Mon Jun 12, 2023 – 1:43 pm EDT
This article was originally published by The Defender — Children’s Health Defense’s News & Views Website.
(Children’s Health Defense) — Advisers to the U.S. Food and Drug Administration (FDA) on Thursday recommended approval of AstraZeneca’s new monoclonal antibody, which the drugmaker said is designed to protect infants and toddlers up to age 2 from respiratory syncytial virus (RSV).
The drug, nirsevimab, would be delivered to newborns in a single shot at birth or “just before the start of a baby’s first RSV season, or as a larger dose in a second RSV season in children who are highly vulnerable,” CNN reported.
Members of the independent committee, which includes several pediatricians, “were enthusiastic about the potential” of the antibody, STAT reported, as was Thomas Triomphe, executive vice president of vaccines at Sanofi, which will market the drug in the U.S.
In a statement, Triomphe said:
Most babies hospitalized with RSV are born at term and healthy, which is why interventions specifically designed to protect all infants are likely to result in the greatest impact.
We are encouraged by the advisory committee’s positive vote based on the compelling clinical development
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