- Pfizer and BioNTech are expected to formally request emergency approval of their COVID-19 vaccine for children ages 5 to 11 in the coming weeks.
- The Pfizer-BioNTech vaccine is fully approved for people 16 and older and is available under emergency use for adolescents ages 12 to 15.
- Pfizer and BioNTech said last week that no serious side effects were found during the vaccine trial for 5- to 11-year-olds.
Today, Pfizer and BioNTech announced that they have submitted initial data to the Food and Drug Administration (FDA) from their COVID-19 vaccine trial in children ages 5 to 11.
The companies plan to formally request an emergency use authorization (EUA) of the vaccine for use in this age group in the coming weeks, they said in a statement.
The Pfizer-BioNTech vaccine is fully approved for people 16 and older and is available under an EUA for adolescents ages 12 to 15.
Last week, the companies released results from a phase 2 and 3 trial showing that the vaccine was safe and generated a “robust” immune response in children 5 to 11 years old.
This study included 2,268 children from the United States and several other countries. They received two doses of the vaccine around 21 days apart.
The dose used in the trial — 10 micrograms — is a third of that used for people 12 and older.
Researchers measured children’s immune response by looking at the level of neutralizing antibodies in their blood.
“These results — the first from a pivotal trial of any COVID-19 vaccine in this age group — were comparable to those recorded in a previous Pfizer-BioNTech study in people 16 to 25 years of age, who were immunized with 30 microgram doses,” the companies said in a statement.
They plan to submit the data from the full phase 3 trial to a scientific peer-reviewed publication.
Source: healthline