U.S. FDA authorizes Pfizer's COVID-19 vaccine for emergency use in children 5 to 11

The U.S. Food and Drug Administration on Friday paved the way for children agedfive to 11 to get Pfizer-BioNTech'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.

"Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy," Dr. Janet Woodcock, the acting FDA commissioner, said in a statement.

"Our comprehensive and rigorous evaluation of the data pertaining to the vaccine's safety and effectiveness should help assure parents and guardians that this vaccine meets our high standards."

Canadian decision pending

A few countries have begun using other COVID-19 vaccines in children under 12, including China, which just began vaccinations for three-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.

WATCH | Canadian decision notexpectedbefore mid-November:

Chief medical adviser says we are weeks away from final authorization of COVID-19 shots for children 5-11 years old

3 years ago

Duration 2:15

Dr. Supriya Sharma, Heath Canada's chief medical adviser, says a decision is likely to come by the middle or end of November and the department does encourage children to get the flu shot.

A corresponding decision from Canadian regulatorswill not come before the middle or end of November, a senior official said earlieron Friday.

"I think we're still at least a few weeks away from a final decision," Dr. Supriya Sharma, Health Canada'schief medical adviser,said at a public briefing.

After the FDA announcement, Health Canada said on Twitter it was aware of the agency's move and reiterated that its review is ongoing.

Health Canada received Pfizer-BioNTech's submission for approval and associated data slightly later than the FDA.Canada is expecting 2.9 million child-size doses of the vaccine if it is approved, enough for every child to get their first dose.

Doctors welcome move

Pfizer plans to begin shipping millions of vials of the pediatric vaccine in orange caps to avoid mix-ups with the purple-capped adult doses to doctors' offices, pharmacies and other vaccination sites. Following CDC approval, 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, five- to 11-year-olds still have been seriously affected including over 8,300 hospitalizations in the U.S., about a third requiring intensive care, and nearly 100 deaths since the start of the coronavirus pandemic, according to the FDA.

With the extra-contagious delta variant circulating, the U.S. government has counted more than 2,000 coronavirus-related school closings just since the start of the school year, affecting more than a million children.

"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," said Dr. Kawsar Talaat of Johns Hopkins University. "The vaccine will protect them and also protect our communities."

The American Academy of Pediatrics also issued a statement welcoming theFDA's move.

"More than six million children have been infected with this virus since the beginning of the pandemic, and children have suffered in numerous other ways," said presidentLee Savio Beers.

"Authorization of the vaccine for younger children is an important step in keeping them healthy and providing their families with peace of mind."

WATCH |Communitieswork to get children vaccinated:

Communities work to get parents on board with COVID-19 vaccines for kids

3 years ago

Duration 2:05

Community groups are using some of the lessons they learned in overcoming COVID-19 vaccine hesitancy in adults to help parents on board with vaccinating their children.

Some propose targeted use

Earlier this week, FDA's independent scientific advisers voted that the pediatric vaccine's promised benefits outweigh any risks. But several panellists 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 per centof five- 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.

WATCH |Pfizer says vaccine nearly 91%effective in younger kids:

Pfizer releases clinical trial data for COVID-19 vaccine for children aged 5 to 11

3 years ago

Duration 2:03

Pfizer publicly released data from its coronavirus vaccine trial appearing to show that it's both safe and effective for children aged five to 11. But that data is now being reviewed by regulators, and parents want to carefully weigh the risks.

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 per centeffective 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 per centof 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.