by Lauren Niergaard
The Food and Drug Administration is considering whether to allow COVID-19 vaccination in children ages 5 to 11 using child-sized doses.
Until now, only people 12 and older could be vaccinated in the US, with shots made by Pfizer and its partner BioNTech. This has been a major disappointment for many pediatricians and parents, especially as the extra-infectious Delta variant has raged through poorly vaccinated communities – and the schools in them.
On Thursday, the companies formally applied for low-dose emergency use for children ages 5 to 11. Here’s what to expect:
Q:Why do young children need vaccines?
A:The virus usually causes more severe illness in older adults than in children. But it can sometimes be severe even in young people. According to the American Academy of Pediatrics, COVID-19 has killed at least 520 children in the US
The delta version also caused a surge in children’s infections, making it difficult to keep schools fully open and students in the classroom. A recent Kaiser Family Foundation survey found that nearly a quarter of parents with kids in the classroom this fall say they’ve already had to quarantine a child because of potential virus exposure.
Q: How early can immunizations begin for children under the age of 12?
A: The first ones under consideration are shots for children ages 5 to 11. FDA advisers are expected to publicly discuss Pfizer’s evidence on October 26, setting the stage for the agency to declare whether the shots are suitable for the roughly 28 million youth in that age group. are safe and effective.
If that happens, there’s one more step: Advisors from the Centers for Disease Control and Prevention will decide whether to actually recommend vaccinations to children. CDC makes the final call.
FDA vaccine chief Dr. Peter Marks has said the agency will make a decision “hopefully within a few weeks” after Pfizer submits its data.
Q: Will young children get the same dosage as teens and adults?
A: No. Pfizer aims to give children ages 5 to 11 one-third the dose of everyone 12 and older.
Q: What is the evidence that kid-sized shots work?
A: Pfizer conducted a low-dose study in 2,268 volunteers in this age group, with two-thirds given the vaccine and the rest given the dummy shot. The company says that vaccinated children aged 5 to 11 developed levels of antibodies that fight the coronavirus, which were as strong as those found in teens and young adults after regular-strength shots.
Q: Was the vaccine safe for young people?
A: Younger children experienced similar or less temporary side effects such as sore arms and pain than adolescents.
An extremely rare risk of both the Pfizer and Moderna vaccines is inflammation of the heart, usually in young men or boys. The CDC estimates that for every one million fully vaccinated boys aged 12 to 17, the shots will prevent about 5,700 COVID-19 cases, 71 hospitalizations, and two deaths, while the heart will cause no more than 69 cases of inflammation of the larynx. It’s difficult for scientific studies to detect such a rare problem, so regulators have to debate the potential for that risk with low-dose shots for young children.
Q: If it is approved, will the child-size vaccine come in a special package?
A: Yes, Pfizer plans to ship vials specifically marked for pediatric use with low doses in order to avoid mixing any dosages.
Q: What about vaccinations for children under the age of 5?
A: Stay tuned: The results of the study are expected later this year.
The Associated Press Department of Health and Science receives support from the Howard Hughes Medical Institute’s Department of Science Education. AP is solely responsible for all content.