Johnson & Johnson COVID-19 Vaccine Booster Shot unanimously recommended for emergency use authorization by FDA advisory committee.

The vote was based on findings from two Company clinical trials, including the Phase III ENSEMBLE 2 study, which evaluated a booster dose of the Johnson & Johnson COVID-19 vaccine administered two months after the single-shot, as well as a large and robust real-world evidence study. The Company also presented data that support the increased potential of a booster when administered at six months. Phase III clinical data and real-world data both demonstrated the Johnson & Johnson single-shot COVID-19 vaccine was strong and long-lasting.

The Company’s EUA amendment submission included results from the Phase III ENSEMBLE 2 study, which found a booster dose at two months provided 94 percent protection against symptomatic (moderate to severe/critical) COVID-19 in the United States (CI, 58%-100%) and 100 percent protection (CI, 33%-100%) against severe/critical COVID-19, at least 14 days post-booster vaccination. Also submitted were findings from a Phase 1/IIa study evaluating a booster dose given six months after the first shot, which show antibody levels increased nine-fold one week after the booster, and continued to climb to 12-fold higher four weeks after the booster..