Some pregnant women remain unsure about how to receive the COVID-19 vaccine because safety data is scarce and health agency guidelines are poor. vague and in some cases contradictory.
But Dr. Anthony Fauci, the nation’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 have been “none.” warning sign “.
“We have had many pregnant women vaccinated. The FDA has followed them and will continue to follow them, ”he said during a roundtable discussion for the media at the IAS COVID-19: Prevention Conference. “Even if we don’t have good data about it, the data we are collecting about it so far does not show any warning signs.”
The guidelines of the Center for Disease Control and Prevention say that the decision to be vaccinated depends on the mother, in consultation with her doctor. Fauci said on Monday that the agency is joining this recommendation.
The American College of Obstetricians and Gynecologists (ACOG) said that COVID-19 vaccines authorized 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 updated the recommendations on Friday that appear to contradict American agencies and organizations. WHO guidelines say that pregnant women can be vaccinated only if they are at high risk of exposure to coronavirus, such as working in the healthcare field, or if they have underlying medical conditions that put them at risk for serious illness.
“We recognize that the conflicting recommendation from the World Health Organization can be disturbing to many pregnant women who are currently struggling with the decision to get vaccinated,” said Dr. Christopher Zahn, vice president for practical activities at ACOG.
Zahn noted that, even in the absence of safety data, the first evidence from animal studies led experts to believe that 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 live viruses that could make a person sick. The mRNA, a genetic code that instructs cells to produce the so-called spiked protein that triggers an immune response, also does not enter the nucleus and cannot cause any genetic changes.
“With that said, each person must make the best decision for themselves, together with their clinical care team, when feasible, based on the information and data that are currently available,” said Zahn.
The reason that there is little safety data is because pregnant women were excluded from the Pfizer-BioNTech and Moderna vaccine trials. But while data on the vaccine is scarce, some studies have shown the dangers of COVID-19 among pregnant women.
According to a CDC study published in November, pregnant women aged 35 to 44 with COVID-19 were almost four times more likely to need invasive ventilation and twice as likely to die than non-pregnant women of the same age.
A more recent study from the University of Utah Health also found that pregnant women who become seriously or critically ill because of COVID-19 are at a higher risk of dying and suffering serious pregnancy complications compared to pregnant women who were asymptomatic or had mild symptoms. .
Of the seriously ill pregnant women, 50% of them needed a cesarean section, 50% of their babies went to the neonatal intensive care unit (NICU), 42% had a premature birth less than 37 weeks and 40% developed high blood pressure during pregnancy.
“This is another piece of the puzzle, as women assess whether they would like to receive the vaccine during pregnancy, despite having no data at all,” said Dr. Torri Metz, lead author, subspecialist in maternal-fetal medicine and a professor associate at the University of Utah Health.
The maternal mortality rate in the study was 0.3%, which is higher than the mortality rate for pregnant women without COVID-19, of 17.4 deaths per 100,000 live births, according to the most recent 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 are no data on women in the first and second trimesters, as most mothers were in the third. quarter and would have had to give birth in July.
Women’s health experts say pregnant women should have been included in vaccine testing from the start, so that they could make evidence-based decisions.
“The problem is that people try to protect pregnant women from research and, ultimately, it doesn’t benefit pregnant women or their babies,” said Metz. “They really need to be included in the research from the start so that we have the information we need to advise them.”
A Pfizer spokesman said the company will test its vaccine on pregnant women in the coming months, according to The New York Times. Moderna also plans to establish a registry to observe side effects in pregnant women, similar to the CDC and FDA.
One might think that pregnant women would hesitate to enroll in clinical studies, said Metz, but some are eager to participate.
“I get several emails asking for 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 advocate is to make this an option for patients from the start.”
Follow Adrianna Rodriguez on Twitter: @AdriannaUSAT.
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