CEPI Says Bundibugyo Ebola Vaccines Could Be Trial-Ready in Months

A health worker is dressed up in personal protective equipment (PPE) at the Evangelical Medical Centre as agencies intensify efforts to contain a new Ebola outbreak caused by the Bundibugyo virus strain, in Bunia, Ituri province, Democratic Republic of Congo. Image credit: Reuters/Gradel Muyisa Mumbere

CEPI was one of the early investors that helped to develop a vaccine at the height of the Covid-19 pandemic.

Richard Hatchett, head of CEPI, told Reuters on Monday that it was possible to get Ebola Bundibugyo (BDBV) vaccines ready for trials within a couple of months.

There are currently no approved BDBV vaccines or treatments.

Hatchett said the promise of vaccines on "a not infinitely distant horizon" should help to start conversations about who would buy them and fund any roll-out.

But he cautioned that vaccine development can be unpredictable, and the challenging security situation in eastern Congo would complicate trials.

There have been 282 confirmed cases in Congo, including 42 deaths, and around 1,100 suspected cases, according to the Africa Centres for Disease Control and Prevention and the World Health Organisation.

Another nine cases have been confirmed in Uganda, including one death.

Global health agencies have declared the outbreak a public health emergency.

Clinical tests

CEPI has committed up to $50m to support preclinical and early clinical development of Moderna's investigational BDBV vaccine candidate.

The funding would also support manufacturing and progression to later-stage trials if early data are positive, Moderna said.

"We have worked on Ebola in preclinical models showing great results," Moderna chief executive Stephane Bancel said in a telephone interview.

Given the lethality of Ebola, the aim would be to create a vaccine that prevents disease while attempting to simplify the dosing strategy, he said.

At this point, it's not clear whether the vaccine could be given in one or two doses. That would be ironed out in the phase one trial before moving into larger trials, which he said would need to be done in Africa.

"Our goal is to move as fast as we can without compromising safety, and to be as helpful as we can," he said.

CEPI said it would also invest up to $8.6m for a shot developed by the University of Oxford and manufactured by the Serum Institute of India, and an initial $3.2m for a vaccine developed by the International Aids Vaccine Initiative.

IAVI's single-dose Bundibugyo vaccine candidate uses the same technology as Merck's approved vaccine Ervebo for the Zaire ​strain, the first strain of Ebola to be discovered in what was then Zaire and is now the Democratic Republic of Congo.

It has shown survival benefit in animal studies.

IAVI CEO Mark Feinberg said in a press briefing that it remains unclear which partners would be responsible for organising or conducting clinical trials for the vaccine candidate.

He noted that multiple studies were conducted during the 2014-2016 West African Ebola outbreak, with support from US agencies and the World Health Organisation.

"We understand from the WHO more recently that they won't be assuming that role in the future," Feinberg said, adding it would require "tens of millions of dollars until we're in a position to enter the clinic".

The WHO did not immediately clarify its stance on sponsoring or conducting trials.

Oxford's candidate, ChAdOx1 Bundibugyo, uses the same technology as that of the Oxford/AstraZeneca Covid-19 vaccine.

Hatchett said Oxford and Serum had demonstrated in a different outbreak last year — Rift Valley Fever in Mauritania and Senegal — that they could make doses ready for trial in around six weeks, far quicker than typical timescales that have in the past run to years.

Once a vaccine is developed, Hatchett said the next challenge is ensuring access to the shots where they are needed. He said 300,000 doses of Ervebo were needed to bring the 2018-2020 Ebola Zaire outbreak under control in a similar region of Congo.

Separately, global vaccine alliance Gavi on Friday committed up to $50m to the Ebola response, and the World Bank's Pandemic Fund announced up to $220.6m in grants.