Some pregnant women remain unsure about getting the COVID-19 vaccine because safety data is scarce and health authority guidelines are vague and in some cases contradictory.
But Dr. Anthony Fauci, the country’s leading infectious disease specialist, said on Monday that about 10,000 pregnant women in the US have been vaccinated since the Food and Drug Administration approved two vaccines, and so far there are “no red flags.”
“We have vaccinated many pregnant women. The FDA has followed them and will continue to follow them, ”he said during a round table on the media at the IAS COVID-19 conference: Prevention. “Even though we don’t have good data on it, the data we collect so far on it doesn’t have any red flags.”
Centers for Disease Control and Prevention guidelines say the decision to be vaccinated to the mother is in consultation with her health care provider. Fauci said on Monday that the agency is holding that recommendation.
The American College of Obstetricians and Gynecologists (ACOG) said COVID-19 vaccines approved by the U.S. Food and Drug Administration should be made available to pregnant women who choose to receive the vaccine.
But the World Health Organization on Friday updated recommendations that appear to contradict US agencies and organizations. According to WHO guidelines, pregnant women should only be vaccinated if they are at high risk of exposure to the coronavirus, such as working in healthcare, or if they have underlying medical conditions that put them at risk of serious illness.
“We recognize that the conflicting recommendation from the World Health Organization could be troubling to many pregnant individuals who are currently grappling with the decision whether or not to get vaccinated,” said Dr. Christopher Zahn, ACOG’s vice president of practice operations.
Zahn noted that even in the absence of safety data, early evidence from animal studies has led experts to believe there should be no harmful effects on the fetus or female reproduction.
In addition, mRNA vaccines, such as those made by Pfizer-BioNTech and Moderna, do not contain a live virus that can make someone sick. The mRNA, the genetic code that instructs cells to make the so-called enriched protein that triggers an immune response, also does not penetrate the nucleus and cannot cause genetic changes.
That said, each person should make the best decision for themselves, in collaboration with their clinical care team if possible, based on the information and data currently available, Zahn said.
The reason there is little safety data is because pregnant women were excluded from Pfizer-BioNTech and Moderna vaccine studies. But while data on the vaccine is sparse, 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 receive invasive ventilation and twice as likely to die than non-pregnant women of the same age.
A more recent University of Utah Health study also found that pregnant women who become severely or critically ill from COVID-19 are at greater risk of dying and experiencing severe pregnancy complications compared to pregnant women who were asymptomatic or had mild symptoms.
Of the pregnant women who were critically ill, 50% required a caesarean 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 of that puzzle, as women are weighing whether to have the vaccine during pregnancy, despite really having no data,” says Dr. Torri Metz, lead author and a maternal-fetal medicine subspecialist and associate professor at Utah Health.
The maternal death rate in the study was 0.3%, which is higher than the death rate for pregnant women without COVID-19, with 17.4 deaths per 100,000 live births, according to the latest data from the CDC.
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The study examined medical records of 1,219 pregnant women from 33 hospitals in 14 states from March 1 to July 31, 2020. These limitations mean that there is no data on women in their first and second trimester, as most mothers were in their third trimester and had to give birth in July.
Women’s health experts say that pregnant women should have been involved in vaccine trials from the outset so that they could make fact-based decisions.
“The problem is that people are trying to protect pregnant women from research and that is ultimately not good for pregnant people or their babies,” Metz said. “They really need to be involved in the research from the outset so that we have the information we need to guide them.”
A Pfizer spokesman said the company will test its vaccine in pregnant women in the coming months, according to The New York Times. Moderna also plans to set up a registry to observe side effects in pregnant women, similar to the CDC and FDA.
You might think pregnant women are hesitant to sign up for clinical trials, Metz said, but some would like to participate.
“I get numerous emails asking about opportunities to participate … they want to be part of these studies that will give us information about the vaccine and pregnancy,” she said. “The most important thing we can argue for is to make that an option for patients from the start.”
Follow Adrianna Rodriguez on Twitter: @AdriannaUSAT.
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