Johnson & Johnson COVID-19 Vaccine Booster Shot Authorized for Emergency Use by U.S. FDA

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 recommendation from the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) based on data provided by the Company, including efficacy, safety and immunogenicity data from its clinical trials and real-world evidence data. When administered as a primary or booster dose, following initial vaccination with the Company’s COVID-19 single-shot vaccine, it provided protection against symptomatic disease and was generally well-tolerated, highlighting the favorable benefit-risk profile of a booster dose in light of the ongoing pandemic.“We welcome the FDA’s decision to authorize emergency use of our COVID-19 vaccine as a booster,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson &Johnson. “Our data support a schedule that provides benefit to individuals based on...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Latest News Source Type: news

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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
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