Pfizer and BioNTech announced that they had submitted data to the Food and Drug Administration showing that their COVID-19 vaccine was safe and effective for children between the ages of 5 and 11.
The vaccine demonstrated a “favorable safety profile and elicited robust neutralizing antibody response” in children who had received two doses, according to the companies. The clinical trial included 2,268 participants.
The FDA has said it will review the data as quickly as possible.
The companies said they expected to file a request for an emergency use authorization with the FDA for use of the vaccine in children ages 5-11 in the coming weeks. An EUA permits a vaccine to be administered without first having to go through full approval.
Dr. Scott Gottlieb, the former head of the FDA and now a member of the board of directors of Pfizer, recently said that a vaccine could be available for children ages 5-11 by the end of October or November.
The companies are also testing the vaccine on children under the age of 5. The results from those trials are expected as soon as the fourth quarter of this year.
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Original Author: David Hogberg
Original Location: Pfizer submits data on COVID-19 vaccine for children ages 5-11 to FDA