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Miller Fisher - 1 Jerica Pitts - 1
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Disease Control - 1 GSK - 1 Pfizer - 1 Infants - 1 R.S.V - 1

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3 mentions found


☆ F.D.A. Approves Pfizer’s R.S.V. Vaccine for Older Adults
  + stars: | 2023-05-31 | by ( Christina Jewett | ) www.nytimes.com   time to read: +3 min
Each year, about 60,000 adults 65 and older are hospitalized with R.S.V. The Centers for Disease Control and Prevention estimated that in one year, more than 21,000 people in that age group would need to take the GSK vaccine to prevent one R.S.V. Several treatments, including a maternal vaccine and a monoclonal antibody for infants against R.S.V., are under agency review. The GSK vaccine, called Arexvy, was nearly 83 percent effective against severe R.S.V. The final vote of the F.D.A.’s advisory panel in favor of the Pfizer vaccine’s safety and efficacy was 7 to 4.
Persons: Miller Fisher, Jerica Pitts Organizations: Disease Control, GSK, Pfizer, Infants, R.S.V
☆ FDA advisors recommend Pfizer RSV vaccine for older adults, despite possible Guillain-Barre risks
  + stars: | 2023-02-28 | by ( Spencer Kimball | ) www.cnbc.com   time to read: +5 min
The vote followed concerns at the FDA and among advisory committee members about two cases of Guillain-Barre syndrome among about 20,000 vaccine recipients. The FDA has asked Pfizer to conduct a safety study on Guillain-Barre syndrome, which the company has agreed to do. There currently is no approved RSV vaccine for the elderly. Pfizer's vaccine contains both strains of RSV, which circulate at the same time during fall and winter. 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.
☆ FDA says Guillain-Barre syndrome is possible risk of Pfizer's RSV vaccine for older adults
  + stars: | 2023-02-24 | by ( Spencer Kimball | ) www.cnbc.com   time to read: +5 min
Guillain-Barre syndrome, or inflammatory neuropathy, is a rare disorder in which the body's immune system mistakenly attacks the nerves. There was also a possible case of Guillain-Barre syndrome in GSK 's RSV vaccine trials, but the company said there was insufficient evidence to confirm a diagnosis. They will also vote Wednesday on GSK's RSV vaccine for older adults. The Guillain-Barre casesIn Pfizer's trial, a 66-year-old man in the U.S. with a history of hypertension developed Guillain-Barre symptoms seven days after vaccination. He was hospitalized again after suffering a fall and was subsequently diagnosed with Guillain-Barre Syndrome.
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