A healthcare worker prepares to administer Pfizer-BioNTech COVID-19 vaccines at an elementary school vaccination site for children ages 5 to 11-year-old in Miami, Florida, U.S., on Monday, Nov. 22, 2021.
Eva Marie Uzcategui | Bloomberg | Getty Images
The Centers for Disease Control and Prevention hasn’t yet approved Covid-19 vaccines for kids under 5, but it’s laying the ground work to distribute the shots, telling state and local health officials they could receive their first shipments by Feb. 21.
The CDC plans to roll out 10 million doses in three phases as soon as the Food and Drug Administration authorizes the lower-dose, 3-microgram Pfizer and BioNTech shot for children 6 months to 4-years-old, according to a new planning document quietly issued Sunday. State and local health officials could start preordering the first doses Monday and will start receiving vaccine shipments on Presidents’ Day, according to the CDC.
Local officials need to identify where and how the vaccines will be distributed. However, administration of the shots cannot begin until the CDC has given its stamp of approval for the vaccine, which will likely come quickly after the Food and Drug Administration authorizes it later this month.
The FDA’s panel of outside vaccine experts is scheduled to meet on the shots Tuesday.
In the planning document, the CDC said the federal government has procured enough shots to vaccinate the 18 million children in U.S. who are 6 months through four years of age.
The FDA has moved to rapidly get the shots authorized on an emergency basis amid mounting pressure from parents and doctors as the omicron variant has led to an increase in children hospitalized with Covid.
At the FDA’s request, Pfizer and BioNTech submitted their application to authorize the first two-doses of what will ultimately be a three-dose vaccine for children under 5.
Pfizer amended its clinical trial in December to evaluate a third dose after two shots did not induce an adequate immune response in children 2- to 4-years-old. Pfizer and BioNTech said they will submit data on the third dose to the FDA in the coming months.
By expediting authorization of the first two-doses, parents will be able get the first two-doses for their kids in preparation for the final third dose at a later date. Pfizer said in December that no safety concerns were identified in the 3 microgram dose, which is much smaller than the 30 microgram shot approved for adults.
Pfizer CEO Albert Bourla told CNBC on Tuesday that the data is good and he believes chances are high that the FDA will approve the first two-doses. Data on the vaccine is expected Friday when briefing documents for the FDA’s vaccine advisory committee are published. The committee has a meeting scheduled Feb. 15 to discuss the shots for toddlers to 4-year-olds.
