Other safety alerts
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| European Union: PRAC finds no link between mRNA COVID-19 vaccines and postmenopausal bleeding |
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European Medicines Agency (EMA) announces that the Pharmacovigilance Risk Assessment Committee (PRAC) concluded that there was insufficient evidence to establish a causal association between the COVID-19 vaccines Comirnaty and Spikevax and cases of postmenopausal bleeding.
Postmenopausal bleeding is commonly defined as vaginal bleeding occurring one year or more after the last menstrual period. Postmenopausal bleeding is always considered abnormal and can be a symptom of serious medical conditions.
Recently, new information emerged from the medical literature as well as post-authorisation data that prompted investigation into postmenopausal bleeding with the two vaccines. The PRAC assessed all available data, including findings from literature, and available post-marketing spontaneous reports of suspected adverse reactions. After careful review, the PRAC considered that the available data do not support a causal association and an update of the product information for either vaccine is not warranted.
The committee will continue to monitor this issue for both Comirnaty and Spikevax through the established safety monitoring practices.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-4-7-march-2024
In Hong Kong, there are 3 Comirnaty vaccine products which are registered by Fosun Industrial Co., Limited:
- Comirnaty Dispersion For Injection COVID-19 mRNA Vaccine (Nucleoside Modified) 30 Micrograms/Dose (HK-67665);
- Comirnaty Original/Omicron BA.4-5 Dispersion For Injection COVID-19 mRNA Vaccine (Nucleoside Modified) (15/15 Micrograms)/Dose (HK-67666); and
- Comirnaty Omicron XBB.1.5 Dispersion For Injection COVID-19 mRNA Vaccine (Nucleoside Modified) 30 Micrograms/Dose (HK-68019).
There are 4 Spikevax vaccine products which are registered by Moderna Hong Kong Limited:
- Spikevax Bivalent Original/Omicron BA.4-5 Dispersion For Injection COVID-19 mRNA Vaccine (Nucleoside Modified) (50 Micrograms/50 Micrograms)/ml (HK-67830);
- Spikevax Bivalent Original/Omicron BA.4-5 Dispersion For Injection In Pre-filled Syringe COVID-19 mRNA Vaccine (Nucleoside Modified) 25 Micrograms/25 Micrograms (HK-67831);
- Spikevax XBB.1.5 Dispersion For Injection In Pre-filled Syringe COVID-19 mRNA Vaccine 50 Micrograms/Dose 0.5ml (HK-68081); and
- Spikevax 2023-2024 Formula (XBB.1.5) Suspension For Injection COVID-19 mRNA Vaccine 250 Micrograms/2.5ml (HK-68127).
All products are prescription-only medicines. The Department of Health will remain vigilant on safety update of the products issued by other overseas drug regulatory authorities.
Ends/Saturday, Mar 9, 2024
Issued at HKT 12:00
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