Merck announces scale-up plans for Ebola vaccine production
The vaccine, known as V920, will be produced to meet the ‘ongoing, unpredictable, and evolving’ situation in the Democratic Republic of Congo (DRC), and neighboring countries.
Over the next 6-to-18 months, Merck, known as MSD outside of North America and Mexico, will produce an estimated 650,000 1.0mL investigational doses of the treatment.
This will double previous levels of production, after the company produced 245,000 doses since May 2018.
In order to scale-up its production, it will utilize its planned commercial manufacturing site in Germany and add new production capability through a clinical manufacturing site in the US.
The German commercial production site has yet to receive approval but Paula Annunziato, VP of Merck Research Laboratories, said, “A top priority for us remains achieving registration of V920 and regulatory approval of our German manufacturing site, so that licensed supply can be produced over time to support global public health preparedness and health security objectives.”
The production plans will be partially funded by the US Department of Health and Human Services, which provided $23m (€20m) for a year’s supply of the V920 vaccine.
This additional funding means that the various US authorities have provided a total $176m to the development and manufacturing of the investigational vaccine.
Rick Bright, director of the Biomedical Advanced Research and Development Authority, said at the time of the announcement that funding the vaccine was the “best way to protect people at home.”
Priority review for vaccine
As well as revealing its production plans for the vaccine, Merck announced that the US Food and Drug Administration (FDA) had accepted its biologics license application (BLA) and granted the investigational treatment priority review.
As a result, the FDA is set to provide its response to the application by March 14, 2020. The priority review follows on from the European Medicines Agency accepting the vaccine for review in March 2019.
