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This low-dose coronavirus vaccine is safe for kids 5-11, Pfizer says

Pfizer-BioNTech said its coronavirus vaccine will be submitted to the FDA for approval

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The Pfizer COVID-19 vaccine at a hospital in Providence, Rhode Island.

In this Dec. 15, 2020, file photo, a droplet falls from a syringe after a person was injected with the Pfizer COVID-19 vaccine at a hospital in Providence, R.I.

David Goldman, Associated Press

Pfizer and BioNTech said Monday that a lower dose of the current coronavirus vaccine is safe and created an immune response to the coronavirus for children 5 to 11 years old.

  • In a release, the companies said “the vaccine was safe, well tolerated and showed robust neutralizing antibody responses” for children 5 to 11 years old, who do not currently have a COVID-19 vaccine to keep them safe from the virus.
  • The dose given to these children is about one-third the amount given to adults.

The companies said they will submit data on their findings to the Food and Drug Administration. The companies hope that the vaccine will be sent to the FDA by the end of September.

  • “Then, the data — not yet published or peer-reviewed — will be scrutinized by regulators to ascertain that the vaccine is safe and effective. That could take weeks, or up to a month,” according to The Washington Post.

This is about on pace with what experts expected to happen with a vaccine for children under 12. Dr. Rochelle Walensky, the director of the Centers for Disease Control and Prevention, said last week that the COVID-19 vaccine for children under 12 years old would likely be available by the end of 2021.

  • “We want to move quickly, we anticipate moving quickly, but we also want to have the efficacy data and the safety data that the (Food and Drug Administration) will require ... to make sure that it is the right thing for kids,” she said.

Dr. Scott Gottlieb, the former FDA commissioner, said on ”Face the Nation,” said Pfizer expects the vaccine could be released by Halloween in a best case scenario.

  • “In a best-case scenario, given that timeline they’ve just laid out, you could potentially have a vaccine available to children aged 5 to 11 by Halloween,” Gottlieb said. “If everything goes well, the Pfizer data package is in order, and FDA ultimately makes a positive determination, I have confidence in Pfizer in terms of the data that they’ve collected. But this is really up to the Food and Drug Administration to make an objective determination.”