NBC NEWS - Pfizer-BioNTech said on Monday that the companies' two-dose Covid-19 vaccine was safe and showed a "robust" antibody response in children ages 5 to 11.
Based on data collected in a trial that included more than 2,000 children, Pfizer and its German partner, BioNTech, said in a press release that the vaccine was "safe, well tolerated, and showed robust neutralizing antibody responses" for this age group. No Covid vaccines have yet been authorized or approved for use in children under 12.
The children in the trial were given two smaller doses of the vaccine than those given to people 12 and older, according to the release. The companies said that it produced antibody responses, and side effects, in children that were comparable to those seen in a study of people 16 to 25 who received the full dose of the vaccine.
More than 466.5 million Covid vaccine doses have been given in the U.S., according to the Centers for Disease Control and Prevention. The vaccine developed by Pfizer-BioNTech is one of three in use in the U.S., along with Moderna and Johnson & Johnson.
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Around 12.7 million children under the age of 18, or around 54 percent of 12- to 17-year-olds, have received at least one dose of a Covid vaccine, according to an American Academy of Pediatrics analysis of CDC data as of Sept. 15.
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In August, the AAP recommended against giving the vaccine to children under 12 until it was authorized by the Food and Drug Administration.
"We intend to submit the data by the end of the month and then of course it will be up to the FDA to review that data and determine whether the vaccine can be released for broad use," Dr. Bill Gruber, Pfizer’s senior vice president of vaccine clinical research and development as well as a pediatrician, told NBC's "TODAY" show. "We hope that will go expeditiously."
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