Pfizer announced Monday clinical data shows its COVID-19 vaccine is safe and effective in kids aged 5-11, and the company plans to apply for emergency approval from the Food and Drug Administration (FDA) by the end of the month.
Children aged 5-11 developed equivalent antibody levels to teenagers and young adults in tests despite only receiving a third of the dose that is currently being given to individuals aged 16 and over, Pfizer senior vice president Dr. Bill Gruber told the Associated Press. The kids’ dose resulted in similar or fewer side effects than have been seen in teens, Gruber added.
BREAKING: Pfizer says its COVID-19 vaccine works for kids ages 5 to 11; plans to seek authorization for this age group soon. https://t.co/YDoxAlNmab
— The Associated Press (@AP) September 20, 2021
“I think we really hit the sweet spot,” Gruber said. (RELATED: FDA Panel Votes Against Biden Booster Plan, Only Approves For Seniors And At-Risk Americans)
The company will apply for Emergency Use Authorization (EUA) from the FDA by the end of September, and regulators will try to take up the question in a matter of weeks, FDA chief Dr. Peter Marks previously told the AP. Pfizer’s COVID-19 vaccine was previously authorized under EUA until August, when it was fully approved by the FDA.
Most western countries have not authorized the use of the vaccines in children under age 12, although Cuba and China have authorized their home-grown vaccines for kids as young as two years old. The World Health Organization has advised that it is “less urgent” that kids get vaccinated against COVID-19 right now that adults unless they are in a high-risk group, as the virus tends to be less dangerous in children. 287 American children under age 12 have died of COVID-19 since the pandemic began, according to the Centers for Disease Control and Prevention.