其 他 安 全 警 示
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| The United Kingdom: Updates to the pregnancy and breastfeeding information for Spikevax COVID-19 vaccine and Comirnaty COVID-19 Vaccine (English only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that they have made changes to the product information for the Spikevax (Moderna) COVID-19 Vaccine and the Comirnaty (Pfizer/BioNTech) COVID-19 Vaccine to reflect the large amount of real-world data on pregnancy and breastfeeding that has now been collected. The available data are reassuring on safety and that the vaccines can be used during pregnancy and breastfeeding.
A large amount of information from pregnant women vaccinated with Spikevax and Comirnaty during the second and third trimester has not shown negative effects on the pregnancy or the newborn baby.
Published studies from the USA and Norway have compared miscarriage rates for vaccinated and unvaccinated women who were pregnant over the same time periods. The studies included data from a large number of women (more than 15,000) who received Spikevax or Comirnaty COVID-19 vaccines. Both studies found that the occurrence of miscarriage was equally likely amongst unvaccinated women as amongst women at the same stage of pregnancy who were vaccinated in the previous 3 to 5 weeks. These studies provide strong evidence for no increased risk of miscarriage in association with the mRNA vaccines in current use.
The numbers of Yellow Card reports for pregnant women are low in relation to the number of pregnant women who have received COVID-19 vaccines to date. There is no pattern from the reports to suggest that any of the COVID-19 vaccines used in the UK, or any reactions to these vaccines, increase the risk of miscarriage, stillbirths, congenital anomalies or birth complications.
There is no current evidence that COVID-19 vaccination while breastfeeding causes any harm to breastfed children or affects the ability to breastfeed. Spikevax and Comirnaty can be given during breastfeeding.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/covid-19-vaccines-and-medicines-updates-for-april-2022
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 DH will remain vigilant on any safety update of the product issued by other overseas drug regulatory authorities.
Related news on the safety data associated with the use of mRNA vaccines during pregnancy was previously issued by European Medicines Agency (EMA), and was posted on the Drug Office website on 19 Jan 2022.
Ends/Wednesday, Apr 20, 2022
Issued at HKT 16:00
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