COVID vaccine

COVID Vaccine for 12-to-15-Year-Olds: What We Know So Far Ahead of FDA Ruling

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

Here's what we know so far.

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.

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.

"Now what's important to note is that ... there have been clinical trials that have been going on for 12- to 15-year-olds, so this has been studied in this age group," Dr. Candice Robinson, medical director for the Chicago Department of Public Health, said Tuesday. "The same way it was studied in the adults before it was authorized for use in adults, it's also been studied in our 12- to 15-year-olds as well. And what they found [is] it works for most studies. The high level overviews work very well, been very protective in that age group, and they found no series safety or concerns about that, and so we'll get more of that data as the FDA ... makes that decision."

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.

Robinson also noted that 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.

"I think the side effect profiles for kids are probably some of the same things we see, you know, with vaccines with adults," she said. "The sore arms and things like that are kind of the most common side effects after vaccination and things that kids see after their vaccination with their routine vaccinations, as well, but no serious safety concerns have been identified with the use of Pfizer in this age group at this time."

Chicago's top doctor also said preliminary information did not indicate younger groups saw more or less side effects than others.

"From the preliminary information that I've seen, they were not seeing higher side effects in kids, and they were seeing very, very good levels of protection when they look for antibodies in the blood. [It's] actually been a little better than what they'd seen in the young adults," CDPH Commissioner Dr. Allison Arwady said.

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," Robinson said. "You really want to get your kid vaccinated to make sure that they are covered and protected [to] get that most protection from that vaccine against COVID. So the recommendation will be ... the same if the FDA authorizes it."

Arwady also noted that, assuming both the FDA and CDC recommend use of the vaccine in such populations, that earlier vaccinations will be beneficial for some.

"Don't wait until, you know, just prior to school," she said. "We know kids are wanting to do sports this summer and go to camp and be with friends, and we still have a lot of COVID around. ... When I think about being able to have kids over 12 vaccinated, we know older kids, you know, are more likely to spread COVID than the youngest kids. And so [I'm] really excited about the possibility of having a vaccine."

NBC Chicago/Associated Press
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