Johnson & Johnson on Thursday said it had filed for approval from European regulators for its two-dose experimental vaccine to protect against Ebola, reported Reuters. The application submission comes less than a month after the agency recommended approval of Merck & Co Inc’s (MRK.N) vaccine.
The pharmaceutical giant 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.
J&J’s vaccine requires two injections to be given to the patients about eight weeks apart, the first developed using the company’s technology and the second from Denmark-based biotech Bavarian Nordic A/S.
The drugmaker said its applications are supported by data from more than 10 studies that have tested the regimen in adults and children. The company added that it was discussing with the US Food and Drug Administration the dataset that would be required for approval by the United States.
The recent Ebola outbreak, which began in the Democratic Republic of Congo in August 2018, is the second-worst Ebola outbreak that has killed more than 2,000 people. The Ebola outbreak that began in 2013 and continued till 2016 in West Africa had killed more than 11,300.
Last month, the World Health Organization (WHO) hailed the EMA’s recommendation for approval of Merck’s Ebola vaccine as a “triumph for public health” that could save many lives.
Notably, the DRC health authorities are introducing Johnson & Johnson’s vaccine this month to counter the current outbreak in the country’s eastern provinces, where Merck’s vaccine is already in use.
Johnson & Johnson said its Janssen unit is also working in collaboration with WHO to enable registration of the Ebola vaccine regimen in African countries.
