Pfizer announced Monday that its COVID-19 vaccine for children ages 5 to 11 is safe and effective at a third of the dose that teenagers and young adults are getting, according to recent results from its clinical trials.
Although this news is welcoming to many families, many are wondering what is next on the timeline. When will the U.S. Food and Drug Administration (FDA) approve the shots?
Here is more on what to know about what to expect from the Pfizer vaccine in young children.
Although some clinical trial data has been publicized, Pfizer still has to submit a formal application to the FDA with detailed data so the vaccine can be reviewed for emergency use authorization.
For children ages 5 to 11, Pfizer expects to submit this data by the end of the month.
Based on the FDA approval process for adults and adolescents, children ages 5 to 11 could start seeing shots in arms four to five weeks from now, according to Dr. Evan Anderson, a physician at Children’s Healthcare of Atlanta and associate professor of pediatrics and medicine at Emory University School of Medicine.
Yes. While the dose for children will be 10 micrograms instead of 30 micrograms like it is for adults, children will still receive the vaccine in a two-shot regimen.
Pfizer is still studying the vaccine in ages 2 to 5 and in ages 6 months to 2 years. The company said it will have data on those age groups by the end of the year, and will hopefully seek emergency use authorization for those age groups by early 2022.
Those age groups are being tested on the 3-microgram dose.
So far, the Pfizer COVID-19 vaccine has been fully approved for people as young as 16 and available for emergency use authorization for children as young as 12.
The Moderna and Johnson & Johnson vaccines have been approved under emergency use authorization for people ages 18 and older.
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