FDA to authorize Pfizer coronavirus vaccine for those as young as 12

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File- This Dec. 4, 2017, photo shows the Pfizer company logo at the company’s headquarters in New York. The federal government has agreed to pay nearly $2 billion for 100 million doses of a potential COVID-19 vaccine being developed by the U.S. drugmaker and its German partner BioNTech. (AP Photo/Richard Drew, File)

WASHINGTON (NewsNation Now) — Teenagers as young as 12 could soon get the Pfizer COVID-19 vaccine shot.

The U.S. Food and Drug Administration is expected to authorize Pfizer’s COVID-19 vaccine for young adults age 12 and older by next week, a federal official and a person familiar with the process told the Associated Press, setting up shots for many before the beginning of the next school year.

Currently, those 16+ are approved for the shot.

The federal official, speaking on the condition of anonymity to preview the FDA’s action, said the agency was expected to expand its emergency use authorization for Pfizer’s two-dose vaccine by early next week, and perhaps even sooner. The person familiar with the process, who spoke on condition of anonymity to discuss internal matters, confirmed the timeline and added that it is expected that the FDA will approve Pfizer’s use by even younger children sometime this fall.

The FDA and Pfizer refused to comment about possible authorization.

Pfizer has been testing the vaccine for children between the ages of 12-15 for the past several months and announced recently they would seek authorization from the FDA to expand access.

In March, the drugmakers said the vaccine was found to be safe, effective and produced robust antibody responses in 12- to 15-year olds in a clinical trial.

Kids had side effects similar to young adults, the company said. The main side effects are pain, fever, chills and fatigue, particularly after the second dose. The study will continue to track participants for two years for more information about long-term protection and safety.

The FDA action will be followed by a meeting of a federal vaccine advisory committee to discuss whether to recommend the shot for 12- to 15-year-olds. Shots could begin after the Centers for Disease Control and Prevention adopts the committee’s recommendation. Those steps could be completed in a matter of days.

The New York Times first reported on the expected timing for the authorization.

Pfizer isn’t the only company seeking to lower the age limit for its vaccine. Results also are expected by the middle of this year from a U.S. study of Moderna’s vaccine in 12- to 17-year-olds.

But in a sign that the findings were promising, the FDA already allowed both companies to begin U.S. studies in children 11 and younger, working their way to as young as 6 months old.

While younger people are at dramatically lower risk of serious side effects from COVID-19, they have made up a larger share of new virus cases as a majority of U.S. adults have been at least partially vaccinated and as higher-risk activities like indoor dining and contact sports have resumed in most of the country.

Officials hope that extending vaccinations to teens will further accelerate the nation’s reduced virus caseload and allow schools to reopen with minimal disruptions this fall.

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