J&J COVID-19 vaccine booster shot backed by FDA AdCom

The US Food and Drug Administration’s 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 (NYSE: JNJ) COVID-19 vaccine for adults aged 18 and older at least two months following initial vaccination with the single-shot vaccine, the company stated.

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 J&J 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.

Questions on level of efficacy