Other safety alerts
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| Australia: Pfizer COVID-19 vaccine (Comirnaty) - Addition of safety information about myocarditis and pericarditis to Product Information |
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The Therapeutic Goods Administration (TGA) announces that 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.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/media-release/pfizer-covid-19-vaccine-comirnaty-addition-safety-information-about-myocarditis-and-pericarditis-product-information
In Hong Kong, the above product is not registered pharmaceutical product under the Pharmacy and Poisons Ordinance (Cap. 138). The COVID-19 vaccine by Fosun Pharma/BioNTech (i.e. Comirnaty) is authorised for emergency use in Hong Kong in accordance with the Prevention and Control of Disease (Use of Vaccines) Regulation (Cap. 599K). The package insert of Comirnaty has already been updated to include myocarditis and pericarditis as its adverse reactions. Related news was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 12 Jun 2021, with the latest update posted on 10 Jul 2021. Letters to inform local healthcare professionals were issued by the Department of Health (DH) on 28 Jun 2021. The DH will remain vigilant on safety update of the product issued by other overseas drug regulatory authorities.
Ends/ Saturday, Jul 24, 2021
Issued at HKT 12:00
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