Safety Alerts and Products Recalls > ADRs that result in revision of product information on suspension of marketing authorisation

ADR that result in revision of patient information   The United States: FDA approves required updated warning in labeling of mRNA COVID-19 Vaccines regarding myocarditis and pericarditis following vaccination       Attachment: The United States: FDA approves required updated warning in labeling of mRNA COVID-19 Vaccines regarding myocarditis and pericarditis following vaccination   Related Information: FDA approves required updated warning in labeling of mRNA COVID-19 Vaccines rega... Posted 2025-06-26 European Union: PRAC update on risk of myocarditis and pericarditis with mRNA va... Posted 2021-12-04 European Union: PRAC assessing further data on risk of myocarditis and pericardi... Posted 2021-10-30 Australia: Pfizer COVID-19 vaccine (Comirnaty) - Addition of safety information ... Posted 2021-07-24 European Union: Comirnaty and Spikevax: possible link to very rare cases of myoc... Posted 2021-07-10 The United Kingdom: COVID-19 vaccines: Review of extremely rare reports of myoca... Posted 2021-07-08 Canada: Health Canada updates Pfizer-BioNTech and Moderna COVID-19 vaccine label... Posted 2021-07-02 Moderna and Pfizer-BioNTech COVID-19 vaccines: increased risks of myocarditis an... Posted 2021-06-28 The United States: Moderna and Pfizer-BioNTech COVID-19 vaccines: increased risk... Posted 2021-06-26 European Union: COVID-19 vaccines: update on ongoing evaluation of myocarditis a... Posted 2021-06-12