FDA Commissioner ‘encouraged’ by vaccines but wants to see more data
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The success of vaccine trials by two pharmaceutical companies gives hope to millions of Americans and sent the stock market soaring. However, FDA Commissioner Dr. Stephen Hahn says he needs to see more data before proclaiming success.
"We just don’t just look at a press release," Hahn told 5 Eyewitness News on Tuesday. "We don’t just look at a scientific paper. But we’ll look at the raw data from a clinical trial. Our scientists will do their own analysis and that’s how we will ensure the safety and effectiveness of a vaccine."
Hahn says he’s encouraged by news from Pfizer about a vaccine with 90 percent effectiveness, and news from Moderna about a separate vaccine with 94.5 percent effectiveness. But the FDA still needs to see the raw data and study the safety of the vaccines.
"We are optimistic by the reports of this high level of effectiveness for both of the vaccines," he says. "But I think we’re getting to the point we need to see the data. We need to analyze the data. We need to make sure we’re comfortable with that and of course that only hits the effectiveness side. We will need to see the safety data as well."
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This Aug. 2, 2018, file photo shows the U.S. Food and Drug Administration building behind FDA logos at a bus stop on the agency's campus in Silver Spring, Md.[AP Photo/Jacquelyn Martin, File]
Pfizer says COVID-19 vaccine is looking 90% effective
Both companies say so far they haven’t seen anything to lead them to believe the vaccines aren’t safe. However, public opinion polls show that nearly 50% of Americans say they’ll be reluctant to take a vaccine.
Dr. Hahn says the FDA will work to ensure Americans know they won’t approve any vaccine unless it’s proven to be safe.
"I think it’s really good news that both of these vaccines have been reported to have very high levels of efficacy, effectiveness, but we’ll have to see what the data show," he said. "One thing I can promise the American people is that we will not cut corners in our assessment of these vaccines."
Hahn says so far the companies have not applied for formal FDA approval of their vaccines. He expects that in the next few weeks.
Once approval is given, it will be up to the Centers for Disease Control (CDC) to organize the distribution of the vaccines.