FDA Approves RSV Shot Despite High Infant Risk - AI Podcast

Story at-a-glance Merck's respiratory syncytial virus (RSV) shot clesrovimab (Enflonsia) was approved even though 11.71% of babies in the trial experienced serious adverse events, including seizures, brain injury, and death Infants who got clesrovimab had a 350% higher risk of upper respiratory infections — exactly the type of illness this shot claims to prevent The injection is given in a single, fixed dose regardless of infant weight, putting smaller, younger babies at greater risk due to disproportionately high exposure Babies who received the shot had a threefold increase in severe neurological reactions compared to those given a placebo Only about 25 babies in the U.S. succumb to RSV each year, making the known risks of clesrovimab far outweigh the threat the virus poses to most children

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