Covid-19 vaccines leave pregnant women at a time

“What is my son’s risk if I have the vaccine? This blank space, that data-free zone for not knowing what the effects would be, is really troubling, “said Jennifer Lewey, a 40-year-old cardiologist at the University of Pennsylvania Hospital who will be out on March 21. .

The dilemma facing expectant mothers such as Dr. Lewey, who now decided to skip the vaccine and rely on masking and other precautions, reveals a loophole in the Covid-19 vaccine during the its rapid development: no tests were performed on pregnant women.

Pfizer Inc.,

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its partner BioNTech BNTX 0.87%

SE and Modern Inc.,

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the companies behind two Covid-19 vaccines authorized in the United States did not enroll pregnant women in the final phase trials to assess whether the shots work safely.

In the absence of data, U.S. Centers for Disease Control and Prevention, the American College of Obstetricians and Gynecologists, and the Society of Maternal-Fetal Medicine say pregnant women should make the decision on their own, encouraging conversations with doctors.

Citing insufficient data, the World Health Organization, for its part, has generally discouraged shooting during pregnancy, with the exception of high-risk people such as health workers or those with certain health problems. But on Friday, the WHO also said on its website that “we have no specific reason to believe that there will be specific risks that would outweigh the benefits of vaccination for pregnant women.”

Michal Elovitz, gynecologist-obstetrician and director of the University of Pennsylvania’s Maternal and Child Health Research Center, said he leaves the decision to his patients after discussing the potential benefits and risks.

Pregnant women are more likely to have a severe case of Covid-19 than women who are not pregnant and are more likely to need a premature birth if they contract the disease, Dr. Elovitz. The vaccine could help reduce the risks. Some vaccines against other infections have also been shown to be safe during pregnancy and offer protection to mother and child, she said.

Most experts say they do not anticipate any problems, depending on how mRNA vaccines work. However, scientists do not yet know if the mRNA vaccine can cross the placenta, and if they can, scientists do not know if it would harm the fetus, according to maternal and fetal health experts. This type of vaccine has never been used during pregnancy, they say. The Pfizer and Moderna vaccines use a gene-based technology called messenger RNA, which had never been eliminated until the time of the pandemic.

Uncertainty makes the decision to vaccinate very difficult, pregnant women say.

“It was a tough decision,” said Brenda Manning, 37, who is currently eligible to receive the vaccine in Dallas, where she lives.

Mrs. Manning has limited exposure to Covid-19 because she is a stay-at-home mom, whose husband works from home. However, her pregnancy and hypertension put her at a higher risk of suffering a severe case of Covid-19, if she succeeds.

After analyzing her options, Ms. Manning decided to enroll in the vaccine, although she has not been given a date for her first dose. He thinks he can make a final call if he gets an appointment before the Feb. 14 due date.

“If they call me first to do it [the baby] come on, I’ll make a decision during the game, “he said. “And if I don’t get a chance to get the vaccine sooner, there’s my answer.”

About 39% of pregnant women surveyed by the University of California, San Diego, and the pregnancy counseling group MotherToBaby said they would not get a vaccine against Covid-19 if they were available, while 25% said they would not get a vaccine during breastfeeding.

Thirteen percent said they would not get the vaccine independently, according to the survey, which began in October and continues.

Christina Chambers, a professor of pediatrics at the University of California, San Diego, who helps lead the survey as part of studies on how Covid-19 and vaccines affect pregnancy and breastfeeding, said women hesitate due to lack of information.

Dra. Chambers said she hopes more pregnant women will feel comfortable with the vaccines as deployment continues.

Ruth Faden, founder of the Johns Hopkins Berman Institute of Bioethics, which helps lead the PREVENT project, which advocates for the inclusion of pregnant women, explains that the delay in the safety of Covid-19 vaccines in pregnant women and fetuses is due to part to the delays in performing animal testing. in the development of vaccines during pandemics.

The U.S. Food and Drug Administration recommends animal studies before researchers test vaccines on pregnant women.

Modern says she did not find her vaccine had any adverse effects on reproduction or development during testing in rats. The company plans to establish a registry to monitor the operation of mothers who received the vaccine during pregnancy and their babies.

Pfizer says it has completed an animal study and sent the data to the FDA. The European Medicines Agency said animal studies found that the Pfizer vaccine had no harmful effects on reproduction or development. Pfizer says it will start a maternal vaccine study during the first half of 2021.

Pfizer and Moderna say they are tracking what happens to people who became pregnant after the vaccination, as well as to pregnant people who passed the pre-vaccination check during the trials.

The UK did not initially include women who were pregnant or would be pregnant at the December deployment of vaccines. Public Health England updated its guidelines in January, however, stating that vaccination could be particularly important for those who are highly exposed to the virus or have certain underlying high-risk health conditions. In these cases, women can choose if they want to get the vaccine after having an argument with their doctor or nurse, the agency said.

In January, the Israeli Ministry of Health updated its guidelines for recommending the vaccine to pregnant women, especially in those with pre-existing medical conditions and in those with high public exposure.

Write to Sarah Toy at [email protected] and Laura Cooper at [email protected]