The Food and Drug Administration expanded the approval of GSK's respiratory syncytial virus vaccine to adults ages 50 to 59 who are at increased risk of getting severely sick from the virus.
About 13 million Americans ages 50 to 59 are at high risk of severe illness from RSV, said Phil Dormitzer, GSK's head of vaccines research and development and infectious disease research, in an interview. The FDA's expanded approval could help GSK maintain its dominance in the RSV market later this fall and winter, when the virusremains "very confident
Safety data in adults ages 50 to 59 was also consistent with data in adults 60 and above, according to GSK. Side effects included fatigue, headache and muscle pain, among others, which were mostly mild to moderate in severity.
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