WASHINGTON (ABC7) — As states begin to move into the next phase of their vaccine rollouts, one group remains a little in limbo: pregnant and breastfeeding women. They weren't included in these clinical trials and they're often not included in many clinical trials, despite leading scientists saying they want to be.
Because of this, there's not much data on side effects or effectiveness of the COVID vaccine for this group. ABC7's Adrianna Hopkins spoke with the author of a new book that explores how women have been left out of medical studies and trials to our detriment, and a pregnant healthcare professional about whether she'll get the vaccine.
"It's something I'm really grappling with, so it's a topic I've been thinking a lot about recently. Day to day I'm still trying to make up my mind since I'm fortunate enough to get the vaccine soon," said Audrey Neff.
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Audrey Neff and her husband are expecting, and as she enters her last trimester of pregnancy in the midst of this ongoing and persistent global pandemic, she's concerned about getting the COVID vaccine, mainly because: "I'm a data-focused person. When there's no data out there I don't feel super confident saying 'yeah this is safe.'"
"This is probably one of the most anticipated vaccines in our lifetime and once again we don't know the impact on pregnant women or breastfeeding women because they're not being included in the clinical trials," said Anushay Hossain, author of Hysterical: How Sexism in Healthcare Kills Women, is slated for release Fall 2021. "There are a lot of pregnant women who want to be tested on. It's almost like women's health and pregnant women's health is an afterthought when we actually should be the priority."
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But it's not just the COVID vaccine clinical trials that the author of "Hysterical: How Sexism Kills Women," Anushay Hossain, points to as problematic. Until the early 1990s, women weren't included in clinical trials and she says to this day the medical industry still excludes women from research. A fact backed by recent research at the University of California, Berkley, and the University of Chicago.
"Right now the standard for health is a middle-aged white male and that's a really big problem. We know better, we should do better, and women not only need to be a priority, women of color need to be a priority."
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As for Neff, she's confident in the COVID vaccine... just not for her... right now.
"I'd feel more comfortable for sure postpartum getting it and frankly if I weren't pregnant, I would've signed myself up as soon as I could."
Hossain's book "Hysterical: How Sexism in Healthcare Kills Women" is slated for release in the Fall of this year. She says it dives into women's experience in healthcare, especially women of color.
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Neff says some of her pregnant colleagues are seeing COVID patients on a daily basis did get the vaccine because the benefits outweighed the risks for them. Her advice is the same as the CDC's for pregnant women - the choice to get the vaccine is up to you. The World Health Organization (WHO) recently recommended pregnant women NOT get the COVID vaccine, citing a lack of data.
Hopkins also spoke with Diana Bianchi, MD, Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, one of 27 institutes in the NIH. She discusses a task force created to address the need for pregnant and breastfeeding people in medical research trials.
Hopkins spoke with Dr. Sarah Crimmins, Medical Director of Labor & Delivery at University of Maryland Medical Center (UMMC) about how she’s advising her patients.
“We’ve had a lot of discussion around this. Our patients are all individuals, I treat each patient as an individual. If they’re being offered a vaccine, they’re in a higher risk group. Every patient I talk to I ask 'what are your risks?' Community transmission? Do you have risk in your occupation? If so you might want to think about getting the vaccine. If you can be without risk you might want to defer getting the vaccine,” said Dr. Crimmins. “If you contract covid during pregnancy, while most people do really well, there’s a higher risk of hospitalization, intubation, preterm delivery as well as a heart and lung machine for those who become pregnant. So the risk versus benefit for some people, if they’re going to be exposed, is something to be considered.”
“What’s the guidance for women who have a high-risk pregnancy or history of preterm labor? Should they wait until 20 weeks or 3rd trimester?” Hopkins asked.
“So we know that you can’t have the vaccine within 2 weeks of other vaccinations. The whooping cough vaccine is recommended at 28 weeks. So we tell women to get the vaccine when given the opportunity because waiting may delay other vaccines recommended during pregnancy,” Dr. Crimmins explained.
“Based on what you know about vaccines and this mRNA technology, how would the unborn baby be affected, if at all?” Hopkins asked.
“We know in the body the mRNA vaccine doesn’t last very long. Because it breaks down so quickly in the body, the belief is it can’t cross the placenta and get to the baby. And if you’re lactating, the stomach acid, even if it got to the breastmilk, would digest the mRNA and have no impact on the baby. We do know there’s some hope that antibodies will cross over the placenta to help the baby. But there’s been no evidence of adverse effects to the unborn child after the vaccine.
Currently, the CDC and the Food and Drug Administration (FDA) have safety monitoring systems in place to capture information about vaccination during pregnancy and will closely monitor reports. Dr. Crimmins hopes we have much more information about pregnant women and covid vaccines at the end of the year.
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