FDA advisory panel OK's Pfizer vaccine for kids 5 to 11 - NBC News

A smaller dose of Pfizer-BioNTech’s Covid-19 vaccine cleared its first regulatory hurdle Tuesday for use in young children, after a Food and Drug Administration advisory committee voted to recommend it for emergency use authorization for those ages 5 to 11.

"This is a much tougher one, I think, than we had expected coming into it," said committee member Dr.

"It just seems to me that in some ways, we’re vaccinating children to protect the adults, and it should be the other way around," said committee member Dr.

Paul Offit, a vaccine researcher at Children’s Hospital of Philadelphia and a committee member, acknowledged the difficulty of the decision.

The vaccine for children ages 5 to 11 is a smaller dose than the one given to those 12 and older — 10 micrograms of mRNA versus 30 micrograms.

Though children are less susceptible to severe illness from Covid, more than 1.9 million children ages 5 to 11 have tested positive for the coronavirus over the course of the pandemic, and more than 8,400 have been hospitalized, said Dr.

When children are hospitalized with Covid, they’re more likely to be admitted to the intensive care unit and more likely to need a ventilator, compared with children hospitalized with the flu, she added.

Ninety-four children have died of Covid, making it the eighth leading cause of death in this age group, she said.

4, as many as 5,217 children of all ages have developed MIS-C, and 46 have died, she said, adding that the condition was most common in children ages 5 to 11. .

Though most cases of the virus in children are mild, kids can still spread it to others, including family members and people at school, Havers said.

In its presentation to the FDA, Pfizer said its vaccine was nearly 91 percent effective at preventing symptomatic illness in kids.

There were three cases of Covid in the vaccine group, compared with 16 cases in the placebo group.

The cases occurred in July through September, when the highly transmissible delta variant was dominant, suggesting that the vaccine held up well against it, Gruber said

Just over 1,500 children ages 5 to 11 received the vaccine in the Pfizer trial (another 750 received a placebo) and there were no cases of myocarditis. 

Mathew Oster of the CDC’s Covid-19 Response Team, said that for 12- to 17-year-olds who received two doses of the Pfizer vaccine, the rate was as high as 56.7 cases per million doses in the three weeks following vaccination

Despite the lack of data on myocarditis, committee member Offit said there were several reassuring factors, including the fact that children will be given a lower dose, and that it appears the risk for the condition is lower is younger children

Pfizer’s Covid vaccine is fully approved for teens and adults 16 and older, and may be given under emergency use authorization for children and teens 12 to 15