The EUL was supported by data from the phase III Ensemble clinical study, showing that the vaccine was well tolerated and provided a 67% decrease in symptomatic COVID-19. The study also demonstrated that the vaccine was 85% effective in preventing severe disease across all regions and protected against different variants.

The EUL procedure streamlines the process by which new or unlicensed products can be assessed for use during public health emergencies by governments and United Nations procurement agencies. The EUL is also required to supply vaccines to the Covax facility for the distribution of COVID-19 vaccines to the participating 190 countries.

In December 2020, the company entered into an agreement with Gavi, the Vaccine Alliance, to support the Covax facility. Johnson & Johnson expects to enter into an advance purchase agreement that would provide up to 500 million doses of the vaccine to Covax through 2022.

Janssen COVID-19 vaccine authorized in EU
Just hours after receiving a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use on March 11,...

Janssen COVID-19 vaccine nearing European approval
Johnson & Johnson announced it has moved a step closer toward marketing authorization for its single-dose COVID-19 vaccine candidate in Europe.

Janssen COVID-19 vaccine becomes 3rd authorized in U.S.
Janssen Biotech's COVID-19 vaccine has received an emergency use authorization from the U.S. Food and Drug Administration. The move allows the vaccine...

FDA committee gives nod to Janssen COVID-19 vaccine
A single-shot COVID-19 vaccine from Johnson & Johnson's Janssen Biotech subsidiary has received a positive recommendation from a U.S. Food and Drug Administration...

J&J submits Janssen COVID-19 vaccine to WHO for emergency use listing
Johnson & Johnson announced it has submitted Janssen's investigational single-dose COVID-19 vaccine candidate to the World Health Organization (WHO)...