Bass, Berry & Sims attorney Clint Hermes provided insight for an article outlining the process for making a COVID-19 vaccine available for the mass population. Following the quick spread of the pandemic, companies are rushing to create a vaccine that will fight the disease. There are several vaccine candidates in animal and human studies now, with more sure to come. However, companies need to prove the vaccines actually work and that requires large human studies.
According to Clint – who is currently advising the Coalition for Epidemic Preparedness Innovation (CEPI), a global partnership to develop and ensure access to vaccines to stop COVID-19 and future epidemics – “a ‘placebo arm’ is necessary to keep both scientists and subjects in the dark. Knowing who got the vaccine can bias the researcher on a subconscious level in the way they collect data, and bias the behavior of the subject too. What you find is that if people are told they were given a vaccine, they are more likely to expose themselves to a virus than if they are uncertain. It’s just human nature to engage in riskier behavior if they think they have been vaccinated.”
Clint further explains that “you won’t see anything deployed in general population without proof of efficacy.” However, he speculates that while a vaccine might not be available to the masses right away “If a vaccine has a good safety profile and might possibly work, you could see people on the front line getting it.”
The full article, “Here’s What We Have to Do to Show a Coronavirus Vaccine Works,” was published on May 26 by MIT Technology Review and is available online. The article was also republished on several blogs, including, Up Technology, New Paper 24 and Mission Everywhere.