J&J confirms FDA panel recommends COVID-19 vaccine for EUA

Johnson & Johnson announced that the U.S. Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee unanimously voted to recommend Emergency Use Authorization for the company’s single-shot COVID-19 vaccine candidate for adults 18 and older, developed by the Janssen Pharmaceutical companies of Johnson & Johnson. The vote was based on a totality of scientific evidence provided by the Company, including efficacy and safety data from the Phase 3 ENSEMBLE trial. “We are extremely grateful to the VRBPAC members for their extensive review of the data supporting emergency use of Johnson & Johnson’s single-shot COVID-19 vaccine candidate,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson. “We believe our COVID-19 vaccine candidate has the potential to help change the trajectory of the pandemic and stand ready to make it available to protect the public as soon as possible.” The next step in the process is for the FDA to decide whether to grant an EUA for Janssen’s COVID-19 vaccine candidate. The recommendation of the FDA Advisory Committee is non-binding, and the final decision on authorization is made by the FDA. Under an EUA, the FDA has the authority to allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions during a declared public health emergency. If authorized by the FDA, the U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will then provide a recommendation on the use and roll-out of the Janssen COVID-19 vaccine candidate.