To Vaccinate or Not Is Question for Pregnant Women Concerned About COVID-19

One of the most difficult questions pharmacists are having to field these days is whether the COVID-19 vaccine is safe and effective for pregnant women. The clinical trials leading to emergency use authorization for both the Pfizer-BioNTech and Moderna vaccines excluded pregnant and lactating women because of liability concerns. Find out how two experts suggest the question be answered, based on information about the use of other vaccines in pregnancy and the risk COVID-19 presents to pregnant women and their unborn children.

DALLAS – Pregnant women know that they are at increased risk of preterm birth or pregnancy loss if they develop a severe case of COVID-19 and desperately want guidance on whether they should be vaccinated.

The problem, according to a Viewpoint article in JAMA, is that pregnant and lactating women were excluded from clinical trials during the development of COVID-19 vaccines due to concerns over liability. In addition, professional organizations have been hesitant to offer guidance on the issue, leaving individual healthcare professionals to try to help pregnant patients reach a decision.

The authors of the viewpoint article --Emily H. Adhikari, MD and Catherine Y. Spong, MD, both of the University of Texas Southwestern Medical Center and Parkland Health and Hospital System in Dallas, suggest that the best way to decide is look at what is already known about other vaccines given during pregnancy.

To do that, Adhikari and Spong advise looking at the available safety and effectiveness data, basic science of mRNA vaccines, and long history of successful administering of other vaccines in pregnant women worldwide.

They point out the pertussis vaccine reduced whooping cough, a potentially fatal respiratory illness in infants, by 85% compared with waiting until after pregnancy. Influenza vaccination during pregnancy, meanwhile, reduced both mother and infant influenza illness by 20% and 30%, respectively.

"We still need granular data on safety in pregnancy and data that shows no adverse pregnancy outcomes," explained Adhikari, an assistant professor of obstetrics and gynecology at UT Southwestern.

"But without that data, we still have to care for our patients. It's not something where we can just wait," added Spong.

The article notes that both the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine have advocated for making COVID-19 vaccines available to pregnant and lactating women. On the other hand, the World Health Organization recommended recently against vaccinating pregnant women using the Moderna vaccine except in select circumstances, but three days softens its statement. It now supports offering the vaccine to pregnant women at high risk of exposure or with comorbidities in consultation with their health care provider.

"I am very supportive of any woman who decides to get the vaccine," Adhikari said. "I fully support that woman's choice. I understand if a woman decides she's not ready for the vaccine, but I also think it's an opportunity for education about vaccines in general."

Adhikari previously published a study of 3,374 pregnant women, including 252 who had contracted COVID-19 during pregnancy and 3,122 who tested negative. She and her colleagues found no increase in adverse pregnancy outcomes overall but did identify an increase in preterm births among the 5% of pregnant women who were hospitalized for COVID-19 respiratory illness.

The current article emphasizes that maternal respiratory illness can create major risks to a pregnancy. "Women who are pregnant, who have severe respiratory distress, who need significant oxygen support -- some intubated for months -- have most risk to the pregnancy," Spong stated.

The authors said they had found no evidence of significant harm from vaccination of pregnant women with the currently used products. "We are doing ongoing data collection to demonstrate what we anticipate but have not shown -- that this vaccine is safe in pregnant women, does not result in harm, and results in no difference in pregnancy outcomes," Adhikari advised. “It’s important for us to study that. That's going to help establish an evidence basis that will allow the public and clinicians to feel more comfortable with the vaccine."

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