Moderna will ask the FDA to authorize its COVID-19 vaccine for children under 6（在线收听）

Moderna will ask the FDA to authorize its COVID-19 vaccine for children under 6

　　Transcript

　　Moderna says its low-dose pediatric vaccine appears to be safe and provide protection for kids ages 6 months to 6 years, and it is asking the Food and Drug Administration for emergency authorization.

　　STEVE INSKEEP, HOST:

　　Many parents of young children have been waiting for this - Moderna says the company's pediatric COVID-19 vaccine is safe and effective for younger kids. The company plans to ask the Food and Drug Administration for emergency authorization. We've called NPR health correspondent Rob Stein, who's been covering this story. Rob, good morning.

　　ROB STEIN, BYLINE: Morning, Steve.

　　INSKEEP: Wow. What have parents of smaller kids - or younger kids, I should say - been going through?

　　STEIN: Yeah, it's been rough for a lot of them, you know, because until now, only kids ages 5 and older have been eligible to get vaccinated, you know, with the Pfizer-BioNTech vaccine, but a low-dose version of that vaccine for these younger kids, it didn't work, so lots of parents of those younger kids have been feeling left behind and anxious, you know, especially with everyone taking off their masks these days. But now Moderna says a low-dose version of its vaccine looks like it would protect those kids, and so the company will ask the FDA to authorize it within weeks. But I should stress that all we have right now is a news release from Moderna. So there are still lots of questions.

　　INSKEEP: Thanks for stressing that. But at least based on what Moderna has said, what evidence do they have for success?

　　STEIN: Well, the company tested two doses of a version of this vaccine that contains one-quarter of the dose that adults get one month apart. This was on thousands of kids, ages 6 months through 5 years. And first of all, the company says the vaccine looks safe, no signs of that heart inflammation that has occurred very rarely among young men and no signs the vaccine causes more high fevers than any other vaccine, which has been a big concern. And it looks like the vaccine generates the same kind of immune response - equivalent levels of so-called neutralizing antibodies that has protected grown-ups. So the hope is that should protect these little ones against the most important thing, which is getting seriously ill.

　　Now, the company says two doses of the vaccine was only about 40% effective against the omicron variant, you know, protecting kids from getting mildly or moderately ill. So that's kind of disappointing, you know, just like the adult vaccine, though not totally unexpected. So Moderna plans to test a third dose, a booster, to see if that pumps the protection back up better.

　　INSKEEP: Well, what then turns this announcement, this press release, into an approved vaccine?

　　STEIN: Yeah, so after the company formally asks for authorization, the FDA will decide what to do. The agency usually convenes outside advisers to analyze the data and make a recommendation about whether to authorize the vaccine. Then the CDC will weigh in. Both those steps could happen fast, though. And the FDA is also waiting for word from Pfizer about its vaccine. Pfizer's testing a third dose, and those results should be available sometime next month.

　　INSKEEP: Rob, I got to ask - how much demand is there going to be for this vaccine, assuming it's approved?

　　STEIN: Yeah, good question, Steve. You know, less than a third of parents of kids ages 5 to 11 have gotten their kids the Pfizer vaccine, even though they've been eligible for months. And with the omicron surge fading, many parents may feel, you know, less urgency to vaccinate their kids, especially since COVID doesn't tend to make kids as sick as it makes adults. But many infectious disease experts say, look; kids can still get very sick, even die. So they hope parents will vaccinate their little ones, especially since omicron could surge again. And, you know, you never know - another variant could erupt.

　　INSKEEP: Rob, thanks for the update, as always.

　　STEIN: Sure thing, Steve.

　　INSKEEP: NPR health correspondent Rob Stein.