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Some pregnant women are unsure of receiving the COVID-19 vaccine because safety data is scarce and guidelines from health agencies 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 United States have been vaccinated since the Food and Drug Administration authorized two vaccines, and so far, there was “no alarm signal”.
“We have vaccinated a lot of pregnant women. The FDA has been monitoring them and will continue to monitor them, ”he said during a media roundtable at the IAS COVID-19: Prevention Conference. “Even though we don’t have good data on this, the data we’re collecting on it so far doesn’t have a red flag.”
Guidelines from the Centers for Disease Control and Prevention say the decision to get the vaccine is up to the mother in consultation with her health care provider. Fauci said on Monday the agency was sticking to this recommendation.
The American College of Obstetricians and Gynecologists (ACOG) has said COVID-19 vaccines approved by the U.S. Food and Drug Administration should be made available to pregnant women who choose to be vaccinated.
But the World Health Organization on Friday updated recommendations that appear to contradict U.S. agencies and organizations. WHO guidelines say pregnant women can only be vaccinated if they are at high risk of exposure to the coronavirus, such as working in health care, or if they have underlying medical conditions that cause them. are at risk of serious illness.
“We recognize that the conflicting recommendation from the World Health Organization could be troubling for many pregnant women who are currently grappling with the decision to get vaccinated,” said Dr Christopher Zahn, vice president of practical activities. of ACOG.
Zahn noted that even in the absence of safety data, early evidence from animal studies has led experts to believe that there should be no harmful effects on the fetus or female reproduction.
In addition, mRNA vaccines such as those manufactured by Pfizer-BioNTech and Moderna do not contain live viruses that could make a person sick. MRNA, the genetic code that instructs cells to make the so-called doped protein that triggers an immune response, also does not enter the nucleus and cannot cause any genetic changes.
“That said, each person should make the best decision for themselves, working with their clinical care team when possible, based on the information and data currently available,” Zahn said.
The reason there is little safety data is that pregnant women have been excluded from the Pfizer-BioNTech and Moderna vaccine trials. But while vaccine data is scarce, a handful of studies have shown the dangers of COVID-19 in pregnant women.
Pregnant women aged 35 to 44 with COVID-19 were nearly four times more likely to require invasive ventilation and twice as likely to die as non-pregnant women of the same age, according to a CDC study released in November.
A more recent University of Utah Health study also found that pregnant women who become critically or seriously ill from COVID-19 are at greater risk of dying and experiencing serious pregnancy complications compared to pregnant women who are asymptomatic or have mild symptoms.
Among critically ill pregnant women, 50% had a caesarean section, 50% of their babies went to the neonatal intensive care unit (NICU), 42% had a premature birth within 37 weeks and 40% developed blood pressure during pregnancy.
“It’s another piece of this puzzle as women weigh whether they would like to receive the vaccine during pregnancy even though they really don’t have the data,” said Dr Torri Metz, lead author and sub-specialist. in Maternal and Fetal Medicine and Associate Professor at the University of Utah Health.
The maternal mortality rate in the study was 0.3%, which is higher than the death rate for pregnant women without COVID-19, at 17.4 deaths per 100,000 live births, according to the latest CDC data.
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The study looked at the medical records of 1,219 pregnant women from 33 hospitals in 14 states from March 1 to July 31, 2020. These limitations mean there is no data on women in their first and second trimesters. because most mothers were in their third trimester and would have had to give birth in July.
Women’s health experts say pregnant women should have been included in vaccine trials early on so they could make evidence-based decisions.
“The problem is, people are trying to protect pregnant women from research and ultimately it doesn’t benefit pregnant women and their babies,” Metz said. “They really need to be included in the research from the start so that we have the information we need to advise them.”
A spokesperson for Pfizer said the company will test its vaccine in pregnant women over the next several months, according to the New York Times. Moderna is also planning to establish a registry to observe side effects in pregnant women, similar to the CDC and the FDA.
You would think pregnant women would be hesitant to enroll in clinical studies, Metz said, but some are eager to participate.
“I receive many emails asking for opportunities to participate & mldr; they want to be part of those studies that will give us information about the vaccine and pregnancy, ”she said. “The most important thing we can advocate for is to make it an option for patients from the start.”
Follow Adrianna Rodriguez on Twitter: @AdriannaUSAT.
Patient health and safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial contributions.
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