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Why There's Little Data on COVID-19 Vaccination and Pregnancy

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COVID-19 vaccines, like many drugs, weren't tested on pregnant people. Pregnant health care workers are still stepping up for their shots.

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CLEVELAND, Ohio - Readers have medical questions about COVID-19 and the coronavirus vaccine, and we're getting answers from health care experts.
Q: I would like an expert to address the concern that a lot of women have regarding the possibility of infertility as a result of getting the vaccine. I've heard of many women, specifically in health care, refusing the vaccine because of this concern.
The American Society for Reproductive Medicine, along with other medical associations and the Mayo Clinic, advise that the COVID-19 vaccine does not cause infertility or harm pregnant women.

The idea that COVID-19 vaccines will bind to placental proteins and prevent pregnancy is being spread by an online disinformation campaign, according to the Mayo Clinic.

"During natural infection, the immune system generates the same antibodies to the spike protein that COVID-19 vaccines would. Thus, if COVID-19 affected fertility, there already would be an increase in miscarriage rates in women infected with COVID-19. This has not happened," states a Mayo Clinic article that debunks COVID-19 myths.

Women who contracted COVID-19 while pregnant did not have an increased rate of miscarriage.

There are no indications that the mRNA platform used in the Pfizer and Moderna vaccines lead to infertility, said Dr. Oluwatosin Goje, an OB/GYN and infectious disease specialist at the Cleveland Clinic.

While the initial vaccine trials did not specifically include pregnant or lactating women, during the course of the studies some women became pregnant, Goje said. Those women remained in the COVID-19 vaccine trials and were studied. No safety concerns were raised.

However, the Centers for Disease Control and Prevention advisory committee urged pregnant women to consult with their doctors before getting the vaccine.

The World Health Organization advised that pregnant women not receive the vaccine, unless they were at high risk for COVID-19 because of work exposures or chronic conditions. It issued guidance on the Moderna vaccine recently, to go along with similar guidance on the Pfizer-BioNTech vaccine.

Other medical associations are advising physicians and patients that the vaccine is safe for pregnant women and does not cause infertility.

"There is no data to suggest that vaccination impacts future fertility," Dr. Hugh Taylor, president of the American Society for Reproductive Medicine, said in a statement. "Because the approved COVID-19 vaccines do not use a live virus, they are not thought to cause an increased risk of infertility, first- or second-trimester loss, stillbirth, or congenital abnormalities."

The American Society for Reproductive Medicine COVID-19 Task Force does not recommend withholding the vaccine from patients planning to become pregnant, are currently pregnant or breastfeeding. The task force encourages those undergoing fertility treatments to get the shots when they are eligible.

A number of women's health organizations recently joined a statement urging female health care workers to get the COVID-19 vaccine. The American College of Nurse-Midwives, the Society of OB/GYN Hospitals and the American College of Obstetricians and Gynecologistswere among the signatories.

Many health care workers who are pregnant or lactating have received the vaccine and have registered for a COVID-19 vaccine registry so that scientists can better understand the impacts of COVID-19 vaccination on pregnancy, the statement said.

The Centers for Disease Control and Prevention is tracking vaccine side effects through a smartphone app called V-Safe. Anyone who gets the COVID-19 vaccine can register at no cost for health check-ins and to report side effects.

Pregnant and lactating women should be offered the vaccine, and discuss the decision with their physician, the Society for Maternal-Fetal Medicine said in a December statement.

The decision should be based onavailable data on vaccine safety, risks to pregnant women from COVID-19 infection, and a patient's risk for infection and severe disease, the Maternal-Fetal Medicinestatement said.

"Health care professionals should also counsel their patients that the theoretical risk of fetal harm from mRNA vaccines is very low," the Maternal-Fetal Medicine statement said.

Do you have questions about the COVID-19 pandemic that you'd like an expert to answer? Send it in a brief email to cleveland.com reporter Julie Washington at jwashington@cleveland.com.
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Does the coronavirus vaccine cause infertility or harm pregnant women?

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The American Society for Reproductive Medicine, along with other medical associations and the Mayo Clinic, advise that the COVID-19 vaccine does not cause infertility or harm pregnant women.The idea that COVID-19 vaccines will bind to placental proteins and prevent pregnancy is being spread by an online disinformation campaign, according to the Mayo Clinic.

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SAN FRANCISCO, Calif. (KRON) - As the rollout of the COVID-19 vaccine continues across California, expecting mothers are expressing mixed feelings about getting the shot when their turn comes up despite the CDC and healthcare providers recommending that taking the vaccine is the safest route while pregnant.

Adding to the confusion, an initial decision by the world health organization this week recommencing pregnant woman not take the Moderna vaccine - now reversed after criticism.

A midwife says her clients are expressing mixed feelings about the shot but the CDC and doctors say it is the safest route for pregnant women, women who are lactating or breastfeeding and also for women who are thinking about getting pregnant.

"We're not only worried about the mother, we're also worried about the fetus as well," Dr. Warner Huh said.

Dr. Warner Huh heads the Department of Obstetrics at University of Alabama Hospital in Birmingham, a leading hospital for women's health.

He says many healthcare providers are recommencing pregnant or lactating women take the COVID-19 vaccine.

His pregnant patients recovered quickly from COVID but some became severely ill.

"They have difficulty breathing, oxygenating, and we have to be worried about the downstream consequences not only on the mother, but also on the fetus or the baby," Dr. Warner Huh said.

Earlier this week, the World Health Organization recommended pregnant women not take the Moderna vaccine unless they're a healthcare worker or have a preexisting condition.

While the CDC and most professional medical societies contend it is the safest route while pregnant and that any potential risks associated with taking the vaccine are minimal compared to catching the virus while pregnant.

On Friday, the WHO reversed its stance after criticism. The guidelines now closely aligns with the CDC.

Expecting mothers are urged to seek guidance from your healthcare providers.

Dr. huh added there's still more to learn.

"There's a lot we know about the vaccine, but there's a lot we don't know about the vaccine, but this is a once in a lifetime pandemic," he said. "We have seen nationally and internationally, pregnant women die as a consequence of COVID-19. You know it's our job to be able to provide what we think is the best prevention strategy for pregnant women."

While healthcare providers are not worried about pregnant women taking the vaccine, they are worried about when it will become available to them. At the moment, expectant mothers are not listed as a top priority in the state's COVID-19 vaccination plan.

Pfizer released the following statement confirming they will begin a clinical study in the first half of 2021 for pregnant women.
Pfizer recognizes that developing a potential SARS-CoV-2 vaccine for broad use is critically important to help stop the pandemic, including for potential use in pregnant women. Pfizer is following guidance provided by the Food and Drug Administration (FDA) for the development and licensure of vaccines to help prevent COVID-19, including the important consideration of use in pregnant and women of childbearing potential. As outlined by the FDA, the agency recommends that industry sponsors first conduct developmental and reproductive toxicity (DART) studies with their respective COVID-19 vaccine candidate, prior to enrolling pregnant women and women of childbearing potential who are not actively avoiding pregnancy in clinical trials. The developmental and reproductive toxicity (DART) study for BNT162b2 is complete and the final report (issued on Dec. 22, 2020) was shared with the FDA, which is the standard procedure.

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Pregnant women debate taking COVID-19 vaccine

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As the rollout of the COVID-19 vaccine continues across California, expecting mothers are expressing mixed feelings about getting the shot when their turn comes up despite the cdc and healthcare providers recommending that taking the vaccine is the safest route while pregnant.