The FDA is slated to make a decision on whether to approve Pfizer's shot in August before respiratory syncytial virus season in the fall.
RSV is a common respiratory infection that causes cold-like symptoms. But older adults and younger children are particularly vulnerable to more severe RSV infections.6,000 to 10,000 seniors and a few hundred children younger than 5, according to the Centers for Disease Control and Prevention. Around one out of every 100 children younger than 6 months of age with an RSV infection may need to be hospitalized, the CDC said.
But Dr. Hana El Sahly, who chairs the FDA advisory committee, said "even if it is late preterm delivery, the fact that we're putting them into preterm delivery while we're sitting here debating the matter intellectually is not trivial."Pfizer's rival GSK halted its own trial on its RSV shot for newborns after noticingon preterm births and neonatal deaths, or when a baby dies during the first 28 days of life.
"Am I concerned about the preterm birth imbalance? Yes. Am I convinced that it's real? No," said Dr. Daniel Feikin, a scientific advisor and respiratory diseases consultant, who voted in favor of the shot's safety. "Certainly in our eyes, there is no definitive evidence to suggest that there is a risk of prematurity," said Dr. William Gruber, Pfizer's senior vice president of vaccine clinical research and development. "So the question is do you hold hostage the potential benefits of the vaccine for something which you have no statistical significance at this point?"
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