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The U.S. Food and Drug Administration will closely examine vaccine clinical trial data to understand how coronavirus vaccines will work for various subgroups of the population, FDA Commissioner Dr.Stephen Hahn said on Tuesday.
“It’s not as easy as saying the top results are X percent effective and X percent side effects,” Hahn said. “Let’s look at these groups, look at the side effects, and look at the effectiveness in each of these groups.”
“When we go through the 44,000 lines of patient data that is part of these clinical trials, we have to ask ourselves these questions. We need to look at it and analyze the data, looking at subsets of patients, ”he added.
If a vaccine doesn’t seem to work for a certain portion of the population, the FDA will tell, Hahn said.
“If we don’t have data to support the use of a vaccine, we’re going to go out and say that,” Hahn said. “And then we’ll have to make decisions about it in the emergency use authorization process.”
Hahn said the FDA will examine the data to understand how these vaccines work for pregnant women, children, people with existing health conditions, and people from minority communities.
“We did not require a pregnancy test to enter clinical trials, which means you know, when we look at the data, that there will likely be women of childbearing age who have become pregnant,” he said. Hahn said. “Will this be enough data for us to be confident, say pregnant women should be vaccinated?” I think this is something we will have to look at. I think it’s unlikely, but we need to look at the data. “
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