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Some pregnant women remain unsure about getting the COVID-19 vaccine because safety data is scarce and health agency guidelines are vague and in some cases contradictory.
But Dr. Anthony Fauci, the nation’s leading infectious disease expert, said Monday that about 10,000 pregnant women in the U.S. have been vaccinated since the Food and Drug Administration authorized two vaccines, and so far there have been “no red flags.”
“We had a lot of pregnant women vaccinated. The FDA followed them and will continue to follow them,” he said during a media roundtable at the IAS COVID-19 Conference: Prevention. “Even though we don’t have good data on it, the data that we’re collecting on it so far has no red flags.”
Centers for Disease Control and Prevention guidelines say the decision to be vaccinated is up to the mother in consultation with her health care provider. Fauci said Monday the agency is sticking with that recommendation.
The American College of Obstetricians and Gynecologists (ACOG) said COVID-19 vaccines authorized by the U.S. Food and Drug Administration should be made available to pregnant women who choose to get the vaccine.
But the World Health Organization updated recommendations Friday that seem to contradict U.S. agencies and organizations. WHO guidelines say pregnant women may be vaccinated only if they're at high risk of exposure to the coronavirus, such as working in health care, or have underlying medical conditions that put them at risk for severe disease.
“We recognize that the conflicting recommendation from the World Health Organization could be unsettling for many pregnant individuals who are currently grappling with the decision about whether to get vaccinated,” said Dr. Christopher Zahn, ACOG’s vice president of practice activities.
Zahn noted that even in the absence of safety data, early evidence from animal studies have led experts to believe that there should be no harmful effects to the fetus or female reproduction.
Additionally, mRNA vaccines such as the ones made by Pfizer-BioNTech and Moderna do not contain live virus that could make a person sick. The mRNA, genetic code that instructs cells to make the so-called spiked protein triggering an immune response also doesn’t enter the nucleus and cannot cause any genetic changes.
“With that said, each person must make the best decision for themselves, in conjunction with their clinical care team when feasible, based on the information and data that is currently available,” Zahn said.
The reason there’s little safety data is because pregnant women were excluded from Pfizer-BioNTech and Moderna vaccine trials. But while data on the vaccine is scant, a handful of studies have shown the dangers of COVID-19 among pregnant women.
According to a CDC study published in November, pregnant women 35 to 44 years old with COVID-19 were nearly four times as likely to require invasive ventilation and twice as likely to die than were non-pregnant women of the same age.
A more recent study from the University of Utah Health also found that pregnant women who become severely or critically ill from COVID-19 are at a greater risk of dying and experiencing serious pregnancy complications compared to pregnant women who were asymptomatic or had mild symptoms.
Of the pregnant women who were critically ill, 50% of them required a Cesarean section, 50% of their babies went to the neonatal intensive care unit (NICU), 42% had a preterm birth at less than 37 weeks and 40% developed high blood pressure during pregnancy.
“This is another piece to that puzzle as women weigh whether they would like to have the vaccine in pregnancy despite really not having data,” said Dr. Torri Metz, lead author and a maternal-fetal medicine subspecialist and associate professor at the University of Utah Health.
The maternal death rate in the study was .3%, which is higher than the mortality rate for pregnant women without COVID-19, at 17.4 deaths per 100,000 live births, according to the latest data from the CDC.
The study examined medical records from 1,219 pregnant women from 33 hospitals in 14 states from March 1 to July 31, 2020. These limitations mean there’s no data on women in their first and second trimester, as most mothers were in their third trimester and would have had to give birth by July.
Women's health experts say pregnant women should have been included in vaccine trials from the beginning so they could make evidence-based decisions.
“The issue is that people try to protect pregnant women from research and ultimately that does not benefit pregnant people or their babies,” Metz said. “They really do need to be included in research from the start so that we have the information we need to counsel them.”
In a statement to USA TODAY, Pfizer said the company plans to begin a clinical study in the first half of 2021 in pregnant women. The New York Times reported that Moderna will establish a registry to observe side effects in pregnant women, similar to the CDC and FDA.
One might think pregnant women would be hesitant to sign up for clinical studies, Metz said, but some are eager to participate.
“I get numerous emails requesting opportunities in participation … they want to be a part of these studies that will give us information about the vaccine and pregnancy,” she said. “The most important thing we can advocate for is making that an option for patients from the beginning.”