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EBOLA

Danish Ebola vaccine enters human trials

Bavarian Nordic's promising Ebola vaccine began Phase 1 human trials this week at Oxford and plans to expand to the United States and Africa shortly.

Published: 8 January 2015 13:11 CET
Danish Ebola vaccine enters human trials
Photo: Bavarian Nordic
The Danish biomedical company Bavarian Nordic has advanced its Ebola vaccine into the human trial phase, the company has announced.
 
According to Reuters, Bavarian’s vaccine is just the third to enter human testing as researchers continue their efforts to contain an outbreak of Ebola that has killed more than 8,000 people in western Africa. 
 
The company began its Phase 1 trials on Tuesday, having enrolled 72 healthy adult volunteers into four groups that will receive different regimens of Bavarian’s MVA-BN Filovirus and Johnson & Johnson’s AdVac. The initial trials are being held at the University of Oxford and Bavarian said that additional clinic studies will soon get underway in the United States and Africa and will ultimately involve some 300 human subjects. 
 
 
If these initial studies produce positive results, the company will move to Phase 2 and Phase 3 trials in the coming months. 
 
“This first-in-human trial of this Ebola vaccine regimen is a testament of the accelerated efforts by Bavarian Nordic, Johnson & Johnson, the public health authorities and other key stakeholders to make the vaccines broadly available to protect families and frontline health care professionals,“ Bavarian Nordic’s president and CEO, Paul Chaplin, said in a statement.
 
Bavarian Nordic is working closely with Crucell Holland BV, a subsidiary of the Janssen Pharmaceutical Companies of Johnson & Johnson.
 
In October, Bavarian Nordic and Crucell Holland BV signed a global licence and supply agreement for the MVA-BN Filovirus Ebola vaccine. 
 
According to the company, when combined with Janssen’s AdVac, MVA-BN Filovirus has demonstrated complete protection against Ebola in pre-clinical studies.  

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EBOLA

Ebola tests sold to Denmark recalled

The US Food and Drug Administration said that Ebola kits sent to Denmark and other countries could result in "life-threatening" false positives.

Published: 24 April 2015 08:07 CEST
Ebola tests sold to Denmark recalled
Photo: Colourbox
US regulators have issued an international recall for a 10-minute Ebola blood test made by a California-based company, saying it has not been proven to work and could put lives at risk.
 
"A recall has been issued for the LuSys Laboratories, Inc., Ebola Virus One-Step Test Kits because the FDA has not cleared or approved the kits for use or sale," said the Food and Drug Administration in a statement emailed to reporters on Thursday.
 
"The results obtained from these test kits have not demonstrated to be accurate and should not be used as in vitro diagnostic tests for Ebola infection."
 
The recall was initially issued in mid-March and applies to test kits exported to Denmark, Sierra Leone and Canada between October 2014 and January 2015.
 
The FDA did not say how many tests were sent out.
 
The recall is described as a Class I, "the most serious type of recall and involve(s) situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death," the FDA said.
 
"A false positive result may be life-threatening by potentially placing the patient in an isolation cohort with Ebola-infected patients."
 
Contacted by AFP, a company representative in San Diego said early trials have shown the test to be 86 percent accurate.
 
The problem with the FDA came down to a labeling error, he said. The equipment had not been properly labeled "for research purposes only."
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