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COVID-19 vaccine safety report - 22-12-2022

Published

Four main COVID-19 vaccines are currently in use in Australia - Comirnaty (Pfizer), Spikevax (Moderna), Vaxzevria (AstraZeneca), and Nuvaxovid (Novavax). Bivalent vaccines for both mRNA vaccines are also now registered in Australia - Spikevax bivalent vaccine and Comirnaty bivalent vaccine. All of these COVID-19 vaccines have met the TGA's high standards for quality, safety and effectiveness.

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

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

Report a suspected side effect.

This is an abbreviated version of the COVID-19 vaccine safety report. For full details, go to the report published on 15 December 2022.

A snapshot - vaccine safety monitoring since the rollout began

Since February 2021, 64 million COVID-19 vaccine doses have been given to Australians. During this time, the TGA has received just over 137,000 suspected adverse event reports. These have come from members of the public, health professionals and local health authorities and the vaccine pharmaceutical companies.

Like other medicine regulators overseas, we monitor these reports, and look at the latest medical literature, media and other potential sources of new safety information. This surveillance acts as an early warning system to identify reporting patterns or trends that need to be investigated for safety concerns.

Since the beginning of the roll out, we have investigated over 120 potential vaccine safety signals. This analysis has resulted in over 55 regulatory actions including 39 safety-related warnings and updates to the Product Information documents for COVID-19 vaccines. This is on top of safety updates initiated by the pharmaceutical companies that sponsor the vaccines. These regulatory actions have been communicated to the general public in this vaccine safety report.

Being able to provide credible and up-to-date information about the benefits and risks associated with the vaccines has been our top priority. We have provided information about what we do know and where there may be uncertainty and responded to dispel misinformation about the safety of the vaccines.

We thank both health professionals and the general public for taking the time to report to us when they have suspected an adverse reaction following vaccination. This has helped us to monitor the safety of the vaccines and take action when needed.

Summary

  • Vaccination against COVID-19 is the most effective way to reduce deaths and severe illness from infection. The protective benefits of vaccination far outweigh the potential risks.
  • The most up-to-date recommendations for use of the COVID-19 vaccines are available from the Australian Technical Advisory Group on Immunisation (ATAGI).
  • 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.
  • Reporting rates of adverse events following COVID-19 vaccination are very stable. Information on vaccine safety in children, adolescents and adults following vaccination is available in the safety report published on 15 December 2022.
  • We are carefully monitoring and reviewing reports of myocarditis and pericarditis (inflammation of the heart or membrane around the heart) following vaccination. These are usually temporary conditions, with most people getting better within a few days.
  • Myocarditis is a known but very rare side effect of the mRNA vaccines. It 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). It occurs in males and females but is more common after the second dose in boys aged 12-17 years (13 cases per 100,000 Comirnaty doses and 24 cases per 100,000 Spikevax doses) and men under 30 (9 cases per 100,000 Comirnaty doses and 20 cases per 100,000 Spikevax doses).
  • We are also closely monitoring reports of thrombosis with thrombocytopenia syndrome (TTS), Guillain-Barre syndrome (GBS) and immune thrombocytopenia (ITP) following Vaxzevria (AstraZeneca) in adults. However, since the end of 2021 very few doses of this vaccine are being used. Detailed information of our analysis of these adverse effects is available in a previous vaccine safety report.

Total adverse event reports following immunisation to 18 December 2022

  • 2.1

    Reporting rate per 1,000 doses

  • 137210

    Total adverse event reports

  • 64444252

    Total doses administered

  • 48622

    Total reports for Vaxzevria

  • 80863

    Total reports for Comirnaty

  • 7393

    Total reports for Spikevax

  • 961

    Total reports for Nuvaxovid

  • 717

    Total reports for brand not specified

Reported side effects for COVID-19 vaccines

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

Anyone can report a suspected side effect, either:

  • directly to the TGA
  • through a health professional
  • by calling the Adverse Medicine Events line on 1300 134 237.

You can report anonymously.

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

The most frequently reported side effects suspected to be associated with the vaccines include headache, muscle and joint pain, fever, chills and nausea. Skin reactions at the site of the injection are also common and can include pain, swelling, redness and an itchy rash. These are recognised side effects of vaccination and are usually transient and mild.

Comirnaty (Pfizer) mRNA vaccines

The Comirnaty (Pfizer) vaccine is provisionally approved for adults and children aged 5 years and over. To 18 December 2022, over 44 million doses have been administered in Australia. A bivalent vaccine from Pfizer is also available as a booster dose in adults.

Updates to the Product Information

Dizziness

Dizziness has been added to the Product Information used by health professionals for both the original and bivalent vaccines as a potential side effect that can occur after vaccination. Dizziness was not observed in the clinical trials but has been reported through real-world use of the vaccine after approval. It is not currently known how frequently this reaction occurs.

Comirnaty bivalent vaccine

The Product Information for the bivalent vaccine has also been updated in line with the original vaccine. This includes updates to the warning about myocarditis and pericarditis, and the addition of non-sexually acquired genital ulceration as an adverse reaction that can potentially occur after vaccination. Details about these changes are described in the vaccine safety report published on 20 October 2022.

Go to the Comirnaty (Pfizer) information page to find out more about this vaccine.

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 vaccines

The original Spikevax vaccine is provisionally approved for adults and children aged 6 years and over. To 18 December 2022, over 5 million doses have been administered in Australia. A paediatric formulation of the original vaccine is available for children aged from 6 months to 5 years (or less than 6 years) as well as a new Spikevax bivalent vaccine for use as a booster dose in adults.

Go to the Spikevax (Moderna) information page to find out more about this vaccine.

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 is provisionally approved for adults. To 18 December 2022, about 236,000 doses of Nuvaxovid (Novavax) have been administered in Australia.

Updates to the Product Information

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, 8 cases were likely to represent myocarditis and 30 were likely to represent pericarditis. See Table 1 below for reporting rates of myocarditis and pericarditis associated with the Nuvaxovid (Novavax) vaccine.

The following warning has been added to the Product Information:

"There is an increased risk of myocarditis and pericarditis in males and females following vaccination with NUVAXOVID (see section 4.8 Adverse Effects (Undesirable effects)). These conditions can develop within just a few days after vaccination and have primarily occurred within 14 days.

Available data suggest that the course of myocarditis and pericarditis following vaccination is not different from myocarditis or pericarditis in general.

Healthcare professionals should be alert to the signs and symptoms of myocarditis and pericarditis. Vaccinated individuals, parents and caregivers should be instructed to seek immediate medical attention if they develop symptoms indicative of myocarditis or pericarditis such as (acute and persisting) chest pain, shortness of breath, or palpitations following vaccination. Non-specific symptoms of myocarditis and pericarditis also include fatigue, nausea and vomiting, abdominal pain, dizziness or syncope, oedema and cough. Healthcare professionals should consult guidance and/or specialists to diagnose and treat this condition."

For further details, please refer to the relevant clinical guidelines developed by the Australian Technical Advisory Group on Immunisation.

Myocarditis has also been added as a potential adverse reaction to the Product Information after been reported during post-market surveillance. It is not known how frequently this reaction occurs as it was identified through spontaneous adverse event reporting.

Go to the Nuvaxovid (Novavax) information page to find out more about this vaccine.

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

Vaxzevria (AstraZeneca) vaccine

The Vaxzevria (AstraZeneca) vaccine is provisionally approved for adults. To 18 December 2022, just under 14 million doses of Vaxzevria (AstraZeneca) have been administered in Australia. Very few doses of this vaccine have been used since 2021.

Go to the Vaxzevria (AstraZeneca) information page to find out more about this vaccine.

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 after COVID-19 vaccination

Myocarditis and pericarditis have been reported for the mRNA vaccines and Nuvaxovid (Novavax) vaccine. For more details about what these adverse effects are, their severity and what symptoms to look out for, please refer to the vaccine safety report published on 15 December 2022.

ATAGI continues to emphasise that the protective benefits of the vaccines far outweigh the rare risk of these side effects.

ATAGI has advised that people who have had suspected vaccine-related myocarditis or pericarditis should defer further COVID-19 vaccine doses until at least 6 weeks after their symptoms have resolved. They should also discuss future vaccine doses with their treating doctor. Refer to expert Guidance on myocarditis and pericarditis after COVID-19 vaccines for more information.

What does the TGA know about myocarditis and pericarditis in Australia?

Reports of suspected myocarditis and pericarditis received by the TGA have been reviewed against internationally accepted criteria to classify if they are likely to be related to vaccination.

Table 1 summarises the most up-to-date reporting rates of likely myocarditis and pericarditis following vaccination for the total population and for key age groups where reporting rates are higher. For more detail about rates in other age groups, refer to the safety report published on 15 December 2022.

Rates of myocarditis and pericarditis following COVID-19 vaccines

Table 1. Reporting rates of likely myocarditis and pericarditis received by the TGA to 18 December 2022

Population group

Dose

Rate per 100,000 doses

Comirnaty

Spikevax

Nuvaxovid

Myocarditis*

Boys 12-17 years

2nd dose

13

24

No cases

Men 18‑29 years

2nd dose

9

20

Total population

All doses

1.6

2.1

3.3

Booster doses**

Less than 1

Less than 1

Rate not reported‡

Pericarditis*

Men 18-49 years

All doses

4.3

5.5

27†

Total population

All doses

2.5

2.3

13

* Classification of myocarditis and pericarditis cases likely to be related to vaccination is based on several factors including the patient’s symptoms and test results, the absence of other known causes of myocarditis and pericarditis, and a doctor’s report in the absence of medical tests and investigations.

** Includes 3rd and 4th dose boosters.

‡ The number of myocarditis cases reported is too low to reliably estimate reporting rates.

† The reporting rate of pericarditis for Nuvaxovid is less certain than for Comirnaty and Spikevax due to the low number of Nuvaxovid vaccine doses given.

Useful links

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

COVID-19 vaccines: Frequently asked questions - 6 December 2022

COVID vaccines - is it true? - 4 Nov 2022

Up-to-date recommendations for the use of COVID-19 vaccines in Australia - 12 December 2022

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

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)

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