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Coronavirus vaccines are coming for kids — but studies have to be finished first

Katelyn Evans, 17, receives a dose of the Pfizer-BioNTech coronavirus vaccine in Cincinnati on Feb. 23. (Cincinnati Children’s Hospital)

More than almost anything, Katelyn Evans yearns to be in a play again — onstage, in front of an audience. When the coronavirus pandemic put the world on pause a year ago, she was a high school sophomore three weeks out from opening night of the musical comedy “Once Upon a Mattress.” The show never went on.

Evans, now 17, feels lucky, overall. No friends or relatives have become seriously ill, and she’s attending school in person in Cincinnati. But she’s keeping a mental tally of the performances that could have been.

“Most people my age are aware we’re not the number one priority for getting the vaccine. … There are people in higher-risk groups than teenagers,” Evans said. Still, she said, “it is a tough age for this to happen. These are once-in-a-lifetime things.”

To help speed the journey back to live theater performances, Evans rolled up her sleeve in October and became one of the youngest volunteers, at that point, in a trial to test an experimental coronavirus vaccine in teens. On Wednesday, pharmaceutical giant Pfizer and its German biotech partner BioNTech announced their vaccine was safe and effective in adolescents as young as 12 — the same vaccine Evans received. Vaccinations could begin before the next school year for younger teens, pending a regulatory green light, Pfizer chief executive Albert Bourla said.

The key to ending the pandemic looms tantalizingly close in the United States — for adults. President Biden vowed that there would be enough vaccine doses for every American adult by the end of May and predicted that, by July 4, enough people will have received shots to make small gatherings safe.

But the security and relief that come with vaccination remain months away for most children and teens. With normalcy in sight after a long year, many families have become focused on the gap in vaccine availability, an immunity purgatory where only some family members will be vaccinated. The delay will ripple beyond individual families, because the threshold for herd immunity almost certainly won’t be reached without providing vaccines to many of the about 73 million people under the age of 18 in the United States.

Vaccines are on their way to children, but it will take time.

Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, says older teens such as Evans will be the first to be offered vaccines, probably by the fall. Elementary-school-age children will probably have to wait until early 2022.

“Vaccinating the children, particularly in the context of the teachers and the parents feeling more confident as we get both high-schoolers and elementary kids back to school, that’s an important goal,” Fauci said. But he cautioned not to get too fixated on a particular fraction of the population being vaccinated for things to improve, because the world will get safer as more people are protected.

“Even if we don’t reach whatever this number of herd immunity is, the more people you get vaccinated, the less virus you have in the community,” Fauci said.

The Pfizer-BioNTech vaccine is already authorized for people age 16 and older. Evans recently got a real vaccine because she received a placebo in the study. Pfizer and BioNTech said in a statement Wednesday that data showing their vaccine was 100 percent effective in preventing symptomatic illness in 12- to 15-year-olds will be submitted to regulators in coming weeks. A similar trial from Moderna is expected to report results by summer.

Moderna this month launched a trial that will gradually decrease in age, from 11-year-olds down to babies. Pfizer and BioNTech recently began testing their vaccine in a similar trial, working first to establish a safe dose and then to test it in children ages 5 to 11, then 2 to 5, and, finally, ages 6 months to 2 years.

AstraZeneca and Oxford University launched a trial in February in children as young as 6 years old. In briefing documents submitted to the Food and Drug Administration, Johnson & Johnson outlined two planned studies in children, one for 12- to 18-year-olds and another that would include children as young as infants.

The euphoria from stunningly effective vaccines late last year has been tempered by the realization that more than a fifth of the U.S. population faces a wait. The gap has become a reminder that even after the scientific success achieved with coronavirus vaccines, the pandemic won’t have a tidy, universal end. Children are at low risk for serious illness, but their lives have been upended by the pandemic.

“As a pediatrician, for sure you hear all the time how this has affected people in many ways, even if it’s not the disease itself,” said Flor Muñoz, a pediatric infectious-disease specialist at Baylor College of Medicine. “There’s no question that children have a lot of consequences from the pandemic, and a vaccine provides hope as much as possible about going back to a near-normal life.”

In the early days of the pandemic, experts debated why so few children were becoming infected and why those who did so often had few or no symptoms. They rarely suffered serious illness.

It is now clear that when tests were limited, children were simply not being counted. According to the American Academy of Pediatrics, children make up about 13 percent of U.S. infections.

Serious cases are scarce in children compared with older adults, and they account for between 1 percent and 3 percent of hospitalizations, according to state data compiled by the American Academy of Pediatrics. Children — particularly young children — don’t appear to spread the virus as efficiently, although data remains sparse. Very seldom, children develop a rare inflammatory syndrome. About 270 of the more than 549,000 pandemic-related deaths in the United States have been in people under the age of 18.

“I can’t predict who is going to be that one child, that handful of children, that get really sick,” said Robert W. Frenck Jr., director of the Vaccine Research Center at Cincinnati Children’s Hospital Medical Center, who is leading the Pfizer trial in which Evans participated.

Adults were the first target in vaccine development because the crisis of the pandemic was driven by severe illness in adults, overwhelming hospitals and accounting for most deaths.

Now that the vaccines have been shown to work exceedingly well, many families are questioning why children weren’t included in those initial trials. But the front-runner vaccine candidates initially sparked skepticism and concern because they relied on new technologies. What if the vaccines had been tested in children at low risk of severe illness and the shots had produced serious side effects or barely worked, Frenck asked. People would have questioned why children were study subjects when the disease presented relatively little risk.

“Children aren’t exempt from the adverse effects of this infection. They can get very sick and even die, but the proportion of children impacted in this way is small compared to adults,” said Archana Chatterjee, dean of the Chicago Medical School and a member of the expert committee that advises the FDA on vaccines. “From an epidemiological standpoint, it made sense to approach the vaccines we’re trying to develop as vaccines for adults first.”

Even pediatricians who wish the pediatric trials had started earlier say vaccine development has moved so rapidly that children won’t be egregiously delayed access. Some debate whether, given the low risk of the virus to children and the still unknown role that children play in transmission, vaccines for children should be held to a higher regulatory standard than emergency use authorization. The frustration that families feel underscores a reality of the pandemic: Vaccination is not a singular solution for the crisis. Mask-wearing will need to continue, even as the world gets safer.

“We don’t have the vaccine availability and accessibility for it to be an on-off switch. It’s pretty much step by step, and the more steps you take, the closer you get to the goal. I do think we’re definitely getting there,” said Sharon Nachman, a pediatric infectious-disease expert at Stony Brook University in New York.

It may be better to think of vaccination unfolding in phases and to realize that scientists are still learning how well the inoculations work. All the vaccines show excellent protection against severe disease, so vaccinating adults first will reduce the threats of death and hospitalization. They also markedly reduce milder cases of symptomatic illness. But vaccine trials are just beginning to rigorously test how well they halt transmission and to learn how safe and effective they are in adolescents and young children.

As the coronavirus joins the ranks of human pathogens that circulate and cause outbreaks, vaccinating children will be needed to help stop outbreaks and transmission. Virus variants may require booster shots.

Children and teenagers volunteering for trials say they are eager for everyone to have greater protection. Most are motivated not because they fear getting sick but because they want to protect vulnerable family members and help get the world back to normal.

Ethan Sullivan, 14, of Miami participated in a trial and received his first shot of the Pfizer-BioNTech vaccine in February. He is more aware of the virus than many middle-schoolers; his parents are doctors, and every day, he asks his father how many cases of covid-19, the disease caused by the coronavirus, were handled in the emergency department.

When Ethan was vaccinated, he found himself questioning whether it was ethical to receive a shot of protection when many of his teachers hadn’t.

“A lot of my teachers are in their 50s and 60s, and they’re at significantly higher risk,” Ethan said. “I’m 14 and healthy and have a zero percent chance of dying of this. When I first thought about it, it didn’t seem fair that I get it before them.”

Ethan is even-keeled about life during the pandemic. Masks are kind of annoying during gym class, but they’re not much trouble. He eats lunch with a small group of friends at school to limit exposure and looks forward to the day everyone is vaccinated.

Once shots are available, families will probably sign up to be vaccinated if the specter of the pandemic continues — much like there’s more interest in a flu vaccine in a year with a significant influenza threat, some specialists said. But if the coronavirus threat subsides, it might be harder to persuade families of the urgency.

In January, Moncef Slaoui, chief scientist for the Trump administration’s effort to accelerate vaccine development, announced that enrollment for Moderna’s teen trial was slow. But Melanie Ivarsson, chief development officer for the company, said Slaoui’s remarks reflected an early stage of the trial and, ultimately, 15,000 families signed up. The company needed only 3,000 volunteers.

Another factor that could influence parents: convenience. If families know they need to keep children home after exposures to the coronavirus to quarantine if they are not vaccinated, the shots could be a powerful motivator for working parents. Children spread many viral diseases, and not having to be on high alert after every runny nose or sneeze could be reassuring.

A growing body of evidence shows that schools with precautions, such as requiring students and staff to wear masks, can function safely before children are vaccinated. If teachers and other adult staff members get shots, those at highest risk will have another layer of protection.

Infectious-disease specialists agree that vaccinating children is crucial, but they also stress that an essential part of childhood can continue even before younger children have access to shots: in-person learning.

“You can fairly state that deaths due to influenza each season are about the same as due to covid-19 in children, and we don’t jump through all the hoops to close schools,” said H. Cody Meissner, a pediatric infectious-disease specialist at Tufts Medical Center in Boston. “We’re making children bear the greatest burden from covid-19 for nonmedical reasons. They’re missing their education, they’re missing socialization, not getting meals. It’s dramatically increasing social inequities in the country.”

Coronavirus: What you need to know

Vaccines: The CDC recommends that everyone age 5 and older get an updated covid booster shot. New federal data shows adults who received the updated shots cut their risk of being hospitalized with covid-19 by 50 percent. Here’s guidance on when you should get the omicron booster and how vaccine efficacy could be affected by your prior infections.

New covid variant: The XBB.1.5 variant is a highly transmissible descendant of omicron that is now estimated to cause about half of new infections in the country. We answered some frequently asked questions about the bivalent booster shots.

Guidance: CDC guidelines have been confusing — if you get covid, here’s how to tell when you’re no longer contagious. We’ve also created a guide to help you decide when to keep wearing face coverings.

Where do things stand? See the latest coronavirus numbers in the U.S. and across the world. In the U.S., pandemic trends have shifted and now White people are more likely to die from covid than Black people. Nearly nine out of 10 covid deaths are people over the age 65.

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