FDA Panel Endorses Pfizer COVID Vaccine for Kids Ages 5-11

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• When might vaccines be available for kids age 5-11?

A panel of U.S. health advisers on Tuesday endorsed kid-size doses of Pfizer’s COVID-19 vaccine, moving the U.S. closer to rolling out vaccinations for children age 5 to 11.

The Food and Drug Administration advisory panel voted unanimously (with one abstention) that the vaccine’s benefits in preventing COVID-19 for that age group outweigh any potential risks — including a heart-related side effect that’s been very rare in young adults who received a much higher dose.

The FDA isn’t bound by the panel’s recommendation and is expected to make its own decision within days.

What’s next

If the FDA fully authorizes the kid-size doses, there’s still another step: Next week, the Centers for Disease Control and Prevention will have to decide whether to recommend the shots and which youngsters should get them.

For parents or caregivers wondering what’s next, the full review process for green-lighting a kid-size doze of the Pfizer vaccination includes four key steps:

1. FDA panel review — endorsed Tuesday, Oct. 26
2. FDA agency review
3. CDC panel review — scheduled for the week of Nov. 1 
4. CDC agency review

If the FDA authorizes the shots following the FDA panel’s endorsement, the Centers for Disease Control and Prevention will make additional recommendations on who should receive them the first week of November.

Children could begin getting vaccinations early next month, with the first youngsters in line fully protected by mid-December.

What could a COVID-19 vaccine for kids look like?

States are getting ready to roll out shots for little arms — in special orange-capped vials to distinguish them from adult vaccines — as soon as the government gives the OK. More than 25,000 pediatricians and other primary care providers have signed up so far to offer vaccinations.

The dose for young children is just one-third of the Pfizer shot already recommended for everyone 12 and older. Moderna also is studying its vaccine for young children.

Full-strength shots made by Pfizer and its partner BioNTech are already recommended for everyone 12 and older, but pediatricians and many parents are clamoring for protection for younger children. The extra-contagious delta variant has caused an alarming rise in pediatric infections — and families are frustrated with school quarantines and having to say no to sleepovers and other rites of childhood to keep the virus at bay.

How did the FDA panel reach its consensus on vaccines for kids?

While children are at lower risk of severe COVID-19 than older people, 5- to 11-year-olds still have faced substantial illness — including over 8,300 hospitalizations, about a third requiring intensive care, and nearly 100 deaths, FDA vaccine chief Dr. Peter Marks told the advisory panel.

“I want to acknowledge the fact that there are strong feelings” among the public for and against child vaccinations, Marks added, noting that the discussion would be on scientific data ,”not about vaccine mandates, which are left to other entities outside of FDA.”

A study of elementary schoolchildren found that the Pfizer shots are nearly 91% effective at preventing symptomatic infection — even though the youngsters received just a third of the dose given to teens and adults.

In a preliminary analysis last week, Food and Drug Administration reviewers said that protection would “clearly outweigh” the risk of a very rare side effect in almost all scenarios of the pandemic.

Pfizer’s study tracked 2,268 children age 5 to 11 who got two shots three weeks apart of either a placebo or the kid dose. Vaccinated youngsters developed levels of virus-fighting antibodies just as strong as teens and young adults who got the full-strength shots.

And so far, 16 kids given placebo shots developed symptomatic COVID-19 compared to three vaccinated youngsters, meaning the vaccine was nearly 91% effective. Most of the study data was collected in the U.S. during August and September as the delta variant surged.

The kid dosage also proved safe, with similar or fewer temporary side effects — such as sore arms, fever or achiness — than those that teens experience. Pfizer more recently enrolled another 2,300 youngsters into the study at the FDA’s request, and preliminary safety data has shown no red flags.

The study isn’t large enough to detect any infrequent side effects, such as the heart inflammation that occasionally occurs after the second dose, mostly in young men and teen boys.

The FDA analysis calculated that in most scenarios of the continuing pandemic, the vaccine would prevent roughly 200 to 250 COVID-19 hospitalizations for every 1 million youngsters vaccinated, with about 58 hospitalizations for heart inflammation. The side effect risk is based on levels in teens, and Pfizer expects it to be far lower in youngsters getting the kid-size dose.

Watch the full  FDA panel review for Pfizer’s COVID vaccine for kids from Oct. 26 below.