It’s important that a diverse group of Americans, including the elderly, is part of the ongoing Covid-19 clinical trials now underway in the United States, US Food and Drug Administration Commissioner Dr. Stephen Hahn said.
“We have been very clear about diversity,” Hahn told the National Consumers League during a discussion Tuesday.
Hahn said the FDA has discussed the importance of including different populations in clinical trials in vaccine development guidelines issued in June.
“We’ve talked a lot about ethnic diversity,” he said. “We also have talked about diversity with respect to those who are elderly, but also those who have comorbidities, other illnesses that put them at risk,” he added.
“We have made it clear that our expectation is that the data we receive will be generalizable to all of Americans,” Hahn said.
He continued that the agency has been looking at enrollment for the clinical trials “to ensure that there’s adequate representation of all groups so that the data are generalizable. That’s very important to the agency,” he said.
However, in the three large-scale vaccine clinical trials currently underway in the US, children are not part of those groups. Hahn did not address that during the discussion.
Source : CNN