What Happened: The FDA said it has amended the emergency use authorization (EUA) originally issued in December last year for administration of the vaccine in individuals 16 years of age and older.
The vaccine will be administered as a series of two doses in adolescents, three weeks apart, the same dosing regimen for the older age group.
The Centers for Disease Control and Prevention’s vaccine advisory committee will meet on Wednesday to review the vaccine for use in the adolescent age group.
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Why It Matters: The FDA authorization allows for a younger population to be protected from COVID-19 and will accelerate the efforts of the U.S. government to drastically reduce infections. Children make up about one-fifth of the U.S. population, according to government data.
The FDA noted that from March 1, 2020, through April 30 this year, about 1.5 million COVID-19 cases in individuals 11 to 17 years of age have been reported to the CDC.
In March, Pfizer and BioNTech said that the vaccine was found to be 100% effective in a Phase 3 trial evaluating its BNT162b2 vaccines in 2,260 adolescents aged 12 to 15 years.
Price Action: Pfizer shares closed 0.7% higher in Monday’s regular trading session at $39.86 and further added 0.3% in the after-hours session to $39.99.
BioNTech shares closed 10.2% higher in the regular trading session at $202.35 and further rose 3.7% in the after-hours session to $209.75.