Bavarian Nordic announced today that he and his partner Janssen Pharmaceuticals, part of Johnson & Johnson, have applied to the European Medicines Agency (EMA) for approval of their two-dose investigation vaccination regime t (Ad26.ZEBOV, MVA-BN Filo)).
The news comes as the new Ebola case was reported today in the Democratic Republic of the Congo (DRC) outbreak, which is part of a volatile pattern observed today by the World Health Organization (WHO) in its weekly insight into the event.
The J&J vaccine before European regulators
The application to the EMA for the Johnson & Johnson Ebola vaccine comes less than a month after the agency's approved VSV-EBOV, the vaccine currently used in a ring vaccination campaign in the areas affected by the outbreak. .
In its announcement, Bavarian Nordic said that the EMA gave an accelerated assessment in September, which will shorten the revised time for the vaccine.
About 500,000 vaccine regimes, provided by Janssen, in the DRC are to be used in a new clinical trial, and in an effort to help prevent the outbreak, planned by the DRC government and its global health partners.
The company said Janssen is in talks with the US Food and Drug Administration to define data for filing for approval of the vaccine under the agency's animal rule contract. He also said that he is working with the WHO to enable the registration of the vaccine in African countries.
New case, 4 other deaths
One new case continues 3 reported yesterday and 7 the previous day.
The most recent infection, noted on the WHO Ebola online dashboard, raises the total total outbreak of 3,286, including 118 cases likely. Health officials are still investigating 531 suspected infections.
Four more people died from their infections, and the death was 2,191 people.
Daily volatility, moving patients
The WHO said today in an outbreak update that 15 cases were reported for the week ending November 5, in line with an average of 19 cases reported for each of the previous 3 weeks.
However, he said that the daily volatility in cases is significant.
Most of the cases over the last three weeks are from four health zones, and the majority of cases are from the Biakato Mines area of the Mandima province of Ituri health zone. The remainder are linked to identified transmission chains in Binase, Katwa and Lwemba health areas. Lwemba where a recent violent attack occurred which killed community health workers who responded to Ebola and was seriously injured by his wife.
The WHO warned that it was possible and expected to circulate to neighboring areas which had an earlier or unaffected impact and should be closely monitored. He also said that about half of people who had been infected for the past 21 days were diagnosed outside the health zone in which they were exposed, mainly those traveling to or from the Mandima health zone.
"This week, a case was found traveling through a new open control point, reinforcing the importance of improving screening along the major passports, transit routes and border points," the WHO said. He also said that the Ebola laboratory was recently opened in the Kasindi health area close to the border with Uganda, which said it would help to identify cases quickly and enable an earlier response.
November 7 Bavarian Nordic Press Release
WHO Ebola dashboard
November 7 WHO update