Infant Deaths Attributed to Underlying Disease Despite Clinical Trials Requiring Healthy Participants
The other 10 infant deaths were attributed to “underlying disease.” However, according to Pfizer, clinical trials typically include healthy participants to assess the safety of the drug and any side effects, and only certain types of trials—such as those for oncology—would warrant the inclusion of sick patients versus healthy people. Before joining a clinical trial, according to the U.S. National Institutes of Health (NIH), participants must be given informed consent, as well as any information that allows the research team to determine whether or not they can participate in the study safely. As for the other 10 children’s deaths—attributed to a number of varying causes such as cardiac disease, a tumor, Covid, a skull fracture, pneumonia, two from gastroenteritis, and two from unknown causes—FDA official Melissa Baylor, MD said none of the deaths appeared to be related to the experimental drug nirsevimab.
Many drugs, including some routine childhood vaccinations for newborns, contain black box warnings on the manufacturer’s product inserts. Still, more often than not, as with the clinical trials of nirsevimab, the diagnosis of SIDS often overrules the occurrence of a potentially lethal drug reaction as the cause of death in an otherwise healthy infant. The FDA is slated to make a final decision on nirsevimab later this year. To date, the agency maintains it has not identified any safety concerns in its review of the drug.
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