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.

“Risk remains very high at national and regional levels but is still low at global level,” says the agency in its latest 18 October update on the virus.

Around 16,000 people have also received Ervebo in clinical trials in Africa, Europe and the US, and the vaccine has also been filed for approval in the US with a decision by the FDA due in March 2020.

Merck’s head of R&D Roger Perlmutter said that the company’s top priority now is to get a facility in Germany that will be used to manufacture Ervebo “so that licensed supply can be used to support global public health preparedness.”

The approval is “a triumph for public health, and a testimony to the unprecedented collaboration between scores of experts worldwide,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus.

“This vaccine has already saved many lives in the current Ebola outbreak, and the decision by the European regulator will help it to eventually save many more,” he added.

The WHO notes that there are some eight Ebola vaccines coming through the development pipeline.

Among these is a two-shot vaccination based on Ad26.ZEBOV from Johnson & Johnson’s Janssen subsidiary and MVA-BN-Filo from Bavarian Nordic has started testing in Uganda, and there are two Ebola vaccines developed by GlaxoSmithKline that were handed over to the US Sabin Vaccine Institute for further development in August.