其 他 安 全 警 示
|
| |
| Australia: Updated warnings for Respiratory Syncytial Virus (RSV) vaccines Arexvy and Abrysvo (English only) |
| |
The Therapeutic Goods Administration (TGA) announces that safety information for Respiratory Syncytial Virus (RSV) vaccines Arexvy and Abrysvo has been updated to reflect the low risk of people contracting Guillain-Barre syndrome (GBS) following vaccination. This is a disorder in which the body’s immune system damages nerve cells, causing muscle weakness and sometimes paralysis. Most people recover completely from GBS, but some serious illnesses can be fatal.
Arexvy and Abrysvo are registered vaccines against Respiratory Syncytial Virus (RSV). This infection affects the respiratory tract and can cause severe disease, particularly in very young and older people.
- Arexvy and Abrysvo are both approved for individuals 60 years and older to prevent lower respiratory tract disease caused by RSV.
- Arexvy is also approved for individuals aged 50 to 59 who are at increased risk for RSV infection.
- Abrysvo is also approved for pregnant women between 24-36 weeks of gestation to prevent lower respiratory tract disease in infants from birth to 6 months of age as they acquire antibodies to RSV while in the womb.
Given the potential severity of RSV infection and the rarity of GBS, the benefit-risk balance remains strongly in favour of vaccination in the target groups.
In November 2024, the TGA conducted a focused signal investigation to review US data presented at the Advisory Committee on Immunization Practices October 2024 meeting. Given the seriousness of this adverse event, and noting that post-marketing data from the US supported an increased risk of GBS after vaccination with Abrysvo or Arexvy, TGA required the Product Information (PI) for these products to be updated to include the risk of GBS.
As of 24 March 2025, the TGA had not received any reports of GBS following vaccination with Abrysvo or Arexvy in Australia.
The risk of GBS as a rare adverse event following vaccination in people aged 60 or over have been included of the Australian PIs for Abrysvo and Arexvy (sections 4.4 and 4.8). The PIs both include similar advice that health professionals should monitor/be alert to signs and symptoms of GBS to ensure correct diagnosis, in order to initiate adequate supportive care and treatment, and to rule out other causes.
Health professionals should:
- be aware of the higher GBS risk in people following vaccination with Arexvy or Abrysvo.
- warn patients of this possible but rare risk and encouraged to seek medical attention if they experience symptoms, as early medical care can reduce severity and improve outcomes.
- be alert to signs and symptoms of GBS to ensure correct diagnosis, in order to initiate adequate supportive care and treatment, and to rule out other causes. Symptoms of GBS include pins and needles (paraesthesia), numbness, weakness and paralysis. Typically, hands and/or feet are affected first, with symptoms progressing up the body to the legs, arms, face and muscles involved with breathing. These symptoms may progress over a few days or weeks.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/news/safety-updates/updated-warnings-respiratory-syncytial-virus-vaccines-arexvy-and-abrysvo
In Hong Kong, Abrysvo Vaccine Powder And Solvent For Solution For Injection (HK-68213) and Arexvy Vaccine Powder And Suspension For Suspension For Injection (HK-67997) are pharmaceutical products registered by Pfizer Corporation Hong Kong Limited and GlaxoSmithKline Limited respectively. Both are prescription-only medicines. So far, the Department of Health (DH) has received one case of adverse event following immunisation with Arexvy, but this case was not related to GBS. The DH has not received any case of adverse event following immunisation with Abrysvo.
Related news was previously issued by the US FDA, and was posted on the Drug Office website on 8 January 2025. Letters to inform local healthcare professionals were issued by the DH on 8 January 2025. As previously reported, the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Monday, May 19, 2025
Issued at HKT 15:00
|
| |
|
