U.S. FDA Prepares Authorization for Janssen's COVID-19 Vaccine

The US Food and Drug Administration Acting Commissioner Janet Woodcock M.D. and the Director of the Center for Biologics Evaluation and Research Peter Marks M.D., Ph.D., issued the following statement late on February 26, 2021.

'Following today’s positive advisory committee meeting outcome regarding the Janssen Biotech Inc. COVID-19 Vaccine, the U.S. Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization. The agency has also notified our federal partners involved in vaccine allocation and distribution so they can execute their plans for timely vaccine distribution.'

This positive statement followed the FDA's Vaccines and Related Biological Products Advisory Committee's 22-0 vote supporting the benefits of the experimental vaccine 'outweigh its risks for use in individuals 18 years of age and older.'

The Janssen COVID-19 vaccine (Ad26.COV2-S) is an experimental vaccine that leverages Janssen's AdVac and PER.C6® technologies. 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. Adenoviruses are a group of viruses that can cause the common cold.

On February 18, 2021, South Africa announced it launched a vaccination program with the Janssen COVID-19 vaccine.

Janssen Biotech Inc. is the vaccine division of the New Jersey-based Johnson and Johnson companies.