A jab given to patients to battle RSV through the NHS could potentially cause a disabling condition known as Guillain-Barré Syndrome, according to experts in the US
Health experts have warned a jab given to pregnant women and pensioners has the potential to cause serious neurological problems.
The Respiratory Syncytial Virus Vaccine helps against the condition known as RSV and, last year, was prescribed to people considered vulnerable in Britain for the first time. Now however the Food and Drug Administration has warned some types of the jab put people at risk of a disabling condition known as Guillain-Barré syndrome (GBS).
The FDA said on its website: “FDA has required and approved safety labeling changes to the prescribing information for Abrysvo (Respiratory Syncytial Virus Vaccine) manufactured by Pfizer Inc. and Arexvy, manufactured by GlaxoSmithKline Biologicals. Specifically, FDA has required each manufacturer to include a new warning about the risk for (GBS) following administration of their Respiratory Syncytial Virus (RSV) vaccine.
“The Prescribing Information for each vaccine has been revised to include the following language in the Warnings and Precautions section. Abrysvo – The results of a postmarketing observational study suggest an increased risk of Guillain-Barré syndrome (GBS) during the 42 days following vaccination with Abrysvo. The results of a postmarketing observational study suggest an increased risk of Guillain-Barré syndrome during the 42 days following vaccination with Arexvy.”
Only Pfizer’s Abrysvo is available through the NHS, and UK packaging already includes the warning. However, the update reinforces the importance of staying informed about potential serious side effects.
A spokesperson for Pfizer said: “As with every medicine and vaccine, Pfizer has robust processes to meet its regulatory responsibilities to closely monitor, report and analyse all adverse events, and collect relevant information to assess any new potential safety risks that may be associated with the RSV (bivalent, recombinant) vaccine.
“As part of our pharmacovigilance efforts and compliance with regulatory requirements related to quality and safety, we also work closely with the MHRA in the UK, as they independently monitor the safety profile of our vaccine.”
The UK leaflet categorises GBS as a “rare” yet serious condition possibly affecting up to one in 1,000 people who have had the vaccine, especially those over 60. GBS is a neurological ailment which can be severe, attacking nerves and warranting hospitalisation for weeks or months.
It can influence a variety of nerves from senses to movement, and even heart rhythm, with initial symptoms manifesting typically in the limbs. Symptoms to watch for include unusual sensations like numbness or a pins and needles effect in hands and feet, followed by muscle weakness and joint mobility issues.
