A COVID-19 vaccine could be available for kids under 12 by the end of the year.

That’s the timeline Rochelle Walensky, director of the U.S. Centers for Disease Control and Prevention, says she’s hoping for, she told NBC’s DIS
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+0.77%

“Today” show Monday when asked when a vaccine for younger children would be available.

“We’re waiting for the companies to submit the data to the FDA,” Walensky said, referring to vaccine makers Pfizer/BioNTech
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and Moderna
MRNA,
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“We’re anticipating that will happen in the fall. We will look at that data from the FDA, from the CDC, with the urgency that we all feel for getting our kids vaccinated, and we’re hoping by the end of the year.” 

Walensky’s comments came as 1 million children in New York City public schools, the nation’s largest school system, headed back to full-time in-person school for the first time in 18 months. The question of when younger children can be vaccinated has been top of mind for many parents, especially as the delta variant has fueled a rise in COVID-19 cases over the summer that appears to be showing signs of peaking in some states, but not others.

Currently the only vaccine available for children is the Pfizer and BioNTech shot, which the U.S. Food and Drug Administration authorized for emergency use on kids ages 12 to 15 in May. Moderna is studying the effects of its vaccine on younger children, and said in July that it hopes to have enough data to apply for FDA authorization by late this year or early 2022. 

Here’s a timeline of when clinical data and emergency use authorizations are expected from various vaccine makers.

“Today” co-anchor Savannah Guthrie asked Walensky why it’s taken longer for a vaccine for young children to become available, given that vaccines for adults were available nine months after the widespread onset of the pandemic in the U.S.

“‘We want to move quickly, we anticipate moving quickly, but we also want to have the efficacy data and the safety data.’”

— Rochelle Walensky, director of the U.S. Centers for Disease Control and Prevention

“We want to move quickly, we anticipate moving quickly, but we also want to have the efficacy data and the safety data that FDA will require so that we know…it is the right thing for kids,” Walensky said.

Others have been more optimistic about when vaccines will be available for children under 12. Former FDA head Scott Gottlieb, who is on the board of Pfizer, said recently that he expects the FDA to spend about four to six weeks evaluating Pfizer’s clinical data on young children, which the company has said should be available by the end of September.

In a “best-case scenario,” Gottlieb told CBS’ “Face the Nation” on Sunday, “you could potentially have a vaccine available to children aged five to eleven by Halloween.” 

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and President Joe Biden’s top medical advisor, has also said he expects younger children to be able to get vaccine shots in October or early November.

Fauci also said recently that a vaccine mandate for schoolchildren is a “good idea.” Some public school systems, including New York City’s, are requiring vaccines for teachers and other staff.

The FDA said Sept. 10 that it would “follow the science” when evaluating vaccines for younger kids.

“It’s important that the public recognize that, because young children are still growing and developing, it’s critical that thorough and robust clinical trials of adequate size are completed to evaluate the safety and the immune response to a COVID-19 vaccine in this population,” said Acting FDA Commissioner Janet Woodcock M.D., and Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Research and Evaluation, in a joint statement. 

They added, “Children are not small adults — and issues that may be addressed in pediatric vaccine trials can include whether there is a need for different doses or different strength formulations of vaccines already used for adults.”

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