AMARILLO, Texas (KFDA) - Pregnant women are now being included in clinical trials for the COVID-19 vaccine.
Although pregnant women are usually excluded from these trials, there was a push for them to be allowed early on in the vaccine development.
Now, Pfizer will enroll 4,000 healthy expectant mothers who are 18 years or older and are 24 to 34 weeks into their pregnancy. They also cannot have already had COVID-19.
The study is designed to check if the vaccine is as effective, as durable, and if it protects the mother for as long as it does the rest of the population.
They will also assess the safety for the mother and the infants, and see if there is a transfer of protective antibodies from the mother to the child.
“We want to get moms protected, we want to understand if there is any specialized concern because of pregnancy and guide on that,” said Stephen Loosli, executive director at Boeson Research and Origin Health.
Clinical trials involving pregnant women are under high scrutiny and must first go through an independent review board.
In this case, Pfizer says they also completed a developmental study on animals which showed no evidence of fertility or reproductive problems.
Half of the women in the trial will receive the vaccine and the other half will receive a placebo.
The trial is expected to last about seven to ten months, at the end of which those with the placebo will be able to get the real vaccine.
“None of these moms want to be COVID positive at delivery. Their fear is that. They want to do it as soon as they feel safe to do it so, to not have that added concern in their life,” said Lossli.
George Barnett, is an OB/GYN at Texas Tech University Health Sciences Center and points out that the data for this study will probably not be out until after pregnant women who are considering the vaccine right now give birth.
However, says it is important to study this population to try to prove safety due to the increase risk pregnant woman face to contracting COVID-19 due to a weaker immune system.
“So you just have to make sure that you inform the patients and discuss the unknown a little bit and discuss the risk of COVID as well and let them decide what is best for them,” says Barnett “It is kind of the risk benefit of do you get the shot not knowing for sure in pregnancy versus running your chances of getting COVID.”
Data from this clinical trial is not expected for another six months. Health officials administering the trial will continue to monitor the infants until about six months after they are born.