As the Centers for Disease Control and Prevention expands its guidance for pregnant women surrounding the coronavirus vaccine, what should women who are pregnant or are planning to become pregnant know about getting vaccinated?
Chicago's top doctor addressed recent news saying data so far has not shown any "safety signals" for pregnant women and their unborn babies.
Here's the latest guidance surrounding pregnancy, fertility and the Pfizer and Moderna COVID-19 vaccines:
Is it Recommended That Pregnant Women Receive the COVID Vaccine?
New guidance from the Centers for Disease Control and Prevention indicates a recent study found "no obvious safety signals" surrounding vaccination in pregnant women.
The researchers looked at data from 35,691 women, who ranged in age from 16 to 54, in a peer-reviewed study published this week in The New England Journal of Medicine. Data used in the research was self-reported using the "v-safe after vaccination health checker," researchers noted.
"No safety concerns were observed for people vaccinated in the third trimester or safety concerns for their babies," CDC Director Dr. Rochelle Walensky said Friday. "As such, CDC recommends pregnant people receive COVID-19 vaccines."
She added that vaccination during pregnancy remains a very "deeply personal decision."
"There's a lot of ongoing studies related to this," Chicago Department of Public Health Commissioner Dr. Allison Arwady said. "I'm sure people may have additional questions and always I refer you to your OBGYN if you're pregnant and you have questions about the vaccine or your particular situation, but broadly really good news coming out in the scientific literature related to the COVID vaccine and pregnancy."
Previously, the Centers for Disease Control and Prevention, along with the Advisory Committee on Immunization Practices, said certain groups like health care personnel and other frontline essential workers should be offered vaccination during the first months of vaccine rollout.
"People who are pregnant and part of a group recommended to receive the COVID-19 vaccine may choose to be vaccinated," the agency stated. "If they have questions about getting vaccinated, a discussion with a healthcare provider might help them make an informed decision."
"Based on how mRNA vaccines work, experts believe they are unlikely to pose a specific risk for people who are pregnant," the CDC stated. "However, the actual risks of mRNA vaccines to the pregnant person and her fetus are unknown because these vaccines have not been studied in pregnant women."
The World Health Organization took a similar stance, saying "we don’t have any specific reason to believe there will be specific risks that would outweigh the benefits of vaccination for pregnant women."
The University of Chicago Medicine agreed with the CDC, saying pregnant women should be given the choice.
"This is an individualized decision and pregnant/breastfeeding people should be offered the choice to get vaccinated," the health system said. "While data is still being collected about these vaccines, we believe that in the vast majority of cases, the benefits outweigh the risks, and the vaccine is much safer than contracting COVID-19."
The American College of Obstetricians and Gynecologists recommends that COVID-19 vaccines "should not be withheld from pregnant individuals who meet criteria for vaccination based on ACIP-recommended priority groups."
"In the interest of patient autonomy, ACOG recommends that pregnant individuals be free to make their own decision regarding COVID-19 vaccination," the group states.
What Data is Available on the Vaccine in Pregnant Women?
The recent study findings cited by the CDC are some of the first surrounding the vaccine and pregnancy, though experts say more research is still needed.
According to the study, pregnant women reported more pain at their injection site than nonpregnant women, but they also reported fewer symptoms of headache, myalgia, chills and fever.
Of the 827 women who had a completed pregnancy following vaccination, 115 resulted in pregnancy loss, the study showed. Researchers said that while the numbers are "not directly comparable" they appear similar to pre-pandemic rates.
The findings are preliminary, looking at data from December 14 to Feb. 28, and researchers recommend "more longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes."
Pregnant women were excluded from trials for the vaccine.
"They did not see higher rates of miscarriage, they did not see higher rates of birth defects," Arwady said. "It's a relatively lower number of people, but really the news, very good there in terms of that this is what was assumed, but really bearing out in the data. Not seeing risks, at least in the studies to date, that link the receiving the COVID vaccine to any poor pregnancy outcome."
Previously, however, White House health advisor Dr. Anthony Fauci said there have been "no red flags" seen in more than 10,000 pregnant women who have received vaccine shots so far.
"The FDA, as part of the typical follow up you have following the initial issuing of any [emergency use authorization] have found, thus far, and we've got to be careful, but thus far, no red flags about that, about pregnant women," Fauci told The Journal of the American Medical Association in an interview.
The CDC said studies of the Pfizer-BioNTech vaccine are ongoing, and both the Pfizer and Moderna vaccine manufacturers "are monitoring people in the clinical trials who became pregnant."
"While safety data on the use of COVID-19 vaccines in pregnancy are not currently available, there are also no data to indicate that the vaccines should be contraindicated, and no safety signals were generated from DART studies for the Pfizer-BioNtech and Moderna COVID-19 vaccines," the American College of Obstetricians and Gynecologists states.
Arwady noted that some studies have also shown that antibodies could transfer to the fetus and offer some protection.
"On the plus side, there have been a couple of studies, just recently... there was one out earlier in April that found that actually when pregnant women or pregnant people were vaccinated, there was quite efficient transfer of the antibodies, the protection, to their fetuses," she said. "And so this is kind of how flu shots work. One of the reasons that flu shots are recommended for women when they are pregnant is because when the woman gets vaccinated against flu, she indirectly provides some protection for the baby and the baby can't get vaccinated in the first six months of life. And so the preliminary information really looks good, that when women are getting vaccinated and they are pregnant. The babies are not only not having a negative outcome but that they are getting some protection from COVID."
What Should Pregnant Women Consider Before Getting the Vaccine?
The CDC recommends expectant women consider the following, and address it with their doctors, as they prepare to make their decision:
- The likelihood of exposure to SARS-CoV-2, the virus that causes COVID-19
- Risks of COVID-19 to them and potential risks to their fetuses
- What is known about the vaccine: how well it works to develop protection in the body, known side effects of the vaccine, and lack of data during pregnancy
Are Pregnant Women at a Higher-Risk for COVID-19 Infections?
The CDC noted that pregnant people who contract COVID-19 "have an increased risk of severe illness," including the risk of an infection that could lead to ICU admission, mechanical ventilation, and possibly death. Pregnant people with COVID-19 could also face an increased risk of adverse pregnancy outcomes, such as preterm birth, the agency added.
According to preliminary findings of a study from the National Institutes of Health, pregnant women who experienced severe symptoms of COVID-19 had a higher risk of complications during and after pregnancy.
"Compared to nonpregnant women who have the same health and age, a COVID-infected woman is about 1.3 to 1.4 times more likely to end up in the hospital when she's pregnant," Dr. Regan Theiler, a Mayo Clinic obstetrician, said in a statement.
On the other hand, the University of Chicago Medicine reports that for some people vaccinated late in their pregnancy, "it is likely that the antibodies your body produces in response to the vaccine will be passed to the fetus through the placenta and may provide some protection against COVID-19, the same way a flu vaccine can help protect your baby against the flu."
What About Vaccine Side Effects?
Pregnant women are not expected to experience more severe side effects from the vaccine, experts said.
In fact, the latest study found that pregnant women reported more pain at their injection site than nonpregnant women, but they also reported fewer symptoms of headache, myalgia, chills and fever.
According to the study, injection-site pain, fatigue, headache, and myalgia were the most frequent reactions reported after either dose for both vaccines and were reported more frequently after the second dose.
Temperatures at or above 38°C were reported by less than 1% of the participants one day after the first dose and by 8% after the second dose for both vaccines.
According to the CDC, some people who receive the vaccine could experience a fever, particularly after their second dose.
"Pregnant people who experience fever following vaccination may be counseled to take acetaminophen because fever has been associated with adverse pregnancy outcomes," the CDC stated. "Acetaminophen may be offered as an option for pregnant women experiencing other post-vaccination symptoms as well."
Pregnant people should also talk to their doctors if they have a history of allergic reactions to any other vaccines or injectable therapy.
What About Women Who Are Breastfeeding?
The CDC reported there is currently "no data on the safety of COVID-19 vaccines in lactating women or on the effects of mRNA vaccines on the breastfed infant or on milk production/excretion."
"mRNA vaccines are not thought to be a risk to the breastfeeding infant," the agency states. "People who are breastfeeding and are part of a group recommended to receive a COVID-19 vaccine, such as healthcare personnel, may choose to be vaccinated."
According to the American College of Obstetricians and Gynecologists, "theoretical concerns regarding the safety of vaccinating lactating individuals do not outweigh the potential benefits of receiving the vaccine."
The University of Chicago Medicine said that experts "do not believe that breastfeeding will provide any antibody protection to the baby."
"However, we do not yet have any data on this point and it should be clarified in future studies," the health care group noted.
Does the COVID Vaccine Affect Fertility?
Chicago's top doctor said this week that there were no indications so far that the COVID vaccines could impact fertility.
Some people who menstruate are reporting changes to their periods after getting vaccinated, but Chicago Department of Public Health Commissioner Dr. Allison Arwady said there have been no signs of any long-lasting symptoms.
"I have not seen anything, to be very clear, that suggests that there is any concerning side effects in the way that would last. I know and there's a local researcher who is looking at some of this related menstruation, but very clear there's not been any link to, you know, problems with fertility, you know, anything that's long-lasting but, you know, the goal of getting a vaccine is for your immune system to learn how to protect yourself against COVID and your immune system can interact, can interface with your, you know, your hormonal levels, etc. and so there is at least some biological plausibility that you could have, you know, some change in terms of a heavier period or a lighter period for example right after getting the vaccination," Arwady said.
COVID-19 mRNA vaccines are not thought to cause an increased risk of infertility, according to ACOG.
The CDC those trying to become pregnant now or who want to get pregnant in the future can receive a COVID-19 vaccine when one is available to them.
"There is currently no evidence that any vaccines, including COVID-19 vaccines, cause fertility problems," the CDC states. "CDC does not recommend routine pregnancy testing before COVID-19 vaccination. If you are trying to become pregnant, you do not need to avoid pregnancy after receiving a COVID-19 vaccine. Like all vaccines, scientists are studying COVID-19 vaccines carefully for side effects now and will report findings as they become available."
If You Plan on Getting Pregnant Should You Delay Getting the Vaccine?
Experts continue to advise discussing vaccination plans with health care providers for those who are or expect to become pregnant.
"Current recommendations say there is no reason to delay conception," the University of Chicago Medicine reports. "If you become pregnant after receiving your first dose of the COVID-19 vaccine, you should not delay getting the second booster dose as scheduled."
The group notes that the second dose is more likely to carry side effects, including a possible fever, however, which is experienced by 10-15% of vaccine recipients.
"If this is a concern, the current recommendation is that you take a pregnancy-safe fever reducer such as Tylenol if you experience a fever after getting vaccinated," the health group recommends. "You may also wish to take Tylenol proactively before getting vaccinated to help prevent a fever."
The American College of Obstetricians and Gynecologists recommends "individuals who are actively trying to become pregnant or are contemplating pregnancy and meet the criteria for vaccination based on ACIP prioritization recommendations" do receive the vaccine. The group also says it is "not necessary to delay pregnancy after completing both doses of the COVID-19 vaccine" and those who become pregnant after receiving the first dose should continue on with their second.
In addition, those undergoing fertility treatments should continue their treatments as well as discuss their vaccination plan with their doctors, medical experts said.
"Speak with your physician and/or fertility specialists to make the decision that is best for you," University of Chicago Medicine recommends.
For a complete look at where and how you can make an appointment in Illinois or where you can receive vaccine information for your area, click here.