Vaccine Advisors To Meet With The FDA Relating to COVID-19 Vaccinations For Youngsters Underneath 12 – CBS Pittsburgh
WASHINGTON (KDKA) – Today, vaccine advisors will meet with the Food and Drug Administration to discuss the next steps for vaccinating children under 12 against COVID-19.
The meeting is not to approve or vote on anything nor is it to talk about a specific drug maker’s vaccine.
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Instead, the purpose is to figure out just how much more information companies will need to provide when trying to be granted approval to vaccinate children.
Children ages 12-15 have already been approved for the vaccine, so this conversation will focus on children ages 11 and younger.
Committee members for the Food and Drug Administration are expected to discuss what is needed for both emergency use and full approval.
For Pfizer, enrollment of 5-to-11-year-olds for trials just began this will and the FDA says a good sample size for approval for kids would be around 3,000 people.
The committee will also talk about the possibility of children getting sicker from the vaccine as well as theoretical situations.
Here in Pittsburgh, UPMC says just having these conversations is a step in the right direction.
“As adults get vaccinated and become more protected and immune to this virus, the virus is still in the community looking for a vulnerable host — and pediatric patients fit that description,” said Dr. Richina Bicette the Associate Medical Director of Baylor College of Medicine.
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Moderna has said they’ll have data for kids as young as 5-years-old by September or October. That’s because COVID-19 has not caused the same number of problems for children as it has for adults.
The FDA says these companies will have to make a strong case if they want the vaccine to be authorized for children.
“What I think we’re going to do with that meeting is we’re going to decide what the parameters are for approval, either through emergency use authorization or for licensure, for much younger age groups,” said Dr. Paul Offit, the director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.
In Pennsylvania, health leaders say this is a good start to getting children vaccinated but with school no longer in session, parents are still being urged to remain cautious with their children.
So far, Pfizer is the only company to seek full authorization for its vaccine.
Moderna says they are planning to seek full authorization soon.
The Pfizer trials will give kids two dozens with only a third of the amount given to teenagers and adults.
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Again, there’s no reason to believe the FDA will approve the vaccine for children just yet but the meeting will discuss and determine what answers are still needed and how much information will be required of companies to provide in order to be given consideration.