Foundation for Vaccine Research

On September 10, 2021, a special tribunal established by the French government launched an inquiry into the activities of former health minister Dr. Agnes Buzyn who was charged with “endangering the lives of others”. It is surprising to learn of this accusation and inquiry into the actions of a public health official whose response to the epidemic was, to all appearances, exemplary.

We compare and contrast the expected duration and number of infections and deaths averted among several designs for clinical trials of COVID-19 vaccine candidates, including traditional randomized clinical trials and adaptive and human challenge trials. Using epidemiological models calibrated to the current pandemic, we simulate the time course of each clinical trial design for 504 unique combinations of parameters, allowing us to determine which trial design is most effective for a given scenario. A human challenge trial provides maximal net benefits—averting an additional 1.1M infections and 8,000 deaths in the U.S. compared to the next best clinical trial design—if its set-up time is short or the pandemic spreads slowly. In most of the other cases, an adaptive trial provides greater net benefits.

The last two and a half years have witnessed a curious debate in virology characterized by a remarkable lack of discussion. It goes by the misleading epithet “gain of function” (GOF) influenza virus research, or simply GOF. As will be seen, there is nothing good to be gained. The controversial experiments confer aerosol transmission on avian influenza virus strains that can infect humans, but which are not naturally transmitted between humans. Some of the newer strains are clearly highly pathogenic for man. It will be shown here that the benefits of the work are erroneous and overstated while the risk of an accident is finite, if small. The consequence of any accident would be anywhere from a handful of infections to a catastrophic pandemic. There has been a single open international meeting in this period, which is surprising given that openness and discussion are essential to good science. Despite US and EU government funding, no risk–benefit analysis has been published, which again is surprising. This research can be duplicated readily in many labs and requires little high tech. It falls under the definition of DURC without the slightest shadow of a doubt and constitutes the most important challenge facing contemporary biology.