Pfizer Submits Application For Approval Of COVID-19 Shot For Adolescents Aged 12 To 15

Pfizer Inc PFE and BioNTech SE BNTX seek complete FDA approval for their COVID-19 vaccine for adolescents ages 12 to 15. The agency had fully approved the vaccine in August for people 16 years and older.

  • The Pfizer-BioNTech vaccine is currently approved for emergency use by the FDA for children 5 to 15 years.
  • Pfizer is seeking approval based on data from a late-stage study of 2,228 children 12 to 15 years old who received a two-shot series of either the vaccine or a placebo.
  • Related Link: Pfizer/BioNTech COVID-19 Vaccine Data For Kids Is Here: What You Need To Know.
  • Researchers found that 30 children in the placebo group developed symptomatic COVID-19, compared with no children in the vaccine group, resulting in 100% efficacy.
  • After the second dose, no significant safety concerns were observed with at least six months of safety data.
  • The dose of 30 milligrams given to adolescents is identical to that administered to people 16 years and older.
  • Price Action: PFE shares are down 3.15% at $59.32, and BNTX stock is down 2.93% at $275.38 during the premarket session on Friday's last check.
Market News and Data brought to you by Benzinga APIs
Comments
Loading...
Posted In: BiotechNewsHealth CareFDAMoversTrading IdeasGeneralBriefsCOVID-19 CoronavirusCOVID-19 VaccinePhase 3 Trial
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!