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 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.
Since it first started in August 2018, the Ebola outbreak has killed
more than 2,000 people, second only to the 2013-16 outbreak in West
Africa that killed more than 11,300.
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The EMA's recommendation for approval in October of Merck's Ebola
vaccine, taken as a single shot, was hailed by the World Health
Organization as a "triumph for public health" that could save many
lives.
This month, health authorities in Democratic Republic of Congo are
introducing Johnson & Johnson's vaccine to counter the current
outbreak in the country's eastern provinces, where Merck's vaccine
is already in use.
J&J's unit Janssen is also working in collaboration with the World
Health Organization to enable registration of the Ebola vaccine
regimen in African countries, the company said.
(Reporting by Tamara Mathias in Bengaluru; Editing by Arun Koyyur)
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