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.