Pfizer asks FDA to authorize COVID-19 vaccine for younger children

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Pfizer and BioNTech on Thursday said They submitted an official application asking the Food and Drug Administration for emergency use authorization for their coronavirus vaccine for children aged 5 to 11.

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why it matters: If approved, it would become the first coronavirus vaccine for young children. The Pfizer-BioEntech vaccine has full FDA approval for people 16 years of age and older and EUA for people between 12 and 15.

big picture: Since the start of the school year, coronavirus infections among children have been on the rise.

  • In August, nearly 30,000 children were admitted to hospitals with the virus. the new York Times, which called it a record high.
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Catch up quickly: Both companies last month presented preliminary data on their vaccines for young children. He said the doses given to children aged 5-11 were one-third the size given to those over the age of 12.

  • The companies found that when the children were given two doses, three weeks apart, they had comparable antibody responses to those between the ages of 16 and 26.

What will happen next: The FDA said it would move quickly on the request and would have a meeting to consider it scheduled for October 26. A decision is expected between the end of October and the end of November, Time notes.

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