CDC Panel Signs Off on COVID Vaccine for Kids 5 to 11, Final Authorization Granted

A Centers for Disease Control and Prevention (CDC) panel on Tuesday formally recommended that children ages 5 to 11 receive Pfizer's kid-sized COVID-19 vaccine, the Associated Press reported.

CDC Director Dr. Rochelle Walensky signed off on the recommendation, announced at approximately 7:45 p.m. Eastern Time, marking the first opportunity in the U.S. for children under 12 to receive the vaccine.

The influential advisory panel voted Tuesday that all children ages 5 to 11 should get Pfizer's pediatric COVID-19 shots, after debating if the vaccination should only be available to children who are most vulnerable to serious illnesses.

"Today is a monumental day in the course of this pandemic," Walensky told the advisory panel Tuesday. "There are children in the second grade who have never experienced a normal school year. Pediatric vaccination has the power to help us change all of that," Walensky said.

Shots could be available to begin this week as Pfizer has begun packing and shipping millions of doses to states and pharmacies across the country.

For more reporting from the Associated Press, see below.

Pfizer Vaccine
A Centers for Disease Control and Prevention panel on Tuesday formally recommended that children ages 5 to 11 receive Pfizer's kid-sized COVID-19 vaccine. Pfizer/Associated Press

Walensky said while the risk of severe disease and death is lower in young children than adults, it is real—and that COVID-19 has had a profound social, mental health and educational impact on youngsters, including widening disparities in learning.

Doctors who've cared for hospitalized youngsters hope parents embrace Pfizer's kid shots, saying they're safe and far better than gambling that a child will escape a coronavirus infection.

"I've seen plenty of children in this age group that have been seriously ill," said Dr. Matthew Linam, an infectious disease specialist at Children's Healthcare of Atlanta. "The risk of significant infection is still very real in this population."

There have been more than 8,300 hospitalizations of kids ages 5 to 11, about a third requiring intensive care, according to government data. The CDC has recorded at least 94 deaths in that age group.

And while the U.S. has seen a recent downturn in COVID-19 cases, experts are worried about another uptick with holiday travel and as winter sends more activity indoors where it's easier for the coronavirus to spread.

Pfizer's kid shots contain a third of the vaccine dose that's already been used to vaccinate millions of people 12 and older. The 5- to 11-year-olds will receive two shots, three weeks apart, the same schedule as everyone else—but a smaller amount in each shot, using a smaller needle.

A study of 2,268 youngsters found the kid-size vaccine is nearly 91 percent effective at preventing symptomatic COVID-19—based on 16 diagnoses among kids given dummy shots compared to just three who got the real vaccination.

The FDA examined more children, a total of 3,100 who were vaccinated, in concluding the shots are safe. The younger children experienced similar or fewer reactions—such as sore arms, fever or achiness—than teens or young adults get after larger doses.

That 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. The FDA ultimately decided the benefits from vaccination outweigh the potential that younger kids getting a smaller dose also might experience that rare risk.

The FDA's decision came after its own advisers struggled with whether every young child needed a vaccine—a key question in Tuesday's deliberations, too. Youngsters hospitalized with COVID-19 are more likely to have high-risk conditions such as obesity or diabetes—but otherwise healthy children can get seriously ill, too.

And many pediatricians and parents have clamored for protection for youngsters so they can resume normal childhood activities without risking their own health—or the fear of bringing the virus home to a more vulnerable family member.

Update (11/2/2021, 7:55 p.m.): This article has been updated to reflect that Dr. Walensky gave final authorization to the Pfizer pediatric COVID-19 vaccine.