Covid-19 vaccines leave pregnant women in dire straits

“What is the risk to my child if I get the vaccine? This empty space, this area with no data of not knowing what the effects would be, is really worrying, ”said Jennifer Lewey, 40-year-old cardiologist at the University of Pennsylvania Hospital, scheduled for March 21.

The dilemma facing pregnant women like Dr Lewey, who has decided not to get the vaccine for now and rely on masking and other precautions, highlights a gap in vaccine verification Covid-19 during their hasty development: they have not been tested in pregnant women.

Pfizer Inc.,

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its partner BioNTech BNTX -0.63%

SE and Moderna Inc.,

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the companies behind two Covid-19 vaccines authorized in the United States, have not recruited pregnant women in late-stage trials assessing whether the vaccines work safely.

In the absence of hard data, the US Centers for Disease Control and Prevention, the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine say pregnant women should make the decision for themselves, by encouraging conversations with physicians.

Citing insufficient data, the World Health Organization, meanwhile, has generally advised against vaccines during pregnancy except for high-risk people like healthcare 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 any specific risks that outweigh the benefits of vaccination for pregnant women.”

Michal Elovitz, obstetrician-gynecologist and director of the University of Pennsylvania’s Maternal and Child Health Research Center, said she leaves the choice to her 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, said Dr Elovitz. The vaccine could help reduce the risks. In addition, some vaccines against other infections have been shown to be safe during pregnancy and provide protection for both mother and child, she said.

Most experts say they don’t anticipate any problems, depending on how mRNA vaccines work. Yet scientists are still unsure whether the mRNA vaccine can cross the placenta, and if it can, scientists are unsure whether it would harm the fetus, maternal and fetal health experts say. This type of vaccine has never been used during pregnancy, they say. The Pfizer and Moderna vaccines use a genetic technology called messenger RNA, which had never been authorized before the pandemic.

The uncertainty makes the choice to vaccinate very difficult, say pregnant women.

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

Ms Manning has limited exposure to Covid-19 because she is a stay-at-home mom whose husband works from home. Yet her pregnancy and high blood pressure put her at a higher risk of having a severe case of Covid-19, if she does.

After weighing her options, Ms Manning decided to sign up for the vaccine, although she did not have a date for her first dose. She thinks she can make one last call if she gets a date before the scheduled date of February 14.

“If I am called to do it before [the baby] comes, I’ll make a decision in match time, ”she said. “And if I don’t have a chance to get the vaccine before that, here’s my answer.”

Some 39% of pregnant women surveyed by the University of California at San Diego and the maternal counseling group MotherToBaby said they would not receive the Covid-19 vaccine if it became available, while 25% said that they would not receive a vaccine while breastfeeding.

Thirteen percent said they would not get the vaccine regardless, according to the survey, which began in October and is continuing.

Christina Chambers, professor of pediatrics at the University of California at San Diego, who is helping to lead the investigation as part of studies on how Covid-19 and vaccines affect pregnancy and breastfeeding, said said the women were reluctant because of the lack. of information.

Dr Chambers said she expects more pregnant women to feel comfortable with vaccinations as the rollout continues.

The delay in establishing the safety of Covid-19 vaccines in pregnant women and fetuses partly stems from delays in performing animal testing, said Ruth Faden, founder of the Johns Hopkins Berman Institute of Bioethics which helps leading the PREVENT project, which advocates the inclusion of pregnant women. in vaccine development during pandemics.

The United States Food and Drug Administration recommends animal studies before researchers test vaccines in pregnant women.

Moderna says he has not found his vaccine to have any adverse reproductive or developmental effects when tested in rats. The company plans to create a registry to track the progress of pregnant mothers and their infants.

Pfizer says it has completed an animal study and submitted the data to the FDA. The European Medicines Agency said animal studies showed Pfizer’s vaccine had no harmful effects on reproduction or development. Pfizer has announced that it will launch a maternal vaccine study in the first half of 2021.

Pfizer and Moderna say they are tracking what happens to those who have become pregnant after vaccination, as well as to all pregnant women who have escaped pre-vaccination screening during trials.

The UK did not initially include women who are pregnant or about to become pregnant in its vaccine rollout in December. However, Public Health England updated its guidelines in January, saying vaccination could be especially important for people at high risk for the virus or with certain underlying high-risk health conditions. In these cases, women may choose to be vaccinated after having had a discussion with their doctor or nurse, the agency said.

In January, Israel’s health ministry updated its guidelines for recommending the vaccine to pregnant women, especially those with pre-existing health conditions and those with high public exposure.

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