Science reports that in response to the latest Ebola outbreak in the Democratic Republic of Congo (DRC), the government is taking steps to implement the use of an unlicensed vaccine.
A vaccine trial protocol developed in collaboration with Epicentre and Doctors Without Borders was submitted to an ethical review board by the government is awaiting a response. The World Health Organization (WHO) has announced that if approved, this trial protocol could lead to doses of the vaccine being administered within 2 weeks. The urgency of this vaccine is further highlighted as the WHO have released a “donor alert”, which means approximately $10.5 million is needed in order to support the study of this vaccine as well as to supplement treatment, surveillance and other efforts to control the outbreak.
The severity of this outbreak still remains unclear. Currently, there are 41 suspected cases of Ebola with only two confirmed. Further samples taken from individuals suspected to have Ebola have tested negative, which could mean that this outbreak is relatively small, confined and possibly coming to an end.
The location of the current outbreak is fairly isolated, with very little access via roads and bridges, which limits the spread but means that access to the area to provide aid is difficult. Helicopters and motorbikes are a necessity, in order to deliver teams and equipment to the Northeastern Bas-Uélé province.
The vaccine, made by the pharmaceutical company Merck, is being stored in the U.S. In 2015 during the Ebola outbreak in West Africa, this vaccine was tested using a design called “ring vaccination”. This means that selected people who were most likely to have come into contact with the Ebola virus were given the vaccine. The trial results demonstrated that the vaccine gave 100% protection within 10 days of immunization. However, Merck was reluctant to apply for regulatory approval since the data was obtained using uncommon methods. Merck wished to perform additional studied to gather more comprehensive safety and efficacy data, limiting administration to an experimental environment.
The current protocol written by Epicentre and the DRC’s Ministry of Health (MoH) would see the vaccine being administered in the same “ring vaccination” design used in 2015, although this time there would be no control group, due to the ethical issues now surrounding withholding the vaccine. Medical Sans Frontier (MSF) state that the protocol would aim to obtain data supporting the effectiveness of the vaccine while it is primarily being used as a public health intervention.
The reason for the delay requesting the vaccine is unclear, and Michael Osterholm, Director of the Center for Infectious Disease Research and Policy at the University of Minnesota in Minneapolis, states that the MoH should have been able to deploy the vaccine much more quickly. He also stated that each African country that is at an increased risk of Ebola should have an approved study protocol in place, with the vaccine stored and ready to use.
For this particular outbreak, experts have reported that they do not expect the spread of the Ebola virus to become as widespread as what was observed in West Africa. Provided the virus does not reach one of the surrounding cities that are more densely populated, they state that this epidemic should be kept under control by isolating and treating patients, quarantine and contact tracing.
Representatives from WHO have travelled to support the actions to tackle the outbreak. In addition, helicopters and planes from the United Nations are assisting with the delivery of teams and equipment. Government officials of the DRC have had daily meetings with various organizations including representatives from international aid, development organizations, WHO, and the U.S. Centers for Disease Control and Prevention.
Written By: Jade Marie Evans, MPharm, Medical Writer