Janssen's COVID-19 Vaccine Readies FDA Presentation
The U.S. FDA's Vaccines and Related Biological Products Advisory Committee will meet on February 26, 2021, in an open session to discuss an emergency authorization for the Janssen Biotech Inc. experimental COVID-19 Vaccine. This authorization would be for active immunization to prevent COVID-19 caused by SARS-CoV-2 in 18 years and older individuals.
Materials for this FDA meeting will be available at the Vaccines and Related Biological Products Advisory Committee meetings main page.
The single-dose Janssen COVID-19 vaccine candidate showed 66% efficacy in Latin America (Brazil strain) and 57% efficacy in South Africa, and 72% efficacy in the USA, where cases of the U.K.'s virus mutation have been identified.
This COVID-19 vaccine leverages Janssen's AdVac and PER.C6® technologies to develop the Ebola vaccine, Ad26.ZEBOV. Janssen’s AdVac® vectors are based on a specific type of adenovirus, which has been genetically modified so that it can no longer replicate in humans and cause disease.
Janssen is a division of the Johnson and Johnson companies.