Johnson & Johnson seeks European approval of its Ebola vaccine

The pharmaceutical giant is also in talks with the US Food and Drug Administration for approval of the two-dose drug.

A Johnson & Johnson building is shown in Irvine, California, U.S., January 24, 2017
Johnson & Johnson says data supporting its experimental Ebola vaccine derives from more than 10 studies that have tested the regimen in adults and children [File: Mike Blake/Reuters]

Johnson & Johnson on Thursday said 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.

Johnson & Johnson said it submitted two marketing authorisation 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 Johnson & Johnson’s technology and the second from Denmark-based biotech Bavarian Nordic A/S.

Johnson & Johnson’s applications are supported by data from more than 10 studies that have tested the regimen in adults and children, the company said.

The drugmaker added it was discussing with the US Food and Drug Administration the dataset that would be required for approval by the United States.

Since it first started in August 2018, the recent Ebola outbreak has killed more than 2,000 people – a death toll second only to that of the 2013 to 2016 outbreak in West Africa, which killed more than 11,300.

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 (WHO) as a “triumph for public health” that could save many lives.

This month, health authorities in the Democratic Republic of the 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.

Johnson & Johnson’s Janssen unit is also working in collaboration with WHO to enable registration of the Ebola vaccine regimen in African countries, the company said.

Source: Reuters