“GBS should therefore be added to the product information as a side effect of Vaxzevria,” the Amsterdam-based agency said.
Guillain-Barre Syndrome was a “very rare” side effect, occurring in under one in 10,000 people, it added.
The disorder is a nerve inflammation that may cause temporary paralysis and difficulty breathing.
In the United States, the very rare syndrome affects an estimated 3,000 to 6,000 people each year and most go on to recover.
The EMA recommended that a warning be added to the information on the vaccine that tells people to seek medical attention if they develop weakness and paralysis in the extremities that can progress to the chest and face.
The European drug regulator had in July listed Guillain-Barre syndrome as a “very rare” side effect of the Johnson & Johnson vaccine, which uses the same adenovirus technology as the AstraZeneca vaccine.
The US Food and Drug Administration also warned in July of an “increased risk” of developing the neurological syndrome with Johnson & Johnson’s dose.
Both regulators stressed that the vaccine’s benefits outweighed the potential risks.
source: HealthWise
