Pfizer and BioNTech vaccine granted emergency use authorization for 12 to 15-year olds

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As we move closer to the end of the school year, many parents are wondering what summer might look like for their children who haven’t been old enough to receive the COVID-19 vaccine yet.

Today, steps were taken to ease some of those concerns and protect a larger group of adolescents as the Centers for Disease Control and Prevention (CDC) recommended the Pfizer and BioNTech’s COVID-19 vaccine for 12 to 15-year-olds. On May 10, the U.S. Food and Drug Administration (FDA) expanded the emergency use authorization the vaccine to include this age group. Previously, the vaccine was only available to people age 16 and older.

This approval couldn’t come soon enough, as recent numbers from the American Academy of Pediatrics show children now account for more than a fifth of new COVID-19 cases in the U.S.

I want to make sure parents feel comfortable choosing to vaccinate their adolescents and teenagers, so I’m answering some of the most common questions below.

What does the authorization of the Pfizer vaccine for 12 to 15-year-olds mean in terms of efficacy?

The data from Pfizer and BioNTech’s clinical trial of more than 2,000 adolescents showed the vaccine is 100% effective at preventing COVID-19 infection.

How was the vaccine tested in this age group?

The vaccine was administered to a group of about 1,000 children, while a similar-sized group received placebo. Researchers compared the groups to see which participants contracted COVID-19. None of the children who received the vaccine got COVID-19, while 18 children who received placebo tested positive for the virus.

Will children in this age group receive the same dose as those who are 16 and older?

Yes. The dose for the 12 to 15-year-old age group is the same as adults – 30 micrograms – and has been shown to have similar safety and efficacy.

What should parents consider if they have a child in this age group?

It’s critical to have your child vaccinated. We know in the short term that COVID-19 can make people really sick, including children. Those of us who worked at Texas Children’s during the pandemic know just how dangerous this disease can be for children. We’re seeing suffering from some long-term and sometimes serious side effects involving their heart and other organ systems, and we don’t want your child to experience this. It’s also important to choose to vaccinate your child because children can spread the disease to other children and adults. We know the vaccine in adults is very effective, but it’s not perfect. We want vaccinated children to serve as an extra barrier to protect grandparents, teachers and other adults they encounter in their environment.

Do you anticipate the other vaccines will be available for this group, too?

On May 6, Moderna announced data from their vaccine trial. Their “Teen Cove” trial evaluated the vaccine in 3,235 teens, two-thirds of whom received the vaccine; the other third received placebo. They found that the Moderna vaccine was 96% effective in preventing COVID-19. While we don’t know exact timing, we expect the Moderna vaccine to be available for teens in the next one to two months. We also expect Johnson & Johnson to be available to adolescents this summer.

How does this development offer hope as we head into the summer and the following school year?

We all want to return to life as we knew it pre-COVID-19. There’s not a person I know that wants to continue missing out on birthday parties, sporting events and other activities. Vaccinating your child is one way we can ensure we can go back to some sense of normalcy sooner rather than later.

How should parents have the conversation about getting vaccinated with their teenagers?

Teenagers take cues from their parent about getting vaccinated. As a parent, your decisions and influence on them is paramount. So please, listen to the information we and other health officials are providing. Talk to your adolescents and teenagers about the importance of protecting themselves and their community.

For additional information and resources, please visit our dedicated COVID-19 vaccine webpages at texaschildrens.org/covidvaccine and women.texaschildrens.org/covidvaccine.