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FDA panel recommends letting kids as young as 5 to get vaccinated


17 out of the 18 members of an advisory panel to the Food and Drug Administration (FDA) voted to amend Pfizer’s Emergency Use Authorization to include kids as young as 5 years old Tuesday. The Pfizer vaccine is currently recommended for everyone 12 years and up.

The video above shows clips from Tuesday’s panel debate.

According to details of a Pfizer study posted online last Friday, child-sized doses of the Pfizer COVID-19 vaccine were shown to be over 90% effective in preventing symptomatic COVID-19 infections in kids 5-11 years old. In the study, which tracked 2,268 kids in the 5-to-11 age group, kids who got the vaccine only received a third of the dose given to teens and adults.

The kid-sized dosage also proved safe, with similar or fewer temporary side effects to what teens experience.  The study isn’t large enough to detect any extremely rare side effects, like the heart inflammation that occasionally occurs mostly in young men and teen boys after the second dose. However last week, FDA reviewers said protection would “clearly outweigh” the risk of those rare side effects.

While children are at lower risk of severe COVID-19 than older people, kids in the 5-to-11-year-old age group still have faced substantial illness.

“There have been over 1.9 million infections, over 8,300 hospitalizations, about a third of which have required intensive care unit stays, and over 2,500 cases of multisystem inflammatory disorder from COVID-19. And there have also been close to 100 deaths, making it one of the top 10 causes of death in this age range during this time,” FDA Deputy Director Doran Fink said at the beginning of Tuesday’s meeting. “In addition, infections have caused many school closures and disrupted the education and socialization of children.”

Also at the beginning of the panel meeting, FDA vaccine chief Peter Marks acknowledged the topic of vaccinating kids was a sensitive one.

“I want to acknowledge the fact that there are strong feelings that have clearly been expressed by members of the public, both for and against the use of the Pfizer-BioNTech vaccine under emergency use authorization for this age group of five to 11-year-old children,” Marks said. “To be clear, today’s discussion is going to be about the scientific data that are presented, and it’s not about vaccine mandates which are left to other entities outside of FDA.”

If the FDA takes the panel’s advice and authorizes the kid-sized doses, the Centers for Disease Control and Prevention will have to decide whether to recommend the shots, as well as who should get them.

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Dr. Paul Offit, committee member: “It’s always nerve wracking I think, when you’re asked to make a decision for millions of children based on studies of only a few thousand children. So I guess the way I struggle or I should try and deal with this is that it’s never when you know everything, you never know everything. The question is whether you know enough, and I think we certainly know that there are many children between 5 and 11 years of age who are susceptible to this disease, who could very well be sickened or hospitalized or die from it.”

Dr. Jeannette Lee, temporary committee member: “At one point we thought if we vaccinated enough people that the, the virus would go away. It’s not going away, and I think we’re going to have to find a way to live with it. And I think the vaccines kind of give us a way to do that.”

Dr. Michael Kurilla, committee member: “There are high-risk individuals, and I think they they do need to be attended to. We do need to provide a vaccine for them, but for many other, for many others, one dose or no dose even, if they’ve had prior COVID infection, I think they may not need anything more.”

Dr. Cody Meissner, committee member: “I’m just worried that if we say yes, that the states are going to mandate administration of this vaccine to children in order to go to school, and I do not agree with that. I think that would be an error at this time until we get more information about the safety. So I think I agree with what everyone else is saying here, we’re we’re in a very difficult decision-making process.”

Dr. Arnold Monto, committee chair: “If we do not approve, we will be denying the vaccine to families that have a vulnerable member present and who who have been keeping their kids in because they’re concerned about infecting that individual. We will be denying the vaccine to others who for one reason or another, want their child to be protected, for a risk which we cannot really accurately estimate.”

Peter Marks, FDA vaccine chief: “The issue of vaccine equity, and that if we try to approve that for some subset of the group that that could potentially lead to a situation where this becomes a vaccine that gets used more in those who are of a socioeconomic status that they are able to maneuver to receive the vaccine that would put some at a disadvantage. So I think we just need to be careful about where we go with that.”