(CNN) In a highly anticipated announcement, Pfizer said on Monday a Phase 2/3 trial showed its Covid-19 vaccine was safe and generated a "robust" antibody response in children ages 5 to 11.
These are the first such results released for this age group for a US Covid-19 vaccine, and the data has not yet been peer-reviewed or published. Pfizer said it plans to submit to the US Food and Drug Administration for emergency use authorization soon.
The trial included 2,268 participants ages 5 to 11 and used a two-dose regimen of the vaccine administered 21 days apart. This trials used a 10-microgram dose -- smaller than the 30-microgram dose that has been used for those 12 and older.
"The 10 microgram dose was carefully selected as the preferred dose for safety, tolerability and immunogenicity in children 5 to 11 years of age," Pfizer said in a news release
Participants' immune responses were measured by looking at neutralizing antibody levels in their blood and comparing those levels to a control group of 16- to 25-year-olds who were given a two-dose regimen with the larger 30-microgram dose. Pfizer said the levels compared well with older people who received the larger dose, demonstrating a "strong immune response in this cohort of children one month after the second dose."
Read More