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FDA expected to authorize COVID vaccine for some adolescents

By Gina DiPietro
Novant Health

Adolescents ages 12 to 15 will soon be eligible to receive the Pfizer coronavirus vaccine — opening up the COVID-19 vaccine to millions of more people. The Food and Drug Administration (FDA) said the vaccine could be authorized for this younger age group by this week. It is currently approved for ages 16 and up.

“It’s taken a while to get this exciting news, but that reflects the safety programs the FDA has in place and what the manufacturers do to ensure the vaccine is safe for everyone we give it to,” said Dr. David Priest, Novant Health senior vice president and chief safety, quality and epidemiology officer.

Since children under 18 account for more than 20% of the U.S. population, this age group could help the U.S. continue to curb the spread of COVID-19. Priest weighed in on that, as well as other common questions as younger people prepare to roll up their sleeves.

Why should children get vaccinated?

We vaccinate children for a whole host of infectious diseases, and we’ve done so for many decades with great success. I think modern society forgets about the devastation of things like polio, measles and mumps, and while the risk of those is rare, we must protect our entire society.

We’re learning more and more about how this virus works in children under 16. What we’ve seen recently is more of them becoming ill, sometimes seriously, and occasionally you have people in that age group who die.

The vaccine will protect an individual child, but also prevent the spread of COVID-19 in the community. That protects all of us, including grandparents, and allows us to get back to the activities we want to do.

How effective is the vaccine for children?

Pfizer’s vaccine is at least as effective in those 12 to 15 years old as it is in adults, according to results from its trial in adolescents, which included more than 2,200 kids.

Adolescents respond very vigorously to vaccines and that’s exciting, because it means they’ll be protected quickly and hopefully for longer periods of time than older folks. That’s all the more reason people in this age group ought to be vaccinated — to prevent COVID spread in our communities.

What would you tell parents who are hesitant?

While the development of the COVID-19 vaccines may seem fast, they’re based on science that has been around for a decade. No steps were skipped whatsoever in the evaluation and safety programs related to these vaccines. There was no turning a blind eye to safety. Thousands of volunteers were willing to be vaccinated to make sure this was safe. The same steps were taken in clinical trials with children.

No manufacturer of a vaccine wants to put out an unsafe vaccine. It would potentially bankrupt a company, so they care very much about safety. They have to prove it is safe and effective, so they’re not in the business of putting stuff out there and hoping it works. And if there’s anything that comes up as a potential safety issue, everything is paused and evaluated to ensure that no one is harmed.

What’s next?

If authorized by the FDA, the Centers for Disease Control and Prevention’s vaccine advisory panel will review Pfizer’s clinical trial data and make a recommendation for the vaccine’s use in adolescents.

Additionally, Pfizer and BioNTech have begun another clinical trial of the COVID vaccine in children ages 5 to 11, the companies announced. Moderna has also begun testing its vaccine in children and results are expected later this year.