JUST IN – FDA grants emergency authorization for Pfizer’s “booster” injections in children and teens ages 12-15.
The “booster” injection for children in the U.S. receives emergency authorization solely on the basis of “real-world” data from Israel. No clinical trials are cited in the FDA press release.
U.S. Food and Drug AdministrationCoronavirus (COVID-19) Update: FDA Takes Multiple Actions to Expand Use of Pfizer-BioNTech COVID-19 VaccineThe FDA amended the emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine to take several actions that will expand the use of the vaccine in certain populations.