Looks like Comirnaty is still flying under a conditional use marketing authorization in Europe. It is up for renewal on December 21, 2021. The ongoing clinical trials and studies do not complete until December 2023. Here is the latest revised safety assessment, provided by the Pharmacovigilance Risk Assessment Committee(PRAC), of the European Medicines Agency

From the latest PRAC report published on November 11, 2021...

1.Updates onsafety assessments for Comirnaty

During its meeting held 25 to 28 October 2021, PRAC assessed new safety data for Comirnaty (see section 2‘How safety is monitored’.

Myocarditis and pericarditis

PRAC is assessing further data on the risk of myocarditis and pericarditis following vaccination with Comirnaty. Myocarditis and pericarditis are inflammatory conditions of the heart. Symptoms can vary but often include breathlessness, a forceful heartbeat that may be irregular (palpitations), and chest pain. PRAC had previously reviewed cases of myocarditis and pericarditis spontaneously reported in the European Economic Area (EEA). The review concluded in July 2021 with a recommendation to list both conditions as side effects in the product information for Comirnaty, together with a warning to raise awareness among health care professionals and people receiving this vaccine. PRAC has now asked the company that markets Comirnaty to perform an in-depth review of all published data on the association of myocarditis and pericarditis with the vaccine, including clinical trial data, data from the literature and other data available in the public domain.

[link to www.ema.europa.eu (secure)]

[link to www.ema.europa.eu (secure)]