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The Food and Drug Administration is considering whether or not to allow COVID-19 vaccinations in children aged 5 to 11 – using doses the size of a child.
Until now, only people 12 years of age and older could be vaccinated in the United States, with vaccines made by Pfizer and its partner BioNTech. This has been a huge frustration for many pediatricians and parents, especially as the extra-contagious delta variant has raged in poorly vaccinated communities – and the schools there.
On Thursday, the companies officially filed an application for emergency use of a lower dose for 5 to 11 years. Here’s what to expect:
Q: Why do young children need a vaccine?
A: The virus usually causes more serious illness in older people than in children. But it can sometimes be serious in young people too. COVID-19 has killed at least 520 children in the United States, says American Academy of Pediatrics
The delta variant has also caused an increase in infections among children, making it more difficult to keep schools fully open and students in class. A recent Kaiser Family Foundation survey found that nearly a quarter of parents with children in class this fall say they have already had to quarantine a child due to possible exposure to the virus.
Q: How soon can vaccinations for children under 12 start?
A: The first things to consider are injections for children aged 5 to 11. FDA advisers are expected to deliberate publicly on Pfizer’s evidence on October 26, paving the way for the agency to declare whether injections are safe and effective for the roughly 28 million young people in this age group.
If so, there is another step: Counselors from the Centers for Disease Control and Prevention will decide whether to recommend children to be vaccinated. The CDC makes the final call.
FDA Chief Vaccine Officer Dr Peter Marks said the agency would decide “hopefully within a few weeks” after Pfizer submitted its data.
Q: Would young children receive the same dose as adolescents and adults?
A: No. Pfizer aims to give children aged 5 to 11 one-third of the dose given to anyone 12 years of age and over.
Q: What is the evidence that child size photos work?
A: Pfizer studied the lowest dose in 2,268 volunteers in this age group, giving two-thirds of the vaccine and the rest of the sham injections. The company says vaccinated children between the ages of 5 and 11 developed levels of coronavirus antibodies as strong as those obtained by adolescents and young adults after regular strength injections.
Q: Was the vaccine safe for young people?
A: Young children have experienced temporary side effects similar to or less than adolescents, such as arm pain and body aches.
An extremely rare risk with Pfizer and Moderna vaccines is heart inflammation, usually in young men or boys. The CDC estimates that for every million boys ages 12 to 17 who are fully vaccinated, the injections would prevent an estimated 5,700 cases of COVID-19, 71 hospitalizations and two deaths while not causing more than 69 cases of heart inflammation. It is difficult for scientific studies to detect such a rare problem. Regulators will therefore need to debate the possibility of this risk with lower dose injections for young children.
Q: If authorized, will the childhood vaccine come in special packaging?
A: Yes, to avoid dosing errors, Pfizer plans to ship specially marked vials for pediatric use containing the lower dose.
Q: What about vaccinations for children under 5?
A: Stay tuned: Study results are expected later this year.
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The Associated Press’s Department of Health and Science receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.
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