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FDA Expected To Grant Authorization For Use Of Pfizer Vaccine On Childen - NPR

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Having reviewd the data on trials, the U.S. Food and Drug Administration is expected to approve the use of the Pfizer vaccine on children as young as 12.

SCOTT SIMON, HOST:

More young people in the U.S. may soon be able to get COVID-19 shots. The Food and Drug Administration is expected to authorize the Pfizer vaccine for use in children as young as 12. The decision's based on trials that show it is safe and effective. And it may be announced within days. NPR's Pien Huang joins us. Thanks very much for being with us.

PIEN HUANG, BYLINE: Thanks for having me.

SIMON: Of course, I don't have to tell you COVID vaccinations right now are open to everyone 16 and older. What do we know - what have we learned about vaccines for younger children?

HUANG: Well, Pfizer, the drug company, released data at the end of March, and it showed that their vaccine works well in children ages 12 to 15 and that the side effects are generally not that bad. They had around 2,200 kids in this age group in their clinical trial, and there were no cases of COVID in the kids who got the vaccine and 18 in the placebo group. And the vaccinated kids had strong levels of antibodies. The side effects that they had were basically what we've heard about for adults. You know, they got pain in the arm, headache, fatigue, maybe fever and chills, especially with that second dose. And Dr. Megan Freeman from the University of Pittsburgh told me that pediatricians like her are delighted.

MEGAN FREEMAN: This is what we've been waiting for this whole time, is to have both data in kids about the safety and the efficacy of vaccination and also to finally be able to get to this point where we have enough availability that kids have kind of moved up on the list.

HUANG: It looks like the FDA is releasing a decision early next week with recommendations also coming from a CDC advisory committee.

SIMON: Scientists have said that children aren't at high risk of getting severely ill from COVID. So why should they get the vaccine at all?

HUANG: I mean, it's true. You know, most cases of coronavirus in children are mild or not even symptomatic. But tens of thousands of kids have been hospitalized from COVID, and there have been several hundred that have died. And it's also hard to predict which child is going to be the one to get very sick or to get long-haul issues with breathing and headaches and fatigue. Kids under 18 also make up 22% of the population, and they can spread the virus. So getting them vaccinated is like blocking off a virus transmission route.

SIMON: And one of the benefits of vaccinating youngsters, too, is that their lives can kind of get back to normal again.

HUANG: Absolutely. Dr. Rochelle Walensky, head of the CDC, shared her 16-year-old son's plans for last night.

(SOUNDBITE OF ARCHIVED RECORDING)

ROCHELLE WALENSKY: He is having two fully vaccinated friends over to watch a movie. It's been a long and coming, seemingly mundane but now very luxurious event. And he can do so because he's fully vaccinated.

HUANG: Teens have been missing out on a huge chunk of socialization. And getting vaccinated means they might not have to quarantine to play sports or wear masks at summer camp. It's going to help end this prolonged period of isolation for them.

SIMON: Pien, once the FDA gives the all-clear, what happens? How do they get the vaccine?

HUANG: Well, it is the same Pfizer vaccine that adults have been getting, you know, the same two doses spread out over three weeks. So teens will be able to get it in a lot of the same places as adults have been going. Jeff Zients, President Biden's coronavirus coordinator, says as soon as the FDA gives the go-ahead, they're making a special push.

(SOUNDBITE OF ARCHIVED RECORDING)

JEFF ZIENTS: Over 15,000 local pharmacies will be ready to vaccinate 12 to 15-year-olds. And we are working to get more pediatricians and family doctors to offer vaccinations in their offices to make it as easy and convenient for adolescents to get vaccinated.

HUANG: Biden is urging states to get at least one Pfizer shot into as many teens as possible by July 4, and that will help ensure that they're fully vaccinated by the time they go back to school in the fall.

SIMON: NPR's Pien Huang, thanks so much.

HUANG: Thanks for having me.

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