(CMR) Pfizer-BioNTech announced on Monday that test trials showed its two-dose COVID-19 vaccine was safe and offered a “robust” antibody response in children ages 5 to 11. German partner BioNTech described the vaccine's use in the age group as “safe, well-tolerated, and showed robust neutralizing antibody responses.”
More than 2,000 children participated in the trial, which Pfizer used to gather the data.
“I feel a great sense of urgency” in making the vaccine available to children under 12, said Bill Gruber, senior vice president of Pfizer. “There’s pent-up demand for parents to be able to have their children returned to a normal life.”
According to the Washington Examiner, Pfizer tested a lower dose amount for the 5 to 11-year-old age group, a third of the regular amount that's in each shot presently.
Gruber said following a second dose, children ages 5 to 11 formed coronavirus antibody levels that are just as strong as teenagers or young adults.
Pfizer is expected to apply to the Food and Drug Administration by the end of September for use in the 5 to 11 age group. Applications are also expected to be made to European and British regulators.
FDA chief Peter Marks said the agency would begin evaluating the data “hopefully in a matter of weeks” after Pfizer submits its study results.