Other safety alerts
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| Australia: Shingrix vaccine and very rare risk of Guillain-Barré Syndrome |
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The Therapeutic Goods Administration (TGA) announces that it has received Australian reports of Guillain-Barré Syndrome (GBS) following Shingrix vaccination.
After investigating this issue and seeking advice from an expert panel, the Product Information (PI) and Consumer Medicine Information (CMI) documents for Shingrix were updated. These changes reflect the new reporting data, recognising that GBS is a very rare adverse event.
The TGA began an investigation into the possible association between Shingrix and GBS in February 2024 after receiving two reports detailing this adverse event.
The Shingrix PI already contained information about an observational study in people aged 65 years and over. The study found an increased risk of GBS (estimated 3 excess cases per million doses administered) observed in the 42 days following vaccination. The PI noted that the evidence was insufficient to determine a causal relationship.
At the time, GBS following Shingrix vaccination had also been reported to the World Health Organisation’s global adverse event reports database. The TGA also identified published literature that suggested a possible association between Shingrix and GBS. Its investigation recommended that GBS be included in the adverse event section of the Australian Shingrix PI. This update harmonises the Australian PI with corresponding information from the United States and Canada.
The association between GBS and Shingrix was also considered by an independent expert advisory group on immunisation. This review included discussion of a single adverse event report involving Shingrix and meningoencephalitis. The expert group agreed that inclusion of GBS as an adverse event in the Shingrix PI was appropriate and recommended raising awareness of the possibility of GBS following Shingrix.
The TGA’s public Database of Adverse Event Notifications included 13 reports of GBS following Shingrix vaccination up to 18 September 2024. The reports involved patients of both sexes. All were aged from their mid-60s to mid-80s. No deaths were reported.
Health professionals should be aware of GBS cases following vaccination with Shingrix. Patients should be warned of this possible but very rare risk and encouraged to seek medical attention if they experience symptoms, as early medical care can reduce severity and improve outcomes.
Shingrix is not generally recommended for people with a history of GBS whose first episode occurred within 6 weeks of receiving any vaccine (such as an influenza vaccine or a previous dose of Shingrix vaccine). Those with a history of GBS not associated with Shingrix should discuss the risks and benefits of receiving Shingrix with a health professional.
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/shingrix-vaccine-and-very-rare-risk-guillain-barre-syndrome
In Hong Kong, Shingrix Vaccine Powder And Suspension For Suspension For Injection (HK-66840) is a pharmaceutical product registered by GlaxoSmithKline Limited, and is a prescription-only medicine. So far, the Department of Health (DH) has received 4 cases of adverse events following immunisation with Shingrix, but these cases were not related to GBS.
Related news was previously issued by the US Food and Drug Administration, and was posted on the Drug Office website on 25 Mar 2021. Letters to inform local healthcare professionals were issued by the DH on 25 Mar 2021. In Feb 2022, the Registration Committee of the Pharmacy and Poisons Board discussed the matter, and decided that the sales pack labels and/or package inserts of locally registered Shingrix vaccine should include the relevant safety information about increased risk of Guillain-Barré syndrome in individuals aged 65 years or older. The DH will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities.
Ends/Tuesday, Oct 29, 2024
Issued at HKT 17:00
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