On Oct. 5, 2021, Johnson & Johnson announced it had submitted data to the U.S. Food and Drug Administration (FDA) to support use of a booster shot of the Johnson & Johnson COVID-19 vaccine in individuals 18 years of age and older.

The submission included recent results from the Phase 3 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 COVID-19 in the U.S.