Hospital workers are under an immense amount of stress this year. But help might be on the way soon as a federal advisory committee recommended Tuesday that they be first in line for vaccines.
But what if they are pregnant?
Like all pregnant women, health care workers will be operating without much data, as pregnant women have been excluded from clinical trials so far.
Pregnant women are commonly excluded from research, something that has frustrated Dr. Emily Miller for years. Miller is the assistant professor in the Division of Maternal-Fetal Medicine at Northwestern Medicine’s Feinberg School of Medicine, where she has been closely following the lack of data on pregnant women and new vaccines.
“As it turns out, pregnant women can be doctors and nurses and respiratory therapists,” she said. “This is putting our pregnant health care workers in a place where they haven’t been given a lot of concrete guidance because they’ve been systematically excluded.”
This essentially results in “clinical experimentation on pregnant women, as vaccines are distributed and administered without the safeguards of research in place,” according to a Society for Maternal-Fetal Medicine statement released Tuesday. Miller is a member of the task force.
The group recommended that health care workers be offered the vaccine if pregnant.
In general, for pregnant women, the Society for Maternal-Fetal Medicine recommended access to COVID-19 vaccines in all phases of future vaccine campaigns.
The statement noted that with mRNA vaccines, likely to be the first available and which induce an immune response, the theoretical risk of fetal harm is very low.
Miller acknowledged that people have “lingering questions” about COVID-19 and the new vaccines.
“It has to be balanced against the risk of not getting the vaccine, which is the risk of acquisition of (COVID-19), which has concrete and well-documented risks,” she said. “Through that lens, if we can remember that there is no zero-risk option, then the balance at this point favors receiving the vaccine.”
The society criticized the lack of available data and noted that if multiple vaccines become available, “some vaccines may be more suitable for pregnant women.”
As much as the limited data frustrates Miller, she emphasized that what is known is that if women are pregnant, or become pregnant, and contract COVID-19, they are at risk of getting very sick.
“That’s super worrisome,” she said.
Women considering becoming pregnant will similarly have no available information on pregnancy after getting the vaccine.
Dr. Ann Borders, an OB-GYN and executive director of the Illinois Perinatal Quality Collaborative, said she expects vaccination will be recommended for women considering pregnancy, as they are entering a high-risk category. Borders plans to bring up the topic on a call this Friday with the collaborative.
Lactating women also have been left out of clinical trials, even though, as the Society for Maternal-Fetal Medicine’s statement noted, “there is no biological plausibility for the exclusion of lactating women.”
Miller said this highlights that women deserve more information.
“We need to be shifting our mindset from this mantra of we need to protect pregnant women from participating in trials, and instead shift it to we need to protect pregnant women from being excluded from these trials,” she said.
Miller said she will be watching closely to see if the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices offers any pregnancy-specific guidance. She also expects that, out of the many people involved in trials, some will become pregnant after taking the vaccine.
Patients should discuss options with their OB-GYNs.
“There isn’t a simple answer to questions about whether pregnant people, or those considering pregnancy, should take the COVID-19 vaccine, especially since no vaccine is currently approved,” Christopher Zahn, the vice president of practice activities of the American College of Obstetricians and Gynecologists, said in a statement. “When the vaccines do become widely available, unfortunately, we have no data on the safety of the vaccine in pregnant and lactating individuals because they were excluded.”
Zahn said patients should consider any available data, patients’ individual risk factors and their “unique needs, desires and values.”
The CDC’s general guidelines for vaccinating pregnant women, which were last updated in 2016, notes that the benefits, in general, “usually outweigh potential risks when the likelihood of disease exposure is high.”
Already, OB-GYNs strongly encourage, for example, a flu vaccine, as pregnant women are similarly more prone to getting sicker from the flu, because of changes in the immune system, heart and lungs during pregnancy.
The Illinois Department of Public Health has long emphasized the importance of health care providers’ advice to pregnant women, noting that women who received a recommendation for a flu vaccine and an offer of vaccination were six times more likely to be vaccinated, compared with women who did not receive a recommendation or an offer of vaccination.
Miller hopes women feel empowered by discussing this issue with their provider.
“Getting COVID-19 in pregnancy is incredibly serious,” she said. “Let’s empower you to do everything, to use every tool in the toolbox to stay safe.”