COVID-19 vaccine weekly safety report - 26-05-2022

• 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 2-3 of those who receive Spikevax (Moderna). However, it is more common after the second dose in 12-17 year-old boys (12 cases per 100,000 Comirnaty doses and 21 cases per 100,000 Spikevax doses) and men under 30 (8 cases per 100,000 Comirnaty doses and 18 cases per 100,000 Spikevax doses).
  • To 22 May 2022, the TGA has received 555 reports which have been assessed as likely to be myocarditis from about 40.5 million doses of Comirnaty (Pfizer) and 92 reports which have been assessed as likely to be myocarditis from about 4.4 million doses of Spikevax (Moderna). We have received 2 reports which have been assessed as likely to be myocarditis from about 140,000 doses of Nuvaxovid.
• 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.

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 Aboriginal and Torres Strait Islander people

The TGA's safety monitoring has not identified any additional or specific risks with the COVID-19 vaccines in Aboriginal and Torres Strait Islander people compared to the overall population. The reporting rate of adverse events is slightly lower for Aboriginal and Torres Strait Islander people - at 1.4 reports per 1000 vaccine doses - but the type and frequency of adverse effects are very similar.

In the AusVaxSafety survey, which has collected responses from about 92,000 Aboriginal and Torres Strait Islander people after they have received a COVID-19 vaccine dose, adverse events experienced by Aboriginal and Torres Strait Islander people are very similar to the overall population. The most common reactions include injection-site reactions, fatigue, headache and muscle and joint pain. These were generally mild and short-lived.

More detail about vaccine side effects in Aboriginal and Torres Strait Islander people for each individual vaccine is available on the AusVaxSafety website.

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 and is not impacting overall reporting rates in this age group.

To 22 May 2022, we have received about 4,160 reports from approximately 3.6 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 22 May 2022, we have received about 1,420 reports from approximately 2.2 million Comirnaty (Pfizer) doses administered in this age group. The most common reactions reported included chest pain, vomiting, fever, headache and abdominal pain. We have received 33 reports of suspected myocarditis and/or pericarditis in this age group. Following review of information in the reports, 4 were likely to represent myocarditis and another 6 reports were likely to represent pericarditis.

The latest safety data from the AusVaxSafety survey tells us that children aged 5–11 years report fewer side effects than older Australians following their second vaccine dose. About a third of children reported an expected adverse reaction compared to just over half of older individuals in the first 3 days after vaccination. Children aged 5-11 years were also less likely to see a doctor after a second vaccine dose, with medical attendance rates similar to those reported for other childhood immunisations.

Survey data also shows that as with adults, side effects appear to be more common after the second vaccine dose (reported by 33% of children) than after the first (26% of children). Most reactions are mild and temporary. Local reactions at the injection site (such as pain, swelling, redness and itching) are the most common, followed by headache and fatigue.

These observations in Australian children are in line with what was reported in the clinical trials and from real-world experience from the US, where over 8 million doses of the vaccine have been given to this age group.

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. It is not expected that the types of side effects will be different to first and second vaccine doses based on experience in Australia from AusVaxSafety, recent observations from the Centers for Disease Control and Prevention (CDC) in the US and the results of clinical trials. Together with other international regulators we are monitoring the type and frequency of adverse events after different vaccine combinations.

To 22 May 2022, approximately 13.6 million boosters or third doses have been administered in Australia. We have received approximately 8,100 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.

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. A US CDC study of active and passive surveillance data of COVID-19 vaccine booster doses (September 2021 - February 2022) found a similar trend. In men aged 18 - 24 years, the reporting rate of likely myocarditis was less than 1 in 100,000 mRNA vaccine booster doses compared to about 6 in 100,000 second doses. There is no indication that these events are more serious than after earlier doses. A similar US study of COVID-19 vaccine booster doses in adolescents (December 2021–February 2022) found the reporting rate of likely myocarditis was about 1 in 100,000 Comirnaty (Pfizer) booster doses in boys who had received the Comirnaty (Pfizer) vaccine for their first and second doses. This reporting rate is lower than was observed after a second dose. Another study in young military recruits in Israel found the risk of myocarditis was also less after a third Comirnaty dose than after a second 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

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 22 May 2022, about 58.8 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 867 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).

The 11 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. 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.

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

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

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 has been provisionally approved for adults and children aged 5 years and over. To 22 May 2022, about 40.5 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).

The Spikevax (Moderna) vaccine has been provisionally approved for adults and children aged 6 years and over. To 22 May 2022, about 4.4 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).

The Nuvaxovid (Novavax) vaccine has been provisionally approved for adults. To 22 May 2022, about 143,000 doses of Nuvaxovid (Novavax) have been administered in Australia. The TGA has received 709 reports of suspected adverse events. We are closely monitoring these reports. The most commonly reported reactions include chest pain, headache, fatigue, paraesthesia and dizziness.

Paraesthesia is an unusual feeling in the skin, such as tingling or a crawling sensation, and has also been reported for other COVID-19 vaccines. It is not known why paraesthesia sometimes occurs after vaccination, but it is thought it may be a stress-related response to immunisation rather than an immune reaction.

We have 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, one case was likely to represent myocarditis and 10 were likely to represent pericarditis. We are closely monitoring these reports and investigating whether there is an association between the Nuvaxovid (Novavax) vaccine and myocarditis and pericarditis. We will provide more information on this when the investigation is finalised.

In the AusVaxSafety survey, the most commonly reported reactions to Nuvaxovid (Novavax) are fatigue, injection-site reactions and headache. These are expected side effects that were also seen in clinical trials.

The Vaxzevria (AstraZeneca) vaccine has been provisionally approved for adults. To 22 May 2022, about 13.8 million doses of Vaxzevria (AstraZeneca) have been administered in Australia. However, since the end of 2021 very few doses are now 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 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). 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.

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. A recent study of patient data from 40 healthcare systems in the US found that heart complications were low overall but they were much higher after infection with the SARS-CoV-2 virus than after vaccination in males and females in all age groups. Similar findings were observed in population-based studies from Israel and the UK. In the Israeli study, COVID-19 infection was estimated to cause 11 cases of myocarditis per 100,000 people whereas the Comirnaty (Pfizer) vaccine was estimated to cause 2-3 cases of myocarditis per 100,000 people. An increase in other cardiac effects, such as pericarditis, arrhythmias and heart attacks, was also seen following SARS-CoV-2 infection in both of these studies.

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.

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 22 May 2022, from approximately 13.6 million booster or third doses, we have received 30 reports of likely myocarditis and 75 reports of likely pericarditis for Comirnaty (Pfizer) and 18 reports of likely myocarditis and 17 reports of likely pericarditis for Spikevax (Moderna). The median age of affected individuals was 33 years old.

Who is at risk of these heart problems?

Myocarditis is more commonly reported after the second dose in 12-17 year-old boys (12 cases per 100,000 Comirnaty doses and 21 cases per 100,000 Spikevax doses) and men under 30 (8 cases per 100,000 Comirnaty doses and 18 cases per 100,000 Spikevax doses). However, even in this population it remains rare. A similar trend for myocarditis has also been observed in a descriptive study of reporting data in the US.

A European review of myocarditis and pericarditis data in teenage boys and young men (12-29 years old) found for Comirnaty, there were 2 - 6 extra cases of myocarditis per 100,000 vaccinated individuals after a second dose compared to unvaccinated individuals. For Spikevax, there were 13 - 19 extra cases of myocarditis per 100,000 vaccinated individuals compared to unvaccinated individuals. 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.

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.

In the US descriptive study of myocarditis cases, the majority of those under 30 years of age were admitted to hospital but symptoms had resolved by the time they were discharged. The most common treatment for these individuals was nonsteroidal anti-inflammatory drugs, such as ibuprofen.

Evidence from a US surveillance survey 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. 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.

As part of our ongoing monitoring, we work with local health authorities to follow up on previously reported cases which could not be classified as likely or unlikely myocarditis or pericarditis due to insufficient information.

Reporting rates of likely myocarditis and pericarditis are given in Tables 2 and 3.

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

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, especially in the age categories where a low number of doses have been given. Rates of pericarditis by age are given for Comirnaty (Pfizer) and Spikevax (Moderna) in Table 3.

We continue to monitor Australian reports on 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).

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