The Health and Human Services (HHS) funding will support continued development of V920, a live viral vectored vaccine designed to protect against Zaire Ebola virus, says Merck.
Merck & Co. began developing a vaccine to protect against the Ebola virus following the 2014-2016 Ebola outbreak in West Africa.
In 2017, the firm received a definitive contract funded by the Office of the Assistant Secretary for Preparedness and Response of the HHS, originally worth $126 million (€114 million), to aid development of the investigational vaccine, known as V920.
Now the HHS, through the Biomedical Advanced Research and Development Authority (BARDA), has pledged a further $23 million to Merck to support production of V920 as part of its response to the latest Ebola virus outbreak in the Democratic Republic of the Congo (DRC)
“The funding from this award will support continued vaccine development efforts as well as additional manufacturing activities that will help expand supply of V920,” Merck spokesperson Pamela Eisele told Bioprocess Insider.
“Merck remains fully committed to supporting ongoing, international outbreak response efforts in the Democratic Republic of the Congo (DRC) and neighboring countries, which are being led by WHO and others.”
V920 is a live, attenuated, replication competent, recombinant, viral vectored vaccine designed to help protect against Zaire Ebola virus.
“To make the vaccine candidate, the vesicular stomatitis virus was weakened by removing one of its genes,” said Eisele. “That gene is replaced with a single Ebola virus gene. The vaccine candidate cannot cause Ebola because it contains only a single gene of the Ebola virus, and only the whole Ebola virus can cause Ebola virus disease.”
While the vaccine is still in development, more than 192,000 people have been vaccinated with V920 through compassionate use.
However, a rolling Biologics License Application (BLA) submitted to the US Food and Drug Administration (FDA) for V920 last year is complete and the application is now under review. A Marketing Authorization Application (MAA) is also under review by the European Medicines Agency (EMA).
“In parallel, and in close collaboration with FDA and EMA, submissions also have been made to the WHO to achieve prequalification status and to health authority representatives of the African Vaccine Regulatory Forum (AVAREF),” said Eisele.