LEILA FADEL, HOST:
The Trump administration is planning to overhaul how the government evaluates and approves vaccines after a claim by the FDA that at least 10 children died because of COVID-19 vaccines. NPR health correspondent Rob Stein is following all this and joins me now. Good morning.
ROB STEIN, BYLINE: Good morning.
FADEL: So what do we know about these deaths that the administration says happened because of COVID vaccines?
STEIN: You know, Leila, we don't know much. This claim came out in an internal email a top Food and Drug Administration official named Dr. Vinay Prasad sent out Friday. In the email, which NPR reviewed, Prasad says the deaths occurred between 2021 and 2024 and were discovered during a recent investigation. He calls this a, quote, "profound revelation." Prasad's boss, Dr. Marty Makary, talked about this Saturday on Fox News.
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MARTY MAKARY: This was data that was accumulated during the Biden administration. They did not make it public. And we believe in a radical transparency agenda, so we're going to make that information available.
STEIN: But the FDA hasn't done that yet.
FADEL: OK. So how are we supposed to evaluate what they're saying?
STEIN: Exactly. I spoke to several independent experts over the weekend who said they are very skeptical, especially given Health Secretary Robert F. Kennedy Jr.'s antivaccine views. Dr. Fiona Havers is an infectious disease scientist who used to work at the Centers for Disease Control and Prevention.
FIONA HAVERS: Having the FDA announce a link between COVID-19 vaccines and pediatric deaths is another way that this administration is using government resources to further an antivaccine message.
STEIN: Nevertheless, the FDA officials are citing the deaths as part of the reason the agency plans to impose new standards for approving vaccines of all kinds going forward.
FADEL: So what exactly is the agency planning to do?
STEIN: The internal FDA email lays out a long list of potentially far-reaching changes, like demanding much more extensive testing before approving vaccines for pregnant women, demanding new evidence about vaccines to protect people against pneumonia and even revamping the process for evaluating the annual flu shot. Here's FDA Commissioner Marty Makary again.
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MAKARY: We're just getting back to science. We're getting back to gold-standard science.
STEIN: You know, all of this is setting off alarm bells among many public health experts. The new standards would force vaccine manufacturers to conduct even bigger, more complicated and expensive studies that would make it much more difficult, if not impossible, for, say, the annual flu shots to be ready in time every year. I talked about this with Dr. Jesse Goodman at Georgetown University. He used to regulate vaccines at the FDA.
JESSE GOODMAN: It really doesn't make sense, given that there have been no problems identified with the current system of vaccine approval.
FADEL: OK. Is there a timetable for when these changes might happen?
STEIN: Not yet. But this comes just as the CDC is convening what could be a crucial two-day meeting this week to consider upending how kids get vaccinated against dangerous infectious diseases like measles, polio and hepatitis.
FADEL: That's NPR health correspondent Rob Stein. Thank you, Rob.
STEIN: You bet. Transcript provided by NPR, Copyright NPR.
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