Pfizer gives FDA data for COVID-19 vaccine, seeking to use for children ages 5 to 11

Editor’s Note: This article has been updated to reflect a correction that NBC News made to the article that this article cited.

(NBC News/WHEC) — Pfizer-BioNTech Tuesday gave data to the U.S. Food and Drug Administration (FDA) needed to extend its COVID-19 vaccine emergency use authorization (EUA) for children ages 5 to 11.

It’s expected that the FDA would take several weeks to analyze the data from a trial that included more than 2,000 children before granting EUA.

In that trial, NBC News says children younger than 12 were given smaller doses of the vaccine than those 12 and older. Those doeses did produce an antibody response according to Pfizer, and it was comparable to those seen in a study of people 16 to 25 who received full doses. It also reportedly caused similar side effects to those seen in adults, which have included arm soreness and fatigue.

The Pfizer vaccine has been available to Americans 12 and older since May, but children younger than 12 aren’t currently able to get a COVID-19 vaccine.

The Pfizer vaccine is FDA approved for people 16 and older. When the FDA granted its approval, it kept the vaccine’s EUA for children 12 through 15, citing that because its use in kids that age had been granted EUA later, there was less data to use in its approval decision.

The Moderna and Johnson & Johnson vaccines were only extended EUA for people 18 and older and haven not been FDA approved yet.

There have been more than 43 million cases of COVID-19 confirmed in the U.S. since early 2020, which has led to at least 692,784 deaths, according to a running tally by NBC News as of Tuesday morning.