Johnson & Johnson Seeks FDA Emergency Use Nod For COVID-19 Booster Dose

Johnson & Johnson JNJ has submitted data to the FDA seeking emergency use approval of its single-dose COVID-19 vaccine in individuals 18 years of age and older.
The submission includes results from the Phase 3 ENSEMBLE 2 study that booster shot at two months provided 94% protection against symptomatic COVID-19 in the U.S.
100% protection was observed against severe/critical COVID-19, at least 14 days post-booster vaccination.
Also, part of the submission is Phase 1/2a data showing when a booster is given six months after the single shot, the antibody levels increased nine-fold one week after and continued to climb to 12-fold higher four weeks.
Related Link: Johnson & Johnson COVID-19 Booster Shot Generates 9X Spike-Binding Antibodies, Early Data Shows.
The vaccine, when given as a booster or primary dose, was generally well-tolerated.
Price Action: JNJ stock is up 0.48% at $159.98 during the premarket session on the last check Tuesday.