In a press release Wednesday, Moderna announced that the company will soon seek FDA Emergency Use Authorization to administer its vaccine to children ages six-months to six-years-old.
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The biotech company has released clinical trial data showing that two doses of its pediatric vaccine generated a strong immune response in kids, without causing significant risk. The neutralizing antibody levels in children six-years-old and under were similar to those seen in adults, Moderna revealed.
Dr. John Moore, Professor of Microbiology and Immunology at Cornell, explained to KCBS Radio's "Ask An Expert" how the FDA will decide if the vaccine is safe and effective.
"The FDA advisory panel of independent experts will soon get a full data package and a meeting will be set up in several weeks time, maybe a month or so," he said. "The independent experts will review the entire data package, take into account the state of the pandemic, the needs of children of different categories, different ages, different health conditions and make a recommendation."
Moore said he hopes the recommendation the panel makes is what the FDA leadership continues with, but it may not be. "Until that process plays out it's very hard to judge what’s going to happen," he explained.
The full data package from Moderna will also be released to the public on the FDA's website and all the advisory committee meetings are open access, Moore added, illustrating the transparency of the process.
Pfizer has also been testing a similar mRNA vaccine in young children, but ran into some problems due to the size of the vaccination dose earlier this year. "They didn't get the dosing right and they're now revisiting the design of their trials and are in discussions with the FDA about it," Moore said.
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