Other safety alerts
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| European Union: Comirnaty and Spikevax: possible link to very rare cases of myocarditis and pericarditis |
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The European Medicines Agency (EMA) announces that its Pharmacovigilance Risk Assessment Committee (PRAC) has concluded that myocarditis and pericarditis can occur in very rare cases following vaccination with the COVID-19 vaccines. Comirnaty and Spikevax (previously COVID-19 Vaccine Moderna).
PRAC is therefore recommending listing myocarditis and pericarditis as new side effects in the product information for these vaccines, together with a warning to raise awareness among healthcare professionals and people taking these vaccines.
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.
Healthcare professionals should be alert to the signs and symptoms of myocarditis and pericarditis. They should tell people receiving these vaccines to seek immediate medical attention if symptoms indicative of myocarditis or pericarditis occur. These include breathlessness, a forceful heartbeat that may be irregular and chest pain. Healthcare professionals should consult applicable guidance and/or consult specialists (e.g. cardiologists) to diagnose and treat these conditions.
At this point in time, no causal relationship with myocarditis or pericarditis could be established with two other COVID-19 vaccines authorised in the European Economic Area (EEA), COVID-19 Vaccine Janssen and Vaxzevria, and PRAC has requested additional data from the companies marketing these vaccines.
EMA confirms that the benefits of all authorised COVID-19 vaccines continue to outweigh their risks, given the risk of COVID-19 illness and related complications and as scientific evidence shows that they reduce deaths and hospitalisations due to COVID-19. EMA will also send a direct healthcare professional communication (DHPC) to healthcare professionals.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/comirnaty-spikevax-possible-link-very-rare-cases-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). 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 8 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 10, 2021
Issued at HKT 12:15
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