Coronavirus Vaccines for Children Are Coming

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The Food and Drug Administration appears on the verge of allowing the Pfizer-BioNTech coronavirus vaccine to be used in children ages 12 to 15. The authorization may come next week, if not before.

At the end of March, Pfizer and BioNTech announced that a clinical trial of 2,260 12- to 15-year-olds showed their vaccine was 100 percent effective at preventing COVID-19.

The vaccine could be available to 12- to 15-year-olds within days of FDA authorization. That’s what happened when the FDA cleared the Pfizer-BioNTech vaccine for adults.

News of the FDA’s likely approval of the Pfizer-BioNTech vaccine in teens was first reported by the New York Times on May 3.

The FDA declined comment on when the vaccine would be approved in teens, but said, “We can assure the public that we are working to review the request as quickly and transparently as possible.” Two vaccine experts Consumer Reports spoke with said approval was likely imminent.

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.

Moderna’s vaccine is currently authorized for use in anyone 18 and older, while the Pfizer-BioNTech vaccine can currently be used in anyone 16 or older.

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 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 nearly 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 strains of the virus now circulating—such as the B.1.1.7 variant, currently the main strain 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 if 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, Poland says, but still very protective. 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 doses as adults on the same schedule, with a second dose three weeks after the first.

For the future, though, vaccine manufacturers are testing lower doses of the Pfizer and other vaccines for younger children to see if that provides the same immune system response as higher doses, 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 side effects aren’t a bigger issue for younger children. And he notes one of the reasons to test lower doses 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, we will not go too fast, we will go in a careful, cautious manner,” she says.

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 are authorized by the FDA under an Emergency Use Authorization. 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 likely will require proof of vaccination, he says.

Edwards says she hopes that people are convinced to get children vaccinated based on the “incredible success” we’ve seen the vaccines have at preventing disease so far.