COVID-19 vaccine safety report - 28-07-2022

• 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 in every 100,000 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 21 cases per 100,000 Spikevax doses).
  • To 24 July 2022, the TGA has received 615 reports which have been assessed as likely to be myocarditis from about 42.8 million doses of Comirnaty (Pfizer) and 101 reports which have been assessed as likely to be myocarditis from about 5 million doses of Spikevax (Moderna).
• 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).

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 - external site.

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 24 July 2022, we have received about 4,230 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 24 July 2022, we have received about 1,580 reports from approximately 2.3 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 37 reports of suspected myocarditis and/or pericarditis in this age group. Following review of the reports, 4 were likely to represent myocarditis and another 7 reports were likely to represent pericarditis.

Survey data from AusVaxSafety show that:

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

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 - external site website. A decision aid is available for parents and carers - external site 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 people who have recently had COVID-19, a 3-month interval is recommended before having a winter booster dose.

To reduce the burden of severe disease from emerging Omicron variants BA.4 and BA.5, the Australian Technical Advisory Group on Immunisation (ATAGI) has updated its advice for a winter booster dose of COVID-19 vaccines - external site. All adults aged 50 to 64 years are now recommended to receive a winter booster dose of a COVID-19 vaccine, and those aged 30 years and over may now have a winter dose if they choose. ATAGI also recommends a winter booster dose for people at higher risk of severe disease including:

• all adults aged over 65 years
• residents of aged care and disability facilities
• Aboriginal and Torres Strait Islanders aged 50 and over
• people who are severely immunocompromised
• those aged 16 and over with a medical condition or complex health needs that increase their risk of severe disease or a poor outcome

A first booster dose of Comirnaty (Pfizer) is also recommended for adolescents aged 12-15 years - external site at greater risk of severe disease.

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

To 24 July 2022, approximately 14 million people have received boosters in Australia. This includes 3.6 million people who have received a fourth dose. We have received approximately 8,900 reports of suspected adverse events identified as occurring after a booster dose. These reports do not suggest any emerging safety concerns with a booster dose that are different to the first and second vaccine doses.

Adverse event reports for booster doses include a small number of myocarditis and pericarditis cases. This is a recognised risk with the Comirnaty (Pfizer) and Spikevax (Moderna) vaccines and we are closely monitoring these events. So far, reports of myocarditis after a booster dose are very rare, occurring in less than 1 in every 100,000 vaccinated people.

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. They occur when the immune system is stimulated and were seen in the COVID-19 vaccine 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 deaths reported in the days and weeks after COVID-19 vaccination. Read more about this process in a previous report. Since the beginning of the vaccine rollout to 24 July 2022, about 61.9 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 910 reports received and reviewed. 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. A recent analysis of survey data - external site affirms the safety of the Comirnaty (Pfizer) and Vaxzevria (AstraZeneca) vaccines. Results largely reflect what was seen in the clinical trials, with injection-site pain, fatigue, headache, and muscle pain being the most common reactions. Most reactions were short-lived and just under 1% of respondents sort medical advice because of an adverse reaction in the first 3 days after vaccination.

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

• Comirnaty (Pfizer) adult formulation - external site and paediatric formulation (5-11 years) - external site
• Spikevax (Moderna) - external site
• Vaxzevria (AstraZeneca) - external site
• Nuvaxovid (Novavax) - external site

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.

The Comirnaty (Pfizer) vaccine is provisionally approved for adults and children aged 5 years and over. To 24 July 2022, about 42.8 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 - external site (for consumers) and Product Information - external site (for health professionals).

The Spikevax (Moderna) vaccine is provisionally approved for adults and children aged 6 years and over. To 24 July 2022, about 5 million doses have been administered in Australia.

A paediatric dose has recently been provisionally approved for children aged from 6 months to 5 years (or less than 6 years). This vaccine is made in the same way as the formulations for older children and adults but is a more dilute version.

The KidCOVE clinical trial, which was conducted in the US and Canada and enrolled just over 6000 children aged 6 months to 6 years, found the safety and efficacy of the vaccine was similar to that seen in adults. Most adverse effects were mild–moderate and generally reported after the second dose. Common reactions to the vaccine included irritability and crying, redness and swelling at the injection site, tiredness, fever, muscle pain and swelling or tenderness of lymph nodes near the injection site.

The new paediatric vaccine has not been rolled out in Australia yet. The expert Australian Technical Advisory Group on Immunisation (ATAGI) - external site is currently reviewing data on the impact of COVID-19 infection in young children. The group will advise the Minister for Health about vaccination in this age group in the coming weeks.

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 - external site (for consumers) and Product Information - external site (for health professionals).

The Nuvaxovid (Novavax) vaccine is provisionally approved for adults. To 24 July 2022, about 189,200 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 21 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 - external site (for consumers) and Product Information - external site (for health professionals).

The Vaxzevria (AstraZeneca) vaccine is provisionally approved for adults. To 24 July 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.

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.

Update to the Product Information

Tinnitus (ringing or other sound in one or both ears) has been added to Section 4.8 of the PI as a potential, but uncommon, adverse event following vaccination with Vaxzevria. This potential safety signal was identified from analysis of global data during post-market surveillance.

Tinnitus is common generally with 2 in every 3 people experiencing it at some point in their life. It can be caused by many factors including hearing loss, an ear infection or other underlying ear problems. Tinnitus can also be caused by some medicines, and there have been reports of tinnitus in people with COVID-19 disease. Sometimes, however, it is not clear why people develop tinnitus.

You should seek medical attention if you suspect you have tinnitus, especially if the sound is getting worse or is affecting your sleep or daily living.

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

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 - external site.

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 - external site 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 - external site 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 21 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 24 July 2022, from approximately 14 million people who have received booster doses, we have received 43 reports of likely myocarditis and 85 reports of likely pericarditis for Comirnaty (Pfizer) and 20 reports of likely myocarditis and 20 reports of likely pericarditis for Spikevax (Moderna). The median age of affected individuals was 32 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 Table 2 and Table 3.

Reports of suspected myocarditis and pericarditis

Notes for Table 1

* 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.

Correction: In the last safety report, published on 14 July 2022, the number of suspected pericarditis cases associated with the Comirnaty vaccine in 12–17 year olds should have been 183 not 289 and the number of likely pericarditis cases should have been 76 not 96.

Rates of likely myocarditis

Notes for Table 2 and Table 3

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

‡ To 24 July 2022, from about 2.3 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.

Correction: In Table 2 of the last safety report, published on 14 July 2022, the rate of likely myocarditis cases associated with the Comirnaty vaccine in the 40–49 year old age group should have been 1.2 not 2.8 for males and 1.4 not 1.0 for females.

Rates of likely pericarditis

Notes for Table 4

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

‡ To 24 July 2022, from about 2.3 million Comirnaty (Pfizer) vaccine doses given, 1 probable and 6 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 - external site developed by ATAGI and the Cardiac Society of Australia and New Zealand (CSANZ).

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