Research & Development
US FDA committee votes to recommend Johnson & Johnson's COVID-19 vaccine candidate' Emergency Use Authorisation
1 March 2021 -

The United States Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) has unanimously voted to recommend Emergency Use Authorisation of United States-based Johnson & Johnson's (NYSE: JNJ) single-shot COVID-19 vaccine candidate for adults 18 and older, it was reported on Friday.

The product is produced by the Janssen Pharmaceutical Companies of Johnson & Johnson. If authorised by the FDA, the United States Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) will then provide a recommendation on the use and roll-out of the Janssen COVID-19 vaccine candidate.

The vote was based on a totality of scientific evidence provided by the company, including efficacy and safety data from the Phase three ENSEMBLE trial. The trial is a randomised, double-blind, placebo-controlled clinical trial in individuals 18 years of age and older and was designed to assess the safety and efficacy of the company's vaccine candidate in protecting against both moderate and severe COVID-19 disease, with assessment of efficacy as of day 14 and as of day 28 as co-primary endpoints. The trial enrolled a total of 43,783 subjects.