FAST VAX FACTS — The parents of very young children have waited for well over a year for a vaccine that protects their kids from Covid. Their hopes have been repeatedly dashed. Now, it seems like that vaccine may finally be here — except it doesn't work as well as expected. Moderna announced last month that it would ask the FDA to approve its vaccine for children 6 and under for emergency use. But the vaccine's efficacy — how effective these shots are at keeping young children from catching Covid — wasn't as exciting. It is expected to prompt an active debate at the FDA, as regulators decide whether the data is enough to greenlight the shot for kids. In children 6 months to 2 years, 43.7 percent were protected against any form of disease. In the 2 to 6 years group, Covid cases decreased even less, by 37.5 percent. Despite those disappointing numbers, the company said the protection was similar to a two-dose vaccine in adults against the Omicron variant, which predominated during Moderna's trial with young children. To help break down the research and discuss what could come next once the data moves to the FDA in the coming weeks, Nightly talked with Chandy John, a pediatric infectious diseases expert at Indiana University. This conversation has been edited. What stood out to you about Moderna's data? With the caveat that it would be so much nicer to have full details, what stood out to me was that the efficacy wasn't great, but there was efficacy. And that very importantly, there were no negative safety signals. Kids seemed to do really well with this. And just a note they made: The incidence of high fevers above 104 were really quite rare, but it did happen every now and then. It was less than 1 in 1,000 that your child may have a high fever but usually that's well tolerated. As a pediatric infectious diseases doctor, I always think that transparency and acknowledgment of any problem there may be is important. Is there anything else the efficacy rate fails to capture? They didn't have any severe disease or hospitalization or death in the study, which is great. But it means you can't study that outcome. On the one hand, one group will say: Well, they had, you know, 6,700 kids, and they didn't have any hospitalizations or deaths. So why do you even need this vaccine? But we have the numbers: Tens of thousands of children, including many under 6, were hospitalized during the Omicron wave with Covid-19. Even a relatively rare outcome like hospitalization, that's tens of thousands of kids who may be affected if you have millions of them getting the infection. So it couldn't be studied in this study, but it's likely that its efficacy is even better for protecting against severe disease, just based on what we've seen in every other study in adults and children. That's to me another strong reason for thinking it is worthwhile to get young children vaccinated. What have we learned about how Covid affects children below the age of 6? The data shows a much higher risk of death in children below 1, which goes down dramatically between ages 1 and 14, and then starts climbing again after 16. But among children younger than 18, the highest rate of death is in children under age 1. The number of these children as a fraction of the population is relatively small, but the data clearly show they are at highest risk for death among children, and I think highest risk of hospitalization as well. The risk of death, 60 per 1 million, is still lower than adults, especially older adults. But it's the highest among children. It's unclear why, but probably has to do with a less well-developed immune system in children less than 1 year, as is true for other respiratory viruses like RSV, and possibly also lack of exposure to other coronaviruses, as compared to older children. During Omicron, the under-6 age group bore a lot of disease, and I think part of that is because there was no vaccine available. It was far from all of it, because the vaccination rates in 6- to 11-year-olds in particular are not great in the U.S. overall, but I think having no vaccine available for those younger kids did shift a larger brunt of the infection to them. Myocarditis, or inflammation of the heart, has been a concern when it comes to vaccinating children. What do we know about how it affects this younger age group? For young adults, data shows that spacing out the second dose to be eight weeks or more after the first substantially reduced the rate of myocarditis to where it's really no more prevalent than it is in the general population. The CDC did recommend children 12 to 17 could get the eight-week spacing, and I think that's what most of us are recommending now to essentially take the risk of myocarditis out of the equation. In 5 to 11, there really has not been a myocarditis signal at all so far, so that's really good news. For very young children — which you need a larger study to definitively say anything about myocarditis — but in this first Moderna study, there was no myocarditis. The question then becomes, could it have been a 70 percent or 80 percent effective vaccine if we had a higher dose? But if we did, would we have more myocarditis? These are the things that make these trials so difficult to do. Welcome to POLITICO Nightly. In an hour and change from Nightly's publish time, the college basketball national title game will tip off, featuring editor Chris Suellentrop's Kansas Jayhawks vs. Myah Ward's North Carolina Tar Heels. Despite the bad blood, we still managed to get a newsletter out today, possibly because Tyler Weyant hasn't thought much about his Maryland Terrapins in months. Reach out with news, tips and ideas at nightly@politico.com. Or contact tonight's author at mward@politico.com, or on Twitter at @MyahWard.
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