MICHEL MARTIN, HOST:
Federal health officials want new testing rules for vaccines. Vaccine experts are worried that these rules will make it harder for the public to get access to some shots, including the next versions of COVID-19 boosters. NPR health correspondent Rob Stein is with us now to tell us more about this. Good morning, Rob.
ROB STEIN, BYLINE: Good morning, Michel.
MARTIN: So what's this new requirement?
STEIN: The Department of Health and Human Services says all new vaccines must be compared to a placebo, you know, a harmless, inactive substance like saline. The new administration says this is necessary to make sure all new vaccines are safe. Now, officials are being kind of cagey about whether this would apply to the next tweaks to the COVID vaccines, but they're indicating that it would, and that's causing a lot of concern among vaccine experts. I talked about this with Dr. Peter Hotez at the Baylor College of Medicine. He thinks this is another attempt by Health and Human Services Secretary Robert F. Kennedy Jr. to undermine vaccines.
PETER HOTEZ: He appears to be on full-on attack mode when it comes to vaccines. And it's so self-defeating for our country and globally as well. It's dangerous.
STEIN: Hotez says it's especially dangerous right now because vaccination rates are so low, measles is causing outbreaks around the country and COVID is still making lots of people sick, sometimes, you know, really sick. And Hotez says Kennedy has been doing lots of things to undermine confidence in vaccines and complicate their approval, like launching a new study looking at vaccines in autism, even though any connection like that has been debunked.
MARTIN: But this whole thing about placebos, but isn't that the way that most new vaccines, new drugs and vaccines, are evaluated anyway? So why is that unreasonable?
STEIN: Yeah. Yeah, absolutely, Michel. And that's kind of what's puzzling many scientists. The administration is saying that the vaccines kids routinely get weren't compared to placebos, and that's just not true - most were. And the same goes for the COVID vaccines. They were all tested against placebos and found to be very safe and effective. And all the vaccines that people get are continuously monitored to make sure they're safe.
There's a bunch of problems with demanding that all new shots go through yet another big placebo study. First of all, experts say it's just not always necessary. The next COVID shots, for example, aren't really new vaccines - they're just modified versions of the original vaccines. They'll be tweaked to target the latest strains and provide the best protection, just like the flu vaccines have been getting tweaked every year for decades. Any new placebo study would have to be huge, and that means it would cost a lot of money and take a long time. In fact, critics say it would probably take too long for the vaccines to be available in time for next fall. I talked about this with Dr. Paul Offit at the University of Pennsylvania.
PAUL OFFIT: What the administration is arguing for is a trial that will make the vaccine no more safe, no more effective. And all it will do is make it arguably more expensive and less available in a timely manner.
STEIN: Offit and others also argue it would be unethical to give people a useless placebo for a potentially deadly disease when they could be getting a vaccine that has been clearly shown to be safe and very effective.
MARTIN: So what does the administration say about all this?
STEIN: So in a statement, HHS spokesman Andrew Nixon says that the existing methods for guaranteeing the safety of vaccines are inadequate, and the technology that's used for the COVID vaccines hasn't been around for decades like the technology used to make flu vaccines. He also argues that it's necessary to restore public trust in vaccines. He says, quote, "the public deserves transparency and gold-standard science, especially with evolving products," unquote.
MARTIN: That's NPR health correspondent Rob Stein. Rob, thank you.
STEIN: You bet, Michel.
(SOUNDBITE OF PLACEBO SONG, "BURGER QUEEN") Transcript provided by NPR, Copyright NPR.
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