Submission of Emergency Use Authorization amendment to the FDA to support booster of its single-shot COVID-19 vaccine.

The submission includes recent results from the Phase III ENSEMBLE 2 study that found a booster of the Johnson & Johnson COVID-19 vaccine given 56 days after the primary dose provided 94 percent protection against symptomatic (moderate to severe/critical) COVID-19 in the U.S. (CI, 58%-100%) and 100 percent protection (CI, 33%-100%) against severe/critical COVID-19, at least 14 days post-booster vaccination.

Also part of the submission is Phase 1/IIa data showing that when a booster of the Johnson & Johnson COVID-19 vaccine was given six months after the single shot, antibody levels increased nine-fold one week after the booster and continued to climb to 12-fold higher four weeks after the booster. The vaccine, when given as a booster or primary dose, was generally well-tolerated.

Last month, the Company released data reinforcing the strong and long-lasting protection of its COVID-19 vaccine. The largest real-world evidence study for a COVID-19 vaccine reported to date in the U.S. demonstrated stable vaccine effectiveness of 79 percent (CI, 77%-80%) for COVID-19-related infections and 81 percent (CI, 79%-84%) for COVID-19-related hospitalizations. There was no evidence of reduced effectiveness over the study duration conducted from March to July 31, 2021. Comparable vaccine effectiveness was demonstrated when the study was extended to August 31, 2021, including when the Delta variant became dominant in the U.S. Sequencing data were not available for analysis. These data were consistent with the Phase III ENSEMBLE trial, where strong protection against severe/critical disease and death was observed at least 28 days post-final vaccination.