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Pfizer seeking approval for COVID-19 vaccine to be used on children 5 years and under

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Posted: Wednesday, February 2, 2022. 8:39 pm CST.

By Benjamin Flowers: Pfizer-BioNTech is preparing to seek approval from the United States Food and Drug Administration (FDA) for a COVID-19 vaccine to be used in children five years old and under, reports The Washington Post.

Pfizer has reportedly not yet submitted its letter seeking approval from the FDA, and said in a statement issued on Monday, “We’re continuing to collect and analyze data from both two and three doses in our younger age cohort,” the company said.

Pfizer has been testing 3 microgram doses for the 6 months to five-year age group, while children 5-11 years have been authorized to receive 10 microgram doses. Everyone else 12 years and older receives 30 microgram doses.

The Washinton Post cites an unnamed source with knowledge of the plan who said that federal regulators want to begin reviewing the data on two doses of the vaccine for this age group while the companies continue to gather data on a potential three-dose regimen and that approval could come by the end of February.

The Pfizer vaccine has been approved for children as young as 5 years, while Moderna and Johnson & Johnson’s vaccines are still only authorized for adults. Children under 5 are the only age group in the U.S. not authorized to receive a COVID-19 vaccine.

NBC News said that data it has compiled suggests that there are an estimated 19.5 million children under 5 in the U.S. and Puerto Rico who have been infected with COVID-19.

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