However, there’s one peculiar caveat to the Pfizer/BioNTech vaccine— and to other major vaccine trials, too: none included pregnant women in their clinical trials. Indeed, not one of the vaccines expected to be approved by the FDA in the next couple weeks, including the Pfizer/BioNTech one, have been tested on pregnant women directly, leaving a cohort of people who are vulnerable to COVID-19 with no direct information on how the vaccine will affect them or their fetuses.
“We don’t know anything directly about the safety of the vaccine in pregnant or in lactating persons because they were all excluded from the vaccine trials,” Dr. Melissa Simon, Director of the Center for Health Equity Transformation at Northwestern’s Center at Northwestern University’s Feinberg School of Medicine, told Salon in a phone interview. “The only thing that could have possibly happened, which we won’t know until the data are unblinded, is if any of the participants in the vaccine trials got pregnant during the course of participating in the trial.”
The exclusion speaks to a long-lived trend in America’s healthcare system, in which pregnant women are actively excluded from the clinical vaccine trials and critical research in healthcare.
Correct. We don’t test drugs on pregnant women. Because we don’t know. In fact, drug tests are largely to overwhelmingly upon male subjects because we don’t want to go testing on pregnant women nor women who might become pregnant during the trial. Because – we don’t know.
We’d sorta like to avoid the two deaths for the price of one thing as – and they will at times – things go wrong. That’s when we’re not pondering how the hormonal changes of pregnancy make wider application of lessons learned a tad difficult.