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Young kids 5 to 11 are a one step closer to a COVID-19 vaccine

ARI SHAPIRO, HOST:

For younger kids, Halloween this year could mean chocolate bars, lollipops and maybe a COVID-19 vaccine. Today Pfizer-BioNTech asked the FDA to authorize its vaccine for emergency use in kids ages 5 to 11. It's an incremental step in the process. An FDA advisory panel will still need to consider the request. There's a meeting scheduled for October 26. Every step on the journey to vaccine approval prompts new questions from parents who've had to navigate school and other parts of their kids' daily lives without the protection of the vaccines. Dr. Grace Lee is a pediatrician at Stanford's Lucile Packard Children's Hospital, and she chairs the CDC's Advisory Committee on Immunization Practices. Thanks for joining us.

GRACE LEE: I'm glad to be here. Thank you.

SHAPIRO: What are the questions or concerns that you are hearing most from parents right now?

LEE: So it's been a mix of what people have been asking, I think. I have many parents, families and community members who are really eager to have vaccines available for children of school age - so 5 to 11 years of age. I think, of course, you know, people are also always asking about safety of vaccines, and that's a really important and critical point. But I think that in general, most parents are really excited to have another tool in their toolbox to be able to protect their kids and their family members and their communities. That goes beyond masking, distancing and other interventions that are happening.

SHAPIRO: As you look at the impact of the delta variant on kids, what are the stakes here?

LEE: Well, we clearly have been seeing a greater number of infections that are incurring in children, and I think it just reflects a number of infections that we're seeing in communities. Similar to, you know, prior increases when we've seen in the past, it really does relate to community transmission. The more that we can do to help our communities increase their vaccination rates, the more it helps everyone - and particularly those who are not yet able to be vaccinated.

SHAPIRO: Am I correct that as far as the impact of the delta variant on kids, we are seeing more kids being hospitalized, but the rates of kids to adults is still much lower for children? Is that correct?

LEE: It is, in that, you know, older adults are clearly at higher risk for severe disease, particularly - and as we know, many of the individuals who are hospitalized now with severe infection are unvaccinated. I will say, though, it's really important to remember that some kids can actually have very serious disease from COVID-19 infection, and we're not always good at predicting who is going to, you know, have severe consequences of infection. So even though overall the rate tends to be lower than adults, it's still a concern, and it's still a preventable infection.

SHAPIRO: Dr. Fauci has said these vaccines could be authorized maybe by Halloween. This hearing is October 26. When do you think kids could actually go to their pediatrician and get a shot?

LEE: It's a great question. I'm going to give you a longer answer, which is that there's a really clear process that we have in place for the approval of vaccines. So first, we have to wait for companies to do the trials and submit the data. FDA needs to review that data, including their own primary analysis of that data, to ensure that those data make sense. In this instance, for these vaccines, there's also a FDA advisory committee called VRBPAC that meets to discuss and advise the FDA commissioner. Then the FDA determines whether or not authorization or approval is granted. After that process, our advisory committee, ACIP, weighs in on those recommendations for use of the vaccines in the U.S. population - looking at information about benefit-risk balance, equity values, acceptability, feasibility and resource use, and we provide our recommendations to the director of the CDC. Basically, we need all of those steps to happen before a vaccine becomes available for use for the - in our pediatricians' offices. And I would say that a really important part of that process is public deliberation. I mean, that has been fundamental to the work of the ACIP.

SHAPIRO: I mean, just to boil it down, does that process typically take a week, a month, several - like, what are we talking about?

LEE: That process usually takes months. And so clearly, with COVID-19 and being in a public health emergency, that process has been accelerated. But what I would emphasize - that process is an incredibly important process not only to make sure that we are reviewing all of the data as carefully as possible and making the best possible decision in the moment, even given the uncertainties, but I also think it's really fundamental to public trust in vaccines and the vaccination program. So that process to me is a really incredibly important one, and though we want that to be accelerated, we don't want it to be rushed.

SHAPIRO: What can you tell us about the dosage? Is it going to be different than for older kids?

LEE: We know that the dose will be lower than the currently approved Pfizer product, and that makes sense and is pretty typical for most vaccines and drugs in general - for there to be a lower dose. And again, making sure that that lower dose maintains the same level of immune response as well as the same safety profile will be incredibly important.

SHAPIRO: How big a concern are reports of myocarditis - which is an inflammation of the heart - that some people have gotten after receiving an mRNA vaccine? I understand it's more common in young men and teenage boys. Is that right?

LEE: Yes, there have been several published studies that have shown that there is an increased risk. I think it's really important to place those data in context. We also know that COVID-19 infection itself has resulted in significant inflammation of the heart or myocarditis. That also occurs, as well as other types of severe systemic syndromes like MIS-C. And the risk of those is actually higher following infection than the risk following vaccination. I do think that it is inevitable that all of us at some point - unless you maintain a perfect bubble - will be exposed to COVID, so there is always that risk of infection. That can occur over time, and it's important to know that that accumulates over time. Whereas the risk of following vaccination is low and as known to be at one point in time. And then you achieve that protection from the severe consequences of COVID.

SHAPIRO: We've been talking about 5 to 11-year-olds. The last thing I want to ask you about is kids under 5 and what, if anything, you can tell us about when they might be able to get vaccinated.

LEE: So I'm looking forward to that data as well. I don't have that on my horizon yet, so I couldn't comment about it.

SHAPIRO: Dr. Grace Lee is a pediatrician at Stanford Children's Health. Thank you.

LEE: Thank you. Transcript provided by NPR, Copyright NPR.