On Oct. 13, Pfizer announced that Cincinnati Children's Hospital would begin enrolling children in COVID-19 vaccine clinical trials, making Pfizer the first U.S. company to test an experimental coronavirus vaccine on children.
The FDA requires institutions that test drugs and biologics in children to have a pediatric plan in place, but some say the rule "is lenient to the point of being no rule at all." As Dr. Robert Frenck, director of the Cincinnati Children's Hospitals Center for Vaccine Research told TIME magazine, "The plan can be simply 'We don't have a plan.'"
On Oct. 22, the FDA's Vaccines and Related Biological Products Advisory Committee convened a panel of experts to discuss coronavirus vaccines. Committee members expressed wariness about giving the shots to children, arguing that the risks could well outweigh the benefits. Leading National Institutes of Health (NIH) researcher Dr. Luigi Notarangelo went further, frankly stating that coronavirus vaccines "should not be considered for use" in children "at this point" and adding that the evidence presented at the meeting had been insufficient to answer pressing questions about safety.