CDC to Decide Which Kids Get Pfizer Vaccine After FDA Grants Emergency Use

The Food and Drug Administration (FDA) on Friday Pfizer-BioNTech's announced it had authorized the coronavirus vaccine for emergency use in children ages 5 to 11.

The FDA approved a smaller dose size for children, which is roughly a third the amount given to adults and teenagers. Up to 28 million children in the group will now be eligible to receive the smaller dose in two injections spaced three weeks apart.

On Tuesday, advisers to the Centers for Disease Control and Prevention are expected to announce more detailed recommendations on which young people should get vaccinated. The agency's director is then expected to make a final decision soon afterward.

"With this vaccine kids can go back to something that's better than being locked at home on remote schooling, not being able to see their friends," Dr. Kawsar Talaat of Johns Hopkins University said in a press statement. "The vaccine will protect them and also protect our communities."

Children are thought to be at a lower risk of severe illness or death from COVID-19 than older people. However, 5- to 11-year-olds have been seriously affected by the virus. The FDA said the age group has experiencing 8,300 hospitalizations—with roughly a third requiring intensive care—and almost 100 deaths since the start of the pandemic.

For more reporting from the Associated Press, see below.

Pfizer
The U.S. moved a step closer to expanding vaccinations for millions more children as a panel of government advisers on October 26, endorsed kid-size doses of Pfizer's shots for 5- to 11-year-olds. Above, an October 2021 photo shows kid-size doses of its COVID-19 vaccine in Puurs, Belgium. Pfizer via AP, File

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. Kids will get two shots, three weeks apart.

Earlier this week, FDA's independent scientific advisers voted that the pediatric vaccine's promised benefits outweigh any risks. But several panelists said not all youngsters will need to be vaccinated, and that they preferred the shots be targeted to those at higher risk from the virus.

Nearly 70 percent of 5- to 11-year-olds hospitalized for COVID-19 in the U.S. have other serious medical conditions, including asthma and obesity, according to federal tracking. Additionally, more than two-thirds of youngsters hospitalized are Black or Hispanic, mirroring long-standing disparities in the disease's impact.

The question of how broadly Pfizer's vaccine should be used will be a key consideration for the CDC and its advisers, who set formal recommendations for pediatricians and other medical professionals.

A Pfizer study of 2,268 schoolchildren found the vaccine was nearly 91 percent effective at preventing symptomatic COVID-19 infections, based on 16 cases of COVID-19 among kids given dummy shots compared to just three who got vaccinated. The kid dosage also proved safe, with similar or fewer temporary reactions—such as sore arms, fever or achiness—that teens experience.

But the study wasn't large enough to detect any extremely rare side effects, such as the heart inflammation that occasionally occurs after the second full-strength dose, mostly in young men and teen boys. It's unclear if younger children getting a smaller dose also will face that rare risk.

Some parents are expected to vaccinate their children ahead of family holiday gatherings and the winter cold season.

But a recent Kaiser Family Foundation survey suggests most parents won't rush to get the shots. About 25 percent of parents polled earlier this month said they would get their children vaccinated "right away." But the remaining majority of parents were roughly split between those who said they will to wait to see how the vaccine performs and those who said they "definitely" won't have their children vaccinated.

The similarly made Moderna vaccine also is being studied in young children, and both Pfizer and Moderna also are testing shots for babies and preschoolers.