The trial, which has not yet begun recruiting, is aiming to enroll about 1,000 females over 18 who will be studied over a 21-month period, according to a posting on ClinicalTrials.gov.
The Centers for Disease Control and Prevention (CDC) states that pregnant women can get a COVID-19 vaccine, but clinical trials specifically studying the jabs among this population were not included when the Food and Drug Administration granted any of the vaccines’ emergency use authorization.
More data involving this population will be welcomed by the medical community, experts tell Fox News.
“I do think that more data is always helpful when it comes to offering reassurance to patients,” Dr. Linda Eckert, professor in obstetrics and gynecology at the University of Washington, wrote in an email, later adding, “I do feel confident in the vaccines we have available but welcome more data. I strongly believe and know that the risk of COVID infections in pregnancy are significant, and so I tell individuals who chose to be vaccinated that it seems like a wise decision for the protection of their own health and the health of their pregnancy.”
Eckert also serves as the American College of Gynecology (ACOG) liaison to the CDC’s Advisory Committee on Immunization Practices (ACIP), and co-authored ACOG’s Practice Advisory on COVID-19 vaccination in pregnant and lactating individuals.
An “official” trial with observational data typically affords several advantages, like robust and complete data and strict, standardized definitions for outcomes allowing for quality comparisons, Eckert said. Some outcome measurements in Moderna’s study include the number of participants who have infants with suspected major and minor congenital malformations and the number of participants with any pregnancy complications, but these measurements are “completely standard for any medication or vaccine given to pregnant women,” Eckert stresses.
“There has not been any indication of increased risk with any of these outcomes thus far,” she wrote. “It actually should reassure a pregnant individual that we are continuing to collect data. It is a sign of just how seriously everyone feels about safety of vaccines.”
Dr. Oluwatosin Goje, OB/GYN and infectious disease specialist at Cleveland Clinic, said current data suggests the Moderna vaccine is safe for pregnant women. Goje also recommends pregnant women get vaccinated, noting the risks of COVID-19 infection during pregnancy exceed potential concerns about the vaccine.
Preliminary data collected from the CDC and FDA safety monitoring systems “did not identify any safety concerns for pregnant people who were vaccinated or their babies,” and areas of continued research include longer-term data for pregnant women vaccinated early in their pregnancies, or shortly before becoming pregnant, with months-long follow-up of the infant.
Fox News’ Alexandria Hein contributed to this article.