Previously we have revealed that the Moderna and Pfizer vaccine trials employed numerous exclusions, including high blood pressure, diabetes, and even obesity. Pregnancy was an additional category of exclusion, which now, with vaccine rollout being imminent, raises questions regarding just how safe these experimental drugs might be for pregnant women and their unborn children. In the absence of even a single case from the clinical studies, one can only speculate based on general vaccine safety during pregnancy.
There are many reasons for study exclusions. Fundamentally, many drugs are only appropriate for certain individuals; for example, we do not test medications for ovarian cancer on male subjects. Some types of participants may be difficult to recruit, slowing development and increasing costs. In other cases, there is a concern that some study subjects might be at high risk of serious adverse events. For instance, the flu vaccine is not tested on the elderly for fear that the placebo recipients might contract a fatal case of influenza. Finally, pharmaceutical companies, who invest heavily in their R & D, have a vested interest in obtaining excellent outcomes which become more likely in a carefully selected population.
While there are good reasons for clinical trial exclusions, there also needs to be acknowledgment that the development of vaccines used to prevent COVID-19 infections ought to be different. To effectively bring the pandemic to an end, we need to reach the point of global herd immunity, necessitating that the vaccine be given to as much of humanity as possible. The clinical trials should have reflected this goal by minimizing exclusions to generate the most reliable data on the safety and efficacy of the vaccines across a broad and diverse population. Instead, we are left hoping that these medications will work similarly for all recipients, and special categories of individuals, such as pregnant women, are relegated to making independent risk and benefit assessment without even general guidance from drug manufacturers.