An influential advisory panel voted Tuesday that all children ages 5 to 11 should get Pfizer’s pediatric COVID-19 shots, putting the U.S. on the brink of a major expansion of vaccinations—and a final decision is expected within hours.
The Food and Drug Administration already has OK’d kid-size doses—just a third of the amount given to teens and adults—as safe and effective for the younger age group.
The Centers for Disease Control and Prevention formally recommends who should receive FDA-cleared vaccines, and its advisers decided Pfizer’s shots should be opened to all 28 million children ages 5 to 11.
If the CDC’s director, Dr. Rochelle Walensky, signs off, it will mark the first opportunity for Americans under 12 to get the powerful protection of any COVID-19 vaccine.
Shots into little arms could begin this week, as Pfizer already is packing and shipping the first orders, millions of doses, to states and pharmacies to be ready.
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% 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.
More health care and Big Pharma coverage from Fortune:
- ‘Vax’ is Oxford English Dictionary’s word of the year
- With a vaccine mandate looming, these apps help businesses check which employees got vaxxed
- Novavax COVID-19 vaccine’s long-delayed global rollout will start in Indonesia, fueling hope for more equitable distribution
- 100 million Indians have skipped their second vaccine dose, leaving the country vulnerable to a third COVID wave
- A COVID scare trapped 33,000 visitors inside Shanghai Disneyland in a ‘surreal’ scene
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