Pfizer and BioNTech announced Monday morning that three doses of its COVID-19 vaccine show an 80% efficacy in children under 5.

The results of the Phase 2/3 trial found that after the third dose, the vaccine elicited a strong immune response in children. The dose level is one-tenth the dose level for adults and was administered during the time when the Omicron variant was the predominant COVID variant.

“The study suggests that a low 3-ug dose of our vaccine, carefully selected based on tolerability data, provides young children with a high level of protection against the recent COVID-19 strains,” said Prof. Ugur Sahin, M.D., CEO and co-founder of BioNTech, said in a statement.

Sahin added that the companies are preparing to submit the new data and appropriate documents to the Food and Drug Administration and the European Medicines Agency for emergency use authorizations later this week.

“Our COVID-19 vaccine has been studied in thousands of children and adolescents, and we are pleased that our formulation for the youngest children, which we carefully selected to be one-tenth of the dose strength for adults, was well tolerated and produced a strong immune response,” said Albert Bourla, CEO of Pfizer, in a statement

The announcement that the Pfizer-BioNTech vaccine is effective in kids under 5 came days after both the FDA and the Center for Disease Control and Prevention’s independent advisory council approved vaccine boosters for kids between the ages of 5 and 11.