Pfizer Inc (NYSE:PFE) and BioNTech SE (NASDAQ: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.
