A health care worker administers a dose of the Pfizer-BioNTech COVID-19 vaccine to a child at a pediatrician’s office in Bingham Farms, Michigan. Federal agencies are considering whether to start giving the vaccine to children ages 5 to 11 in the near future.
Emily Elconin/Bloomberg via Getty Images
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Emily Elconin/Bloomberg via Getty Images
A health care worker administers a dose of the Pfizer-BioNTech COVID-19 vaccine to a child at a pediatrician’s office in Bingham Farms, Michigan. Federal agencies are considering whether to start giving the vaccine to children ages 5 to 11 in the near future.
Emily Elconin/Bloomberg via Getty Images
Updated Oct. 29, 5:55 p.m. ET
Children as young as 5 may be able to get vaccinated against COVID-19 in the U.S. as soon as next week.
While some parents aren’t sure how they feel about this, others are waiting eagerly for a chance to protect their children from COVID-19.
But federal agencies can’t be rushed. Here’s what still needs to happen before the Pfizer-BioNTech shots can start going into kids’ arms.
Currently, Pfizer is the furthest along in this process, but Moderna has shared some promising results from its vaccine trial with this age group, and Johnson & Johnson is expected to begin vaccine trials for young kids in the future as well. Here are more details on what the regulatory process entails and how it is going for the Pfizer vaccine.
Step 1: Drugmakers complete the clinical trial
Pfizer and BioNTech have completed a three-phase clinical trial in children 5 to 11 years old. The companies submitted all of the data from that trial and an application for emergency use authorization to the Food and Drug Administration on Oct. 7.
The main study included 2,250 kids and found that the lower-dose version of the vaccine was 90.7% effective in preventing symptomatic COVID-19. It was given as a series of two shots, 21 days apart, and the dose was 10 micrograms, a third of the dose given to adults and teenagers.
No serious side effects such as heart inflammation were reported, although with only a few thousand children included in the research, that sort of rare problem wouldn’t necessarily be detected.