COVID-19 vaccine weekly safety report - 17-02-2022

The most frequently reported side effects suspected to be associated with the vaccines include injection-site reactions, such as a sore arm, headache, muscle and joint pain, fever and chills. 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 reports in people aged under 18 years. To 13 February 2022, we have received about 3,500 reports from approximately 3.4 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 Comirnaty (Pfizer) vaccine is now being given to 5–11 year olds in Australia. This follows provisional approval by the TGA and a recommendation by the Australian Technical Advisory Group on Immunisation (ATAGI).

The TGA is also closely monitoring adverse event reports in this younger age group. To 13 February 2022, we have received 622 reports from approximately 1.1 million Comirnaty (Pfizer) doses administered in 5-11 year olds. The most common reactions reported include chest pain, vomiting, fainting, nausea and paleness. We have received 10 reports of suspected myocarditis and/or pericarditis in this age group. Following review of information in the reports, none were likely to represent myocarditis. One report in a 10-year-old boy possibly represented mild pericarditis when assessed against internationally accepted criteria for this condition.

Evidence from clinical trials and real-world experience from overseas indicate that side effects most commonly seen in this age group were mild and temporary similar to the safety profile in older populations. In clinical trials of over 2000 children, most side effects were reported in the first 2-3 days after vaccination with the most common being a sore arm (70% of children), headache (25%) and tiredness (25%).

In the US, over 8 million doses of the vaccine have already been given to children aged 5–11 from 3 November to 19 December 2021. A review of active and passive vaccine surveillance data published by the US Centers for Disease Control and Prevention (CDC) found similar safety findings to the clinical trial with most side effects being mild. A survey conducted shortly after vaccination found that about 5% of children missed school (usually only a single day or less) after a first dose and 7% missed school after a second dose.

Reports of more serious effects following vaccination in children in the US were extremely rare with 100 reports from 8.7 million vaccine doses - the most common were fever, vomiting and in some cases seizures. Importantly, reports of myocarditis were also very rare in the US, with 11 confirmed reports from over 8 million doses - these were all mild cases.

New safety data from the AusVaxSafety survey indicates that the Comirnaty (Pfizer) vaccine is well tolerated in children aged 5-11 years, with less adverse reactions reported after vaccination than in older Australians. The most frequently reported side effects include local reactions at the injection site such as pain, swelling, redness and itching. Headache and fatigue were also common.

More information and frequently asked questions about COVID-19 vaccines in children are available on the National Centre for Immunisation Research and Surveillance website.

Booster doses

The TGA is monitoring the safety of booster vaccine doses in adults. It is not expected that the types of side effects will be different to first and second vaccine doses based on the results of clinical trials, and observations from regulators overseas where more booster doses have been given. Together with other international regulators we are monitoring the type and frequency of adverse events after different vaccine combinations.

The Comirnaty (Pfizer) and Spikevax (Moderna) vaccines are recommended for use as booster doses for adults in Australia. For people who are immunocompromised, a third dose is given as part of their primary vaccine course. This is not considered to be a 'booster'. The latest vaccination recommendations are available from ATAGI.

To 13 February 2022, approximately 10 million boosters or third doses have been administered in Australia. We have received approximately 3,150 reports of suspected adverse events identified as a third or booster dose. These reports do not suggest any emerging safety concerns with use of a booster dose that is different to the first and second vaccine doses received. Although data is very limited at this point, rates of reporting for adverse events of special interest such as myocarditis, pericarditis and anaphylaxis appear to be lower following booster doses.

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. There is no indication that these events are more serious than after earlier doses.

The most common adverse events reported to the TGA following a booster dose are swollen lymph nodes (also called lymphadenopathy), headache, fatigue, muscle pain and fever. 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. There was more information about this potential side effect in the 6 January 2022 report.

Reports of death in people who have been vaccinated

Large scale vaccination means that some people will experience a new illness or die within a few days or weeks of vaccination. These events are often coincidental, rather than being caused by the vaccine. As the number of people being vaccinated has increased, so has reporting of fatal events with a temporal association with vaccination. Review of these individual reports and patterns of reporting does not suggest that the vaccines played a role in the vast majority of these deaths.

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 13 February 2022, about 52.4 million doses of COVID-19 vaccines have been given. The TGA has identified 11 reports where the cause of death was linked to vaccination from 765 reports received and reviewed. The deaths linked to vaccination occurred after the first dose of Vaxzevria (AstraZeneca) - 8 were thrombosis with thrombocytopenia syndrome (TTS) cases, 2 were linked to Guillain-Barre syndrome (GBS) and one was a case of immune thrombocytopenia (ITP).

AusVaxSafety - a national survey on COVID-19 vaccine safety

AusVaxSafety actively collects responses from Australians about adverse events after they have received a COVID-19 vaccine. It tells us what proportion of people experience an adverse event and what the most common reactions are. It also measures how frequently people go to the doctor or miss work or study because of an adverse event. Reassuringly, 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.

Results are given for everyone who has taken the survey, which is about 5 million Australians so far. Data is presented for each vaccine and for the first, second and third or booster doses. Vaccine safety data is also given for subgroups of the population including:

• children aged 5–11 age years
• adolescents
• Aboriginal and Torres Strait Islander people
• people affected by cancer or who have received a transplant
• pregnant women

For more details and results of the survey, go to the AusVaxSafety website.

Comirnaty (Pfizer) mRNA vaccine

To 13 February 2022, about 35.2 million doses of Comirnaty (Pfizer) 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

To 13 February 2022, about 3.4 million doses of Spikevax (Moderna) 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 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 in Australia after meeting the TGA's high standards for quality, safety and effectiveness. We will be closely monitoring the safety of this vaccine as it is rolled out and will provide regular updates in this report.

This is a protein-based vaccine containing the SARS-CoV-2 spike protein mixed with an adjuvant to enhance its effectiveness. Advice from ATAGI recommends 2 doses of the vaccine given at least 3 weeks apart. Three doses are recommended for people who are severely immunocompromised. Nuvaxovid (Novavax) is not currently recommended for use as a booster vaccine.

The safety of Nuvaxovid (Novavax) has been assessed in several placebo-controlled clinical trials which included about 34,000 participants. In one of the trials, local reactions at the injection site, such as tenderness and pain, were reported by the majority of people but were more common after the second dose (79% of participants) than the first dose (58% of participants). More generalised symptoms, such as headache, muscle pain, fatigue and malaise, were also more commonly reported after the second dose (70% of participants) than the first (50%). These symptoms are recognised side effects of vaccination and are common with the other COVID-19 vaccines.

Serious adverse events were rare in the trials. Two cases of myocarditis were reported in young males after they received a second dose of the vaccine. However, a link to the vaccine could not be confirmed for these cases.

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

To 13 February 2022, about 13.7 million doses of Vaxzevria (AstraZeneca) have been administered in Australia. However, very few doses are now being used, particularly since the end of 2021. This vaccine has recently received provisional approval to be used as a booster dose. Individuals seeking a booster dose of Vaxzevria (AstraZeneca) should discuss this with their health professional. 

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 the 27 January 2022 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 172. Of these, 148 (83 confirmed, 65 probable) were related to a first dose of Vaxzevria (AstraZeneca) and 24 to a second dose (5 confirmed, 19 probable).

Haemophagocytic lymphohistiocytosis (HLH)

The TGA recently carried out an investigation into a very rare and potentially fatal condition called haemophagocytic lymphohistiocytosis (HLH) after receiving 4 reports in adults who had received the Vaxzevria (AstraZeneca) vaccine. A handful of HLH cases have also been reported overseas after vaccination with Vaxzevria (AstraZeneca) and other COVID-19 vaccines. The current evidence does not indicate that the vaccine caused these events, but we continue to closely monitor this safety concern and will report more information should it arise.

Our investigation examined the Australian reports of HLH and evidence from overseas regulators and the medical literature. We also sought independent expert advice from the Advisory Committee on Vaccines (ACV). Our investigation concluded that a causal relationship between HLH and vaccination with Vaxzevria (AstraZeneca) could not be established. The Australian reports of HLH were highly complex and, in some cases, other causes such as infection could not be excluded.

HLH is an inflammatory condition that is poorly understood. Cases in children are usually due to genetic disorders. However, in adults, HLH appears to occur when the immune system is abnormally activated. HLH is a known complication of COVID-19 and other types of infections. It has also been reported following influenza vaccination, and in association with malignancies and autoimmune disease. People who develop HLH have signs and symptoms similar to someone with an overwhelming infection (sepsis), such as a fever and abnormal blood tests. The diagnosis and management of HLH is complex and requires input from a specialist doctor.

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.

ATAGI advises 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.

How common are myocarditis and pericarditis?

In some countries, higher rates of myocarditis and pericarditis have been reported with Spikevax (Moderna) than with Comirnaty (Pfizer). In Australia, we are seeing slightly higher estimated rates of myocarditis for Spikevax - 1.6 cases per 100,000 Spikevax doses versus 1.3 cases per 100,000 Comirnaty doses. This difference is smaller than that reported overseas, including in the UK and Canada.

Pericarditis has been reported in 2-3 in every 100,000 people who receive an mRNA vaccine. Preliminary analysis of Australian data indicates pericarditis following vaccination occurs most commonly in people aged under 50 years, with a trend to a higher rate in the 18-39 year old group. It remains a rare adverse event.

Do myocarditis and pericarditis occur after a booster dose?

Myocarditis and pericarditis can occur after a booster dose but this is rare. 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 13 February 2022, from approximately 10 million booster or third doses, we have received 6 reports of likely myocarditis and 25 reports of likely pericarditis for Comirnaty (Pfizer) and 4 reports of likely myocarditis and 8 reports of likely pericarditis for Spikevax (Moderna). The median age of affected individuals was 33 years old.

Myocarditis following COVID-19 vaccination is most likely to be reported in adolescents and young men, whereas the median age of people who have received a third or booster dose of a COVID-19 vaccine to date is 54 years. The TGA will continue to closely monitor myocarditis and pericarditis following booster or third doses as the booster roll-out extends to younger age groups, who have a higher risk of myocarditis. We are also closely monitoring myocarditis and pericarditis with different vaccine combinations for first and second doses and boosters. At this point, although we have only a small number of reports of pericarditis and /or myocarditis, we have not seen any patterns or trends in the data to indicate any difference with mixed vaccine combinations.

Who is at risk of these heart problems?

Myocarditis is more commonly reported after the second dose in 12-17 year-old boys (11 cases per 100,000 Comirnaty doses and 15 cases per 100,000 Spikevax doses) and men under 30 (7 cases per 100,000 Comirnaty doses and 15 cases per 100,000 Spikevax doses). However, even in this population it remains rare.

A European review of myocarditis and pericarditis data in teenage boys and young men (12-29 years old) found for Comirnaty (Pfizer), there were 2-6 extra cases of myocarditis per 100,000 vaccinated individuals after a second dose compared to unvaccinated individuals. For Spikevax (Moderna), there were 13-19 extra cases of myocarditis per 100,000 vaccinated individuals compared to unvaccinated individuals. Australian data does not show as large a difference in the incidence of myocarditis between Comirnaty (Pfizer) and Spikevax (Moderna).

A study by the Centers for Disease Control and Prevention (CDC) (pdf,606kb) in the US found in 18-39 years olds there was approximately 2 extra cases of myocarditis and pericarditis reported per 100,000 Comirnaty (Pfizer) second doses and 3 extra cases per 100,000 Spikevax (Moderna) second doses.

In Australia the rates of pericarditis are similar between the mRNA vaccines. Emerging Australian and international data indicate that pericarditis is more common in people under 50 years of age than in older people.

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 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.

Evidence from a US surveillance survey (pdf,1.1Mb) of patients who had myocarditis following vaccination indicates that most patients fully recover without lasting impacts on their quality of life or ability to work. The survey, which was conducted 3 months after the initial myocarditis diagnosis, involved mostly men under 30 years after their second vaccine dose (and their treating doctors). There were no deaths from myocarditis reported in these patients.

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.

Initial tests for those presenting with symptoms include ECG, troponin levels and chest X-ray. Brief guidance on the initial assessment of children and adolescents with symptoms has been published by the Paediatric Research in Emergency Departments International Collaborative (PREDICT) network.

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. Tables 2 and 3 present the rates of myocarditis and pericarditis.

We have received a small number of reports of myocarditis and pericarditis after a third or booster dose. These reports are very rare and there is no indication that they are more serious than after earlier doses.

Table 1. Reports of suspected myocarditis and pericarditis received by the TGA to 13 February 2022

		Comirnaty (Pfizer) (35.2 million doses given)		Spikevax (Moderna) (3.4 million doses given)
				All cases	Cases in adolescents (12-17 years)	All cases	Cases in adolescents (12-17 years)
Suspected myocarditis cases*		1,071	184	132	26
Likely myocarditis†‡	Level 1	37	7	0	0
	Level 2	333	103	42	14
	Level 3	79	11	12	3
Unlikely myocarditis		254	21	32	3
Insufficient information		368	44	46	6
Suspected pericarditis cases		2,287	151	214	11
Likely pericarditis£		815	61	66	3

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

^‡ 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 was 12 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.

Rates of myocarditis by age, sex and dose are given for Comirnaty (Pfizer) and Spikevax (Moderna) in Table 2. The estimated reporting rates in Australia appear similar to overseas rates. The rates for Spikevax (Moderna) are less certain due to low numbers of cases overall. Rates of pericarditis by age are given for Comirnaty (Pfizer) and Spikevax (Moderna) in Table 3.

Table 2. Rates of likely myocarditis cases following the mRNA vaccines^‡ A. Comirnaty (Pfizer)

Age (years)	All doses		Second doses
		Rate* per 100,000 doses		Rate* per 100,000 doses
Male		Female	Male	Female
12-17	6.5	1.4	10.8	2.4
18-29	3.9	1.1	6.7	2.0
30-39	1.6	0.6	1.9	0.5
40-49	0.7	0.6	1.2	0.9
50-59	0.4	0.3	0.1	0.4
60-69	0.1	0.2	0.5	0.0
70+	0	0.1	0	0.4
All ages*	1.9	0.7	3.7	1.1

B. Spikevax (Moderna)

Age (years)	All doses		Second doses
		Rate* per 100,000 doses		Rate* per 100,000 doses
Male		Female	Male	Female
12-17	8.3	1.9	15.0	2.7
18-29	5.6	0.7	14.5	0.0
30-39	2.9	0.4	5.3	0.0
40-49	0.8	0.4	0.0	0.0
50-59	0.4	1.1	0.0	2.6
60-69	0.0	0.0	0.0	0.0
70+	0.0	0.0	0.0	0.0
All ages*	2.4	0.6	7.4	0.9

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

^‡ To 13 February 2022, from about 1.1 million vaccine doses given, no likely cases of myocarditis have been reported in children aged 5-11 years.

 

Table 3. Rates of likely pericarditis cases following the mRNA vaccines‡

Age (years)	Rate* per 100,000 doses
		Comirnaty (Pfizer)	Spikevax (Moderna)
12-17	2.0	0.9
18-29	3.3	4.0
30-39	3.7	4.2
40-49	2.2	1.8
50-59	1.3	0.5
60-69	0.5	0.0
70+	0.2	0.0
All ages*	2.3	1.9

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

^‡ To 13 February 2022, from about 1.1 million vaccine doses given, one possible case of mild pericarditis has been reported in children aged 5-11 years. As this number is so low, we are unable to estimate reliable rates of pericarditis in this age group.

We continue to monitor Australian reports of myocarditis and pericarditis and will provide regular updates in this report as more information becomes available. We are also working closely with international medicines regulators to share emerging safety information.

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

Useful links

Tested positive for COVID-19? Find out what you need to do

Watch this video to find out how the TGA monitors and reports the safety of COVID-19 vaccines

Top 3 COVID-19 vaccine questions - Avoiding certain things before a RAT, testing for kids, and variants picked up by tests - 11 February 2022

Top 3 COVID-19 vaccine questions - Novavax booster, oral pill, and home cleaning after infection - 8 February 2022

ATAGI update following weekly COVID-19 meeting - 11 February 2022

ATAGI statement on the use of Novavax COVID-19 vaccine (Nuvaxovid) - 24 January 2022

Myocarditis and pericarditis following COVID-19 mRNA vaccines - Melbourne Vaccine Education Centre - 18 January 2022

COVID-19 vaccines: Frequently asked questions - 3 February 2022

COVID vaccines - is it true? - 11 February 2022

RMIT ABC Fact Check

Latest advice on COVID-19 vaccination for pregnant and breastfeeding women - 18 August 2021

Coronavirus (COVID-19) case numbers and statistics

Australia's COVID-19 vaccine rollout

TGA COVID-19 vaccines hub

Australian Government Department of Health COVID-19 vaccines hub

COVID vaccine information in your language

Database of Adverse Event Notifications (DAEN)

Nuvaxovid (Novavax) vaccine - clinical trials

Comirnaty (Pfizer) vaccine - phase III clinical trial

Comirnaty (Pfizer) vaccine - clinical trials in children under 12 years

Vaxzevria (AstraZeneca) vaccine - phase III clinical trial

Spikevax (Moderna) vaccine - phase III clinical trial