On Friday, Pfizer, Inc. and BioNTech SE announced plans to extend rolling submissions to the Food and Drug Administration (FDA) seeking to amend the emergency use authorization (EUA) of the companies' vaccine to include that age group.
According to a Centers for Disease Control and Prevention (CDC) document, the shipment of the Pfizer-BioNTech COVID-19 vaccine for children ages six months to four years is planned to begin upon authorization from the FDA.
"However, vaccine administration can only begin following the CDC recommendation," the agency wrote, noting that current planning is for a sequenced rollout involving an initial total of approximately 10 million doses.
"This will be split into two separate thresholds, with five million doses each. The first threshold of five million doses will make up Sequence 1a and Sequence 1b. The second threshold of five million will be Sequence 2. There will be continued supply in addition to the initial 10 million doses following Sequence 2," the document reads.
All providers and facilities that order Sequence 1a "must be able to receive vaccine shipment" on Feb. 21.
The document, notably, "may be updated as other manufacturers submit applications for FDA review."
The FDA is currently considering authorizing the use of the Pfizer vaccine in the age group and the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) is scheduled to meet on Feb. 15 to discuss the matter.
Pfizer submitted data to the agency for two doses of what is expected to be a three-dose series.
While early Pfizer data has shown the vaccine is safe and produces an immune response, the drugmaker announced last year that the two-dose shot proved to be less effective at preventing COVID-19 in kids ages 2-5.
The CDC-linked Advisory Committee on Immunization Practices is anticipated to meet within several days of VRBPAC.
In November, the FDA and CDC authorized the COVID-19 vaccine for children ages 5-11 years old. The Pfizer-BioNTech two-dose series currently remains the only recommended vaccine for children ages 5-11 years old.
Children under the age of 5 – of which the document notes that there are approximately 18 million children – are the only age group not yet eligible for the shots.
Each dose for younger children is one-tenth the dose given to older children and adults.
There are no plans to test shots in newborns.
The Associated Press contributed to this report.