U.S. The Food and Drug Administration will take a closer look at the vaccine’s clinical trial data to understand how the coronavirus vaccine will work for different subtypes of the population, FDA Commissioner Dr. Step. Stephen Hahn said Tuesday.
“It’s not as easy to say as the top result is X percent effective and X percent side effects,” Hahn said. “Let’s look at these groups, let’s look at the side effects and let’s look at the effectiveness of each of these groups.”
“As we go through the data lines of 44,000 patients in these clinical trials, we have to ask those questions. We have to look at the sub-subsets of patients and diagnose them, ”he added.
If a vaccine doesn’t seem to be working for a specific segment of the population, the FDA will say so, he said.
“If we don’t have data to support the use of the vaccine, we’ll come out and say,” Hahn said. “And then we have to make some decisions about it in the emergency use authorization process.”
Hayne said the FDA will look to the data to understand how the vaccine works for pregnant women, children, current health conditions and people from minority communities.
“We did not require a pregnancy test for admission to clinical trials, which means that when we look at the data there are likely to be women of childbearing age who have become pregnant.” “Will there be enough data to be confident to say, pregnant women should be vaccinated? I think that’s something we have to take a look at. I think that’s unlikely, but we need to look at the data. “
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