FDA OKs Pfizer-BioNTech Vaccine For Use in 12- to 15-year-olds

Move clears path for vaccinations in lower risk, but still significant, population.
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The U.S. Food and Drug Administration expanded the emergency use authorization of the COVID-19 vaccine from Pfizer  (PFE) - Get Report and BioNTech  (BNTX) - Get Report to include people aged 12 through 15 Monday.

The move had been expected in recent days. While the symptoms of COVID are generally milder in younger people, the agency said about 1.5 million cases had been reported in people aged 11 to 17, since March 1 of 2020.

“The FDA’s expansion of the emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine to include adolescents 12 through 15 years of age is a significant step in the fight against the COVID-19 pandemic,” said Acting FDA Commissioner Janet Woodcock, M.D., in a statement. “Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic.”

The Pfizer-BioNTech COVID-19 vaccine is administered as a series of two doses, three weeks apart. It is one of three vaccines currently approved for emergency use in the U.S. to combat the COVID-19 pandemic. The others include a single-shot vaccine from Johnson & Johnson  (JNJ) - Get Report and a two-shot vaccine from Moderna  (MRNA) - Get Report.

The FDA considered results from an ongoing randomized, placebo-controlled clinical trial in the U.S. involving 2,260 participants ages 12 through 15 years old.

The most commonly reported side effects in the adolescent clinical trial participants were pain at the injection site, tiredness, headache, chills, muscle pain, fever and joint pain. The side effects were more common after the second injection, according to the FDA statement.

Shares of Pfizer rose 17 cents, or 0.4%, to $40.03 in after-hours trading.  BioNTech ADRs rose $7.15, or 3.5%, to $209.50 in after-hours trading.