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The Pfizer-BioNTech coronavirus vaccine can now be used in children ages 12 to 15, according to the Food and Drug Administration, which extended authorization of the vaccine to that age group on Monday.
Exactly when 12- to 15- year-olds will start getting vaccinated could vary from state to state, but could be within days, after an advisory committee to the Centers for Disease Control and Prevention issues recommendations for use of the vaccine in this age group.
“Having a vaccine authorized for a younger population is a critical step in continuing to lessen the immense public health burden caused by the COVID-19 pandemic,” said Peter Marks, MD, PhD, director of FDA’s Center for Biologics Evaluation and Research. “The FDA can assure the public and medical community that the available data meet our rigorous standards to support the emergency use of this vaccine in the adolescent population 12 years of age and older.”
At the end of March, Pfizer and BioNTech announced that a clinical trial of 2,260 children ages 12 to 15 showed that their vaccine was 100 percent effective at preventing COVID-19. In FDA's announcement, the agency confirmed that Pfizer and BioNTech's data showed that vaccine to be safe and effective for adolescents.
Later this month, Moderna could ask the FDA to authorize its vaccine, which uses similar technology, for people 12 to 17, according to Gregory Poland, MD, director of the Vaccine Research Group at the Mayo Clinic who studies vaccine response in adults and children.
Getting children vaccinated is essential for controlling the COVID-19 pandemic, Poland says. “If you want your child to go to school, if you want them to be safe, to have the normal social experiences that are important to childhood, please protect them by getting them vaccinated,” he says.
To better understand what we know about COVID-19 vaccines for children, CR consulted with experts and reviewed the available data. Here are answers to some common questions parents may have.
Do Kids Really Need to Get Vaccinated Against COVID-19?
Yes, they should.
In the early months of the pandemic, scientists learned that children and teens were less likely to get severely ill with COVID-19, though some still became very sick. So far, children make up about 13 percent of COVID-19 cases overall in the U.S., with adolescents more likely to develop severe disease like adults, says Kathryn Edwards, MD, scientific director of the Vanderbilt Vaccine Research Program and a professor of pediatrics.
But they account for almost a quarter of new cases, and some states, including Colorado and Michigan, are seeing a rapid spread of coronavirus infections among children.
Some of that is because as adults get vaccinated, they’re less likely to get infected, making children a greater proportion of overall cases. But another reason, Poland says, is that variants of the virus now circulating—such as the B.1.1.7 variant, currently the most prevalent in the U.S.—are more infectious. And that makes vaccinating children, who have always faced some risk from the virus, even more urgent.
“The estimate is there have been around 300 to 600 pediatric COVID deaths,” Poland says. “That’s likely to increase if we don’t stop transmission by getting as many people immunized as possible.”
Vaccination also helps prevent other serious outcomes in children, Edwards says. In rare cases, children who have had COVID-19 have developed a condition, known as MIS-C, that can cause organ damage and even death. Scientists are also following children who have gotten COVID-19 to see whether any have lingering problems, especially cardiac issues.
Are the Vaccines Effective in Kids?
So far, efficacy data on the Pfizer-BioNTech vaccine in children looks “stellar,” Poland says.
According to Pfizer and BioNTech, a clinical trial of that vaccine in 12- to 15- year-olds found it 100 percent effective at preventing COVID-19. Children in that age group had even higher levels of antibodies in response to the vaccine than 16- to 25-year-olds.
It’s likely that in the real world the vaccine may be somewhat less effective but still very protective, Poland says. Clinical trials in adults conducted before vaccines were widely released showed the Pfizer-BioNTech and Moderna vaccines to be 95 percent effective against the disease; initial real-world effectiveness data from the U.S. indicates these vaccines are about 90 percent effective.
Information on the effectiveness of vaccines made by Moderna, Johnson & Johnson, and Novavax in children should be available soon, Poland says.
Do Kids Get the Same Shot as Adults?
Yes, at least for now. In Pfizer-BioNTech’s clinical trial, 12- to 15-year-olds received the same vaccine and dosages as adults, on the same schedule, with a second dose three weeks after the first.
For the future, though, vaccine manufacturers are testing lower dosages of the Pfizer and other vaccines for younger children to see whether that provides the same immune system response as higher dosages, Edwards says.
Are the Vaccines Safe for Kids?
Common side effects reported in children so far are similar to those in adults: injection site pain, fatigue, headaches, muscle aches, chills, joint pain, and fever. And as in other age groups, these were “well tolerated” in 12- to 15-year-olds, Pfizer and BioNTech say.
“The reaction profiles were pretty comparable to what we see in adults,” Edwards says.
Poland says that experts will be watching closely to ensure that side effects aren’t a bigger problem for younger children. He adds that one of the reasons to test lower dosages is to try to minimize side effects for the youngest children.
Regardless, people shouldn’t let fear of short-term side effects be a reason to avoid getting a vaccine that can prevent a disease from causing long-term damage or death, he says.
When Will Younger Children Be Eligible?
That’s not certain, but perhaps as early as next fall. That’s according to a May 4, 2021, Pfizer earnings call, in which the company described plans to seek FDA authorization for use of that vaccine in children ages 2 to 11 in September. Pfizer also said it hopes get authorization for the vaccine in infants in November.
While there’s no guarantee, Poland says he thinks it’s likely younger children could get access to the vaccine in the fall.
Edwards says exactly when younger children will be eligible depends on how the trials go. “We’re all working really hard to make sure the vaccines are safe and effective” she says. “We will not go too fast. We will go in a careful, cautious manner.”
Will Schools Require Kids to Be Vaccinated Against COVID-19?
More than 100 colleges and universities in the U.S. have said they’ll require students to be vaccinated against COVID-19 if they want to return to school in the fall.
Schools that serve younger children already often require proof of various immunizations before children enroll, but it’s not yet clear whether a COVID-19 vaccine will become one of them. Right now, those vaccines have an emergency use authorization from the FDA. Until vaccines receive full approval, Poland says he thinks schools probably won’t require kids to have one. But after the FDA does fully approve the vaccines for children, many schools are likely to require proof of vaccination, he says.
Edwards says she hopes that people are persuaded to get children vaccinated based on the “incredible success” we’ve seen the vaccines have at preventing disease so far.
Editor's note: This article was updated after FDA authorized the Pfizer-BioNTech vaccine for use in 12- to 15-year-old children. It was originally published on May 4, 2021.