Other safety alerts
|
| |
| European Union: PRAC assessing further data on risk of myocarditis and pericarditis with mRNA vaccines |
| |
The European Medicines Agency (EMA) announces that their safety committee (PRAC) is assessing further data providing more information on the risk of myocarditis and pericarditis following vaccination with COVID-19 vaccines Comirnaty and Spikevax (previously COVID-19 Vaccine Moderna).
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.
The 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 these vaccines, together with a warning to raise awareness among healthcare professionals and people getting these vaccines.
The committee has now asked the companies that market these vaccines to perform an in-depth review of all published data on the association of myocarditis and pericarditis, including clinical trial data, data from the literature and data available in the public domain.
EMA will continue to monitor the vaccines’ safety and effectiveness and will communicate further when new information becomes available.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-25-28-october-2021
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 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 24 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, October 30, 2021
Issued at HKT 12:00
|
| |
|
