Merck, known as MSD outside North America and Mexico, has announced that it is working to initiate the manufacture of licensed doses of the product, for which the US Food and Drug Administration (FDA) approval was announced on December 19, 2019.
Licensed doses are expected to become available in the third quarter of 2020, according to the company. Reuters also reported that Merck plans to price the product at the ‘lowest possible’ access cost for low- and middle-income countries.
Ervebo (Ebola Zaire vaccine (rVSVΔG-ZEBOV-GP)) is a genetically engineered, live, attenuated vaccine, administered as a single-dose injection, indicated for patients of 18 years and older.
Anna Abram, FDA deputy commissioner for Policy, Legislation, and International Affairs, stated that the risk of Ebola virus disease spread in the US remains low.
The product has been distributed in the Democratic Republic of Congo since 2018, in order to fight the currently ongoing, world’s second largest outbreak of Ebola virus disease. Another outbreak in Guinea, Liberia and Sierra Leone resulted in the death of more than 11,000 people from 2014 to 2016.
Merck’s vaccine was approved by the European Medicines Agency (EMA) about a month prior to the FDA approval, after going through a long development journey.
Gavi, the vaccine alliance backed by Bill and Melinda Gates Foundation, announced in December a five-year investment of $178m (€160m) to create a stockpile of 500,000 vaccines that will be distributed for free in low and middle-income countries.
