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

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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 that kids and teens 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  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 their expert advisory panel before expanding booster authorization to this age group, and Marks said this was, in part, due 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 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.

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