The U.S. Food and Drug Administration (FDA) is considering authorizing the use of the Pfizer Inc (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) vaccine in the age group even though it did not meet a key target in a clinical trial of two- to four-year-olds.
The drugmakers said they submitted data supporting authorization at the request of the FDA in order to address an urgent public health need in the age group.
Outside advisers to the FDA are scheduled to meet on Feb. 15 to discuss whether to recommend the regulator to authorize the vaccine. The roll out of the vaccine for children under the age of 5, the only age group not yet eligible for the shots, is set to begin less than a week after the meeting.
According to the CDC document, the U.S. government is planning to ship an initial 10 million doses of the Pfizer/BioNTech vaccine to states and other entities before the end of February, should the FDA authorize their use.
There are about 18 million children aged between 6 months to 4 years in the United States, and there will be additional supply beyond the first 10 million doses, the CDC said.
The first roll out, which begins on Feb. 21, will prioritize areas where children are at higher risk for severe COVID-19 disease.
Jurisdictions and federal pharmacy partners will receive second and third shipments of doses on Feb. 23 and Feb. 25 or about a week after the CDC recommendation.
Young children will receive a lower dose of the vaccine, if it is authorized. Pfizer/BioNTech tested a 3-microgram dose of the vaccine in the age group, compared with a 10-microgram dose in 5- to 11-year-olds and 30 micrograms for people aged 12 and older.