(The Baltimore Sun) Johnson & Johnson plans to test its coronavirus vaccine in infants and even in newborns, as well as in pregnant women and in people who have compromised immune systems.
The bold plan for expanded clinical trials met with the approval of Dr. Ofer Levy, director of the Precision Vaccines Program at Harvard’s Boston Children’s Hospital and a member of the Food and Drug Administration advisory committee that reviewed the company’s vaccine data.
When Levy saw the outlines of the planned trials, “they turned my head,” he said. They were reported as part of the company’s application to the FDA for emergency use approval and discussed at the FDA meeting.