Widespread Boosters At A Standstill, Vaccines For Young Kids In : Consider This from NPR The FDA Advisory Committee decided not to approve boosters for people sixteen and up. Instead, they made a recommendation for those 65 and up, or younger people at high risk to get a booster shot right now from Pfizer-Biontech.

Boosters Won't Make It To Everyone For Now, But Vaccines For Young Children Are Coming

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ARI SHAPIRO, HOST:

The Biden administration had hoped that this would be the week when people 16 and up would be able to start getting COVID-19 vaccine boosters, but that's not what happened.

ANTHONY FAUCI: The advisory committee felt that at this particular time, there wasn't enough data to allow the booster recommendation for everyone.

SHAPIRO: That's Dr. Anthony Fauci, President Biden's chief medical adviser.

FAUCI: So they made the recommendation for those 65 years of age and older and those 18 to 64 who are in the situation where they may be at high risk to develop severe disease.

SHAPIRO: The people doing the approving are the FDA Advisory Committee, and the booster is from Pfizer-BioNTech. So we're only talking about one of the three vaccines that Americans have received. Fauci hopes that this pause might give Moderna and Johnson & Johnson time to catch up in the approval process.

FAUCI: The question is, when will there be enough data to be able to be submitted to the FDA to get a recommendation likely through an emergency use authorization?

SHAPIRO: He says that could happen in the next three weeks.

FAUCI: Hopefully for both of them at that time so that there isn't a delay for the people who originally got Moderna and who originally got J&J.

SHAPIRO: For those who got the J&J shot, there is some good news this week. The company announced that a second dose two months or later after the first would give 94% immunity against COVID.

SAAD OMER: I think a lot of people were waiting for data on additional doses of J&J.

SHAPIRO: Dr. Saad Omer is director of the Yale Institute for Global Health.

OMER: There was concern amongst those people who had received a single dose about less than equivalent protection compared to the other vaccines. So I think it will be well-received.

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SHAPIRO: Some medical experts don't think we should be focusing on booster shots for vaccinated Americans as growing numbers of unvaccinated people are dying.

LUCIANA BORIO: The best way to protect us all individually and collectively is to get more people vaccinated, especially the unvaccinated. They're driving this pandemic.

SHAPIRO: Dr. Luciana Borio is a former acting chief scientist for the FDA.

BORIO: I fear that, you know, the discussion on boosters has somehow overshadowed the most important message, which is to get more people vaccinated here and globally.

SHAPIRO: CONSIDER THIS - most vaccinated adults will have to wait to get a booster shot. But this week brought us one step closer to a day when younger children can get the vaccine. From NPR, I'm Ari Shapiro. It's Tuesday, September 21.

It's CONSIDER THIS from NPR. This week, Pfizer-BioNTech announced that its vaccine is safe for kids ages 5 to 11. Up until now, age 12 had been the cutoff.

PETER HOTEZ: Well, I think it's really important news.

SHAPIRO: Dr. Peter Hotez is co-director of the Center for Vaccine Development at Texas Children's Hospital.

HOTEZ: We're seeing so many kids now in this delta wave across the country, especially in the southern part of the U.S. and in the Mountain West. A lot of kids getting admitted to pediatric hospitals, children's hospitals, even pediatric ICUs.

SHAPIRO: Hotez told NPR and WBUR's Here & Now that about 2,000 kids ages 5 to 11 have been vaccinated in the Pfizer-BioNTech trial. And Hotez says the dosage was smaller than what adults got.

HOTEZ: So it's 10 micrograms versus 30 micrograms for the older teenagers and the adults.

SHAPIRO: Hotez says a smaller vaccine dosage doesn't necessarily mean a smaller effect.

HOTEZ: Vaccines are not so dose-dependent often. And by that, I mean it's not like a small molecule drug or a medicine that you take, where twice the - twice the dose may have twice the effect.

SHAPIRO: In fact, sometimes smaller doses actually produce stronger immune responses.

HOTEZ: So for instance, with the Moderna boost that's coming up, it's likely that that's going to be half the dose of the previous ones because that may - there's a phenomenon in vaccines called fractional dosing where you even get a better immune response.

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SHAPIRO: Well, as we know, it can take weeks or months from when a company like Pfizer says a vaccine is ready to go to when people start getting shots in arms. So I spoke with NPR's Allison Aubrey about what has to happen before kids around the country can get the go ahead.

ALLISON AUBREY, BYLINE: The companies say the vaccine was safe, it was well-tolerated and it triggered a strong immune response. And the vaccine-makers say the side effects are about the same as those seen in teens and young adults, such as a sore arm or muscle aches. Albert Bourla, the chairman and CEO of the company, said the trial results provide a foundation for seeking authorization of the vaccine for children 5 to 11 years old, and the company plans to submit them to the FDA with urgency, he said.

SHAPIRO: A foundation for seeking authorization - so what are the next steps to getting authorization?

AUBREY: Well, the FDA officials have said that they will let the data guide them here, and they hope to have pediatric COVID-19 vaccines available in the coming months, they say. I spoke to David Kimberlin, a pediatric infectious disease doctor at the University of Alabama at Birmingham. He also serves as a liaison from the American Academy of Pediatrics to the CDC's advisory committee. Here he is.

DAVID KIMBERLIN: Now, of course, it has to be authorized by the Food and Drug Administration first, and then it has to be recommended for use by the CDC's Advisory Committee on Immunization Practices. And it appears to me now that we're back on track for an October, maybe even mid to late October recommendation.

AUBREY: He says it's a very fluid situation, but certainly the FDA receiving data from Pfizer sets the process in motion.

SHAPIRO: And there's time pressure to get this done quickly, right? Haven't pediatricians been urging the FDA to move as fast as possible?

AUBREY: That's right. Both Pfizer and Moderna expanded their clinical trials in children, and this was done to ensure they could pick up on rare adverse events. Now these trials are ongoing. But back in August, as the delta variant fueled the surge in cases among children, the American Academy of Pediatrics said that delta had kind of changed the equation. Given the urgency, the group said the FDA should strongly consider authorizing vaccines based on data from the initial cohort, or the initial group of children. So, you know, there's some tension, Ari, between wanting to inoculate children against the virus as soon as possible, but also to make sure that the vaccine is safe and that the benefits do outweigh the risks. Dr. Kimberlin says the process is working, and advisers to the FDA will weigh in, and they will speak up if they see any concerns as they review the data.

KIMBERLIN: Parents can be, you know, really confident - if the authorization is made and the recommendation is made, they can be really confident that it was done right, that it was based on the data, that it was based on science.

AUBREY: And this comes amid a surge in cases in kids.

SHAPIRO: Not only a surge in cases, but also child hospitalizations are up, right?

AUBREY: That's right. I mean, most cases among kids are mild, but many pediatric clinics and ERs are full, especially in states that have been hardest hit by this surge. There are just so many cases among kids right now, Dr. Kimberlin says.

SHAPIRO: A quarter of a million children every week over the last, you know, couple or three weeks being diagnosed with COVID - these are outpatient and inpatient, of course. But those numbers are unprecedented.

AUBREY: So that's the latest on vaccine shots for children. What about news that we might get this week on booster shots for adults? What's the latest there?

AUBREY: Sure. Well, the FDA is expected to announce a decision any time now, really, Ari, on a Pfizer booster. CDC advisers voted late last week in favor of boosters for people 65 and up and those at high risk. Now, the agency typically follows the advisers' guidance here, and the CDC's Advisory Committee on Immunization Practices is scheduled to meet this Wednesday. So we could hear a decision very soon.

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SHAPIRO: NPR correspondent Allison Aubrey.

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SHAPIRO: While parents anxious to get their school aged kids vaccinated may have to wait until at least October, some countries have already started giving shots to younger children. My colleague Leila Fadel spoke with NPR correspondent and editor Maria Godoy about what lessons the U.S. can learn from the rollout elsewhere.

LEILA FADEL, BYLINE: So what other countries have started vaccinating young children?

MARIA GODOY, BYLINE: Only a small number of countries are already vaccinating kids under 12. Cuba has started vaccinating kids as young as 2 with its own proprietary vaccine. Cambodia is giving shots to kids 6 and up. And China has approved two of its vaccines for use in kids as young as 3. Israel is vaccinating kids as young as 5 with the Pfizer vaccine, but only if they have severe underlying health conditions. And Chile this month started mass vaccinations for 6 to 11 year olds. It's using the Chinese-made Sinovac vaccine.

FADEL: So what do we know about how these vaccines in general are performing in kids?

GODOY: Well, there's a good sense of the safety profile of these vaccines. Let's look at Chile, for example. They're already moving ahead with Sinovac, even though the phase three trials, which really give you a big picture of safety and efficacy, they're just getting started. What we do know from earlier trials is that the vaccine is safe in children 3 and up and produces a strong immune response, although this was only in about 550 kids, which is not a lot.

But I spoke with Dr. Miguel O'Ryan. He's a pediatric infectious disease specialist in Chile who advises the government on its vaccine strategy. He said Chilean officials were shown unpublished data that convinced them that the Sinovac vaccine was safe for kids this young. And Chile is running its own studies as it rolls the vaccine out to get more data on it.

FADEL: OK, so Chile is moving forward, and the U.S. may make a decision in a couple of weeks. Are more countries likely to follow?

GODOY: You know, the big question other than safety is, how effective are these vaccines in young kids? And we don't really know a lot about that yet. For example, Pfizer hasn't released data on whether any kids in the trial have gotten COVID, so we can't compare how often kids in the vaccinated group versus the placebo group got sick. So we don't know, for example, is it 90% effective at preventing infection? What we do know from data so far is that both Pfizer and Sinovac vaccines elicit a strong immune response in kids, akin to that in adults. We just don't have direct efficacy data yet. Given that uncertainty, Chile's Miguel O'Ryan says vaccinating younger kids isn't necessarily a clear-cut decision for countries at this time.

MIGUEL O'RYAN: You know, you can either wait for - have more data to support this strategy or move forward with that uncertainty if you have already covered the high-risk groups.

GODOY: And Chile has done that. More than 87% of its adults are fully vaccinated now.

FADEL: So we're talking about strategies for vaccinating kids under 12. Meanwhile, some countries are still deciding whether to vaccinate even older kids, right?

GODOY: Yeah. In the U.K. recently, a government advisory board actually recommended limiting vaccines for 12 to 15 year olds to those with underlying health conditions. They just weren't convinced that the risk of potential side effects was worth the benefit, given the low risk of hospitalization and death for children, though some kids can get very sick and even die. But these advisers were actually overruled by government health officials who thought minimizing disruptions to the school year was the stronger argument in favor of vaccinating kids 12 and up.

SHAPIRO: NPR science editor and correspondent Maria Godoy.

You're listening to CONSIDER THIS FROM NPR. I'm Ari Shapiro.

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