COVID-19 vaccine weekly safety report - 23-06-2022

Information about the TGA's safety monitoring of COVID-19 vaccines.

Published

23 June 2022

Four COVID-19 vaccines are currently in use in Australia - Comirnaty (Pfizer), Spikevax (Moderna), Vaxzevria (AstraZeneca), and Nuvaxovid (Novavax). To be registered for use, these vaccines must have met the TGA's high standards for quality, safety and effectiveness.

The TGA closely monitors reports of suspected side effects (also known as adverse events) to the COVID-19 vaccines. This is the most intensive safety monitoring ever conducted of any vaccines in Australia.

We encourage people to report suspected side effects, even if there's only a very small chance a vaccine was the cause. Learn more about causality and our COVID-19 vaccine safety monitoring and reporting activities.

Report a suspected side effect.

Summary

Vaccination against COVID-19 is the most effective way to reduce deaths and severe illness from infection. The protective benefits of vaccination far outweigh the potential risks.
Like all medicines, COVID-19 vaccines may cause some side effects. The most frequently reported include injection-site reactions (such as a sore arm) and more general symptoms, like headache, muscle pain, fever and chills. This reflects what was seen in the clinical trials.
We are carefully monitoring and reviewing reports of:
- myocarditis and pericarditis (inflammation of the heart or membrane around the heart) following vaccination, particularly in younger age groups
- thrombosis with thrombocytopenia syndrome (TTS), Guillain-Barre syndrome (GBS) and immune thrombocytopenia (ITP) following Vaxzevria (AstraZeneca) in adults.
Myocarditis is a known but very rare side effect of Comirnaty (Pfizer) and Spikevax (Moderna). It is usually temporary, with most people getting better within a few days. Myocarditis is reported in around 1-2 in every 100,000 people who receive Comirnaty (Pfizer) and around 2 of those who receive Spikevax (Moderna). However, it is more common after the second dose in 12-17 year-old boys (13 cases per 100,000 Comirnaty doses and 20 cases per 100,000 Spikevax doses) and men under 30 (8 cases per 100,000 Comirnaty doses and 19 cases per 100,000 Spikevax doses).
- To 19 June 2022, the TGA has received 581 reports which have been assessed as likely to be myocarditis from about 41.4 million doses of Comirnaty (Pfizer) and 96 reports which have been assessed as likely to be myocarditis from about 4.6 million doses of Spikevax (Moderna). The total number of cases has decreased this week as we identified some reports were duplicates.
Thrombosis with thrombocytopenia syndrome (or TTS) is a very rare but serious side effect of Vaxzevria (AstraZeneca). Our analysis shows it is reported in about 2 in every 100,000 vaccinated people following the first dose. The risk of TTS is much lower after the second dose (0.3 in every 100,000 vaccinated people).
- No new cases of vaccine-related TTS have been reported this year.

Total adverse event reports following immunisation to 19 June 2022

2.2
Reporting rate per 1,000 doses
132155
Total adverse event reports
59938059
Total doses administered
48048
Total reports for Vaxzevria
77246
Total reports for Comirnaty
6541
Total reports for Spikevax
777
Total reports for Nuvaxovid
640
Total reports for brand not specified

Reported side effects for COVID-19 vaccines

Learn more about how the TGA identifies and responds to safety issues.

Anyone can report a suspected side effect, either:

directly to the TGA
through a health professional
by calling the NPS MedicineWise Adverse Medicine Events phone line for consumers.

You can report anonymously.

Learn more about how to report a suspected side effect to a COVID-19 vaccine.

The most frequently reported side effects suspected to be associated with the vaccines include headache, muscle and joint pain, fever, chills and nausea. Skin reactions at the site of the injection are also common and can include pain, swelling, redness and an itchy rash. These are recognised side effects of vaccination and are usually transient and mild. More information about what to expect and how to manage any symptoms after you receive your vaccine are available from NPS MedicineWise.

Vaccine safety in children and adolescents

The TGA is closely monitoring adverse event reports in people aged under 18 years. Although we continue to receive a small number of reports, this is decreasing each week.

To 19 June 2022, we have received about 4,200 reports from approximately 3.7 million doses of Comirnaty (Pfizer) and Spikevax (Moderna) in 12-17 year olds. The most commonly reported reactions are chest pain, headache, dizziness, nausea and fever.

The TGA is also closely monitoring adverse event reports in 5-11 year olds. To 19 June 2022, we have received about 1,500 reports from approximately 2.2 million Comirnaty (Pfizer) and Spikevax (Moderna) doses administered in this age group. The most common reactions reported included chest pain, vomiting, fever, headache and abdominal pain. We have received 35 reports of suspected myocarditis and/or pericarditis in this age group. Following review of the reports, 4 were likely to represent myocarditis and another 6 reports were likely to represent pericarditis.

Survey data from AusVaxSafety survey show that:

children aged 5-11 years report fewer side effects following a second COVID-19 vaccine dose than older Australians
children and adults are more likely to experience side effects after a second COVID-19 vaccine dose, but most reactions are mild and temporary.

These observations are consistent with what was reported in the clinical trials and from overseas experiences.

More information and frequently asked questions about COVID-19 vaccines in children are available on the National Centre for Immunisation Research and Surveillance website. A decision aid is now available for parents and carers who may be hesitant to get their children vaccinated.

Booster doses

The TGA is monitoring the safety of booster vaccine doses in adults. A booster dose is an additional vaccine dose given after the primary vaccine course. In Australia, the booster dose is most commonly a third dose of an mRNA vaccine. A fourth dose has also been recommended for people over 65 years of age, and a winter booster dose is now recommended for people aged 16-64 years who have:

a medical condition that increases their risk of severe COVID-19 illness
a disability with significant or complex health needs or multiple comorbidities that increase the risk of poor outcomes from COVID-19.

Last week, ATAGI recommended that adolescents aged 12-15 years who are at greater risk of severe disease from COVID-19 should be given a first booster dose of Comirnaty (Pfizer).

In this report, we refer to a booster dose as either a third or fourth dose.

To 19 June 2022, approximately 13.8 million people have received boosters in Australia. This includes 2.1 million people who have received a fourth dose. We have received approximately 8,400 reports of suspected adverse events identified as occurring after a booster dose. These reports do not suggest any emerging safety concerns with use of a booster dose that are different to the first and second vaccine doses received.

Our booster or third dose reports include a small number of cases of myocarditis and pericarditis (inflammation of the heart). This is a recognised risk with the Comirnaty (Pfizer) and Spikevax (Moderna) vaccines and we are closely monitoring these events. So far, reports after booster doses are very rare with myocarditis reported in less than 1 in every 100,000 people after they receive a booster dose.

The most common adverse events reported to the TGA following a booster dose are headache, swollen lymph nodes (also called lymphadenopathy), chest pain, fatigue and muscle pain. Swollen lymph nodes are a normal and known side effect of vaccines and occur when the immune system is stimulated and were seen in the clinical trials. More detail about this potential side effect is given in a previous vaccine safety report on the 6 January 2022.

Reports of death in people who have been vaccinated

Vaccines can lead to death in extremely rare instances. However, most deaths that occur after vaccination are not caused by the vaccine. In large populations in which a new vaccine is given, there are people with underlying diseases who may die from these diseases. When a vaccine is given in that same population, the link between the vaccine and death is usually coincidental – not caused by the vaccine. These deaths are carefully reviewed for whether vaccines could be the cause and for the vast majority that is not the case.

The TGA closely reviews all adverse events after COVID-19 vaccination where a fatal outcome is reported. Read more about this process in a previous report. Since the beginning of the vaccine rollout to 19 June 2022, about 59.9 million doses of COVID-19 vaccines have been given in Australia. The TGA has identified 13 reports where the cause of death was linked to vaccination from 889 reports received and reviewed. The total number of deaths reported has decreased following a reporter correcting the information provided to the TGA as the individual had not died. All deaths linked to vaccination as a likely cause occurred after the first dose of Vaxzevria (AstraZeneca). As previously reported, 8 were associated with thrombosis with thrombocytopenia syndrome (TTS) cases, 2 were linked to Guillain-Barre syndrome (GBS), 2 related to very rare conditions involving the nervous system, and one was a case of immune thrombocytopenia (ITP).

The 13 deaths likely to be related to vaccination occurred in people aged 34–81 years old. There have been no deaths in children, adolescents or younger adults determined to be linked to COVID-19 vaccination.

AusVaxSafety - a national survey on COVID-19 vaccine safety

AusVaxSafety has collected responses from over 6 million Australians about adverse events after they have received a COVID-19 vaccine. Survey results largely reflect what was seen in the clinical trials, with injection-site reactions, fatigue, headache, and muscle and joint pain being the most common reactions.

On the AusVaxSafety website, survey results are presented for each COVID-19 vaccine:

For each vaccine, survey results are given for different age groups and different populations, such as Aboriginal and Torres Strait Islander people, those affected by cancer or who have received a transplant, and pregnant women.

Comirnaty (Pfizer) mRNA vaccine

The Comirnaty (Pfizer) vaccine has been provisionally approved for adults and children aged 5 years and over. To 19 June 2022, about 41.4 million doses have been administered in Australia.

The TGA is actively investigating reports of myocarditis (inflammation of the heart) and/or pericarditis (inflammation of the membrane around the heart) associated with mRNA vaccines. We continue to work with international regulators on this safety signal (see below).

Up-to-date information for Comirnaty (Pfizer), including details of potential side effects , can be found in the Consumer Medicine Information (for consumers) and Product Information (for health professionals).

Spikevax (Moderna) mRNA vaccine

The Spikevax (Moderna) vaccine has been provisionally approvedfor adults and children aged 6 years and over. To 19 June 2022, about 4.6 million doses have been administered in Australia.

The TGA is actively investigating reports of myocarditis (inflammation of the heart muscle) and/or pericarditis (inflammation of the membrane around the heart) associated with mRNA vaccines. We continue to work with international regulators on this safety signal (see below).

Up-to-date information for Spikevax (Moderna), including details of potential side effects, can be found in the Consumer Medicine Information (for consumers) and Product Information (for health professionals).

Nuvaxovid (Novavax) vaccine

The Nuvaxovid (Novavax) vaccine has been provisionally approved for adults. To 19 June 2022, about 156,800 doses of Nuvaxovid (Novavax) have been administered in Australia.

The TGA has received a small number of reports of suspected myocarditis and/or pericarditis in people who have received the Nuvaxovid (Novavax) vaccine. After assessing these against a set of internationally accepted criteria, 3 cases were likely to represent myocarditis and 12 were likely to represent pericarditis. As a result of our investigation, the Product Information (PI) for Nuvaxovid (Novavax) has been updated to include pericarditis as a potential adverse event.

Anaphylaxis, paraesthesia and hypoaesthesia (tingling and numbness of the skin) have also been added to the Nuvaxovid (Novavax) PI as potential adverse events. These adverse events are also recognised for other COVID-19 vaccines in use in Australia.

More information for Nuvaxovid (Novavax), including details about its ingredients and potential side effects, can be found in the Consumer Medicine Information (for consumers) and Product Information (for health professionals).

Vaxzevria (AstraZeneca) vaccine

The Vaxzevria (AstraZeneca) vaccine has been provisionally approved for adults. To 19 June 2022, about 13.8 million doses of Vaxzevria (AstraZeneca) have been administered in Australia. However, since the end of 2021 very few doses are being used.

The TGA is closely monitoring rare reports of blood clots with low blood platelets (also called thrombosis with thrombocytopenia syndrome or TTS) linked to this vaccine, immune thrombocytopenia (ITP) and Guillain-Barre Syndrome (GBS). These are rare but serious side effects, with TTS reported in about 2 in every 100,000 people after receiving Vaxzevria (AstraZeneca) and ITP and GBS reported in about one in every 100,000 people. Detailed information of our analysis of these adverse effects is available in a previous vaccine safety report vaccine safety report.

With only limited use of the Vaxzevria (AstraZeneca) vaccine now in Australia, we have not received any new reports of confirmed or probable TTS this year. The total number of TTS cases reported in Australia is 173. Of these, 149 (83 confirmed, 66 probable) were related to a first dose of Vaxzevria (AstraZeneca) and 24 (5 confirmed, 19 probable) to a second dose. There has been no change in the reporting rates for ITP, GBS or TTS this year but we continue to monitor for reports to identify new information about these risks.

More general information for Vaxzevria (AstraZeneca), including details of potential side effects can be found in the Consumer Medicine Information (for consumers) and Product Information (for health professionals).

Myocarditis and pericarditis with mRNA vaccines

ATAGI continues to emphasise that the protective benefits of the mRNA vaccines far outweigh the rare risk of these side effects in all eligible age groups.

Current evidence tells us the risk of myocarditis and other heart effects is much higher after COVID-19 infection than after COVID-19 vaccination.

ATAGI has advised that people who develop myocarditis attributed to their first vaccine dose should defer further doses of an mRNA COVID-19 vaccine and discuss this with their treating doctor.

For those with suspected pericarditis after a first dose, future dose recommendations depend on test results and the person's age and sex. Refer to expert Guidance on myocarditis and pericarditis after mRNA COVID-19 vaccines for more information.

What are myocarditis and pericarditis?

Myocarditis is inflammation of the heart, and pericarditis is inflammation of the membrane around the heart. They can occur as rare adverse events after vaccination with the mRNA vaccines Comirnaty (Pfizer) and Spikevax (Moderna).

When do myocarditis and pericarditis occur?

Cases typically occur within 10 days, with symptom onset often within 5 days of vaccination. Some published evidence found pericarditis symptoms may occur later, commonly 2-3 weeks after vaccination. Our analysis indicates that most of the patients with likely myocarditis experienced symptoms within 3 days of vaccination.

Who is at risk of these heart problems?

Myocarditis is more commonly reported after the second dose in 12-17 year-old boys (13 cases per 100,000 Comirnaty doses and 20 cases per 100,000 Spikevax doses) and men under 30 (8 cases per 100,000 Comirnaty doses and 19 cases per 100,000 Spikevax doses). However, even in this population it remains rare. The number of cases has decreased this week as we identified some reports were duplicates.

Do myocarditis and pericarditis occur after a booster dose?

Myocarditis and pericarditis can occur after a booster dose but this is rare. Australian and international data indicate that myocarditis and pericarditis are reported less commonly after a booster dose than after a second dose. The rate of reporting of myocarditis and pericarditis is less than 1 in every 100,000 people after a booster dose. There is no indication that these events are more serious than after earlier doses.

To 19 June 2022, from approximately 13.8 million people who have received booster doses, we have received 37 reports of likely myocarditis and 78 reports of likely pericarditis for Comirnaty (Pfizer) and 20 reports of likely myocarditis and 18 reports of likely pericarditis for Spikevax (Moderna). The median age of affected individuals was 31 years old.

How serious are myocarditis and pericarditis?

Myocarditis is often mild, and cases usually resolve after a few days with treatment and rest. Some cases are more serious and need to be treated in hospital.

Our analysis has found about half of the patients with suspected myocarditis or pericarditis were admitted to hospital. Nine people with likely myocarditis or pericarditis were treated in intensive care. This represents less than 1% of all likely cases. Most patients admitted to hospital were discharged within 4 days.

What myocarditis and pericarditis symptoms should I look out for?

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, particularly if they occur within 1-5 days of vaccination.

What does the TGA know about Australian myocarditis and pericarditis cases?

Reports received by the TGA of suspected myocarditis and pericarditis for the 2 mRNA vaccines are provided in Table 1. We have reviewed these reports against an internationally accepted criteria to classify the likelihood of myocarditis. This assessment does not determine whether cases have been caused by vaccination.

Reporting rates of likely myocarditis and pericarditis appear similar to overseas rates and are given in Tables 2 and 3.

Table 1. Reports of suspected myocarditis and pericarditis received by the TGA to 19 June 2022 ^¥
		Comirnaty (Pfizer) (41.4. million doses given)		Spikevax (Moderna) (4.6 million doses given)
		All cases	Cases in adolescents (12-17 years)	All cases	Cases in adolescents (12-17 years)
Suspected myocarditis cases*		1,331	217	185	32
Likely myocarditis^†‡	Level 1	38	7	2	0
	Level 2	425	136	78	21
	Level 3	118	12	16	3
Unlikely myocarditis		399	33	45	4
Insufficient information		351	29	44	4
Suspected pericarditis cases		2,739	180	288	15
Likely pericarditis^£		962	73	93	3

* Cases reporting both myocarditis and pericarditis are included in suspected myocarditis cases.

^¥ The total number of reports can fluctuate slightly over time as duplicate reports may be identified and deleted and cases may be reclassified after receiving additional information.

^‡ Cases classified as level 1 are confirmed to be myocarditis based on strong clinical evidence including the patient's symptoms, and results of tests and imaging indicating a diagnosis of myocarditis. Level 2 cases are probably myocarditis based on a combination of symptoms and routine tests for heart conditions. Level 3 cases are possibly myocarditis based on symptoms and a doctor's report that myocarditis is the most likely diagnosis in the absence of medical tests and investigations. For all cases of suspected myocarditis, where possible, other known causes of the patient's symptoms or test results are ruled out before cases are classified.

^† The youngest case classified as 'likely myocarditis' to date is 6 years old.

^£ Classification of likely pericarditis is based on the patient's symptoms and test results and the absence of other known causes of pericarditis.

Table 2. Rates of likely myocarditis cases following Comirnaty (Pfizer)^‡
Age (years)	All doses		Second doses
	Rate* per 100,000 doses		Rate* per 100,000 doses
	Male	Female	Male	Female
5-11	0.3	0.1	0.2	0
12-17	7.8	1.5	12.8	2.4
18-29	4.6	1.3	8.2	2.3
30-39	1.9	0.7	2.5	0.9
40-49	0.7	0.7	1.0	1.2
50-59	0.4	0.3	0.2	0.3
60-69	0.2	0.3	0	0.4
70+	0.1	0.1	0	0.4
All ages*	2.2	0.8	4.2	1.3

Table 3. Rates of likely myocarditis cases following Spikevax (Moderna) ^†
Age (years)	All doses		Second doses
	Rate* per 100,000 doses		Rate* per 100,000 doses
	Male	Female	Male	Female
12-17	10.6	3.0	20.2	5.1
18-29	9.5	1.6	18.5	3.6
30-39	3.1	0.6	5.0	0
40-49	1.6	0.3	1.6	0
50-59	0.9	1.5	2.0	5.0
60-69	0	0.3	0	0
70+	0	0.2	0	0
All ages*	3.6	1.0	9.9	2.4

* The rate includes cases of myocarditis that occurred after vaccination but may not be vaccine related.

^‡ To 19 June 2022, from about 2.2 million vaccine doses given, 4 likely cases of myocarditis have been reported in children aged 5-11 years following vaccination with Comirnaty (Pfizer).

^† The rates for Spikevax (Moderna) are less certain due to low numbers of cases overall and small changes in case number can lead to fluctuations in the rates for different groups.

Table 4. Rates of likely pericarditis cases following the mRNA vaccines
Age (years)	Rate* per 100,000 doses
Age (years)		Comirnaty (Pfizer)	Spikevax (Moderna)
5-11^‡	0.3	-
12-17	2.2	0.9
18-29	3.5	4.2
30-39	3.9	4.4
40-49	2.4	2.1
50-59	1.3	0.9
60-69	0.7	0.3
70+	0.3	0
All ages*	2.4	2.2

* The rate includes cases of pericarditis that occurred after vaccination but may not be vaccine related.

^‡ To 19 June 2022, from about 2.2 million Comirnaty (Pfizer) vaccine doses given, 1 probable and 5 possible cases of pericarditis have been reported in children aged 5-11 years. No cases of pericarditis have been reported following Spikevax (Moderna) in this age group.

For more information, see guidance on myocarditis and pericarditis developed by ATAGI and the Cardiac Society of Australia and New Zealand (CSANZ).