Pharma, health groups partner to produce Ebola vaccine for clinical trials

CHICAGO – Hilleman Laboratories, a Singapore-based joint venture between Merck & Co. and global charity Wellcome, is preparing to manufacture doses of an experimental vaccine against the rare Bundibugyo strain of Ebola, which is linked to a rapidly spreading outbreak in the Democratic Republic of Congo.

The initiative is supported by up to $8.5 million in funding from the global partnership Coalition for Epidemic Preparedness Innovations (CEPI), according to those involved in the effort.

“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 added.

As of July 29, the outbreak in eastern Congo had infected 3,360 people and killed 1,487. There are currently no approved treatments specifically for Bundibugyo Ebola.

CEPI has also committed up to $8.6 million to support the development of a separate Bundibugyo vaccine candidate from the University of Oxford, which began its first human trial earlier this month.

That vaccine is based on the ChAdOx1 technology used in the Oxford–AstraZeneca COVID-19 vaccine and is being manufactured by the Serum Institute of India.

CEPI has also pledged up to $50 million to develop a Bundibugyo Ebola vaccine with Moderna.

The Merck and Wellcome collaboration will advance the manufacturing of a single-dose vaccine developed by the International AIDS Vaccine Initiative (IAVI), which the World Health Organization identified in May as the most promising candidate.

The vaccine uses the same recombinant vesicular stomatitis virus (rVSV) platform used by Merck’s approved Ervebo Ebola vaccine, which targets the more common Zaire strain of Ebola.

Hilleman Laboratories will use starting materials produced by IAVI to create finished doses for early-stage clinical trials. Merck will provide technical support and contribute scientific and manufacturing expertise on the rVSV platform.

Doses could be ready for clinical testing by the end of this year, Tarit Mukhopadhyay, Merck’s head of infectious disease and vaccine discovery, said in an interview.

Earlier this year, Merck and CEPI partnered on a $30 million program to improve the manufacturing process of Ervebo, with the goal of making the vaccine more affordable and accessible for low- and middle-income countries by increasing production yield and extending shelf life.

Hilleman Laboratories has the capacity to produce tens of thousands of doses, which should be sufficient for clinical testing, Mukhopadhyay said. If larger-scale production becomes necessary, the partners have agreed to transfer the vaccine technology to a larger 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.

Aside from vaccine testing, treatment trials are also underway for Mapp Biopharmaceuticals’ pan-Ebola virus antibody drug MBP134 and Gilead Sciences’ antiviral drug remdesivir, both alone and in combination.

The WHO is also considering trials of Regeneron Pharmaceuticals’ antibody drug maftivimab, combined with two other antibodies, as well as Gilead’s oral antiviral drug obeldesivir.

-Reporting by Julie Steenhuysen in Chicago; Editing by Bill Berkrot/Reuters