FDA Issues EUA for Pfizer COVID-19 Vaccine for Children

The FDA has issued an emergency use authorization for Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include children 5 through 11 years of age. The vaccine is two-dose primary series, three weeks apart, but is a lower dose (10 micrograms) than that used for individuals 12 years of age and older (30 micrograms).

In addition, the U.S. government has purchased 50 million more doses of the companies’ COVID-19 vaccine, to prepare for the pediatric vaccine rollout after FDA grants EUA, Pfizer and BioNTech said in a news release. The companies expect to deliver all of these doses by April 30, 2022.

In the United States, COVID-19 cases in children 5 through 11 years of age make up 39% of cases in people younger than 18 years of age. According to the CDC, about 8,300 cases in children 5 through 11 years of age resulted in hospitalization. As of Oct. 17, 691 deaths have been reported in those less than 18 years of age.

Related: FDA Advisory Committee Recommends Pfizer Vaccine for Children

The authorization was supported by data from a study that enrolled 4,700 children 5 through 11 years of age in the United States, Finland, Poland and Spain. In studies, the immune response was comparable to that of older participants.