美国国家公共电台 NPR--The FDA is reviewing COVID vaccines for children 5 and younger（在线收听）

The FDA is reviewing COVID vaccines for children 5 and younger

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Food and Drug Administration advisers are opening a two-day meeting to review Moderna and Pfizer-BioNTech's COVID-19 vaccines for children, including the first vaccines for kids younger than age 5.

RACHEL MARTIN, HOST:

Months of waiting could finally be over for parents who want their young kids vaccinated against COVID-19. Today, the Food and Drug Administration kicks off a two-day meeting. At the end of it, they'll decide whether to authorize the first vaccines for children younger than 5. NPR health correspondent Rob Stein has been following all this. Good morning, Rob.

ROB STEIN, BYLINE: Good morning, Rachel.

MARTIN: Rob, I feel like we have had this conversation many times...

STEIN: I know.

MARTIN: ...And there's always another obstacle, another obstacle. So here we are. A lot of adults I know have had four vaccine shots. The youngest kids have had zero. Why has this taken so long?

STEIN: Yeah, Rachel, it's been a maddening wait for many parents of babies, toddlers and other young kids. They're the last group to get a chance to get vaccinated. And that's because the studies for these littlest kids started later than adults and older kids, and it turned out to be a lot trickier than expected to find just the right dose for these littlest ones. But it looks like Moderna and Pfizer and BioNTech finally did it. The FDA has released the agency's assessments of both vaccines and concludes that both look like they safely stimulate enough immunity to protect kids as young as 6 months old.

MARTIN: Which is good. Tell us more about these two vaccines. There are some important differences to note, right?

STEIN: Yeah, yeah. The Moderna vaccine is two shots that kids get a month apart. Each shot for the youngest kids contains about one-quarter the dose that adults get. The Pfizer-BioNTech vaccine contains just one-tenth the dose adults get. So the youngest kids need three shots of that vaccine. The first two are spaced three weeks apart; the third comes two months later. So, you know, if these vaccines get authorized, you can see it could get kind of tricky for parents deciding which to get. Both vaccines look good. It's stimulating the immune system enough to protect kids from severe disease. But the Moderna vaccine was only about 38 to 50% effective at protecting kids against getting sick at all. The Pfizer-BioNTech vaccine was about 80%. But those estimates are based on very small numbers, so it's unclear how the vaccines will really stack up against each other, especially against the newer omicron subvariants.

I talked to some parents who say they want Moderna just because two shots means it won't take as long to vaccinate their kids. Others may prefer the Pfizer-BioNTech vaccine because the lower dose may cause fewer fevers, though that's not really clear yet either.

MARTIN: So parents have to weigh all that.

STEIN: Right.

MARTIN: This two-day meeting opens today. Walk us through the next steps here.

STEIN: Yeah, yeah. Today, the FDA advisers will review Moderna's vaccines for kids ages 6 through 17. Now, this isn't as important since these kids can already get the Pfizer-BioNTech vaccine. But that's - that sets the stage for the main event tomorrow, when the advisers will consider the two vaccines for kids younger than age 5. It looks like a reasonable bet the advisers will recommend authorization. I talked about this with Dr. Ofer Levy, a Harvard pediatrician on the committee considering these vaccines.

OFER LEVY: These vaccines appear to be safe and appear to induce an antibody response that's believed to contribute to protection and are associated with a reduced risk of COVID. So those are three positive features of the data that I'm reviewing at this point.

STEIN: If the committee recommends authorization, the FDA and CDC will likely give the green light by the end of the week.

MARTIN: And then when can kids get the shots?

STEIN: You know, the Biden administration is already shipping millions of doses of the vaccine out. So pediatricians, hospitals and other places can start vaccinating these kids as early as next Tuesday if the authorization goes through and everything goes smoothly.

MARTIN: All right, we will wait and we will see. NPR health correspondent Rob Stein. Thanks for the update, Rob.

STEIN: Yeah, sure thing, Rachel.