Pregnant women were not included in the COVID vaccine study, how do you decide to inject?

As a doctor, Faye is eligible for the COVID vaccine and is usually vaccinated without hesitation to protect the patient.

But there are wrinkles: Faye herself has been pregnant for about 6 months. And there is little data on the potential effects of vaccines during pregnancy.

This is because pregnant people were not included in the vaccine’s clinical trials. At the beginning of the trial, if you were pregnant, you were disconnected.

Katie Schubert, chairman and chief executive officer of the Women’s Health Research Association, said that historically, clinical trials included only men.

Even as pharmaceutical companies began to include more women in their studies, they excluded pregnant women for fear of what the drug would do to the developing foetation.

This is also due to what happened in the 1960s when a drug called thalidomide was widely prescribed for morning sickness.

“It caused malformations in the baby-shortening or lack of limbs,” Schubert said. “It’s pretty scary when you think about the use of drugs that you think are probably safe, but it turns out that it’s not.”

According to Schubert, pharmaceutical companies are worried that the same thing will happen again, so they generally exclude pregnant women when researching new drugs, treatments and vaccines.

Over the years, pharmaceutical companies have also been responsible, the complexity of including pregnant people in their studies, and the potential for deploying new drugs or vaccines if someone in a clinical trial has bad pregnancy results. We have expressed concern about the damage caused by the pregnancy. There is no evidence that the bad results came from the drug.

But Schubert said researchers have learned a lot about how to assess drug safety since the 1960s. Before Start a clinical trial.

Therefore, she advocates including more pregnant people in her study.

“It can be risky, but I think it really has to be taken into account automatically when thinking about a global health pandemic,” she said.

National Institute of Health Task force Over the past few years, we have come up with recommendations on specific ways to include pregnant people in more studies.

Dr. Diana Bianchi was responsible for the task force. She says it is inconsistent to say, “It is not safe for pregnant women to participate in the study, but it is safe to give.” [the COVID vaccine] To them. “

Dr. Linda Eckert, a professor of obstetrics and gynecology at the University of Washington, said: “Once again, we’ll leave the decision burden to pregnant women and their donors. She’s also on the Commission of the Centers for Disease Control and Prevention, which made the policy decision to provide pregnant women in the United States with the Pfizer and Modana vaccines. I am joining.

In Washington, the vaccine line actually goes up when you’re pregnant. Women who are pregnant and have at least one other underlying illness will soon be in line. Pregnant women without other underlying illnesses are in Phase 2.

“We need to weigh the risk of getting a COVID and getting a COVID and getting a vaccine that needs better data,” Eckert said.

The researchers tested both the Moderna and Pfizer vaccines in pregnant rats with no adverse effects.

Eckert said there was no theoretical reason to believe that the COVID vaccine available in the United States could harm a developing foetation.

They do not have a live virus, so they cannot infect the foetation. Also, the mRNA contained in the vaccine cannot be part of the recipient’s DNA and cannot be transferred to the foetation.

Faye, a maternal / fetal doctor, looked at all of them and decided that “the risk of COVID-19 during pregnancy was far worse than the potential risk of the vaccine.” Did.

Faye received her first vaccination on December 24th.

“Before, I was very excited, and a few minutes before I actually received it, I was a little nervous,” she said. “There was a lot of excitement in the room.”

Fay registered in the UW database of pregnant women who received the COVID vaccine. The goal is to track the results and, in the future, provide a little more information when pregnant people make decisions.