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Pfizer COVID-19 vaccine (COMIRNATY) - Addition of safety information about myocarditis and pericarditis to Product Information

23 July 2021

The Product Information (PI) used by healthcare professionals for COMIRNATY has been amended to include safety related information on myocarditis and pericarditis.

Myocarditis is inflammation of the heart muscle while pericarditis is inflammation of the lining around the heart. There are many potential causes of myocarditis and pericarditis, including as a complication in people who are infected with COVID-19 or some other viruses.

Very rare cases of myocarditis and pericarditis have been observed following vaccination with COMIRNATY. These cases have primarily occurred within 14 days following vaccination, more often after the second vaccination, and more often in younger men. The changes to the Australian PI follow similar updates by the European Medicines Agency, Health Canada, the UK’s Medicines and Healthcare products Regulatory Agency and the US Food and Drug Administration.  

The benefits of protection against COVID-19 far outweigh the risks from rare and generally mild side effects. Effects on the heart from COVID-19 infection are much more common and usually more severe than with rare effects from vaccination. The Australian Technical Advisory Group on Immunisation (ATAGI) advises the Government on immunisation issues. ATAGI reaffirms that the benefits of COMIRNATY outweigh these rare risks.

As with all COVID-19 vaccines, the TGA will continue to monitor the safety of COMIRNATY and update recommendations as needed.

If you have any concerns about the COVID-19 vaccines, we encourage you to consult your healthcare professional for advice with regard to your particular situation.

View the updated Product Information on the COVID-19 vaccine: Pfizer Australia - COMIRNATY BNT162b2 (mRNA) page.