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FDA authorizes Pfizer's Covid-19 vaccine for children 5 to 11
(CNN)The US Food and Drug Administration issued emergency use authorization on Friday for Pfizer's Covid-19 vaccine for children 5 to 11. This is the first Covid-19 vaccine authorized in the United States for younger children.
On Tuesday, the FDA's vaccine advisers voted 17-0, with one abstention, to recommend EUA for the vaccine, which is formulated at one-third the dose of the vaccine used for people 12 and older.
Pfizer says a clinical trial showed its vaccine provides more than 90% protection against symptomatic disease among children, even at one-third the dose, and the company hopes the lower dose will reduce the risk of any side effects.
Shots can't be administered yet -- the question now goes to the US Centers for Disease Control and Prevention. The CDC's vaccine advisers, the Advisory Committee on Immunization Practices, meet November 2 to discuss whether to recommend use of the vaccine among US children. Then the CDC director, Dr. Rochelle Walensky, makes the final decision on use of the vaccine.
The White House says it has a plan already in place for distributing vaccines to children. Vaccines could be administered as soon as the CDC signs off.
Pfizer's Covid-19 vaccine was previously authorized for children ages 12 to 15. The vaccine is approved for people age 16 and older.
"As a mother and a physician, I know that parents, caregivers, school staff, and children have been waiting for today's authorization. Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy," Acting FDA Commissioner Dr. Janet Woodcock said in a statement.
"Our comprehensive and rigorous evaluation of the data pertaining to the vaccine's safety and effectiveness should help assure parents and guardians that this vaccine meets our high standards."
The FDA said those ages 5 to 11 account for 39% of Covid-19 cases children.
"The FDA is committed to making decisions that are guided by science that the public and healthcare community can trust," Dr. Peter Marks, who heads the FDA's vaccine arm, the Center for Biologics Evaluation and Research, said in a statement.
