While multiple groups around the world are developing and testing vaccines at a blinding pace, those efforts must still take into account additional factors that are unique to COVID-19
“Failure to do so could lead to setbacks in getting vaccines approved by regulators and delay their deployment,” said Bahaa Abu Raya, a pediatric infectious diseases specialist with the BC Children’s Hospital Research Institute in Vancouver.Dr. Abu Raya is the lead author of a paper published last week in the Canadian Medical Association Journal that makes clear just how difficult the process of assessing COVID-19 vaccines could be.
A third candidate, developed by Massachusetts-based Moderna Inc., is heading to a Phase 3 trial at the end of this month, the company announced Tuesday, after positive results from an early trial, involving 45 individuals, were published in the New England Journal of Medicine. Someone working on a vaccine for influenza or another virus that is endemic to the human population can estimate with some confidence how many people are likely to be infected over a given period of time. Individuals who receive the vaccine in a clinical trial can then be compared to the background infection rate to see if they fare any better. The rate is crucial in determining what size of clinical trial is needed to demonstrate that a vaccine is working.
He added that because infection rates are climbing significantly in some parts of the United States, “it is likely that we will be incorporating a number of U.S. sites” in upcoming clinical trials of the group’s vaccine candidate. The study does not delve into the issue of human challenge trials, which would involve deliberately exposing subjects to COVID-19 after vaccination in order to more directly test vaccine efficacy. In addition to the ethical problem of infecting individuals with a disease that cannot always be treated successfully, some experts have pointed out that such trials are unlikely to provide data that is relevant to those who are most vulnerable to the disease.
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