Pfizer and BioNTech announced they have filed an application to the Food and Drug Administration seeking Emergency Use Authorization for booster doses of its COVID-19 vaccine for children 5-11.
The submitted application to the FDA includes data from its Phase 2/3 clinical trial for kids who got a booster dose about 6 months after their second dose of the Pfizer-BioNTech vaccine.
On Apr. 14, Pfizer announced that booster doses of its COVID-19 vaccine offered a “high immune response” when given to healthy kids ages 5 to 11 years old. The booster dose, the company said, offers an antibody response 36 times greater than levels seen after the original two-dose course of the Pfizer vaccine.
Pfizer also reported that, in its most recent data readout, the vaccine was “well tolerated” by the 401 patient sample size, “with no new safety signals observed.”
Pfizer and BioNTech also plan to submit data and applications for regulatory agencies around the world, including the European Medicines Agency, the European Union's health regulator.
The announcement comes the same day as the Centers for Disease Control reported an estimate that three out of every four children in the United States have been infected with the coronavirus. CDC officials on Tuesday said around 75% of both children and teens had infection-induced antibodies.
The finding came in a new study from the CDC, which showed that more than half of Americans had antibodies from prior infection of COVID-19 as of February of this year.
Spectrum News' Rachel Tillman contributed to this report.