Peter Doshi, associate editor of the British Medical Journal and researcher at the University of Maryland, published a note criticizing the ongoing trials of COVID-19 vaccines. According to the author, none of the trials are intended to determine whether the risk of hospitalization, intensive care, or death of an infected SARS-CoV-2 is reduced.
The third phase of clinical trials is designed to evaluate the effectiveness of the vaccine and its safety for patients. The analysis of the effectiveness of the drug is carried out when volunteers have 150-160 cases of symptomatic COVID-19, regardless of the severity of the disease. However, hospitalizations and deaths are relatively rare in the population of 30,000 subjects, so statistically significant differences cannot be demonstrated. The trials are not at all intended to answer the question of whether a vaccine can prevent the transmission of coronavirus or reduce mortality.
To collect data on a decrease in mortality, the number of subjects must be significantly increased, as must the duration of the trials themselves. In addition, trials usually involve relatively few older adults who are at risk for severe COVID-19. However, in a pandemic, it is necessary to quickly establish whether the vaccine works at all.
It is not too late to influence vaccine development to be sure whether drug safety is being adequately assessed or if knowledge gaps in how the immune system responds to SARS-CoV-2 are considered, Doshi said.