Bavarian Nordic today announced that it and its partner Janssen Pharmaceuticals, part of Johnson & Johnson, have submitted an application to the European Medicines Agency (EMA) for approval of their investigational two-dose Ebola vaccine regimen (Ad26.ZEBOV, MVA-BN Filo).
The news comes as one new Ebola case was reported today in the Democratic Republic of the Congo (DRC) outbreak, part of a fluctuating pattern that the World Health Organization (WHO) noted today in its weekly snapshot of the event.
J&J vaccine before European regulators
The application submission to the EMA for the Johnson & Johnson Ebola vaccine comes less than a month after the agency conditionally approved VSV-EBOV, the vaccine currently used in a ring vaccination campaign in the outbreak-affected areas.
In its announcement, Bavarian Nordic said that in September the EMA granted accelerated assessment, which will shorten the review time for the vaccine.
About 500,000 regimens of the vaccine, provided by Janssen, are in the DRC for use in a new clinical trial, and in an effort to help curb the outbreak, planned by the DRC government and its global health partners.
The company said Janssen is in discussions with the US Food and Drug Administration to define data for filing for approval of the vaccine under the agency's animal rule pathway. It also added that it is working with the WHO to enable registration of the vaccine in African countries.
New case, 4 more deaths
The single new case follows 3 reported yesterday and 7 the day before.
The latest confirmed infection, noted on the WHO's online Ebola dashboard, raises the overall outbreak total to 3,286, which includes 118 probable cases. Health officials are still investigating 531 suspected infections.
Four more people died from their infections, lifting the fatality count to 2,191.
Daily fluctuation, patients on the move
The WHO said today in an outbreak update that 15 cases were reported for the week ending Nov 5, consistent with an average of 19 cases reported for each of the previous 3 weeks.
However, it said the daily fluctuation in cases is notable.
Most of the cases over the past 3 weeks are from four health zones, and the majority of those are from the Biakato Mines area in Ituri province's Mandima health zone. The rest are linked to known transmission chains in Binase, Katwa and Lwemba health areas. Lwemba is where a violent attack recently occurred that killed an Ebola response community health workers and severely injured his wife.
The WHO warned that spread to earlier affected or still unaffected neighboring areas is possible and expected and should be closely monitored. It added that about half of the people infected in the last 21 days were diagnosed outside of the health zone where they were exposed, mostly people traveling to or from Mandima health zone.
"This week, a case was detected while traveling through a newly-opened point of control, reinforcing the importance of enhancing screening along these major passages, transitways and border points," the WHO said. It added that an Ebola lab recently opened in Kasindi health area near the border with Uganda, which it said would help rapidly identify cases and enable an earlier response.
Nov 7 Bavarian Nordic press release
WHO Ebola dashboard
Nov 7 WHO update