Outside the Beltway

FDA Approves Pfizer for Kids 5-11

Good news with mixed messaging.

James Joyner · Saturday, October 30, 2021 · 6 comments

The Food and Drug Administration yesterday issued emergency authorization for children between 5 and 11 years old to get the Pfizer coronavirus vaccine at one-third the dose for 12 and older. The Centers for Disease Control and Prevention is expected to meet next early week to issue detailed implementation recommendations.

AP (“FDA paves way for Pfizer COVID-19 vaccinations in young kids“):

The Food and Drug Administration on Friday paved the way for children ages 5 to 11 to get Pfizer’s COVID-19 vaccine.

The FDA cleared kid-size doses — just a third of the amount given to teens and adults — for emergency use, and up to 28 million more American children could be eligible for vaccinations as early as next week.

One more regulatory hurdle remains: On Tuesday, advisers to the Centers for Disease Control and Prevention will make more detailed recommendations on which youngsters should get vaccinated, with a final decision by the agency’s director expected shortly afterwards.

“The rationale here is protect your children so that they can get back towards normal life,” said FDA vaccine chief Dr. Peter Marks. “The tremendous cost of this pandemic has not just been in physical illness, it’s been in the psychological, the social development of children” too.

A few countries have begun using other COVID-19 vaccines in children under 12, including China, which just began vaccinations for 3-year-olds. But many that use the vaccine made by Pfizer and its partner BioNTech are watching the U.S. decision, and European regulators just began considering the companies’ kid-size doses.

With FDA’s action, Pfizer plans to begin shipping millions of vials of the pediatric vaccine — in orange caps to avoid mix-ups with the purple-capped doses for everyone else — to doctors’ offices, pharmacies and other vaccination sites. Once the CDC issues its ruling, eligible kids will get two shots, three weeks apart.

While children are at lower risk of severe illness or death from COVID-19 than older people, 5- to 11-year-olds still have been seriously affected — including over 8,300 hospitalizations, about a third requiring intensive care. The FDA said 146 deaths have been reported in that age group.

My 12-year-old got vaccinated over the summer and my three stepchildren, wife, and I all did so as soon as we were eligible. My 10-year-old is the lone holdout and we’ll get her dosed as soon as we can. Which shouldn’t be long:

NPR (“Parents should be patient about getting COVID vaccines for kids, White House says“):

[A] top White House official is cautioning that parents shouldn’t expect to be able to get their kids vaccinated the very next day if the Centers for Disease Control and Prevention recommends the vaccine, as it is expected to on Tuesday. Patience may be needed, as it could take several days before shots are readily available.

“We’re talking about a specialized vaccine for children,” said Jeff Zients, the White House’s COVID-19 response coordinator, in an exclusive interview with NPR. “We are hard at work, planning the logistics and making sure that vaccines will be available at tens of thousands of sites that parents and kids know and trust.”

The process isn’t as simple as just opening up appointments at pharmacies, as it was when adult boosters were authorized in recent weeks. Younger children will be getting a smaller dose delivered via smaller needles for smaller arms. It’s a different formulation, in different packaging — a new program for a new population that requires greater sensitivity.

“We urge parents to get ready and make a plan, and the program will be fully up and running the week of November 8th,” Zients said.

“Be patient” is odd messaging. I’m not the world’s most patient man but six days from the expected CDC approval—and nine days from the initial FDA announcement—isn’t exactly a long wait for something this complicated.

Conversely, messaging from the FDA is confusing in the opposite direction. As best I can determine, aside from further minimizing her already-low risk of contracting a serious case of COVID, there is no lifestyle benefit, psychological or otherwise, around the corner. The schools are already open for in-person instruction but continue to observe restrictive COVID protocols even for those fully vaccinated. Her life will be no more “normal” than it is now until and unless vaccination becomes nearly universal.