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Pfizer requests FDA authorization to vaccinate younger teens


FILE – In this Jan. 24, 2021, file photo, a vial of the Pfizer vaccine for COVID-19 is shown at a one-day vaccination clinic set up in an facility in Seattle and operated by Virginia Mason Franciscan Health. Pfizer announced Wednesday, March 31, 2021 that its COVID-19 vaccine is safe and strongly protective in kids as young as 12, a step toward possibly beginning shots in this age group before they head back to school in the fall. (AP Photo/Ted S. Warren, File)

SAN FRANCISCO (KRON) — Younger teens are a step closer at possibly getting the Pfizer COVID-19 vaccine.

Pfizer and BioNTech submitted a request to the U.S. Food and Drug Administration to authorize the vaccine for adolescents ages 12-15, the company said Friday.

At this time, it’s only approved for people who are at least 16 years old and older.

The companies say their Phase 3 trial demonstrated 100 percent efficacy and robust antibody response after the 12-15 year old participants were vaccinated.

If FDA experts approve of the results, it could mean adolescents could get the shots before school starts in the fall.

Pfizer said they used 2,260 volunteers in the U.S., adding that the kids had side effects similar to young adults.

Based on results shared on March 31, 2021, Pfizer said the vaccine “was well tolerated with side effects generally consistent with those observed in participants 16 to 25 years of age. All participants in the trial will continue to be monitored for long-term protection and safety for an additional two years after their second dose.”

The main side effects are pain, fever, chills and fatigue.

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