As the COVID-19 vaccine starts rolling out across the country, pregnant or breastfeeding women may be wondering if they should get it too.

First, the unknowns: Because clinical trials didn't include pregnant patients, there is no conclusive evidence related to vaccine safety and efficacy during pregnancy.

What experts do know: Pregnant patients are at higher risk of severe disease and worse outcomes from COVID-19 than non-pregnant peers and therefore would benefit from protection from the virus.

"We have been following the research and federal guidance closely about pregnancy and the COVID-19 vaccine," says Molly Stout, M.D., MSCI, maternal fetal medicine director at Michigan Medicine Von Voigtlander Women's Hospital.

"Based on the current information available and known risks of COVID-19 severity in pregnancy, we strongly recommend that pregnant and nursing people have access to the vaccine. We advise patients to discuss potential benefits and unknown risks specific to their individual situation with their healthcare provider."

Stout responds to some of the top questions about the COVID-19 vaccine and pregnancy:

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Have the COVID-19 vaccines been studied in pregnancy? 

Stout: No, the vaccines have not been studied in pregnancy specifically. A few unexpected pregnancies occurred during the vaccine trials in participants, but we don't have further data on those cases at this time. There are ongoing efforts to include pregnant women in current COVID-19 vaccine trials.

Is the vaccine safe during pregnancy?

Stout: Because pregnant women were not included in the early studies, we cannot be certain of how well the vaccine will work in pregnancy. The vaccine appears to be 95% effective in reducing COVID-19 disease in non-pregnant individuals. We also do not have specific safety information in pregnancy. However, the consensus of scientists, doctors, and professional organizations in the U.S. is to support pregnant women receiving the vaccine because the health risks of COVID-19 in pregnancy can be severe.

This recommendation is based on the known risk of COVID-19 in pregnancy and the biology of mRNA vaccines – which are made with a string of the virus' genetic material (a "message" of RNA that generates protein) and not the virus itself.

The technology of mRNA vaccines has been available for a long time and in general the risks from this form of vaccine are low. Also, the safety profile of the vaccine from the randomized control trials in non-pregnant individuals suggested no significant safety concerns.

What are possible side effects to the vaccine and could these be harmful to a pregnant patient or fetus?

Stout: It's important to understand that there is no way to get COVID-19 from the vaccine. While some vaccines are called "live" because they contain the virus, the COVID-19 vaccine is not one of them. However, when your immune system is doing its job reacting to the vaccine, you may experience some flu-like symptoms.

Eighty-four percent of people in the studies experienced redness or soreness at the site of the injection, over half felt fatigue and a headache, 1/3 had muscle pain and chills and 15-20% had joint pain or a fever.

Scientists think these symptoms are related to the vaccine activating your immune system to make the cells and proteins against COVID-19. There haven't been any dangerous safety events that occurred more commonly in people who got the vaccine.  

Should I get the vaccine if I am breastfeeding?

Stout: Vaccination is recommended for nursing mothers because benefits of the vaccine outweigh the theoretical risks regarding the safety of vaccinating.

Vaccine trials excluded lactating individuals, so we don't have any clinical data on the safety of the vaccine during lactation. However, because of the biology of the vaccine, (which doesn't involve a live virus) there should be no transfer into breastmilk.

In fact, antibodies from the lactating mother that transfer into the breastmilk may actually protect the breastfeeding child. The Academy of Breastfeeding Medicine does not recommend stopping breastfeeding for people who get the COVID-19 vaccine.

Can the vaccine impact fertility?

Stout: We have seen some misinformation about this topic. It is too early to know whether the vaccine has any impact on fertility, but we don't suspect it does.

The mRNA vaccines do not incorporate into the genetic material of the individual. The mRNA is the code or message to make a protein that helps the body react more quickly if exposed to COVID-19. Thus, there is no genetic reason an egg or a sperm would be affected by the vaccine.

Should women take a pregnancy test before getting the vaccine?

A pregnancy test prior to vaccination isn't recommended or required.

Should pregnant healthcare workers/first responders get the vaccine in the earlier distribution phase if it's available to them? 

Stout: Because of their higher risk of exposure, certain groups have been prioritized for initial vaccine distribution, including healthcare workers, first responders and workers in long-term healthcare facilities.

The general guidance is that pregnant patients who are in these frontline categories should be able to receive the vaccine as soon as they meet the criteria and it's available to them.

If a pregnant woman uses an epi-pen for allergies, is the vaccination schedule – 21 days in between shots for Pfizer – still the same?

Stout: Right now there haven't been any recommendations to change dosing or schedules for the COVID-19 vaccine for people with allergies who experience anaphylaxis.

What are the risks of COVID-19 to pregnant patients?

Stout: Recent studies have suggested that pregnant people who contract COVID-19 have a higher risk of severe illness and outcomes, such as being admitted to intensive care, being put on a ventilator and dying than non-pregnant women with the virus. These risks are higher for women of color, including African-American and Hispanic populations.

Adverse pregnancy outcomes such as preterm birth for COVID-positive patients have also been reported, but data in this area are still evolving.

Given these risks, pregnant patients should consider getting vaccinated against the virus and also take all other precautions to protect themselves from exposure by socially distancing, wearing masks and following safety guidelines.

Can pregnant women infect the fetus with COVID-19?

Stout: Studies are limited in this area as well. There have been cases of newborns testing positive for COVID-19 shortly after birth. What's unclear is whether they were infected with the virus before, during, or after birth from close contact with someone who had the virus.

Most newborns who tested positive for COVID-19 had mild or no symptoms.

Even if the vaccination protects pregnant women, can they still carry the virus and expose others?

Stout: The vaccine has been shown to decrease your chance of having COVID-19 symptoms and severe disease. What is unknown is whether vaccinated people can still carry and transmit the virus. For this reason, the recommendation is to continue to wear masks, socially distance and maintain other recommended safety measures even for people who have been vaccinated.

Will pregnant women's outcomes be tracked as vaccinations continue?

Stout: There have been efforts to collect outcomes data on pregnant women who have received the vaccine and our hope is that vaccine manufacturers report this information as it becomes available.

Development of the COVID-19 vaccine is a major scientific feat and marks the fastest vaccine development and distribution to date. Doctors and scientists agree COVID-19 vaccines will be a critical measure in slowing the spread and mortality associated with COVID-19. The downside of this remarkable scientific success is we have to be able to continue to collect longer term data as we follow pregnant and non-pregnant patients forward in time and continue to track vaccine success.

Is there anything else pregnant patients should know about the vaccine?

Stout: Based on what we know about how COVID-19 may negatively impact a pregnant patient's health, we see great benefits to patients being protected from the virus through all measures available, including the vaccine.

We expect recommendations to continue to evolve as more data are collected about these vaccines and their use in specific populations, including pregnant patients. We will be following this evolving data closely and keeping all obstetric care providers at Michigan up to date.

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