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MHRA Warns of Small Guillain-Barré Syndrome Risk With RSV Vaccines

NHS health workers will be asked to counsel recipients on early signs of the condition to ensure they receive immediate care.

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Overview

  • On July 7, the MHRA issued a drug alert to NHS staff about a small increased risk of Guillain-Barré syndrome following Pfizer’s Abrysvo and GSK’s Arexvy RSV vaccines.
  • The warning is based on 21 UK Yellow Card reports of suspected Guillain-Barré syndrome after more than 1.9 million Abrysvo doses administered to adults aged 75 to 79.
  • Healthcare professionals are instructed to counsel recipients to seek urgent medical attention if they experience tingling, numbness or muscle weakness.
  • The Commission on Human Medicines states that the benefits of RSV vaccination in older adults outweigh the rare risk and notes no evidence of increased risk for pregnant women receiving Abrysvo.
  • Regulatory officials continue investigations using UK monitoring data and a US study that estimated up to nine excess Guillain-Barré cases per million Abrysvo doses.