Pfizer and BioNTech submitted favorable initial data to the Food and Drug Administration on Tuesday for the use of its COVID-19 vaccine in children ages 5 to 11.

While the submitted data is reviewed by the FDA during the next several weeks, Pfizer is preparing a formal submission requesting Emergency Use Authorization of its vaccine for children. They are expected to submit the EUA request in the coming weeks, the company said.

The vaccine trial included over two thousand children and resulted in a “favorable safety profile and elicited robust neutralizing antibody responses using a two-dose regimen,” the drugmaker said in a statement.

A vaccine for Americans under the age of 12 means that many children throughout the country will have a stronger layer of protection when attending classes, especially since the Delta variant has been posing a larger threat to the younger population.

"The FDA takes very seriously the importance of getting vaccines, shown to be safe and effective in children," White House chief medical adviser Dr. Anthony Fauci told MSNBC's "Morning Joe" show. "I would imagine in the next few weeks they will examine that data and hopefully give the O.K. so we can start vaccinating children hopefully by the end of October."

Pfizer also said they expect to release clinical trial data of its COVID vaccine on children between six months to 5 years of age by the end of the year.

The Pfizer-BioNTech COVID vaccine has been approved by the FDA for administration in those 12 and older. The Moderna and Johnson & Johnson vaccine has only been authorized for emergency use on adults 18 and over.


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