Johnson & Johnson announced the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted 19-0 to recommend Emergency Use Authorization (EUA) for a booster dose of the Johnson & Johnson Covid-19 vaccine for adults aged 18 and older at least two months following initial vaccination with the single-shot vaccine.

The vote was based on findings from two company clinical trials, including the phase 3 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 3 clinical data and real-world data both demonstrated the Johnson & Johnson single-shot Covid-19 vaccine was strong and long-lasting.

"Today's recommendation is based on the totality of the evidence, with clinical and real-world data showing that while a single shot offers strong and long-lasting protection against Covid-19, a booster given after the single-dose primary vaccination increases protection, in particular against symptomatic Covid-19," said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson.