Ebola clinical activity heats up with vaccine candidates in works

The Ebola outbreak has taught us that the health systems in West Africa are under-resourced and vulnerable. Scaling up capability of local healthcare provision is an important consideration for control of this virus, and drug makers are gearing up to expedite development of Ebola vaccines.

Ebola Watch

Currently there is no therapy or vaccine available but different vaccine candidates are in different phases of development. However, the World Health Organization (WHO) announced plans for speeding up development and deployment of experimental Ebola vaccines, saying hundreds of thousands of doses should be ready for use in West Africa by the middle of 2015.

Neil Lesser, principal in Deloitte Consulting’s life sciences strategy practice, said the acceleration of clinical activity around Ebola “is a function of greater public and private financing, resources and attention aimed at containing and preventing the spread of disease.”

He also said that regulatory authorities have helped open the door.  “Global authorities are open to accelerated pathways for Ebola drugs and vaccines given the growing concern,” Lesser said. “All of this is proof that biopharma R&D can be nimble and accelerated when unmet need is high, marketplace potential exists and stakeholders on the regulatory and industry sides are aligned in pursuing a common goal.”

Ebola is unlikely to become a profitable endeavor for Western pharmaceutical companies, “affecting primarily the poor in Africa with demand for drugs relatively modest,” according to John Santilli, of Access Market Intelligence, which provides market intelligence to the pharmaceutical and healthcare industries.

“Even a traveler vaccine demand will be relatively low unless they are in close contact with Ebola patients,” he said. “Ebola will be a driver for Western pharmaceutical companies to think differently in scaling up for mass immunizations, as there will be a need for financial backing from governments and other donors.”

Through the acquisition of a Swiss/Italian biotechnology company, Okairos, in May 2013, GlaxoSmithKline acquired a pre-clinical vaccine candidate for Ebola, including the Zaire strain responsible for the current outbreak, which had been co-developed by Okairos and the US National Institutes of Health’s Vaccine Research Center (VRC).

In collaboration with the VRC, this vaccine candidate has been evaluated in pre-clinical studies, the results of which appear promising, according to GSK.

Development of the vaccine candidate is progressing with first phase 1 safety trials underway in the USA, UK and Mali, and further trials due to start in the coming weeks.

The vaccine candidate started first-in-human testing in September. It is currently being tested in small phase 1 clinical trials in healthy volunteers being carried out by the National Institute of Allergy and Infectious Diseases (NIAID) in the United States, the University of Oxford in the UK and by the University of Maryland with The Center for Vaccine Development in Mali. Further phase 1 trials are due to start in other non-affected countries in West Africa in the coming weeks.

These trials will study the safety and immunogenicity of the candidate vaccine. These studies are also designed to help select which dose should to be used for the further development.

In parallel, GSK has begun manufacturing approximately 20,000 additional doses of the vaccine candidate so that if the phase 1 trials are successful, we can begin the next phases of the clinical trial program as soon as possible. The company hopes to commence these trials early in 2015 which will include high-risk populations, such as frontline health workers in the affected countries, including Sierra Leone, and Liberia.

Johnson & Johnson expects to initiate phase 1 clinical trials of an Ebola vaccine in January 2015, in Europe, United States and Africa outside of the outbreak area, to establish that the vaccine is safe.

“If our vaccine shows to be save and immunogenic, which will we know in May 2015, we will discuss with WHO and [local] health authorities on how to deploy as many doses as possible and as such that we will be able to determine if the vaccine works,” said J&J spokesperson Amy Jo Meyer. 

J&J’s vaccine includes technology from Denmark-based Bavarian Nordic called MVA-BN (Modified Vaccinia Ankara - Bavarian Nordic), a proprietary and patented vaccine platform technology suitable for addressing the highly virulent Ebola Zaire species, which is responsible for the current outbreak in West Africa.

“The most important consideration in the current outbreak is that we break the transmission chain,” Meyer said. “This can be established by better quarantine and also by applying vaccines. It may even be possible to reduce the risk of transmission with an effective therapeutic.”