US plans to roll out initial 10 million Covid-19 vaccine doses for children under 5 after FDA authorization, CDC document says

If the Pfizer/BioNTech coronavirus vaccine receives emergency use authorization from the US Food and Drug Administration for children 6 months to 5 years old, the tentative plan is to roll out about 10 million vaccine doses initially, according to a US Centers for Disease Control and Prevention document posted online.

The document, an updated pediatric Covid-19 vaccination planning guide, notes that “planning is for a sequenced rollout involving an initial total of approximately 10 million doses” and that providers and facilities that have ordered doses “must be able to receive vaccine shipment on Monday February 21.”

A child receives a dose of the Pfizer-BioNTech Covid-19 vaccine at a vaccination clinic at an elementary school in San Jose, California, on Nov. 4, 2021.

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The FDA’s vaccine advisory committee will meet February 15 to discuss Pfizer and BioNTech’s request for an emergency use authorization of their vaccine for children as young as 6 months. The virtual meeting will give scientists a chance to go over the available trial data and make a recommendation on whether the vaccine would be appropriate for this age group.

If the FDA then gives the green light, the CDC’s independent vaccine advisory group will convene and make its recommendation. The CDC director needs to sign off before shots can be administered to children in this age group.

Operationally, the United States will be ready to roll out the vaccine for children under 5 once the FDA and CDC make their recommendations, Jeff Zients, the White House’s coronavirus response coordinator, said at a news briefing Wednesday.

“We can start packing and shipping the vaccine once FDA makes its decision,” he said.

A vial of the new children's dose of the Pfizer-BioNTech Covid-19 vaccine (that will supply ten doses, once reconstituted) sits in the foreground as children play in a hospital room waiting to be able to receive the vaccine at Hartford Hospital in Hartford, Connecticut on November 2, 2021. - An expert panel unanimously recommended Pfizer-BioNTech's Covid vaccine for five- to 11-year-olds on November 2, the penultimate step in the process that will allow injections in young children to begin this week in the United States. The Centers for Disease Control and Prevention (CDC), the top US public health agency, was expected to endorse that recommendation later in the day. (Photo by JOSEPH PREZIOSO / AFP) (Photo by JOSEPH PREZIOSO/AFP via Getty Images)

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According to the planning document, the doses for children under 5 will have a maroon cap and be distributed in cartons of 100 doses: 10 vials, each containing 10 doses.

The anticipated dosing size is 3 micrograms of vaccine per dose, with an anticipated three doses in a vaccine series. Pfizer and BioNTech are currently seeking authorization for a two-dose vaccine but are continuing to test a three-dose regimen. They say they will submit the additional data on a third dose in the coming months.

“This vaccine is specifically formulated for these young kids. So we’re launching a new program especially for kids under 5. The planning process is well underway. CDC is working with states to help them prepare. We’ve secured enough vaccine supply for all kids in this age group, all 18 million. We have enough needles, syringes and kits, and these are all specially formulated or made for this age group to send alongside the vaccine,” Zients said Wednesday.

“We’re working closely with pediatricians and family doctors and children’s hospitals and pharmacies to make sure the vaccine is available at thousands of locations across the country,” he said. “So we will be prepared for those parents that are eager to get their kids vaccinated.”

Getting the Covid-19 vaccine helps protect young children around you who are not eligible for the shot.

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The rollout of the coronavirus vaccine for children younger than 5 is expected to mirror the rollout for children ages 5 to 11 in October, Lori Tremmel Freeman, chief executive officer of the National Association of County and City Health Officials, told CNN on Wednesday.

“There will be an emphasis on utilizing the current systems in place for the pharmacy program: registered pharmacies to get the vaccine as well as registered vaccine providers,” Freeman said, adding that children younger than 3 most likely could receive the vaccine at their pediatricians’ offices or other sites. Federal regulations do not allow pharmacists to administer vaccines to children under the age of 3.

Nurse practitioner Sarah Rauner fills a syringe with the Pfizer Covid-19 vaccine to be administered to children from 5-11 years old are seen at the Beaumont Health offices in Southfield, Michigan on November 5, 2021. (Photo by JEFF KOWALSKY / AFP) (Photo by JEFF KOWALSKY/AFP via Getty Images)

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State immunization boards are in conversation with providers to discuss who will be ready to receive the initial doses, said Claire Hannan, director of the Association of Immunization Managers.

“There’s obviously a lot of emphasis on making that vaccine available as soon as it’s authorized. But at the same time, especially with this age group, it’s not something that we want to rush,” Hannan said. “We want to make sure that the providers are comfortable with the product and they’ve had a chance to really look at the data.”

During the previous rollout of vaccine doses for children, about 35% to 40% of children ages 5 to 11 were vaccinated at pharmacies, according to data that NACCHO has received.

Because children 3 and under tend to visit the pediatrician regularly for well visits, Hannan said, there is an emphasis on incorporating the Covid-19 vaccine schedule into those visits. As a result, it might be a slower process than with other age groups.

Recognizing that some parents will be ready to vaccinate their children immediately upon authorization, Hannan said, state health and immunization authorities are identifying clinics and pediatricians who can take on children outside of their regular patient base.

“That is a challenge because pediatricians are stretched very thin right now,” she said, due to staffing shortages, flu season and Covid-19.

There are about 18 million children ages 6 months through 4 years in the United States who potentially will be eligible to get vaccinated against Covid-19.