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Pfizer-BioNTech has submitted data to the Food and Drug Administration to allow its Covid-19 vaccine for use in children aged 5 to 11, officials said on Tuesday.
The FDA is expected to take at least several weeks to analyze data collected in a trial involving more than 2,000 children before granting emergency use authorization.
An official submission to request an authorization for the emergency use of the vaccine from the companies is expected to follow in the coming weeks, officials said in a statement.
“The FDA takes the importance of obtaining vaccines, which have been shown to be safe and effective in children, very seriously,” Dr. Anthony Fauci, the leading national infectious disease expert, said on “Morning Joe” “from MSNBC. “I imagine that over the next few weeks they will review this data and hopefully give their consent so that we can start immunizing children, hopefully by the end of October.”
While the Pfizer vaccine has been available to Americans 12 and older since May, millions of school-aged children are still vulnerable.
Millions of these children have returned to classrooms for in-person instruction in recent weeks, with some districts requiring masks and others not, in one of the country’s most debated topics.
Pfizer said its two-dose Covid vaccine has been shown to be safe, while eliciting a “well-tolerated” and “robust” antibody response among the younger target group.
Children in the Pfizer trial received two doses of the vaccine that were smaller than those given to those 12 and older, the company said. Lower doses produced antibody responses comparable to those seen in a study of people aged 16 to 25 who received full doses. The vaccine also caused side effects similar to those seen in adults, including pain in the arms and fatigue.
The Pfizer-BioNTech vaccine is the only Covid vaccine available to Americans under 18. In June, Moderna submitted data to the FDA to use its Covid vaccine in adolescents aged 12 to 17. Johnson & Johnson is conducting clinical trials of its single-dose vaccine. among younger beneficiaries.
Children face a much lower risk of serious illness, but as schools continue in-person classes, the need to vaccinate young children is important to control the Covid pandemic in the United States More than a quarter of cases Weekly reports of Covids reported in the United States are in children under the age of 18, according to the American Academy of Pediatrics.
There have been more than 43 million confirmed cases of Covid in the United States since early 2020, resulting in at least 692,784 deaths, according to an ongoing NBC News tally on Tuesday.
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