CHMP backs world’s first Ebola vaccine from MSD, NewLink

pharmaphorum | October 21, 2019

CHMP backs world’s first Ebola vaccine from MSD, NewLink
Merck & Co/MSD’s Ebola vaccine has been recommended for conditional approval by the EMA’s main advisory committee, teeing up what looks set to be the first licensed vaccine for the disease within a few weeks. The new vaccine – known during its development as V920 (rVSVΔG-ZEBOV-GP) – will be distributed under the Ervebo brand name if approved by the EMA for active immunisation of individuals aged 18 years and older at risk of infection from the Ebola virus. “This is an important step towards relieving the burden of this deadly disease,” said Guido Rasi, the EMA’s executive director, adding: “Public health authorities in countries affected by Ebola need safe and efficacious medicines to be able to respond effectively to outbreaks and save lives.” The green light comes as an Ebola outbreak continues to afflict the Democratic Republic of the Congo (DRC), with more than 3,100 cases and 2,100 deaths giving a fatality rate of 66%, according to the World Health Organization (WHO). The largest outbreak to date occurred in West Africa in 2014-2016 with more than 11,000 deaths. Ervebo is a recombinant, replication-competent Ebola vaccine, originally developed by NewLink Genetics and licensed to Merck in 2014, that has been given to hundreds of thousands of people in the DRC outbreak on a compassionate-use basis to try to limit the transmission of the disease.There are signs that the spread of new cases is reducing, with the number of affected areas in DRC reducing over the last few weeks and a shift from urban to harder-to-access rural areas, according to the WHO. Neighbouring countries Uganda and Tanzania also have a few confirmed cases but cross-border controls seem to be limiting the spread.

Spotlight

In July, the Pharmaceutical Executive published its latest annual ranking of the top 50 biopharma companies according to prescription drug sales in 2018. Once again, Pfizer led the ranking with $45 billion in sales spurred by its top sellers Prevnar 13, Lyrica and Enbrel.

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