Date: 08-Nov-2019

Johnson & Johnson files for European approval of Ebola vaccine

Johnson & Johnson said on Thursday it had filed for an approval from European regulators for its two-dose experimental vaccine to protect against Ebola, less than a month after the agency recommended approval of Merck & Co Inc's vaccine. J&J said it submitted two marketing authorization applications to the European Medicines Agency (EMA) for its vaccine regimen targeting the Zaire strain of the Ebola virus, which most commonly causes outbreaks of the deadly disease. The company's vaccine requires two injections administered about eight weeks apart, the first developed using J&J's technology and the second from Denmark-based biotech Bavarian Nordic A/S. Johnson & Johnson's applications are supported by data from over 10 studies that have tested the regimen in adults and children, the company said. The drugmaker added it was discussing with the Food and Drug Administration the dataset that would be required for U.S. approval.