MHRA Alert – RSV Vaccines and Guillain-Barré Syndrome Risk in Older Adults

Safety Alert: RSV Vaccines and Guillain-Barré Syndrome

The MHRA has identified a small but increased risk of Guillain-Barré syndrome (GBS) following vaccination with two RSV vaccines in adults aged 60 years and older. Healthcare professionals should be alert to this potential adverse effect and ensure appropriate patient counselling and monitoring.

Key Points

• A small increase in GBS risk has been observed following vaccination with Abrysvo (Pfizer) and Arexvy (GSK) RSV vaccines
• The risk applies to adults aged 60 years and older
• GBS is a rare but serious neurological condition; clinicians should recognise early signs including ascending paralysis and sensory disturbance
• The benefit-risk profile of these vaccines remains favourable for the target population, but informed consent is essential

Affected Medications

• Abrysvo (Pfizer RSV vaccine)
• Arexvy (GSK RSV vaccine)

Recommended Actions

• Review patient eligibility and risk factors before administration
• Provide clear information about GBS symptoms during pre-vaccination counselling
• Advise patients to seek immediate medical attention if they develop muscle weakness, tingling, or difficulty with eye movements or facial movements in the weeks following vaccination
• Report any suspected cases of GBS following RSV vaccination via the Yellow Card scheme
• Document the discussion and patient understanding in clinical records

For the full regulatory update and detailed guidance, refer to the MHRA drug safety update.