Unapproved Merck Ebola vaccine still needs to obtain importation license and agreement on research protocols, says WHO spokesman Tarik Jašarević


From Fierce Pharma

As the death toll mounts in a new Ebola outbreak in the Democratic Republic of Congo, health officials are preparing to deploy Merck & Co.’s experimental vaccine against the virus. The pharma giant revved up the development project amid a major Ebola breakout in 2014 and 2015.

The new outbreak—so far limited to remote areas in the Congo—started in early April, according to a Monday update from the World Health Organization. Of the 39 people infected, 19 have died, translating into a 49% fatality rate. The agency is working with Gavi, the Vaccine Alliance; Médecins Sans Frontières; and the DRC’s Ministry of Health to introduce the shot in a ring vaccination approach, a WHO spokesperson confirmed Monday.

But because Merck’s Ebola shot hasn’t yet won regulatory approval, officials must obtain an importation license, plus establish a “formal agreement on the research protocols,” WHO spokesperson Tarik Jašarević told FiercePharma.

 

Since then, governments, nonprofits and pharma companies have come together to form the Coalition for Epidemic Preparedness Innovations, an international group designed to prepare for potential epidemics before they happen. The group set the MERS-CoV, Lassa and Nipah viruses as its initial targets. 

https://www.fiercepharma.com/pharma/merck-s-investigational-ebola-vaccine-set-for-use-against-deadly-new-ebola-outbreak-congo

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