February 5, 2021 -- Johnson & Johnson announced that Janssen Biotech has submitted an application to the U.S. Food and Drug Administration (FDA) requesting emergency use authorization (EUA) for its investigational single-dose Janssen COVID-19 vaccine candidate. The agency has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on February 26 to discuss the candidate.
The EUA submission is based on safety and efficacy data from the phase III Ensemble study, which demonstrated that the single shot vaccine achieved all primary and secondary end points.
The company expects to start shipping product immediately following the authorization. Johnson & Johnson expects to supply 100 million doses to the U.S. in the first half of 2021.
The company has also initiated rolling submissions with several health agencies outside the U.S. and will submit a conditional marketing authorization application with the European Medicines Agency in the coming weeks.
The vaccine was developed using Janssen's AdVac vaccine platform and can be stored in most standard refrigerator temperatures.
On February 26, the FDA committee will discuss the safety and effectiveness of the Janssen COVID-19 vaccine based on an understanding of the scientific data.