Jan 7 (Reuters) - GSK and Pfizer's ( PFE )
respiratory syncytial virus (RSV) vaccines will carry warnings
that they can increase the risk of developing a rare
neurological disorder, the U.S. Food Drug Administration said on
Tuesday.
The regulator conducted a postmarketing trial which
suggested increased risk of Guillain-Barré syndrome (GBS) 42
days following vaccination.
However, the available evidence was insufficient to
establish a causal relationship, the FDA said.
The risks flagged in the prescribing information of GSK's
Arexvy and Pfizer's ( PFE ) Abrysvo were not the regulator's strictest
"boxed" warnings.
GBS is a rare disorder in which the body's immune system
damages nerve cells, causing muscle weakness and sometimes
paralysis. RSV, which typically causes cold-like symptoms, is a
leading cause of pneumonia in toddlers and older adults.
In Arexvy's clinical trial, a participant had developed GBS
after receiving the vaccine, while in Abrysvo's trial, one
participant developed the disease and another got a variant of
it.
Last year, advisers to the U.S. Centers for Disease Control
and Prevention had postponed endorsing Arexvy's use in the 50-59
age group. They had also flagged the risk of GBS.