Ebola Vaccine Trials Move Forward, With Question of Who Pays Left Unanswered

Trials to learn the safety of vaccines to prevent the spread of the Ebola virus are moving as fast as possible in the United States and in Great Britain, as public health officials on both sides of the Atlantic scramble to contain the worst-ever outbreak of the disease.

Meanwhile, the question of who will pay for to develop and distribute doses of the vaccine has not been answered, but published reports suggest wealthier countries, aid groups, the military, or some combination may foot the bill, which will bring a rethinking of how to create better incentives to fund developing of life-saving prevention and cures for diseases that threaten poor nations first, with less obvious commercial value.

As reported in the current issue of Evidence-Based Immunology and Infectious Disease, a news publication of The American Journal of Managed Care, the 2 leading vaccine candidates are a vaccine being co-developed by the National Institutes of Health and GlaxoSmithKline (GSK), and a vaccine being developed by a small US drugmaker, NewLink Genetics, which is working with the University of Maryland on a vaccine that was originally developed for public health agencies in Canada.

A meeting in Geneva end of September—convened by the World Health Organization (WHO)—brought together scientists, public health officials, and individuals from the industry and regulatory agencies (including from the FDA and the European Medicines Agency), who emphasized the need to expedite phase 1 trials and share the resulting data. This would allow for faster initiation of phase 2 trials.

Phase 2a trials, which determine dose levels, are proposed to be conducted in Africa outside the infection zone, and would be conducted in parallel with phase 2b trials in exposed populations, to determine the efficacy of the vaccine. Many reports have surfaced of volunteers, including healthcare workers, receiving doses of vaccine as part of these trials.

Reports have indicated that the first groups to eventually receive vaccines will be healthcare workers exposed to patients in clinics and hospitals, family members of patients, and people who cleanse and bury deceased patients. According to EBIID, a follow-up meeting of the WHO is planned for early next month, when preliminary results from the phase 1 trials will be available, to decide the future course of action.

Whichever vaccine reaches the infection zone first matters less than changing the way the world approaches their development going forward, a leading public health expert told USA Today.

"The political bet is that the US and World Health Organization have been so embarrassed and burned by this event that they will be willing to change the way they do business," said Professor Lawrence Gostin of the Georgetown University Law School, who studies global health issues. "To me, Ebola is a game changer. All the things we thought about in terms of research priorities and development of drugs and vaccines need to be rethought."

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