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UK Drug Safety Update · UK · 7 Jul 2025 · Safety alert & recall

Abrysvo (Pfizer RSV vaccine) and Arexvy (GSK RSV vaccine): alert to Guillain-Barré syndrome risk in older adults

Original title: Abrysvo▼ (Pfizer RSV vaccine) and Arexvy▼ (GSK RSV vaccine): be alert to a small risk of Guillain-Barré syndrome following vaccination in older adults

AI-generated summary

RSV vaccines Abrysvo and Arexvy carry a small increased risk of Guillain-Barré syndrome in adults aged 60 and older, according to this UK medicines safety alert. The Commission on Human Medicines advises the benefits outweigh this risk in older adults. No increased risk has been found in pregnant women receiving Abrysvo, the only RSV vaccine approved in pregnancy. Healthcare professionals should watch for Guillain-Barré syndrome symptoms and report suspected cases via Yellow Card.

From UK Drug Safety Update

There is currently no evidence of an increased risk of Guillain-Barré syndrome in pregnant women following vaccination with Abrysvo, the only RSV vaccine approved for use during pregnancy. The Commission on Human Medicines (CHM) advise that the benefits of vaccination against RSV outweigh the small risk of developing Guillain-Barré syndrome in older adults.

there is a small increase in the risk of Guillain-Barré syndrome following vaccination with Abrysvo and Arexvy in adults (aged 60 years and older). Currently, there is no evidence of an increased risk of Guillain-Barré syndrome in pregnant women following vaccination with Abrysvo, the only RSV vaccine approved for use during pregnancy

be attentive to signs and symptoms of Guillain-Barré syndrome in all recipients of Abrysvo and Arexvy to ensure early and correct diagnosis, initiate adequate supportive care and treatment, and rule out other causes

early medical care can reduce severity and improve outcomes

report suspected adverse drug reactions associated with Abrysvo and Arexvy on a Yellow Card

the RSV vaccine helps protect against respiratory syncytial virus (RSV), a virus which can make older adults and babies seriously ill. RSV can cause a type of chest infection called bronchiolitis in babies which can cause breathing problems and may need to be treated in hospital. RSV can also cause a serious lung infection (pneumonia) in and older adults requiring hospital care in some cases

the Pfizer RSV vaccine Abrysvo is currently offered in NHS vaccination programmes against RSV to adults aged 75-79 years old and to pregnant women to help protect babies after they are born

the GSK RSV vaccine Arexvy is not currently available on the NHS but may be available privately for use in individuals aged 60 years and older, or those aged 50–59 years who are at increased risk of RSV disease; Arexvy should not be given to pregnant individuals

rare or very rare cases of Guillain-Barré syndrome have been reported in older adults who have received the Abrysvo or Arexvy RSV vaccines respectively. Currently, there is no evidence that the Abrysvo RSV vaccine increases the risk of Guillain-Barré syndrome in pregnant women

Guillain-Barré syndrome is a serious nerve condition. It usually affects your arms and legs first before you get symptoms in other parts of your body

you might feel tingling, numbness or pins and needles in your feet and hands first. This is usually followed by muscle weakness and difficulty moving your joints

other symptoms can include:

- tingling, numbness or pins and needles in your feet and hands

- muscle weakness and difficulty moving your joints

- sharp, shooting pain (nerve pain), often in your legs or back

- problems breathing

- problems with your face, such as drooping face muscles or trouble swallowing or speaking

- problems with your eyes, such as double vision

some people’s symptoms become so severe that they are not able to move their legs, arms and face (paralysis)

Excerpt from the official page. The original is authoritative. Continue reading at UK Drug Safety Update ↗