Johnson & Johnson announced the 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 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.
"Johnson & Johnson is steadfast in its commitment to protect as many people globally as possible against the continued spread of COVID-19," said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson. "Today's recommendation by the VRBPAC is another step toward ensuring that those who have received the single-shot Johnson & Johnson vaccine – or will receive it in the future – are provided the opportunity to increase their protection against COVID-19. We look forward to sharing these data with regulatory bodies and advisory groups around the world to address the continued threat of COVID-19."
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