FDA panel greenlights vaccines for kids, paving the way for authorization

Vaccines for 28 million American children are on the way to authorization after an advisory panel at the Food and Drug Administration voted in support of the Pfizer vaccine for kids 5-11 on Tuesday afternoon.

The vote was the first step in a regulatory process for the two-shot Pfizer vaccine that could allow kids to get their first shots in early November and become fully immunized by early December.

Next, leaders of the FDA have the chance to officially sign off, potentially as soon as Tuesday night. If and when this happens, the White House will begin shipping doses, senior officials told governors on a call Tuesday afternoon that was obtained by ABC News.

But there are still more steps before shots go into arms: If authorized by the FDA, the process would move to the Centers for Disease Control and Prevention next Tuesday, when a CDC panel meets to discuss the same data reviewed by the FDA advisers.

"If all goes well, and we get the regulatory approval, and the recommendations from the CDC, it's entirely possible, if not, very likely, that vaccines will be available for children from 5 to 11 within the first week or two of November," Dr. Anthony Fauci, chief medical adviser for the White House, said in an interview on Sunday on ABC's "This Week."

MORE: CDC signs off on Moderna, J&J boosters, mixing and matching doses

Many parents are desperate to protect their children after the delta surge over the summer led to increased cases and hospitalizations among kids. Though the variant is not more deadly, it is more transmissible -- and because kids are unvaccinated, the variant rocketed through schools and camps.

The most recent data from Pfizer's clinical trials found that the vaccine for 5-11 year olds was nearly 91% effective against symptomatic illness.

The vaccine also appeared safe. None of the children in the clinical trials experienced a rare heart inflammation side effect known as myocarditis, which has been associated with the mRNA vaccines in very rare cases, mostly among young men.

PHOTO: Pfizer/BioNTech's new pediatric COVID-19 vaccine vials are seen in this undated handout photo. (Pfizer handout via Reuters, FILE)
PHOTO: Pfizer/BioNTech's new pediatric COVID-19 vaccine vials are seen in this undated handout photo. (Pfizer handout via Reuters, FILE)

The Pfizer vaccine, if authorized for kids, will be given at a smaller, one-third dose.

The White House has purchased enough pediatric doses to vaccine all 28 million children ages 5 to 11. If authorized, it will be distributed to thousands of sites, including pediatricians, family doctors, hospitals, health clinics and pharmacies enrolled in a federal program that guarantees the shots are provided for free.

Some states are planning to provide the vaccine through schools as well.

The 5-11 age group would be the youngest and latest to receive eligibility. The Pfizer vaccine has already been authorized for adolescents 12 and up, and everyone 18 and older is eligible for all three vaccines, Pfizer, Moderna and J&J.

MORE: COVID-19 updates: Pfizer vaccine highly effective in children 5-11

Whether parents will embrace the vaccines for their kids is still a question. In a September poll, the Kaiser Family Foundation found that about a third of parents with kids ages 5-11 were willing to vaccinate their kids right away, while another third wanted to "wait and see." The figures represented a slight uptick in vaccine acceptance among parents of elementary-school-aged kids since July.

Although children are less likely to die of COVID-19 than older adults, pediatricians say there is still an urgent need for a safe vaccine for children. Children can still become very sick and spread the virus to others. So far, more than 6 million children have tested positive in the United States, according to the American Academy of Pediatrics.

Trials for children 2 years and up, the next age group that could become eligible, are ongoing. Data from the clinical trials is expected sometime this winter.

ABC News' Anne Flaherty contributed to this report.

FDA panel greenlights vaccines for kids, paving the way for authorization originally appeared on abcnews.go.com

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