Updated Feb 1, 2022 - Health

Pfizer asks FDA to authorize COVID vaccine for kids under 5

Picture of a nurse putting a vaccine on a little girl while her brother covers his eyes

A nurse gives a little girl a shot of the Pfizer COVID-19 vaccine while her brother covers his eyes at a vaccination site in Florida. Photo: Paul Hennessy/SOPA Images/LightRocket via Getty Images

Pfizer and BioNTech on Tuesday asked the Food and Drugs Administration to authorize its COVID-19 vaccine for children 6 months to 5 years old.

The big picture: Hospitalizations of younger children have reached their highest levels since the beginning of the pandemic.

  • More than 4 in 100,000 kids under 5 have been hospitalized since mid-December, compared to approximately 1 per 100,000 hospitalizations for children ages 5 to 17.

State of play: Federal regulators could authorize the vaccine and make it available by the end of February, Axios' Caitlin Owens reports.

  • The Pfizer-BioNTech vaccine would be initially available as a two-dose regimen. However, recent data has shown that two shots of the vaccine did not produce a sufficient immune response in children aged 2 to 4.
  • An adequate immune response was seen in children 6 months old to 2 years old.
  • Pfizer said it would continue to research how well three doses of its vaccine work on younger children.
Go deeper