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Moderna’s decision to launch a study of its COVID-19 vaccine in pregnant women should reassure the public and help build confidence in the safety of the jab, experts said.
The trial, which has yet to begin recruiting, aims to enroll approximately 1,000 women over the age of 18 who will be studied over a 21-month period, according to a post on ClinicalTrials.gov.
The Centers for Disease Control and Prevention (CDC) say pregnant women can receive a COVID-19 vaccine, but clinical trials specifically studying vaccines among this population were not included when the Food and Drug Administration granted it. authorization for emergency use of one of the vaccines. .
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More data regarding this population will be welcomed by the medical community, experts told Fox News.
“I think more data is always useful when it comes to reassuring patients,” wrote Dr. Linda Eckert, professor of obstetrics and gynecology at the University of Washington, in an email, adding later: “I feel confident in the vaccines we have, but I welcome more data. I firmly believe and know that the risk of COVID infections during pregnancy is significant, so I tell people who have chosen to be vaccinated as 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 with the CDC Advisory Committee on Immunization Practices (ACIP) and co-authored the ACOG Practice Advisory on COVID-19 Vaccination. in pregnant and breastfeeding people.
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An “official” trial with observational data usually offers several advantages, such as strong, comprehensive data and strict, standardized definitions of results that allow for quality comparisons, Eckert said. Some outcome measures in Moderna’s study include the number of participants who have infants with suspected major and minor birth defects and the number of participants with pregnancy complications, but these measures are “completely standard for any drug or vaccine given. to pregnant women, “Eckert stressed.
“There has been no indication of an increased risk with any of these results so far,” she wrote. “It should actually reassure a pregnant person that we are continuing to collect data. It is a sign that everyone is serious about vaccine safety.”
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Dr. Oluwatosin Goje, OB / GYN and infectious disease specialist at the Cleveland Clinic, said current data suggests the Moderna vaccine is safe for pregnant women. Goje also recommends that pregnant women get vaccinated, noting that the risks of COVID-19 infection during pregnancy outweigh 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 have been vaccinated or their babies,” and areas of continued research include data to be released. longer term for pregnant women vaccinated at the start of their pregnancy, or soon after. before becoming pregnant, with several months of follow-up of the infant.
Alexandria Hein of Fox News contributed to this article.
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