Pfizer submits data on COVID-19 vaccine for children ages 5-11 to FDA

Pfizer submits data on COVID-19 vaccine for children ages 5-11 to FDA
·1 min read

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.

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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.

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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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Tags: News, Healthcare, Coronavirus, Vaccination, Pfizer, Delta Variant, Pharmaceutical Industry, Science

Original Author: David Hogberg

Original Location: Pfizer submits data on COVID-19 vaccine for children ages 5-11 to FDA

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