TAMPA, Fla. — Some people in the medical field call them "drug orphans."
Research on pregnant women and the way medications and vaccinations help or hurt them is limited. It's been a persistent problem for years as companies choose to exclude them from studies time and time again.
So here we are during a global pandemic, and yet the person walking around with at least two beating hearts isn't accounted for.
Doctors are trying to convince companies conducting vaccine trials to act soon. With so many women on the front lines of hospitals and schools, it's critical to have clear evidence that a vaccine is safe and effective on this particular group of women.
"Pregnant and breastfeeding women who are not yet in these studies, and I've been saying since the beginning, if we don't have a vaccine that's safe for women who are pregnant, want to get pregnant, or are breastfeeding, we don't have a universal vaccine for healthcare workers," said Dr. Jeanne Marrazzo, who sits on the Board of Directors with the Infectious Diseases Society of America.
Dr. Judette Louis is the Department Chair of Obstetrics and Gynecology at the University of South Florida.
She's been a longtime advocate for more medical research on pregnant women, and she's recently been in conversation with the Food and Drug Administration about including child-bearing women in COVID-19 vaccine trials.
To understand the complexity of this research gap, Louis answered some important questions.
Q: Why aren't pregnant women included in vaccination trials (COVID-19 or otherwise)?
A: From the beginning when they’re designing the study, they say who can enroll in it. Typically they will exclude pregnant women. Those conducting the studies known as principle investigators say they exclude pregnant women because they’re trying to protect pregnant women and their babies. They’ll say they’re worried that if they include pregnant women and that if the medication or vaccine is harmful, that you’ve now put a pregnant woman and her baby at risk.
Q: How do you resolve this dilemma?
A: We’ve been holding high-level meetings with the pharmaceutical companies and begging them to try and get approval to include pregnant women.
Q: With a push for a coronavirus vaccine as soon as possible, what are we going to do if pregnant women aren't involved?
A: What I suspect will happen is that they will find a vaccine and they’ll say it works well in the general population and then we’ll have to fight for approval to use it in pregnant women and then the studies in pregnant women will be more delayed. In the meantime, you still have pregnant women who are getting COVID and ending up in the intensive care unit.
Q: Why are companies so reluctant to include pregnant women?
A: People will get nervous and say '"Ah! This bad thing happened and it was because of the medication" without truly establishing that it was the medication. There are some medications out there that have been shown to cause birth defects but there are plenty of others that have not, but people are nervous.
Researchers now know that pregnant women with COVID-19 are more likely to end up in the intensive care unit with complications. CDC data shows 48 pregnant women have died from COVID-19.
According to Louis, their susceptibility to complications is the primary reason to protect pregnant women through research rather than from research.
"They are a group that needs that information, need interventions that will help them whether it’s a vaccine or a treatment drug and if you exclude them from the trials you create a situation where they are even further harmed," she said.
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