The comments this month from the head of the UN Ebola response mission in West Africa that there is still a huge risk the disease could spread to other parts of the world serve as a warning that the crisis remains a humanitarian emergency. As the European Commission Humanitarian Aid and Civil Protection ECHO Factsheet published just this month sets out, as of 5 December 2014, over 17,000 people have been infected and more than 6,000 people have died.
However, the clinical trials process does seem to be offering some hope. On 26 November 2014, researchers from the National Institute of Health (NIH) and GlaxoSmithKline (GSK) reported the results of the Phase I clinical trial of their Ebola vaccine. The trials are taking place under the auspices of the World Health Organisation (the WHO).
Volunteers, aged between 18 and 50, were split into two groups of 10; the first received the vaccine at a lower dose, and the second at a higher dose. Administered to all 20 participants at the NIH’s National Institute of Allergy and Infectious Diseases in Bethesda, Maryland, the vaccine was not only tolerated by all patients, but, also, more promisingly, produced immune system responses. After four weeks, all 20 volunteers showed signs of antibodies, with those who received the higher dose of the vaccine presenting higher antibody levels. Of equal importance, none of those participating in the trial showed any adverse side effects.
The vaccine itself contains segments of the Ebola virus’s genetic material, as well as two of the virus species, although researchers have confirmed that the vaccine does not contain the actual virus.
This success has not been replicated in all clinical trials, however. A vaccine being developed by Merck and NewLink was suspended when four of the 59 volunteers complained of joint pains in their hands and feet. The University of Geneva Hospital has offered some reassurance, commenting that the four volunteers affected “are all fine and being monitored regularly”. It is thought that the trial will resume on 5 January after checks have confirmed that the pains were “benign and temporary”.
In dealing with Ebola, the WHO has departed from standard evidence-based treatment and has set ethical guidelines for the use of new therapies and interventions, with the aim of securing a vaccine over a much shorter time frame than is usually the case. It is hoped that such a departure will prove that flexibility can triumph without compromising long-term ethical concerns. Insurers will be watching with interest before passing judgement.