4:13 PM, Feb 27, 2020


FDA issues emergency approval Pfizer's COVID-19 vaccine for kids as young as 5

CDC must issue its own approval, will meet next week
Pfizer Children Vaccines
Posted at 3:27 PM, Oct 29, 2021

WASHINGTON — The FDA on Friday issued emergency approval for a smaller dose version of Pfizer's COVID-19 vaccine for use in children aged 5 to 11.

The agency's decision comes just days after the Vaccines and Related Biological Products Advisory Committee voted 17-0 (with one doctor abstaining) to recommend the shots.

"The tremendous cost of this pandemic has not just been in physical illness, it's been in the psychological the social development of children," said Dr. Peter Marks, director of the Center for Biologics Evaluation and Research at the FDA.

The Centers for Disease Control and Prevention (CDC) is scheduled to consider the shots early next week. The agency's Advisory Committee on Immunization Practices must first give its own recommendation before agency director Dr. Rochelle Walensky gives final approval.

Officials estimate that the vaccines could be available to children as early as the first or second week in November.

Last week, the White House said that if and when Pfizer's vaccine receives full emergency use authorization, it would begin shipping 15 million vaccine doses to clinics around the country for immediate distribution.

Biden Administration officials say the country currently has enough doses on hand to vaccinate every child aged between 5 and 11 that lives in the U.S. The White House says that it will primarily lean on primary care doctors and pharmacies to distribute the vaccines but noted that it is also working with some school boards to offer doses in schools.

Pfizer's COVID-19 vaccine has been fully approved by the FDA for everyone aged 16 and up. The shots are also available for adolescents between the age of 12 and 15 on an emergency use basis.

Marks said the FDA is "probably a few months" away from reviewing data for COVID-19 vaccines for younger children.