NEW YORK — Pfizer and BioNTech are the first companies to request Emergency Use Authorization from the Food and Drug Administration in hopes of expanding the use of its COVID-19 vaccine in children ages 12 to 15. Currently, the vaccine’s EUA is only granted to be used in people age 16 and older.
Pfizer and BioNTech site data from Phase 3 trials conducted through the end of March. Researchers found the vaccine showed 100% efficacy and antibody response following vaccination in children as young as 12. More than 2,200 adolescents were enrolled in the trial.
The companies also reported side effects were generally the same as those experienced in older teenagers and adults who are already approved to get the vaccine. The most common were pain at the injection site, fatigue, headache, chills and nausea.
All children involved in the trial will be monitored for long-term protection and effects for two years after receiving their second dose of the vaccine.
Pfizer and BioNTech said they plan to make similar requests to other regulatory authorities in additional countries soon.
The two companies are also studying the vaccine in children as young as six months.