Moderna launches clinical trial testing whether its COVID-19 vaccine leads to miscarriages or stillbirths in pregnant women or birth defects in newborns despite thousands of mothers-to-be receiving the shot
- Moderna will soon conduct trials to determine whether their vaccine is safe for pregnant women
- The CDC does not recommend for or against pregnant women getting vaccinated
- Pregnant women are more likely to suffer from negative outcomes from COVID-19
- Other studies are being conducted to determine how effective the COVID-19 vaccines are for pregnant women
The Cambridge, Massachusetts-based company announced the trial on Monday, and it expected to begin on July 22.
Scientists will observe the potential side effects the vaccine will have on the pregnant women, the infants, and whether the vaccine could cause complications in pregnancy.
Pregnant women remain in a small group of people who the vaccine has not been fully verified to be safe for.
While pregnant women are eligible for COVID-19 vaccines in the U.S., they are not professionally recommended to take it or not, as there is little data on the vaccines effects on pregnant women.
Earlier this year, the World Health Organization recommended against pregnant women getting the vaccine, before later walking back that advice.
Moderna is currently conducting trials to see how their vaccines effect pregnant women, and their children after birth
The CDC does recommends that pregnant women decide individually with their doctor whether to get vaccinated. The NIH is conducting studies as to whether they develop the same level of antibodies as the average population
According to the U.S. National Library of Medicine, Moderna has not yet began to recruit for the study.
They plan to enroll 1,000 women aged 18 or older who are currently pregnant.
The women all must have received a dose of the Moderna COVID vaccine within the 28 days before their last menstrual period before pregnancy.
Moderna is looking to find trends of pregnancy complications or negative pregnancy outcomes -such as a miscarriage or a stillbirth – among the women who received their vaccine.
The company will also monitor the infants born from the women in the study for one year to find any potential congenital malfunctions, or traits like low birth rate on any other diseases at a young age.
The Centers for Disease Control and Prevention (CDC) says that pregnant women can protect themselves from COVID-19 by getting vaccinated, but they should make the decision on an individual basis after conversations with their doctor.
The agency reports that over 130,000 pregnant women have received at least one shot of a COVID-19 vaccine, with 9,000 having received the Moderna’s.
Studies conducted using the vaccine on pregnant animals found no negative outcomes, per the CDC.
The agency also does not have a solid recommendation for women that are breastfeeding, though a study from April found that antibodies from the vaccine could pass through breastmilk.
The National Institute of Health (NIH) has also begun a study on women who have received the vaccine to see if they are developing normal levels of antibodies.
The NIH notes in their announcement of the study that pregnant women are more likely to suffer negative outcomes, including death, from the virus.
Some research also shows that women who contract COVID while pregnant are more likely to require a premature birth or a C-section delivery.
People who have other conditions that may leave them more vulnerable to the virus, like cancer, develop lower antibody levels from the vaccine than others do, according to other research.
The Moderna shots are the second most common vaccine used in the United States, having been distributed 135 million times.