ISSUE 6 DECEMBER
Reproduced with permission from Therapeutic Goods Administration (TGA) Medicines Safety Update 29 October 2024.
Summary
We [the TGA] have 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.
A warning about GBS was already included in the Shingrix PI. This described the findings of an observational study in individuals aged 65 years or older which showed an increased risk of GBS (estimated 3 excess cases per million doses administered) observed during the 6 weeks following vaccination.
What health professionals should do
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.
We continue to monitor adverse events associated with Shingrix and encourage health professionals to report suspected cases of GBS and other neuroinflammatory conditions after vaccination.
See the full article on the TGA website.
