I’m pregnant. Should I get the COVID-19 vaccine?

The information here is about the Pfizer and Moderna COVID-19 vaccines. These are also called “mRNA” vaccines.

For most people, getting the COVID-19 vaccine as soon as possible is the safest choice. However, trials testing the vaccine in pregnant and breastfeeding individuals have not been completed.

This information will help you to make an informed choice about whether to get the COVID-19 vaccine while you are pregnant, trying to get pregnant, or breastfeeding.

What are the benefits of getting an mRNA COVID-19 vaccine?

1. COVID-19 is dangerous. It is more dangerous for pregnant women.
   • COVID patients who are pregnant are 5 times more likely to end up in the intensive care unit (ICU) or on a ventilator than COVID patients who are not pregnant. ¹
   • Preterm birth may be more common for pregnant women with severe COVID. ²
   • Pregnant women are more likely to die of COVID than non-pregnant women with COVID who are the same age. ^3,4
2. The mRNA COVID-19 vaccines prevent about 95% of COVID.
   • As COVID infections go up in our communities, your risk of getting COVID goes up too.
   • Getting a vaccine will prevent you from getting COVID and may help to keep you from giving COVID to people around you, like your family.
3. The mRNA COVID-19 vaccines cannot give you COVID.
   • These vaccines have no live virus. ⁵
   • These vaccines do NOT contain ingredients that are known to be harmful to pregnant individuals or to the fetus.
   • Many vaccines are routinely given in pregnancy and are safe (for example: tetanus, diphtheria, and flu).

What are the risks of getting an mRNA COVID-19 vaccine?

1. These vaccines have not yet been tested in pregnant women.
   • These vaccines were tested in over 40,000 people and there were no serious side effects related to the vaccine.
   • We do not know if the vaccines work as well in pregnant people as well as they did in non-pregnant women.
   • We do not know whether there are unique downsides in pregnancy, like different side effects or an increased risk of miscarriage or fetal abnormalities.
   • The Moderna vaccine was tested in female rats to look at its effects on pregnancy. No significant negative effects were found on female fertility or fetal development.
   • Some people became pregnant during the vaccine studies. Eighteen of these individuals were in the vaccine group and two months later none had miscarried. There were seventeen individuals in the placebo group who became pregnant and two months later two of them had miscarriages. (In general, 10-20% of pregnancies end in miscarriage).
   • Because these studies are still ongoing we don’t know how the rest of the pregnancies went.
2. People getting the vaccine will probably have some side effects.
3. Many people had symptoms caused by their immune system’s normal response to the vaccine. The most common side effects were: ⁶

• Injection site reactions like a sore arm (~84%)
• Fatigue (~62%)
• Headache (~55%)
• Muscle pain (~38%)
• Chills (~32%)
• Joint pain (~24%)
• Fever (~14%)
• About 1% (1 out of 100) people who get the vaccine will get a high fever (over 102⁰F). A persistent high fever before 7 weeks in pregnancy might increase the risk of fetal abnormalities or miscarriage. The CDC recommends using Tylenol^® (acetaminophen) during pregnancy if you have a high fever. Another option is to delay your COVID vaccine until after 6 weeks of pregnancy.

What do experts recommend?

Because COVID is dangerous and easily spread, the CDC says that the mRNA vaccines for COVID-19 are recommended for adults. ⁷

However, because there are no studies of pregnant individuals yet, there are no clear recommendations for those who are pregnant. This is standard for a new drug and is not due to any particular concern with this vaccine.

The Society for Maternal-Fetal Medicine strongly recommends that pregnant individuals have access to COVID vaccines. They recommend that each person talk to their doctor or midwife about their own personal choice. ⁸

The American College of Obstetricians and Gynecologists recommends that the COVID vaccine should not be withheld from pregnant individuals. ⁹

What else should I think about to help me decide?

1. Make sure you understand as much as you can about COVID and about the vaccine. Ask a trusted source, like your doctor or midwife.
2. Think about your own personal risk. Read below and think about your:
   • risk of getting COVID
   • ability to stay safe from COVID

The risks of getting sick with COVID are higher if you:

• have contact with people outside of your home
• are 35 years or older
• are overweight
• have other medical problems like diabetes, high blood pressure, or heart disease
• are a smoker
• are a racial or ethnic minority or your community has a high rate of COVID infections
• are a healthcare worker ¹⁰

If you are at higher risk of getting COVID, it probably makes sense to get the vaccine.

If you are not at higher risk for COVID and…

• You are always able to wear a mask.
• You and the people you live with can socially distance from others for your whole pregnancy.
• Your community does not have high or increasing COVID cases.
• You think the vaccine itself will make you very nervous (you are more worried about the unknown risks of the vaccine than about getting COVID).
• You have a severe allergic reaction to a vaccine.

…it might make sense for you to wait for more information.

What about breastfeeding?

The Society for Maternal-Fetal Medicine and the Academy of Breastfeeding Medicine report that there is no reason to believe that the vaccines affects the safety of breastmilk. ^{8, 11} The vaccine does not contain the virus so there is no risk of infecting your baby. Because mRNA is fragile, it is very unlikely that any part of the vaccine gets into breastmilk.

When we have an infection or get a vaccine, our bodies make antibodies to fight the infection. Antibodies can pass into the breastmilk and then to the baby and may help prevent infections.

What do pregnant doctors think?

We know COVID can be terrible in pregnancy and we know the vaccine doesn’t contain live virus. I’m approaching my third trimester and I work on the front lines of this disease so for me the choice is clear. I intend to be the first in line as soon as they will let me have one.
– Pregnant Emergency Department Doctor

I am a little nervous about getting something that hasn’t been tested in pregnant patients. Early pregnancy is a nerve-wracking time even without the unknown of a new vaccine. So, I went over the risks and benefits of getting or not getting it as a front-line worker with myself, my partner, and my doctors. We ended up deciding I should get the vaccine.
– Pregnant Emergency Department Doctor

I’m 34 weeks and I’m going to try to get vaccinated after delivery, but during pregnancy, I’m holding out. Pregnant women were excluded from the studies and in the meantime I don’t see COVID patients at work so I feel like my exposure will be low during the second wave.
– Pregnant Physician

I am still breastfeeding my baby and I think the risk of exposing my infant and other children and partner to COVID is far greater than the theoretical risks this novel vaccine may have. I’ve decided to get vaccinated whenever it becomes available.
– Breastfeeding OB/GYN Doctor

More information about mRNA COVID-19 vaccines

How do mRNA COVID-19 vaccines work?

• The Pfizer and Moderna COVID-19 vaccines are mRNA vaccines (messenger RNA).
• mRNA is not new; our bodies are full of it. mRNA vaccines have been studied for the past two decades.
• mRNA vaccines mimic how viruses work. The mRNA is like a recipe card that goes into your body and makes on recipe for a brief time. The recipe is for a small part of the virus (the spike protein).
• When this spike protein is released from cells, the body recognizes it as foreign and the immune system responds. This immune response causes the side effect symptoms (like aches and fever) but leads to improved immunity.
• mRNA breaks down quickly so it only last a brief time.
• This is also how other viruses like a cold work – viruses use our body and cells to make their proteins then our immune system attacks those proteins to keep us healthy.
• There is no way for the vaccine to give people COVID-19. ⁵

What did the research show?

The Pfizer and Moderna mRNA vaccine trials each had over 30,000 people (including those who got a placebo) and showed that the vaccine lowers a person’s chance of getting COVID-19 and severe COVID-19. In each study over 15,000 people got the vaccine and over 15,000 people got a saline injection (placebo).

• After one dose the vaccine appears to be 50% effective. After two doses, both vaccines are about 95% effective.
• In other words, for every 100 people who got COVID-19 in the placebo group only 5 got COVID-19 in the mRNA vaccine group.
• Cases of severe COVID were also reduced in both mRNA vaccine groups.
• There were no serious safety concerns.

Summary

1. COVID-19 seems to cause more harm to pregnant people than in people of the same age who are not pregnant.
2. The risks of getting an mRNA COVID-19 vaccine during pregnancy are thought to be small but are not totally known.
3. You should consider your own personal risk of getting COVID. If your personal risk is high, or there are many cases of COVID in your community, it probably makes sense for you to get the vaccine while pregnant.
4. Whether to get a COVID-19 vaccine during pregnancy is your choice.

You have two options:

1. Get the COVID-19 vaccine as soon as it is available
2. Wait for more information about the vaccine in pregnancy

Tell the CDC about your experience with the vaccine

If you decide to get the vaccine you will get a “V-safe Information Sheet” with instructions about the V-safe website and app. Consider registering so we can better counsel those who are pregnant or breastfeeding in the future.

References

¹ DeBolt CA, et al. Pregnant women with severe or critical COVID-19 have increased composite morbidity compared to non-pregnant matched controls. Am J Obstet 2020 Nov doi: 10.1016/j.ajog.2020.11.022

² Adhikari EH, et al. Pregnancy outcomes among women with and without severe acute respiratory syndrome coronavirus 2 infection. JAMA Network Open 2020 Nov 3(11):e2029256

³ DiMascio D, WAPM working group on COVID-19. Maternal and Perinatal Outcomes of Pregnancy Women with SARScoV- 2 infection. Ultrasound Obstet Gynecol. 2020 Sept. doi: 10.1002/uog.23107.

⁴ Centers for Disease Control and Prevention. Update: Characteristics of Symptomatic Women of Reproductive Age with Laboratory-Confirmed SARS-CoV-2 Infection by Pregnancy Status — United States, January 22–October 3, 2020. November 2020:1-7.

⁵ Abbasi J. COVID-19 and mRNA Vaccines—First Large Test for a New Approach. JAMA. 2020;324(12):1125–1127. doi:10.1001/jama.2020.16866

⁶ https://www.fda.gov/media/144245/download

⁷ https://www.cdc.gov/vaccines/acip/recs/grade/covid-19-pfizer-biontech-etr.html (Accessed Dec14, 2020)

⁸ SMFM statement on COVID vaccination in pregnancy

⁹ https://www.acog.org/en/clinical/clinical-guidance/practice-advisory/articles/2020/12/vaccinating-Pregnant-and- Lactating-Patients-Against-COVID-19 (Accessed December 14, 2020)

¹⁰ Mutambudzi M, Niedwiedz C, Macdonald EB, et al. Occupation and risk of severe COVID-19: prospective cohort study of 120 075 UK Biobank participants. Occupational and Environmental Medicine Published Online First: 09 December 2020. doi: 10.1136/oemed-2020-106731

¹¹ https://abm.memberclicks.net/abm-statement-considerations-for-covid-19-vaccination-in-lactation