Moderna requests FDA authorization for its COVID vaccine for very young kids

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Moderna requests FDA authorization¹ for its COVID vaccine² for very young kids

Transcript³

Moderna announced Thursday that the company has asked the Food and Drug Administration to authorize⁴ a low-dose version of its COVID-19 vaccine as the first vaccine for children younger than age 5.

STEVE INSKEEP, HOST:

We have news this morning from the vaccine-maker Moderna. The company has asked the FDA for emergency use authorization for its vaccine for little kids. It'd be the first COVID shot available in the U.S. for children younger than 5. NPR's Allison Aubrey is covering this story. Allison, good morning.

ALLISON AUBREY, BYLINE⁵: Good morning, Steve.

INSKEEP: OK, so how effective is this vaccine, at least according to Moderna?

AUBREY: Well, the company says two kid-sized vaccine doses spaced about a month apart led to a strong immune response, with antibody levels similar to what they've documented in adults. There were about 7,000 children in this study. Moderna says the vaccine was about 51% effective in preventing infection in babies 6 months old through 2 years and about 37% effective in kids 2 up to 6 years old. Now, this might not sound so great...

INSKEEP: No.

AUBREY: ...But much of their data was collected during the omicron wave, when there was a drop in vaccine effectiveness overall. I talked to Moderna's chief medical officer, Paul Burton, about how the company views the results.

PAUL BURTON: I think the levels of antibody that we see are very reassuring⁶. They should provide good protection. And even the vaccine effectiveness - while it's lower than we have seen, you know, with previous variants⁷, it's certainly what we see in adults, and we know that they have good protection against severe disease and hospitalizations.

AUBREY: Which is what's most important, he says. So, again, not perfect here, but the company emphasizes the strong antibody response in these young children.

INSKEEP: What do pediatricians, independent of the company, say about that?

AUBREY: You know, because the data has just been handed over to the FDA, details of the clinical trial results have really not been available. But generally speaking, pediatricians have been waiting for a vaccine for this age group. I talked to an infectious disease pediatrician in Oregon, Judy Guzman-Cottrill, about what she calls the unmet need.

JUDY GUZMAN-COTTRILL: There are still so many high-risk infants, toddlers and preschoolers with chronic⁸ conditions who are still being admitted to the hospital because of COVID. And it's frustrating⁹ to continue to see these kids with chronic lung disease and other conditions get so sick when we know that COVID vaccines¹⁰ are so incredibly effective at preventing hospitalization.

AUBREY: She says, while it is true that most kids have only mild sickness from COVID, about 20% of the kids who have been hospitalized with very serious inflammatory disease following COVID are younger than 5 years old. So she says, in her mind, there's an urgency to getting vaccines for these very young children, and pediatric groups have really echoed this message.

INSKEEP: I guess we should be frank here - some parents just aren't going to do this because some parents have not had their older kids get vaccines when they were available. But some parents, as we know very well, have been extremely anxious to get this protection for their children.

AUBREY: That's right.

INSKEEP: So what's the FDA timeline?

AUBREY: You know, the agency has a lot to review right now, Steve. Pfizer has been testing its three-dose regimen in young children because the company concluded two doses of its vaccine didn't lead to the protection they had hoped for, so the FDA will analyze¹¹ this data and now all of the Moderna data. So, you know, it's not lost on the agency that, as you just said, lots of parents and pediatricians have been waiting for this. And Dr. Paul Burton at Moderna says the agency will be very careful in its review, but it could happen pretty swiftly.

BURTON: You know, we've seen them review applications within, you know, four weeks, so it might be that by late May they would be in a position to come to a ruling.

AUBREY: But, of course, that timing¹² is up to the Food and Drug Administration, and June may be a better estimate.

INSKEEP: Allison, thanks.

AUBREY: Thank you, Steve.

INSKEEP: That's NPR's Allison Aubrey.