Consider This from NPR - Boosters Won't Make It To Everyone For Now, But Vaccines For Young Children Are Coming

Episode Date: September 21, 2021

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.Learn more about sponsor message choices: podcastchoices.com/adchoicesNPR Privacy Policy

Support for NPR comes from NPR member stations and Eric and Wendy Schmidt through the Schmidt Family Foundation, working toward a healthy, resilient, secure world for all, on the web at theschmidt.org. 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. The advisory committee felt that at this particular time, there wasn't enough data to allow the booster recommendation for everyone. That's Dr. Anthony Fauci, President Biden's chief medical advisor. So they made the recommendation for those 65 years of age and older, and those 18 to 64 who are in a situation where they may be at high risk to develop severe disease. 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. 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? He says that could happen in the next three weeks. 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. 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. I think a lot of people were waiting for data on additional doses of J&J. Dr. Saad Omer is director of the Yale Institute for Global Health. 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. Some medical experts don't think we should be focusing on booster shots for vaccinated Americans as growing numbers of unvaccinated people are dying.

The best way to protect us all individually and collectively is to get more people vaccinated, especially the unvaccinated. They're driving this pandemic. Dr. Luciana Borio is a former acting chief scientist for the FDA. I fear that the discussion on boosters has somehow overshadowed the most important message, which is to get more people vaccinated here and globally. 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 21st. This message comes from WISE, the app for doing things in other currencies. Send, spend, or receive money internationally, and always get the real-time mid-market exchange rate with no hidden fees. Download the WISE app today or visit wise.com. T's and C's apply. Support for NPR and the following message come from Carnegie Corporation of New York, working to reduce political polarization through philanthropic support for education, democracy, and peace. More information at carnegie.org.

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. Well, I think it's really important news. Dr. Peter Hotez is co-director of the Center for Vaccine Development at Texas Children's Hospital. 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. Hotez told NPR and WBUR's Here and 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.

So it's 10 micrograms versus 30 micrograms for the older teenagers and the adults. Hotez says a smaller vaccine dosage doesn't necessarily mean a smaller effect. 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 dose may have twice the effect. In fact, sometimes smaller doses actually produce stronger immune responses. 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 there's a phenomenon in vaccines called fractional dosing, where you even get a better immune response. 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 Alison Aubrey about what has to happen before

kids around the country can get the go-ahead. 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. A foundation for seeking authorization. So what are the next steps to getting authorization?

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. 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. He says it's a very fluid situation, but certainly the FDA receiving data from Pfizer sets the process in motion. And there's time pressure to get this done quickly, right? Haven't pediatricians been urging the FDA to move as fast as possible? 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 already, I mean, 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 advisors to the FDA will weigh in and they will speak up if they see any concerns as they review the data. 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. And this comes amid a surge in cases in kids. Not only a surge in cases, but also child hospitalizations are up, right? 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 the surge. There are just so many cases among kids right now, Dr. Kimberlin says. A quarter of a million children every week over the last, you know, couple of three weeks being diagnosed with COVID. These are outpatient and inpatient, of course, but those numbers are unprecedented. 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? Sure. Well, the FDA is expected to announce a decision any time now, really, Ari, on a Pfizer booster. CDC advisors voted late last week in favor of boosters for people 65 and up and those at high risk. Now, the agency typically follows the advisor's 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. NPR correspondent, Alison Aubrey. 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 Fadal spoke with NPR correspondent and editor Maria Godoy about what lessons the U.S. can learn from the rollout elsewhere. So what other countries have started vaccinating young children? Only a small number of countries are already vaccinating kids under 12. Cuba has started vaccinating kids as young as two with its own proprietary vaccine. Cambodia is giving shots to kids six and up, and China has approved two of its vaccines for use in kids as young as three. Israel is vaccinating kids as young as five

with the Pfizer vaccine, but only if they have severe underlying health conditions. And Chile this month started mass vaccinations for six to 11-year-olds. It's using the Chinese-made Sinovac vaccine. So what do we know about how these vaccines in general are performing in kids? 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 3 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 three 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. 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? 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 percent 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 Orion says vaccinating younger kids isn't necessarily a clear-cut decision for countries at this time. You know, you can either wait for, have more data to support the strategy or move forward with that uncertainty if you have already covered the high-risk groups. And Chile has done that. More than 87% of its adults are fully vaccinated now. So we're talking about strategies for vaccinating kids under 12. Meanwhile,

some countries are still deciding whether to vaccinate even older kids, right? Yeah. In the UK 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 advisors 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.

NPR Science Editor and Correspondent Maria Godoy. You're listening to Consider This from NPR. I'm Ari Shapiro. Support for NPR and the following message come from the Kauffman Foundation, providing access to opportunities that help people achieve financial stability, upward mobility, and economic prosperity, regardless of race, gender, or geography. Kauffman.org.