Johnson & Johnson COVID-19 Vaccine Booster Shot Unanimously Recommended for Emergency Use Authorization by U.S. FDA Advisory Committee

NEW BRUNSWICK, N.J., October 15, 2021 – Johnson &Johnson (NYSE: JNJ) (the Company) today 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 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 ste...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Innovation Source Type: news

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NEW BRUNSWICK, N.J., DECEMBER 5, 2021 – Johnson &Johnson (NYSE: JNJ) (the Company) today announced preliminary results from an independent study, including a subset of participants from the Janssen-sponsored COV2008 study, conducted by Dan Barouch, M.D., Ph.D., et al. of Beth Israel Deaconess Medical Center (BIDMC), which showed that a booster shot of the Johnson &Johnson COVID-19 vaccine (Ad26.COV2.S), administered at six months after a two-dose primary regimen of BNT162b2, increased both antibody and T-cell responses. These results demonstrate the potential benefits of heterologous boosting (mix-and-match)....
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Innovation Source Type: news
NEW BRUNSWICK, N.J., October 21, 2021 – Johnson &Johnson (the Company) today announced that the U.S. Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP), has recommended its COVID-19 vaccine as a booster for all eligible individuals who receive an authorized COVID-19 vaccine. “Today’s recommendation supports the use of the Johnson &Johnson COVID-19 vaccine as a booster for eligible individuals in the U.S. regardless of which vaccine they initially receive,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific...
Source: Johnson and Johnson - Category: Pharmaceuticals Source Type: news
NEW BRUNSWICK, N.J., October 20, 2021 – Johnson &Johnson (NYSE: JNJ) (the Company) today announced the U.S. Food and Drug Administration (FDA) has issued 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 primary vaccination with single-shot Johnson &Johnson COVID-19 vaccine; and for eligible individuals who received a different authorized or approved COVID-19 vaccine. The Johnson &Johnson booster shot will be the same formulation and dosage as the primary shot. The EUA follows a unanimous recommendat...
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NEW BRUNSWICK, N.J., October 05, 2021 – Johnson &Johnson (NYSE: JNJ) (the Company) announced it has 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 includes 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 (moderate to severe/critical) COVID-19 in the U.S. (CI, 58%-100%) and 100 percent protection (CI, 33%-100%) agai...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Innovation Source Type: news
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