The medicines regulator has issued a warning to NHS health staff about a small increased risk of a rare condition affecting the nerves in people vaccinated against respiratory syncytial virus (RSV).
Guillain-Barre syndrome is a rare but serious condition which needs urgent treatment in hospital to prevent it progressing.
It can affect people’s senses, movement, breathing and heartbeat – usually starting in the arms and legs before spreading to other areas.
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a drug alert for the Abrysvo (made by Pfizer) and Arexvy (GSK) vaccines for RSV after they were linked to 21 suspected cases of Guillain-Barre syndrome in adults aged 60 and over.
However, the Commission on Human Medicines still advises that “the benefits of vaccination against RSV outweigh the small risk of developing Guillain-Barre syndrome in older adults”.
In its alert, the MHRA said: “Healthcare professionals should advise all recipients of Abrysvo and Arexvy that they should be alert to signs and symptoms of Guillain-Barre syndrome and, if they occur, to seek immediate medical attention as it requires urgent treatment in hospital.”
It warned staff to be alert to the signs and symptoms of the syndrome.
It added that there is currently no evidence of an increased risk of Guillain-Barre syndrome in pregnant women following vaccination with Abrysvo, the only RSV vaccine approved for use during pregnancy.
The RSV vaccine helps protect against respiratory syncytial virus, which can make older adults and babies seriously ill.
RSV can cause bronchiolitis in babies which can cause breathing problems, while it can cause pneumonia in older people, both of which may require hospital stays.
The Pfizer RSV vaccine Abrysvo is currently offered on the NHS to adults aged 75 to 79 and to pregnant women.
The GSK RSV vaccine Arexvy is not currently available on the NHS but may be available privately in the UK.
Symptoms of Guillain-Barre syndrome can include tingling, numbness or pins and needles in feet and hands, muscle weakness and difficulty moving joints.
There may also be problems breathing and drooping face muscles or trouble swallowing or speaking.
Up to June 2, the MHRA has received 21 Yellow Card reports of suspected Guillain-Barre syndrome in older adults (aged 75-79 where known) following Abrysvo.
This is in the context of over 1.9 million doses of Abrysvo administered, it said.
Over the same time period, the MHRA has not received any Yellow Card reports of suspected Guillain-Barre syndrome following Arexvy, however there has been very limited use of this vaccine in the UK to date.
In the US, one study suggested Abrysvo and Arexvy were associated with nine and seven excess Guillain-Barre syndrome cases per million vaccine doses administered, respectively.
