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The US plan if the vaccine is authorized for young children

2022-02-10T10:35:25.567Z


Here's what the US will do if the Pfizer/BioNTech coronavirus vaccine is licensed for children 6 months to 5 years old.


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(CNN) --

If Pfizer/BioNTech's coronavirus vaccine for children ages 6 months to 5 years receives emergency use authorization from the US Food and Drug Administration (FDA), the tentative plan is to put About 10 million doses of vaccines were initially available to the public, according to a document from the Centers for Disease Control and Prevention (CDC) posted online.

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

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The FDA's vaccine advisory committee will meet on February 15 to discuss Pfizer and BioNTech's request for an emergency use authorization for their vaccine for children up to 6 months.

The virtual meeting will give scientists the opportunity to review available trial data and make a recommendation on whether the vaccine would be appropriate for this age group.

If the FDA gives the green light, the CDC's independent vaccine advisory group will meet and make its own recommendation.

The director of the CDC must give her approval before vaccines can be given 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, White House coronavirus response coordinator, said at a news briefing Wednesday.

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"We can start packaging and shipping the vaccine once the FDA makes its decision," he said.

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

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The anticipated dose size is 3 micrograms of vaccine per dose, with three doses anticipated for each vaccine series.

Pfizer and BioNTech are currently seeking authorization for a two-dose vaccine, but continue to test a three-dose regimen.

They say they will present additional data on a third dose in the coming months.

"This vaccine is formulated specifically for these young children. So we are launching a new program especially for children under 5 years of age. The planning process is underway. CDC is working with states to help them prepare. We have ensured enough supply of vaccine for all children in this age group, all 18 million. We have enough needles, syringes and kits, and they are all formulated or manufactured especially for this age group to ship along with the vaccine," Zients said Wednesday. .

"We are working closely with pediatricians and family doctors, children's hospitals and pharmacies to make sure the vaccine is available in thousands of locations across the country," he said.

"So we will be prepared for those parents who are anxious to vaccinate their children."

The rollout of the coronavirus vaccine for children under 5 is expected to be similar to that of the vaccine for children ages 5 to 11 in October, Lori Tremmel Freeman, executive director of the National Association of County and City Health Officials (NACCHO).

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"There will be an emphasis on using the current systems for the pharmacy program: registered pharmacies to obtain the vaccine, as well as registered vaccine providers," Freeman said.

And he added that children younger than 3 years could probably get the vaccine at their pediatricians' offices or other places.

Federal regulations do not allow pharmacists to administer vaccines to children under 3 years of age.

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

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"There's obviously a lot of emphasis on making the vaccine available as soon as it's licensed. But at the same time, especially with this age group, it's not something we want to rush," Hannan said.

"We want to make sure vendors are comfortable with the product and have had a chance to really look at the data."

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During the previous launch of vaccines for children, about 35% to 40% of children aged 5 to 11 years were vaccinated in pharmacies, according to data received by NACCHO.

Because children younger than 3 years old tend to be taken to the pediatrician regularly for wellness visits, Hannan said, an emphasis is placed on incorporating the COVID-19 vaccination schedule into those visits.

As a result, it could 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 serve children outside of their usual patient base.

"That's a challenge because pediatricians are very overwhelmed right now," he said, due to staffing shortages, flu season and Covid-19.

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

Covid-19

Source: cnnespanol

All news articles on 2022-02-10

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