Covid-19 vaccines leave pregnant women in a dilemma

“What is the risk for my child if I get the vaccine? This blank space, this data-free zone of not knowing what the effects would be, is really worrying, ”said Jennifer Lewey, a 40-year-old cardiologist at the University of Pennsylvania Hospital, scheduled for March 21.

The dilemma faced by pregnant women like Dr. Lewey, who decided to skip vaccination for now and rely on masking and other precautions, highlights a gap in the verification of Covid-19 vaccines during their rushed development: they have not been tested on pregnant women.

Pfizer Inc.,

PFE 0.03%

your partner BioNTech BNTX -1.67%

SE and Modern Inc.,

MRNA -9.11%

the companies responsible for two Covid-19 vaccines authorized in the United States have not enrolled pregnant women in the final stage tests to assess whether the vaccines work safely.

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

Citing insufficient data, the World Health Organization, for its part, generally advises against vaccines during pregnancy, except for high-risk individuals, such as health professionals or those with certain health problems. But on Friday, 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, an 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 have a greater chance of needing a premature birth if they contract the disease, said Elovitz. The vaccine can help to reduce the risks. In addition, some vaccines for other infections have been shown to be safe in pregnancy and offer protection to the mother and child, she said.

Most experts say they do not anticipate any problems, based on how mRNA vaccines work. Still, scientists still do not know whether the mRNA vaccine can cross the placenta, and if it does, scientists do not know whether it would harm an unborn baby, say maternal and fetal health experts. This type of vaccine has never been used in pregnancy, they say. The Pfizer and Moderna vaccines use a gene-based technology called messenger RNA, which had never been released for use until the pandemic.

Uncertainty makes the choice of vaccination very challenging, say the pregnant women.

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

Mrs. Manning has limited exposure to Covid-19 because she is a housewife whose husband works at home. However, her pregnancy and hypertension put her at greater risk of having a severe case of Covid-19 if she contracts.

After weighing her options, Ms. Manning decided to apply for the vaccine, although she did not give a date for her first dose. She imagines that she can make a final call if she gets an appointment before February 14th.

“If I am asked to do this before [the baby] come, I will make a decision at the time of the game ”, she said. “And if I don’t have the opportunity to get the vaccine before that, here’s my answer.”

The way doctors deal with the issue may vary, depending on pregnant women. Many said their doctors advised them on the risks and benefits, before leaving the decision to them. Other women said their doctors encouraged vaccination after these talks.

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

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

Christina Chambers, a professor of pediatrics at the University of California, San Diego, who is helping to conduct the research as part of studies examining how Covid-19 and vaccines affect pregnancy and breastfeeding, said women are hesitant because of lack of information.

Dr. Chambers said she expects more pregnant women to be comfortable with vaccines as implantation continues.

The delay in establishing the safety of Covid-19 vaccines in pregnant women and fetuses is partly due to the delay in animal testing, said Ruth Faden, founder of the Johns Hopkins Berman Institute of Bioethics who helps lead the PREVENIR project, which she advocates the inclusion of pregnant women in vaccine development during pandemics.

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

Moderna says it did not find out that its vaccine had adverse effects on reproduction or development during tests on mice. The company plans to establish a registry to monitor how mothers who had the vaccine during pregnancy and their babies fared.

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

Pfizer and Moderna say they are tracking what happens to those who became pregnant after vaccination, as well as any pregnant women who went through pre-vaccination screening during testing.

The UK did not initially include women who were pregnant or about to become pregnant in its vaccine launch in December. Public Health England updated its guidance in January, however, saying that vaccination may be particularly important for those who are highly exposed to the virus or have certain underlying high-risk health conditions. In such cases, women can choose whether to get the vaccine after talking to their doctor or nurse, the agency said.

In January, the Israeli Ministry of Health updated its guidance to recommend the vaccine to pregnant women, especially those with pre-existing medical conditions and those who have a lot of public exposure.

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