On April 22 a 45-year-old man in a remote area of the Democratic Republic of the Congo (DRC) was diagnosed with the Ebola virus; call him the new "patient zero". In less than a month there were 20 more suspected cases and three deaths. Is this the start of a new outbreak? And if so, what is being done to prevent another outbreak like the 2014-2016 outbreak that killed over 11,000 people in Guinea, Sierra Leone, and Liberia?
It would be encouraging to think that "it'll be different this time", and maybe it will. For one thing, Merck has developed a vaccine that appears to be effective against the 2014-2016 strain of Ebola. There are already stockpiles of the vaccine on ice. But the vaccine is still considered "experimental". It has not yet been approved by the FDA, and so it can only be used in carefully monitored clinical study protocols designed to document the vaccine's safety and effectiveness. The DRC does not yet have an approved clinical study protocol on file, according to an article in Science. The government will need to decide whether standard containment strategies are likely to suffice, or whether it can establish an approved study protocol quickly enough to be able to vaccinate people at risk before the outbreak gets much worse.
You might think it would be a no-brainer to establish a clinical study protocol. It is not. Requirements would include the ability to keep the vaccine refrigerated the vaccine at all times - no small task in remote region of the country. Furthermore, an approved clinical study protocol would require extensive record-keeping, including follow-up of all vaccine recipients for an extended period of time. There's even a requirement for ethical oversight and for obtaining informed consent from all vaccine recipients.
And so we wait. We wait to see what the DRC does about this latest outbreak, and whether the outbreak spreads.
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