The decision was based on data from the phase III Ensemble study demonstrating that the vaccine was well tolerated and achieved a 67% reduction in symptomatic COVID-19 disease in participants who received the vaccine compared to participants who received the placebo.

Johnson & Johnson said it is committed to making the vaccine available on a nonprofit basis for emergency pandemic use. It will begin delivery of the single-dose COVID-19 vaccine in the EU in the second half of April and supply a total of 200 million doses to the EU in 2021.

The Janssen COVID-19 vaccine has already been granted an emergency use authorization from the U.S. Food and Drug Administration on February 27, and it received an interim order authorization in Canada.

Johnson & Johnson has also filed for an emergency use listing with the World Health Organization, as well as with other countries worldwide.

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.
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J&J submits Janssen COVID-19 vaccine to WHO for emergency use listing
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Janssen's COVID-19 vaccine submitted to EMA for emergency use
Johnson & Johnson announced that Janssen has submitted a conditional marketing authorization application to the European Medicines Agency (EMA) for...