Maker of promising Alzheimer’s drug Leqembi expects full FDA approval this summer, expanded Medicare coverage Symptoms can range from brief weakness to paralysis.
Most patients, even those with severe cases, recover.
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Though the FDA views Guillain-Barre syndrome as an important potential risk, Pfizer executive Alejandra Gurtman maintained that the company did not identify any safety concerns during the trial and that the vaccine was well tolerated. Dr. David Kaslow, a senior official in the FDA's vaccine division, said safety monitoring will be "critically important" if Pfizer's RSV vaccine is approved.
Among adults of all ages hospitalized with RSV, 19% require intensive care and 4% die, according to CDC data from three seasons. Mortality is the highest among seniors.
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