Moderna launches clinical trial to test whether its COVID-19 vaccine leads to miscarriages or stillbirths in pregnant women or birth defects in newborns, despite thousands of expectant mothers getting the shot
- Moderna will soon conduct trials to determine if their vaccine is safe for pregnant women
- The CDC does not recommend getting vaccinated for or against pregnant women
- Pregnant women are more likely to suffer negative consequences from COVID-19
- Other studies are underway to determine how effective the COVID-19 vaccines are for pregnant women
Moderna Inc will soon begin testing its COVID-19 vaccine on pregnant women.
The Cambridge, Massachusetts-based company announced the trial Monday and is expected to begin July 22.
Scientists will observe the possible side effects that the vaccine will have on the pregnant women, the infants and whether the vaccine can cause complications during pregnancy.
Pregnant women remain in a small group of people for whom the vaccine has not been fully verified to be safe.
Although pregnant women in the US are eligible for COVID-19 vaccines, they are not professionally advised to use it or not as there is little data on the effects of vaccines on pregnant women.
Earlier this year, the World Health Organization advised pregnant women not to get the vaccine, before withdrawing that advice later.
Moderna is currently conducting trials to see how their vaccines affect pregnant women and their children after birth na
The CDC recommends that pregnant women decide individually with their doctors whether to get vaccinated. The NIH is conducting studies to see if they develop the same level of antibodies as the average population
According to the US National Library of MedicineModerna has not yet started recruiting for the study.
They plan to enroll 1,000 women aged 18 or older who are currently pregnant.
The women must all have received a dose of the Moderna COVID vaccine in the 28 days before their last pre-pregnancy period.
Moderna is looking for trends of pregnancy complications or negative pregnancy outcomes — such as miscarriage or stillbirth — in the women who received their vaccine.
The company will also monitor the babies born to the women in the study for a year to find possible birth defects or features such as a low birth rate for 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 that they should make the decision on an individual basis after talking to their doctor.
The agency reports that more than 130,000 pregnant women have received at least one shot of a COVID-19 vaccine, and 9,000 the Modernas.
Studies conducted with the vaccine on pregnant animals found no negative results, according to the CDC.
The agency also doesn’t have a solid recommendation for breastfeeding women, though an April study found that antibodies from the vaccine can pass through breast milk.
The National Institute of Health (NIH) has also begun a study of women who have received the vaccine to see if they develop normal levels of antibodies.
The NIH notes in their announcement of the study that pregnant women are more likely to experience negative consequences, including death, from the virus.
Some Research also shows that women who get COVID during pregnancy are more likely to have a premature birth or delivery by cesarean section.
People who have other conditions that make them more vulnerable to the virus, such as cancer, develop lower antibody levels from the vaccine than others, according to other research.
The Moderna injections are the second most widely used vaccine in the United States and have been distributed 135 million times.