FDA says it won’t cut corners for vaccine for young kids
While awaiting Pfizer trial data for kids ages 5 to 11, the Food and Drug Administration is vowing not to cut corners.
The FDA said, "it’s critical that thorough and robust clinical trials of adequate size are completed to evaluate the safety and the immune response."
"Children are not small adults -- and issues that may be addressed in pediatric vaccine trials can include whether there is a need for different doses or different strength formulations of vaccines already used for adults," the FDA said.
When the FDA receives a completed emergency use authorization request, "the agency will carefully, thoroughly and independently examine the data to evaluate benefits and risks and be prepared to complete its review as quickly as possible, likely in a matter of weeks rather than months."
"However, the agency’s ability to review these submissions rapidly will depend in part on the quality and timeliness of the submissions by manufacturers," the FDA added.
-ABC News' Anne Flaherty