What was that President Trump used to say about not letting the cure be more painful than the disease?
The latest group of intrepid scientists to test the boundaries of virology and medical ethics belongs to the Leiden University Medical Center in the Netherlands. A team of Dutch researchers has already recruited a team of more than 240 volunteers for what’s called a “human challenge” study.
For those who aren’t familiar with the concept, a “challenge” study involves deliberately exposing subjects – animals, or (in this case) human volunteers – to the virus to test the effectiveness of various vaccine candidates.
One could call it a ‘trial by fire’.
So far, Moderna and Pfizer have touted headline numbers claiming their vaccines are 95% effective. Only time will tell whether these vaccines actually prevent infection in 19 out of 20 recipients. Meanwhile, the “dosing error” that led AstraZenaca and Oxford to offer conflicting assessments of its adenovirus-vector vaccine depending on different dosing regimens is only the one of the trial’s shortcomings. It has also been revealed that the vaccine’s best data was gleaned from a group of exclusively younger patients, meaning older more vulnerable patients may be at risk of seeing serious infections develop anyway.
The plan for the “challenge study” is being championed by an organization called 1Day Sooner, which is dedicated – as its name suggests – to accelerating the quest for an effective COVID-19 vaccine. Quarantine facilities in London have already been reserved by the group, which said it expects the trials to begin in January – provided regulators grant their blessing.
With vaccine development and administration still a far-off prospect for millions of Americans, the Trump Administration has promised to start vaccinating health-care workers and the most vulnerable patients by mid-December.
Officials have said vaccines will begin to ship out hours after the FDA grants emergency use approval to Pfizer and/or Moderna. Markets appear to have already internalized this outcome, evidenced by the Dow’s record close yesterday.
1Day Sooner has allies in the biotech space that are willing to supply the equipment the company would need to conduct the study. One British biotech firm said last month that it was already in advanced talks with HMG over permission to create and provide strains of the virus for what would be a groundbreaking study.
Though Reuters didn’t name it in the version of its report published online, the biotech firm referenced above appears to be Open Orphan, a British firm that one Twitter user said “is the only company in the world with a commercial human challenge study model for Covid 19.”
According to a press release published in October, Open Orphan is already working with two British institutions on a “challenge” study using Orphan’s plan. Results are expect by May. At this point, with the biggest economies set to have a virtual monopoly on the first wave of vaccine product, a study like this that could accelerate development of other more traditional vaccine approaches could be enormously valuable.