Full Pfizer Vaccine Approval Stirs Questions Over Off-Label Uses

Full approval of Pfizer’s Covid-19 vaccine makes it easier for providers to prescribe off-label uses—such as boosters or shots for children under 12—but federal agreements may curb an uptick in that practice.

The Food and Drug Administration approved Pfizer’s biologics license application Monday for those 16 and older, a landmark decision that makes for the first time a Covid-19 vaccine available outside of an emergency use authorization. Access to products under an EUA requires that providers stick to the terms of that authorization. Once approved, prescribers generally have more flexibility to offer a medical product for a reason not listed ...