Not everyone who contracts the Ebola virus dies, the survival rate is actually around 30%, which means some kind of immunity to the disease is possible.
Experimental treatments and vaccines against Ebola exist but there was little interest from governments in streamlining the bureaucracy before the recent outbreak, so they have not undergone phase 2 trials - the U.S. Congress did add $90 million to the $29 billion budget of the National Institutes of Health after Director Francis Collins said money was the thing that had prevented a vaccine in the past.
Writing in Frontiers in Immunology, the
International Union of Immunological Societies
is joining a shocking number of groups calling for shortcuts in informed consent, methodology and approval of vaccine candidates to speed up immunization in African countries.
"The current Ebola outbreak, is an unprecedented disaster for humans. This virus cunningly hijacks the human immune system with devastating effects. Without blocking transmission, Ebola may become endemic," says Prof Clive Gray, co-author of the editorial from the Institute of Infectious Diseases and Molecular Medicine, University of Cape Town, South Africa. "Efforts are being made on health communication in order to prevent the spread of this virus from person to person. This is essential but not enough. Stakeholders need to work together to accelerate the roll out of vaccines and therapies."
According to the IUIS paper, among the promising vaccines being tried today is the Cad3 Ebola vaccine developed using chimpanzee adenovirus. This vaccine was found to protect animals with a single dose and is currently undergoing phase 1 trials, where researchers test the vaccine candidate in a small group of people to evaluate safety, determine safe dosage and identify side effects - in other words, no one even knows if it works yet, they just want to make sure it isn't going to harm someone. Another promising vaccine candidate is VSV-EBOV, but it has also only been tested in animal models. Phase 1 trials for it started in October.
Commenting on the need for a vaccination strategy, Prof Marylyn Addo, Department of Medicine, Division of Emerging Infections and Tropical Medicine, University Medical Centre, Hamburg, Germany explained, "the fact that the current outbreak of Ebola is through a single strain with low mutability, suggests that vaccine strategies could be easily achievable. Understanding how immunity works in survivors of Ebola may further contribute to strategic vaccine design and optimization. We need to speed up the development process in order to advance clinical testing and, ultimately, the deployment of effective vaccines. However, despite the urgency of the situation, the safety of the vaccines for recipients needs to be ensured and cannot be compromised."
Alongside vaccination, experimental therapies are also available to treat people who are already infected with the virus. ZMapp, for example, was long ignored by the NIH and was instead funded by the Department of Defense. It combines antibodies that cling to the virus and allow the immune system to clear it. The drug has been tried on animals and humans with different outcomes. Currently the drug is not available, so it cannot be tested further.
Other therapeutic approaches are siRNA (also known as TKM-Ebola) and Favipiravir (T705). "These drugs need to be tried for efficacy and safety, but currently we do not have time to conduct traditional studies," explained Prof Reinhold Schmidt, Director of the Centre of Internal Medicine, Division of Immunology and Rheumatology, University of Hannover, Germany.
How many cancer patients feel the same way? The blanket exemption from lawsuits if products are rushed through approval would have the US Supreme Court tied up for decades.
The IUIS paper calls for a speedy roll-out of a human vaccine to Ebola, though none yet exist. "Of course we do not overrule the need for trials to ensure safety, but IUIS is calling on authorities to speed up the process by a) performing parallel animal safety and immunogenicity studies alongside human phase 1 clinical trials with small sets of volunteers to assess safety and optimal dosage and b) rapidly designing and implementing phase 2 clinical trials." Schmidt concluded: "Time is not on our side. Funding is urgently needed, as well as a more flexible and speedy process to make vaccines available to populations at greatest risk, in order to halt this devastating Ebola outbreak."
If that process was adopted for all drug approval, the pharmaceutical industry would not be abandoning most product development, where the onerous path to market means up to a billion dollars in costs with a 95% chance of failure. With Ebola, the first mainstream media 'the cure was worse than the disease' article will bring talks about bypassing ethics and methodology to a halt.