BREAKING: FDA panel recommends first shot to prevent RSV in infants by vaccinating pregnant mothers. If the shot gets approved, it would be the first RSV vaccine that confers protection to babies.
Alex Kormann / Star Tribune via Getty Images fileAn independent advisory committee to the Food and Drug Administration voted Thursday to recommend a shot that protects infants from RSV by vaccinating their mothers while pregnant.
In healthy adults, lower respiratory illness caused by RSV is typically mild, but it can be more severe in babies and older adults. The virusunder 5 every year in the U.S. and up to 10,000 people ages 65 or older, according to the CDC. Severe infections can result in pneumonia or bronchiolitis, which inflames airways and clogs them with mucus.
In a clinical trial with nearly 7,400 participants, the vaccine lowered the risk of severe disease from RSV among infants by 82% within roughly three months after birth. By around six months, efficacy was around 69%. Infantsare especially vulnerable to severe cases of RSV, which stands for respiratory syncytial virus.
Dr. Paul Offit, a member of the FDA advisory committee and director of the Vaccine Education Center at Children’s Hospital of Philadelphia, said the outcome of GSK’s trial was relevant to Pfizer’s study, since the two vaccines are similar.
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