Other safety alerts
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| The United States: The Janssen COVID-19 Vaccine: myocarditis, pericarditis and facial paralysis |
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The US Food and Drug Administration (FDA) announces that the Janssen COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) was revised to include a warning conveying that reports of adverse events following use of the vaccine under emergency use authorization suggest increased risks of myocarditis and pericarditis, particularly within the period 0 through 7 days following vaccination. The Fact Sheet for Recipients and Caregivers was also revised to include information about myocarditis and pericarditis following administration of the Janssen COVID‑19 Vaccine. An additional revision to the Fact Sheets was made to include that facial paralysis (including Bell’s Palsy) has been reported during post-authorization use.
Please refer to the following website in FDA for details:
http://www.fda.gov/news-events/press-announcements/fda-roundup-march-14-2023
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Wednesday, Mar 15, 2023
Issued at HKT 14:00
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