A majority of the FDA panel said GlaxoSmithKline's RSV vaccine safety data was adequate and advisors were unanimous that the shot’s efficacy was good But some expressed concern that the shots could be associated with risks of rare nervous system disorders
GSK did not have data on how long protection from the vaccine lasts and how it performs in people with weak immune systems, according to FDA.
Guillain-Barre syndrome is a rare neurological disorder with symptoms ranging from weakness to paralysis. Most people recover even from severe cases, according to the National Institutes of Health. "It's not something that you routinely see one or two cases," said Griffin, an FDA committee member, who voted no on the shot's safety but yes on its efficacy.
The FDA, in a briefing document, said the rate of Guillain-Barre syndrome in older adults is about 1 in 100,00 among people 60 years and older. In GSK's trial, it was more like 1 in 15,000.
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