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title: Pfizer Starts COVID-19 Vaccine Tests in Children Under 12
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# Pfizer-BioNTech Have Started Testing Their COVID-19 Vaccine in Children Under 12

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<!-- video src="https://cdn.jwplayer.com/manifests/0dwzz5K2.m3u8" -->
## Video: Tracking the Vaccine: From Freezer to Front Line

[Watch (HLS stream): Tracking the Vaccine: From Freezer to Front Line](https://cdn.jwplayer.com/manifests/0dwzz5K2.m3u8) (4:28)

![Tracking the Vaccine: From Freezer to Front Line](https://cdn.jwplayer.com/v2/media/0dwzz5K2/poster.jpg?width=720)

_Published 2021-01-20. TIME followed the vaccination process from a Walgreens freezer to a long-term care facility to see what the roll out can look like._


![Alice Park](https://static.time.com/v3/assets/bltea6093859af6183b/blt9b1ff6b12c3a4c3f/698a0b4397cdff3e366ba723/200116_Time_Headshots_Day552832-e1583529256299.jpg?branch=production&width=1200&quality=75&auto=webp&crop=1:1)

by 

[Alice Park](https://time.com/author/alice-park/)


![Alice Park](https://static.time.com/v3/assets/bltea6093859af6183b/blt9b1ff6b12c3a4c3f/698a0b4397cdff3e366ba723/200116_Time_Headshots_Day552832-e1583529256299.jpg?branch=production&width=96&quality=75&auto=webp)

## Alice Park


Senior Correspondent

Mar 25, 2021 5:10 PM UTC

![Alice Park](https://static.time.com/v3/assets/bltea6093859af6183b/blt9b1ff6b12c3a4c3f/698a0b4397cdff3e366ba723/200116_Time_Headshots_Day552832-e1583529256299.jpg?branch=production&width=1200&quality=75&auto=webp&crop=1:1)

by 

[Alice Park](https://time.com/author/alice-park/)


![Alice Park](https://static.time.com/v3/assets/bltea6093859af6183b/blt9b1ff6b12c3a4c3f/698a0b4397cdff3e366ba723/200116_Time_Headshots_Day552832-e1583529256299.jpg?branch=production&width=96&quality=75&auto=webp)

## Alice Park


Senior Correspondent

Mar 25, 2021 5:10 PM UTC

Alejandra and Marisol Gerardo are nine years old but already making a little bit of history. The twin sisters are among the first young children to get vaccinated with a COVID-19 shot in Pfizer-BioNTech’s study of its vaccine in kids under age 12.

Alejandra and Marisol had their blood drawn in the morning on March 24, then got their first dose of the two-dose vaccine later that afternoon at Duke University Medical Center, one of four study sites in the U.S. for the trial. “Their primary concern was, ‘is it going to hurt,’” says their father, Dr. Charles Gerardo, chief of emergency medicine at Duke University School of Medicine. “They’re not too worried about the long term side effects; they’re looking at the moment, not the future.”

Testing the vaccine in younger children will answer critical questions about how much immunity the shots can provide, and potentially give parents and education officials more confidence in re-opening schools. While it appears that younger children don’t get as sick with COVID-19 as older teens and adults do, how these children’s immune systems respond to the virus, and to the vaccine, remains a black box. The trial will also help provide some clarity on those questions.

Pfizer-BioNTech says it will test the same vaccine that is currently [authorized](https://time.com/5920134/first-authorized-covid-19-vaccine-us/) for emergency use in the U.S. for those 16 years and older, but this time in children aged six months to 11 years. The company is currently wrapping up a study of its two-dose shot in adolescents aged 12 to 15 years in the U.S. and Europe.

The latest pediatric trial will follow the same three-phased approach as the adult study, with Phase 1 involving 144 children aged five to 11 years at Duke, Boston Children’s Hospital, Cincinnati Children’s Hospital and Johns Hopkins, who will all receive the vaccine but be randomly assigned one of three dosages. If the vaccine is safe in this age group, children aged two to four years will be tested, and if safe in that group, the youngest children from six months to two years will get the vaccine. Depending on the immune responses these children generate, the scientists at Pfizer-BioNTech will make a decision about the safest and most effective dose with which to proceed in its Phase 2 and Phase 3 studies.


Those will include a total of about 4,500 children broken down in the same age categories, this time randomly assigned to receive either the vaccine or placebo in a 2:1 ratio. The results will be analyzed after six months to determine if the children receiving the vaccine both generated a stronger immune response than those getting placebo, and that the response was on par with responses in vaccinated adults. If that’s the case, then Pfizer-BioNTech will submit the data to the U.S. Food and Drug Administration to expand authorization to younger children, and hopefully start vaccinating them by early next year.

Dr. Emmanuel Walter, professor of pediatrics and chief medical officer at the Duke Human Vaccine Institute who is overseeing the trial there, says the study will answer important questions about the safety and dosing of the vaccine for children—specifically whether younger children will need a different dose than adolescents and adults. The trial will test a dose about one-third that of the current adult dose, another that is about half of the adult dose, as well as the adult dose. While the Pfizer-BioNTech COVID-19 shot is the first mRNA technology-based vaccine of any kind to gain FDA authorization, Walter says it’s likely to be safe in children. “I don’t think it’s the platform so much that I would worry about for young children—I feel comfortable giving the mRNA to young children. I think the questions of will they have side effects, will the vaccine be tolerable to children, and do we need to use a smaller dose in young kids, are the biggest things.”


So far, Walter says that they have seen an “overwhelming” response to the pediatric trial, with parents like the Gerardos expressing interest in enrolling their children. Both Gerardo and his wife, who is an infectious disease physician at Duke, are vaccinated, and he says before his daughters joined the trial, they discussed volunteering with the girls. “They understand that the results are going to impact other kids, and that’s one of the lessons we wanted to teach them with this experience,” he says. “That this was one of the ways to contribute to help other people.”


## Transcript

But I am very excited that you finally come up with a vaccine. I feel the weight of it that this is going to do some good for us. And you know that I'm ready for it to start happening. You know, waiting to be in line to get my shot to. Just all the way to the Yankees or. Don't sign for Colbert. So they don't say. I actually. The biggest challenge has been temperature requirements, because that has to be kept at ultracold temperature of negative seven degrees Celsius. Or if we are transporting in a refrigeration, we have a lot more monitoring for that because it's only good for so many hours if the temperature excursion happens.

And then there is a lot of responsibility in terms of liability. This vaccine has been very popular, so we have security protocols. We are putting SEALs when they're transporting. We have cameras installed specifically for this over and. Yeah. And be sorry. All right. Keep your arm relaxed. Oh, just the needle all done. You're not even bleeding. So my grandmother actually just passed away, I mean, less than two months ago from it. So to be out here protecting other people's grandparents is really touching me personally. Like, I really appreciate the opportunity and just so happy to be a part of it.

The staff members here, we have about 240 that we're doing. We can get through usually with this many immunizations, 40 or 50 an hour at this facility specifically, we have over 100 residents that are all room to room based. So that takes a little more time. And then have you ever had a reaction after receiving a vaccine in the past? I can see how grateful they are. And I'm just grateful and honored to be able to give them the vaccine for me to be able to do it directly. You know, the last patient I just did, she's like, I'm waiting for the vaccine. And I was like, I'm here with the vaccine. And she's like, You're here with the vaccine.

So I'm part of the bigger movement of vaccinating basically America. And that's it. Well, that's the easiest one I ever had. I'm glad with hay fever, I was you know, they can't come and visit me and I can't go visit them. But it's. Oh, gosh, it makes me mad anyway. It really is hard. And it's been harder for a lot of other people who have lost folks. And so I haven't had that problem, but it's awful. So I will mask myself any time to prevent that from happening. When I was a kid, everybody knew people who had somebody in their family that had polio. Any vaccine that prevents unnecessary pain and suffering is a good thing to have.

All right. I'm just going to sanitize your arm real quick. I am happy that my son sometimes he talks to me on Facebook on face time. This time. And my daughter calls me every night. I know I can touch them and see them, but I just think the time will come. I hope. I hope I'm still alive. And make sure you're safe.

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