Chicago: Hilleman Laboratories, a Singapore-based joint venture between Merck and the global charity Wellcome, is gearing up to manufacture doses of a promising experimental vaccine against the rare Bundibugyo strain of Ebola responsible for a fast-spreading outbreak in the Democratic Republic of Congo.
The effort is backed by up to $8.5 million in funding from the global partnership Coalition for Epidemic Preparedness Innovations, or CEPI, those involved in the effort said on Thursday.
“With Bundibugyo virus cases rising at worrying speed, the epidemic is fast becoming a humanitarian crisis,” CEPI Chief Executive Richard Hatchett said in a statement.
“No vaccine is currently approved against the virus, so we are urgently advancing vaccine candidates into testing,” he said.
As of July 29, the outbreak in the eastern Congo has infected 3,360 people and killed 1,487. There are also no approved treatments for Bundibugyo Ebola.
CEPI has said it is investing up to $8.6 million for the development of a separate Bundibugyo vaccine candidate from the University of Oxford, which began a first human trial earlier this month.
The vaccine is based on ChAdOx1 technology, which was used in the Oxford/AstraZeneca COVID-19 vaccine, and is being manufactured by the Serum Institute of India.
CEPI also committed up to $50 million to develop a Bundibugyo Ebola vaccine with Moderna.
The Merck/Wellcome collaboration will advance manufacturing of a single-dose vaccine developed by the International AIDS Vaccine Initiative, which the World Health Organization in May singled out as the most promising candidate.
The vaccine uses the same recombinant vesicular stomatitis virus, or rVSV, platform used by Merck for its approved Ervebo Ebola vaccine that targets the more common Zaire strain.
Hilleman will use starting material generated by IAVI to create finished doses that can be used in early-stage trials. Merck will serve as a technical adviser and contribute scientific and manufacturing expertise on the rVSV platform, the company said.
Doses could be ready for clinical testing by the end of this year, Tarit Mukhopadhyay, Merck’s head of infectious disease and vaccines discovery, said in an interview.
Merck and CEPI earlier this year partnered on a $30 million program to update the manufacturing processes of Ervebo aimed at improving affordability and access for low- and middle-income countries by increasing yield and extending its shelf life.
Hilleman Labs is equipped to make tens of thousands of doses, which should be plenty of supply for testing, Mukhopadhyay said. Should larger-scale production be needed, the partners have agreed to transfer the vaccine technology to a larger-scale manufacturer.
“None of those plans have been solidified,” Mukhopadhyay said.
“We urgently need to strengthen our toolkit against Bundibugyo. The outbreak is in a region faced with conflict, instability, and strained resources, making a holistic response essential,” said Charlie Weller, head of vaccines at Wellcome.
Beyond vaccine testing, treatment trials are underway testing Mapp Biopharmaceuticals’ pan-Ebola virus antibody drug called MBP134, and Gilead Sciences’ antiviral remdesivir, alone and in combination.
The WHO is also considering trials of Regeneron’s antibody drug maftivimab in combination with two other antibodies, and Gilead’s oral antiviral drug obeldesivir.
