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Johnson and Johnson seeks European Medicines Agency nod for Ebola Vaccine


Johnson and Johnson seeks European Medicines Agency nod for Ebola Vaccine

JnJ 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.

New Delhi: Johnson & Johnson (JnJ) said on Thursday it had filed for 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.

JnJ 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.

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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.

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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 the 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.

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Source: Reuters
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