Vaccine for 12-to-15-Year-Olds: What Parents Should Know Ahead of FDA Ruling

With the U.S. Food and Drug Administration expected to authorize emergency use of Pfizer's COVID-19 vaccine for kids aged 12 to 15 potentially by next week, what can parents expect and what is known so far about the COVID vaccines and children?

Here's what experts are saying.

When Could Kids 12 to 15 Get the COVID Vaccine?

A federal official, speaking on the condition of anonymity to preview the FDA's action, told the Associated Press the agency was expected to expand its emergency use authorization for Pfizer's two-dose vaccine by early next week, and perhaps even sooner. The person familiar with the process, who spoke on condition of anonymity to discuss internal matters, confirmed the timeline and added that it is expected that the FDA will approve Pfizer’s use by even younger children sometime this fall.

The FDA action will be followed by a meeting of a federal vaccine advisory committee to discuss whether to recommend the shot for 12- to 15-year-olds. Shots could begin after the Centers for Disease Control and Prevention adopts the committee’s recommendation. Those steps could be completed in a matter of days.

Pfizer isn’t the only company seeking to lower the age limit for its vaccine. Results also are expected by the middle of this year from a U.S. study of Moderna’s vaccine in 12-to -17-year-olds.

But what about younger kids?

According to experts, those under 12 likely won't be able to receive the COVID vaccine until later this year or early next year.

Is the Vaccine Safe for Children?

While many eagerly await a consensus from the FDA and the CDC, some health experts say data so far indicates the vaccine is safe for younger age groups.

Dr. Rick Malley, with Boston Children’s Hospital, said he understands some adolescents and their parents may be hesitant to get the Pfizer vaccine, but he wanted to assure them that, if the FDA determines it’s safe and effective, it makes sense, biologically speaking. He said he could see vaccination appointments available for adolescents pretty rapidly, if they're approved.

"For all of us to get back to a new normal, we’re going to need to vaccinate as much of the population (as possible) and we know that children make up about 20% of the U.S. population," added Dr. Sabrina Assoumou, an infectious disease expert at Boston Medical Center. "So vaccinating children is going to be an important piece of our strategy."

How Effective is the Vaccine for Younger Groups?

The authorization announcement is set to come a month after Pfizer said its shot, which is the only COVID vaccine authorized in the U.S. for those age 16 and older, also provided protection for the younger population.

Pfizer in late March released preliminary results from a vaccine study of 2,260 U.S. volunteers ages 12 to 15, showing there were no cases of COVID-19 among fully vaccinated adolescents compared with 18 among those given dummy shots.

Do Kids Need the Vaccine When They Haven't Been Affected by the Virus as Much as Adults?

According to doctors, the answer is yes.

The number of cases in younger people has been rising in recent months, and children getting vaccinated can help prevent spread among adults as well.

Do Children Experience the Same Side Effects?

Kids had side effects similar to young adults, Pfizer said. The main side effects are pain, fever, chills and fatigue, particularly after the second dose. The study will continue to track participants for two years for more information about long-term protection and safety.

Sore arms and similar common side effects associated with the vaccine were most common for younger populations receiving the vaccine, but said no concerns have so far been raised, though additional data is expected to be released.

What is the Guidance for Parents Should the Vaccine be Recommended by Federal Officials?

The recommendation for parents is the same as they get for vaccinations themselves, according to medical experts. Parents will want to get their children vaccinated to make sure they are covered.

Assuming both the FDA and CDC recommend use of the vaccine in such populations, earlier vaccinations will be beneficial for some -- especially if they are planning to participate in sports or attend camps this summer while COVID is still around.

“We are now learning that these vaccines can interrupt transmission and, therefore, vaccinating adolescents who are highly mobile, who participate in all sorts of activities, is a very good way to try to limit the spread of this virus,” Malley said.

Is the Vaccine Safe for Kids With Seasonal and Peanut Allergies?

According to medical experts, the answer is yes.

What Can You Do If Your Children Aren't Old Enough to Get Vaccinated?

Both Pfizer and Moderna currently have studies that are ongoing for vaccine down to six months, so vaccine for people 12 years of age and younger may be available in the near future. In the meantime, young children will have to continue to wash their hands, wear their masks, social distance and follow CDC guidance for those who are not vaccinated.

Will There Be Exceptions for Younger Children With Certain Conditions?

According to experts, the answer is likely no.