Relieving the Burden

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended granting a conditional marketing approval for Merck Sharp & Dohme’s Ebola vaccine, Ervebo. The vaccine was first developed by NewLink Genetics and licensed to MSD in 2014. According to the EMA, the active substance of Ervebo consists of a live attenuated recombinant Vesicular stomatitis virus (rVSV), which has its VSV envelope glycoprotein replaced with the Zaire ebolavirus (ZEBOV) surface glycoprotein (1). The vaccine is indicated for use in adults aged 18 or over against the Zaire strain of the Ebola virus, which was responsible for the 2014-2016 outbreak in West Africa.

Reviewed under the EMA’s accelerated assessment program, Guido Rasi, Executive Director of the EMA, described the vaccine as “an important step towards relieving the burden of this deadly disease.” Rasi noted that the CHMP’s recommendation was the result of many years of collaborative global effort.

Normally, additional data would still be required for approval, but the vaccine has been recommended for a conditional marketing authorization because it fulfills an unmet medical need, and the benefits of immediate availability are seen to outweigh the risks. MSD will provide more comprehensive data at a later stage. The vaccine has been tested in approximately 16,000 people in clinical trials across Africa, Europe, and the US.

The highly anticipated approval comes as the crisis rages on in the Democratic Republic of Congo. Since the outbreak began in 2018, 3100 people have been infected with the virus and 2100 have died, according to the WHO.

The drug has also been filed for approval in the US, with a decision from the FDA expected in the spring of 2020.