Are COVID-19 Vaccines Safe For Pregnant Women?

There are currently two mRNA COVID-19 vaccines that were granted FDA emergency use authorization. The Johnson & Johnson (J&J)/Janssen COVID-19 vaccine before or during pregnancy found no safety concerns as well. While pregnant and breastfeeding women were not part of vaccine clinical trials, many experts believe vaccines are safe for these groups and outweigh the risks of getting sick from COVID-19. In some states, pregnant women may be eligible for vaccination due to the increased risk of COVID-19 complications.

We interviewed the following experts in women’s health to provide insights on safety data regarding the COVID-19 vaccine and pregnancy: 

Felice Gersh, M.D. is an award-winning OB/GYN specializing in all aspects of women’s health, and founder/director of the Integrative Medical Group of Irvine, in Irvine, CA. Her practice provides comprehensive healthcare for women, combining the best evidence-based therapies from conventional, naturopathic, and holistic medicine.

Lorrie Harris-Sagaribay, MPH, is the Program Coordinator and an information specialist at MotherToBaby North Carolina. She provides exposure counseling in English and Spanish by phone, email, and online chat. Lorrie serves as a member of the Emerging Issues Task Force, which currently focuses on responding to the COVID-19 pandemic. 

Kirstie Perrotta, MPH, is an information specialist at MotherToBaby California, where she provides counseling by phone and chat. Kirstie serves as a member of the Emerging Issues Task Force, which currently focuses on responding to the COVID-19 pandemic.

COVID-19 Vaccines For Pregnant and Lactating Women

Below we have experts answer various questions regarding the COVID-19 vaccines and their effect on pregnant women.

Do you believe that Pfizer and Moderna’s mRNA COVID-19 vaccines are safe for pregnant women?

According to Dr. Gersh, “although there is nothing definitive on this topic, and pregnant women were not in the vaccine trials, I believe the mRNA vaccines are safe in pregnancy.

The mRNA vaccines contain no viruses and cannot enter the cell nucleus to alter the DNA. They rely on the immune system to generate pieces of the spike protein to which the immune system creates antibodies. 

mRNA vaccines are quite brilliant discoveries. Vaccines should be made available to pregnant women, but as no published studies yet exist, they should never feel pressured to getting vaccinated, and it is a personal decision.”

In addition, the MotherToBaby team explains that “although this is the first time this technology has been made available in vaccines, the science behind mRNA vaccines is not new. Researchers have been studying mRNA vaccines for decades.

How to decide if I should get the COVID-19 vaccine while pregnant?

“People who are pregnant and offered the COVID-19 vaccine can discuss the risks and benefits with their healthcare provider,” explains the MotherToBaby Team.

“They can consider their level of risk for coming into contact with the virus, including the current spread of COVID-19 in their community, whether their job or other activities increase their chance of exposure, and how well they can continue to practice preventative measures such as social distancing.

It is also important to consider the possible risks associated with having COVID-19 during pregnancy, and how getting the vaccine may help reduce these risks.”

Do you believe that Pfizer and Moderna’s mRNA COVID-19 vaccines are safe for breastfeeding women?

According to Dr. Gersh, there is no current data on COVID-19 vaccinations and breastfeeding women. She explains that “although no published data exists, there is no mechanism known with the mRNA vaccines to expect them to harm the baby via breast milk. Still, there is no data on this, and that must be discussed.”

In addition, MotherToBaby Team explains that “based on what is known about the way the vaccines work, experts do not believe that the components of the vaccine would enter the breast milk or pose a risk to a breastfeeding infant. Studies have shown that other kinds of vaccines that are routinely given in the United States are not harmful during breastfeeding. (Only smallpox and yellow fever vaccines, which are not routinely given in the U.S., are not recommended for most people while breastfeeding.)”

Will there be more data on how mRNA vaccines may affect pregnant women soon?

The MotherToBaby Team says more information on mRNA vaccines and pregnant women will be coming soon; “Like all new vaccines and medications, it takes time to collect and analyze enough data to be able to assess safety in pregnancy. However, efforts are currently underway to learn more.”

Have any pregnant women in the U.S. or other countries had complications from the COVID-19 vaccines?

Both Dr. Gersh and the MotherToBaby Team have not heard of any serious complications during pregnancy caused by the COVID-19 vaccine. MotherToBaby Team notes that “common side effects after vaccination include pain and swelling at the injection site, fever, chills, tiredness, and headache. These effects are expected as the body learns how to build an immune response and create antibodies. 

Fever is a possible side effect of getting the COVID-19 vaccine. Having a fever of at least 101 degrees for more than 24 hours can increase the chance of neural tube defects (problems with the development of the brain and spinal cord) in the baby. If a pregnant person develops a fever after getting the vaccine, they should try to reduce the fever as soon as possible. Acetaminophen is usually recommended to treat fever in pregnancy, but people can check with their healthcare providers about the best way to lower their fever.”

COVID-19 Vaccine Monitoring Systems for Pregnant People

The COVID-19 vaccines that have been authorized by the FDA were extensively tested and are still being monitored. The CDC has an intense, robust safety monitoring system called the Vaccine Adverse Event Reporting System (VAERS) to track reports of adverse events from the COVID-19 vaccination. Anyone can report possible side effects or health problems after vaccination, and scientists will investigate the report.

In addition, the CDC and other institutions have established many monitoring systems to protect vulnerable populations such as pregnant people specifically. COVID-19 vaccination is highly recommended and encouraged for all over 12 years of age, including women and pregnant people. It is safe to get vaccinated even if you are: 

• Pregnant
• Breastfeeding
• Trying to get pregnant now
• Or might become pregnant in the future

Below we describe some of the ways that the safety of vaccinations is tracked. 

V-Safe COVID-19 Vaccine Pregnancy Registry

V-Safe COVID-19 Vaccine Pregnancy Registry is a smartphone-based tracker for people who are pregnant at the time of vaccination. The purpose is to collect additional information from recently vaccinated pregnant people to help the CDC monitor COVID-19 vaccine safety.

Vaccine Safety Datalink (VSD)

The CDC also established the Vaccine Safety Datalink (VSD) to determine if possible side effects identified are actually related to vaccination. VSD is a network of nine healthcare organizations across the United States that collect data to help the CDC monitor:

• Weekly counts and rates of COVID-19 vaccination in pregnant people
• Miscarriage and stillbirth that occurs among people who received COVID-19 vaccine during pregnancy
• Adverse outcomes in pregnancy following COVID-19 vaccination, including:
  • Pregnancy complications
  • Birth outcomes
  • Infant outcomes for the first year of life (includes infant death, birth defects, and developmental disorders)

Clinical Immunization Safety Assessment (CISA) Project

There are also numerous research studies being conducted about COVID-19 vaccine safety for pregnant individuals. The Clinical Immunization Safety Assessment (CISA) Project enrolls pregnant people who plan to get vaccinated for COVID-19 at three different sites and then follows up with participants throughout their pregnancy and for three months after delivery.

Birth Defects Study To Evaluate Pregnancy Exposures (BD-STEPS)

Another study is BD-STEPS which is an ongoing study to understand the potential causes of birth defects and how to prevent them. The study collects data on COVID-19 vaccination as well. These studies have found no evidence COVID-19 vaccination has implications on pregnancy.

COVID-19 Vaccines And Future Pregnancy

Below we go through the risks of the COVID-19 vaccine and future pregnancy.

Do you believe that Pfizer and Moderna’s COVID-19 vaccines are safe for women trying to get pregnant in the future?

Dr. Gersh explains the truth behind the infertility rumors, “the rumors that the vaccines can affect fertility are pure nonsense and must be countered with science. Moreover, an actual infection with COVID would be more likely to lead to such an outcome than the vaccine. There is no evidence that having a COVID infection renders women infertile. If it were available, I’d encourage women wanting to become pregnant to be vaccinated with one of the mRNA vaccines.”

Likewise, the MotherToBaby team notes that “there is no recommended wait time to become pregnant after getting the vaccine. If someone gets the first vaccine in the series and then becomes pregnant, it is recommended that they still get the second vaccine as scheduled. Because pregnant people who have COVID-19 are at increased risk of severe illness, those who are pregnant and planning pregnancy should take all possible precautions to prevent infection with the virus. This includes getting a COVID-19 vaccine when it becomes available to them.”

Bottom Line

While there is no data from clinical trials on how the COVID-19 vaccines may affect pregnant women, getting the COVID-19 vaccine while pregnant can prevent infection and serious illness from the virus.  Additionally, the American College of Obstetrics and Gynecology recommends that all breastfeeding mothers get the COVID-19 vaccine. 

If you are unsure about getting vaccinated, you should talk to your OB/GYN about your medical history and the risks of contracting COVID-19. Data and information regarding COVID-19 and pregnancy are constantly changing, so staying up to date on medical advice can help guide your decision. 

Sources: 

https://www.acog.org/womens-health/faqs/coronavirus-covid-19-pregnancy-and-breastfeeding