COVID-19 vaccine weekly safety report - 16-06-2022

• 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 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 (13 cases per 100,000 Comirnaty doses and 23 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 12 June 2022, the TGA has received 584 reports which have been assessed as likely to be myocarditis from about 41.2 million doses of Comirnaty (Pfizer) and 100 reports which have been assessed as likely to be myocarditis from about 4.5 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).
• On 10 June 2022, an external Vaccine Safety Investigation Group (VSIG), made up of a number of medical specialists as well as consumer representatives, reviewed the deaths of 2 men from very rare neurological conditions that developed after their first dose of Vaxzevria (AstraZeneca). After close consideration, the expert group agreed that these extremely rare and unusual conditions were most likely related to vaccination based on the lack of evidence for alternative causes and the short period between vaccination and symptom onset.

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 12 June 2022, we have received about 4,190 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 12 June 2022, we have received about 1,480 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 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.

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

To 12 June 2022, approximately 13.8 million people have received boosters in Australia. This includes 1.9 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 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 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 12 June 2022, about 59.7 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 884 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) and one was a case of immune thrombocytopenia (ITP). A Vaccine Safety Investigation Group met on 10 June 2022 and classified 2 more deaths as likely linked to vaccination. Both were following a first dose of Vaxzevria (AstraZeneca) and were related to very rare conditions involving the nervous system.

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:

• 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 12 June 2022, about 41.2 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).

The Spikevax (Moderna) vaccine has been provisionally approved for adults and children aged 6 years and over. To 12 June 2022, about 4.5 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).

The Nuvaxovid (Novavax) vaccine has been provisionally approved for adults. To 12 June 2022, about 153,700 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. 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.

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).

The Vaxzevria (AstraZeneca) vaccine has been provisionally approved for adults. To 12 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.

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.

Outcomes of Vaccine Safety Investigation Group (VSIG) meeting - 10 June 2022

The TGA convened an external expert group to review the deaths of two Victorian men who died within 2 months of receiving their first dose of Vaxzevria (AstraZeneca). Both deaths occurred in mid-2021 and were brought to a VSIG following review of further clinical information. The TGA acknowledges the devastating impact that these deaths have had on the men's families, and we extend our sincere condolences to them.

The expert group assessed whether their conditions could have been caused by vaccination using an internationally-accepted method developed by the World Health Organization. The group included a panel of experts in neurology and pathology, infectious diseases and vaccines, immunology and communication. The panel also included a consumer representative.

The first case involved a 72-year-old man who initially experienced symptoms, including muscle weakness, suggestive of Guillain-Barre Syndrome (GBS) approximately 2 weeks after vaccination. Following a worsening of his condition he sadly died 6 weeks later. Further clinical investigation found that the man experienced a rare and severe form of nerve damage, related to GBS, together with another neurological condition related to transverse myelitis. GBS and transverse myelitis are known, very rare adverse events for Vaxzevria (AstraZeneca). These events were previously identified by the TGA and international regulators, leading to their inclusion in the Product Information. The VSIG agreed that the relatively short time between vaccination and his symptom onset, the unusual nature of the condition and lack of an alternate cause suggested vaccination was the likely cause of these conditions. However, they noted that there was some information missing, including whether he had tested positive for COVID-19, which can also be a cause of the condition.

The second case occurred in a 63-year-old man who developed acute disseminated encephalomyelitis (ADEM) 12 days after vaccination and died from the condition 2 weeks later. ADEM is a very rare neurological condition causing demyelination (damage to the protective covering around nerves) in the brain and spinal cord. In many cases of ADEM, a cause cannot be confirmed. When a cause is found, it most often develops after viral infections such as influenza, and has also been reported after COVID 19. Less commonly, demyelinating disorders have been reported after vaccination, including with Vaxzevria (AstraZeneca) and certain other vaccines. Following review of the available clinical information, the VSIG advised that vaccination was the likely cause of ADEM in this individual given the lack of evidence for alternative causes and the short period between vaccination and symptom onset. However, all other potential causes could not be excluded on the information available to the group, including whether the individual had tested positive for COVID-19. The group also noted that while there are published case reports and case series of ADEM following vaccination, there is not published evidence that the number of cases following vaccination with Vaxzevria (AstraZeneca) exceeds the background rate of ADEM in the population.

The VSIG noted that it was not clear why these individuals experienced these very rare adverse events, and their severity, resulting in death, made these events even more unusual. The VSIG noted that Vaxzevria (AstraZeneca) brings benefits of protection from COVID-19 that far outweigh the risks but acknowledge the sad loss for the families involved.

We reinforce the existing advice in the Product Information for Vaxzevria (AstraZeneca) which states that 'healthcare professionals should be alert of signs and symptoms of demyelinating disorders to ensure correct diagnosis, in order to initiate adequate supportive care and treatment, and to rule out other causes.'

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).

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 23 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.

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 12 June 2022, from approximately 13.8 million people who have received booster doses, we have received 37 reports of likely myocarditis and 77 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.

* 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.

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

^‡ To 12 June 2022, from about 2.2 million vaccine doses given, 4 likely cases of myocarditis have been reported in children aged 5-11 years.

^† 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.

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

^‡ To 12 June 2022, from about 2.2 million Comirnaty 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 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).

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