Janssen COVID-19 vaccine authorized in EU

By The Science Advisory Board staff writers

March 12, 2021 -- Just hours after receiving a positive recommendation from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use on March 11, the European Commission granted a conditional marketing authorization (CMA) to Johnson & Johnson for its single-dose COVID-19 vaccine, developed by Janssen. The CMA is valid in all 27 member states of the European Union (EU), plus Norway, Iceland, and Liechtenstein.

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.

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