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FDA recommends boosters for 12 to 15 year-olds, full approval expected later this week

UPDATED: Mon., Jan. 3, 2022

A health worker gives a shot of the Johnson & Johnson COVID-19 vaccine  in Brasilia, Brazil, June 29, 2021. In the U.S., the Food and Drug Administration is recommended booster shots for children ages 12-15. Full approval is expected this week.   (Eraldo Peres)
A health worker gives a shot of the Johnson & Johnson COVID-19 vaccine  in Brasilia, Brazil, June 29, 2021. In the U.S., the Food and Drug Administration is recommended booster shots for children ages 12-15. Full approval is expected this week.  (Eraldo Peres)

Booster doses for 12-to-15-year-olds will likely be approved by two federal agencies by the end of the week.

The Food and Drug Administration recommended Monday that youths in this age group receive a booster dose of the Pfizer vaccine, based on the agency’s benefit-risk analysis as well as data from Israel.

The risk of the rare side effect myocarditis, specifically in teenage and young adult males, from the Pfizer vaccine is expected to be less severe following booster doses, FDA officials said.

After a booster, the risk of myocarditis – inflammation of the heart muscle – is about a third of the risk after the second dose of the vaccine, Dr. Peter Marks, director of the Center for Biologics Evaluation and Research, told reporters Monday.

Marks indicated that the risk of myocarditis as a side effect of the Pfizer vaccine continues to remain low, about 1 in 10,000 in males who are 16 to 30 years old, Marks said, and that the “overwhelming majority” of those cases are mild and treated without the need for hospitalization.

The FDA did not consult its expert advisory panel before expanding booster authorization to this age group; Marks said this was due, in part, to the current surge in COVID cases nationwide, with the rapidly spreading omicron variant.

The Centers for Disease Control and Prevention will also have to approve booster doses for this age group, which could happen later this week.

The FDA also shortened the time to five months between booster doses and vaccinations for people who received the two-dose Pfizer vaccine. This change in guidance also will apply to 12-to-15-year-olds when they are booster eligible. Below is the updated booster timelines for each vaccine:

  • Johnson & Johnson: get any booster two months after initial shot.
  • Pfizer: get any booster five months after second dose.
  • Moderna: get any booster six months after second dose.

The FDA also authorized a third primary series dose of the Pfizer vaccine for certain immunocompromised children between 5 and 11 years old, including those who have undergone solid organ transplants.

Federal officials encouraged families to seek vaccinations for their children who are 5 to 11 years old, as only 25% of this age group nationwide has been vaccinated thus far.

Arielle Dreher's reporting for The Spokesman-Review is primarily funded by the Smith-Barbieri Progressive Fund, with additional support from Report for America and members of the Spokane community. These stories can be republished by other organizations for free under a Creative Commons license. For more information on this, please contact our newspaper’s managing editor.

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