Pfizer and BioNTech have applied to the Food and Drug Administration for emergency use authorization to administer their coronavirus vaccine to children ages 6 months to 5 years old, the companies announced Wednesday.
Those younger than 5 are the only age group that doesn’t qualify for the vaccines against the coronavirus in the U.S. While a vaccine exists for this group, it hadn’t met the results desired by scientists for a two-dose series produced by the drugmakers and therefore remains unusable, CNN reported.
The 2/3 phase trial consisted of 1,678 children who received a third dose during the period when the omicron variant was dominant. Results released on May 23 showed the vaccine appeared to be safe and had a strong immune response.
However, the results haven’t been peer-reviewed or published by a medical journal, CNN reported.
For children 6 months to 5 years, the Pfizer/BioNTech vaccine is three 3-microgram doses, much smaller than older age groups. The initial two doses for toddlers were given three weeks apart, and the third dose was given at least two months after the second dose.
On June 15, the committee will discuss Pfizer and BioNTech’s application, CNN reported.