FDA grants approval on RSV vaccine.
CLEVELAND, Ohio - The U.S. Food and Drug Administration approved the first RSV vaccine on Monday, clearing the way for usage to prevent RSV in infants from birth to six months.
The vaccine, called Abrysvo, is approved for use at 32 to 36 weeks during pregnancy. The single dose vaccine comes a few months after its approval for people 60 and older. RSV cases have been rising over the last few years, causing respiratory infections in people of all ages, but more frequently in infants. RSV typically is seasonal, appearing prior to flu season and peaking in the winter. While RSV can be problematic to anyone,“in infants and children, the risk of RSV-associated LRTD is highest during the first year of life. According to the Centers for Disease Control and Prevention, RSV is the leading cause of infant hospitalization in the U.S”.
The study that ultimately led to the approval of Abrysvo showed that the vaccine was 81.8% successful in reducing the risk for RSV within 90 days of birth, and 69.4% within 180 days of birth. In a subgroup of women who were 32 through 36 weeks pregnant, severe risk of RSV was reduced by 91.1% within 90 days of birth.
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