of the patients experienced symptoms within 3-4 days of vaccination. Over half of the patients required treatment in hospital, with 5 patients requiring treatment in intensive care.

Preliminary analysis of the likely myocarditis cases suggests that the reporting rates observed in Australia are in the same range as those seen by other regulators, including in the US where a large number of doses has been given, including in children. As in other countries, our analysis suggests there is a higher-than-expected number of cases of myocarditis in vaccinated compared to unvaccinated individuals. Based on the number of reports in both Australia and overseas, it appears that myocarditis can be caused by vaccination, although it occurs very rarely.

Similarly, we have seen that cases are reported more frequently in teenage boys after the second dose. It is important to note that the number of younger people vaccinated is still relatively low in Australia so this analysis is based on limited data. The TGA continues to work with other international regulators to monitor this safety signal and will provide periodic updates in this report.

We know that myocarditis and pericarditis are much more common with COVID-19 infection and damage to the heart is frequently severe after infection. The Australian Technical Advisory Group on Immunisation (ATAGI) have emphasised that the protective benefits of the Comirnaty (Pfizer) vaccine greatly outweigh the risk of these rare side effects.

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. ATAGI advises that people who develop myocarditis or pericarditis attributed to their first dose of Comirnaty (Pfizer) should defer further doses of an mRNA COVID-19 vaccine and to discuss this with their treating doctor.

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