Pfizer has completed its application to the Food and Drug Administration for an emergency use authorization for its COVID-19 vaccine for children under the age of five.
The submission comes one week after Pfizer said that clinical trials showed that three shots of the low-dose pediatric vaccine is safe and provides a robust immune response in young children. The company said that the vaccine has an efficacy of over 80% at preventing symptomatic cases of COVID-19 in children between the ages of six months and five years.
The vaccine could be authorized by mid-June. The FDA’s Vaccines and Related Biological Products Advisory Committee is scheduled to meet on June 15 to discuss the pediatric vaccines developed by Pfizer and Moderna.
If the FDA advisers vote to authorize the vaccines, the Centers for Disease Control and Prevention will then meet to discuss how the vaccines should be administered.
FDA spokeswoman Abigail Capobianco told the Washington Post that the agency will move “as quickly as possible using a science-based approach” when deciding whether to authorize the pediatric vaccines.
“We recognize parents are anxious to have their young children vaccinated against COVID-19,” she said.