J&J submits EMA applications for Ebola vaccine

PharmaTimes | November 08, 2019

Johnson & Johnson has announced the submission of Marketing Authorisation Applications (MAAs) to the European Medicines Agency (EMA) for its investigational Ebola vaccine regimen. The company’s Janssen division is seeking license for the drug for the prevention of Ebola Virus Disease (EVD) specifically caused by Zaire ebolavirus species. The company confirmed that two MAAs have been submitted in parallel supporting each vaccine in the two-dose regimen (Ad26.ZEBOV, MVA-BN-Filo), on the back of a decision from the EMA’s Committee for Medicinal Products for Human Use (CHMP) to grant an Accelerated Assessment for the applications in September. It is “vital that we ensure global preparedness for Ebola given that the world’s largest Ebola outbreaks have taken place in the last six years alone, with the latest currently underway in the Democratic Republic of the Congo (DRC),” said Paul Stoffels, chief scientific officer of Johnson & Johnson.

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ABC delivers a broad array of GLP and CGMP-compliant product development and analytical testing services to the pharmaceutical, biotech, animal health, crop protection, consumer products and chemical industries. This cross-industry, cross-regulatory experience adds value to the process of product development--and will become increasingly important as public scrutiny and global regulations converge on the interrelationships between human, animal and environmental health.

Spotlight

ABC delivers a broad array of GLP and CGMP-compliant product development and analytical testing services to the pharmaceutical, biotech, animal health, crop protection, consumer products and chemical industries. This cross-industry, cross-regulatory experience adds value to the process of product development--and will become increasingly important as public scrutiny and global regulations converge on the interrelationships between human, animal and environmental health.

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