Other safety alerts
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| European Union: COVID-19 vaccines: update on ongoing evaluation of myocarditis and pericarditis |
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The European Medicines Agency (EMA) announces that EMA’s safety committee (PRAC) is continuing its assessment of reports of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the membrane around the heart) in a small number of people following vaccination with COVID-19 vaccines.
The PRAC started its review in April following cases of myocarditis after vaccination with Comirnaty in Israel. Most of these cases were mild and resolved within a few days. They mainly affected males under 30 years of age, with symptoms mostly starting within several days of vaccination with the second dose.
Cases of myocarditis and/or pericarditis were also reported in the EEA following vaccination with all COVID-19 vaccines.
Currently further analysis is needed to conclude on whether there is a causal relationship with the vaccines, and the PRAC is requesting additional data from the companies marketing them.
Myocarditis and pericarditis are inflammatory diseases of the heart that can occur following infections or immune diseases. Depending on the source, the incidence of myocarditis and pericarditis in the EEA ranges from 1 to 10 in 100,000 people per year. Symptoms of myocarditis and pericarditis can vary but often include shortness of breath, a forceful heartbeat that may be irregular, and chest pain. The conditions usually improve on their own or with treatment.
The PRAC encourages all healthcare professionals to report any cases of myocarditis or pericarditis and other adverse events in people having these vaccines. Patients who have symptoms such as shortness of breath, a forceful heartbeat that may be irregular, and chest pain following vaccination should consult their doctor.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/covid-19-vaccines-update-ongoing-evaluation-myocarditis-pericarditis
In Hong Kong, the above products are not registered pharmaceutical products 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 Department of Health will remain vigilant on safety update of the product issued by other overseas drug regulatory authorities.
Ends/ Saturday, 12 Jun, 2021
Issued at HKT 13:00
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