Pregnant or breastfeeding women were purposefully left out of the clinical trials that tested COVID-19 vaccine safety and efficacy in tens of thousands of people across the world. It is considered unethical to allow pregnant women in early clinical trials.

However, the Centers for Disease Control and Prevention (CDC) actually recommends that pregnant women get vaccinated against COVID-19 when doing so is available because pregnant people are at an increased risk of severe illness from COVID-19. According to the CDC, pregnant women are at a higher risk of being admitted to the intensive care unit (ICU), receiving mechanical ventilation, and dying. Additionally, pregnant women with COVID-19 may be at an increased risk of adverse pregnancy outcomes, including preterm birth, compared to pregnant women not infected with the virus.

How safe is a COVID-19 vaccine for people who are pregnant or breastfeeding?

Clinical trials for the coronavirus vaccines, including the mRNA vaccines, have limited data on their safety for women who are pregnant or breastfeeding. This is why vaccine manufacturers are currently planning studies that specifically include people who are pregnant.

These trials are set to commence as soon as Pfizer and Moderna complete their so-called Dart studies, which document developmental and reproductive toxicity. There are also a handful of women who became pregnant while in the midst of the trial who will be monitored through their pregnancy.

Due to this absence of data, the UK has decided to, for the time being, exclude pregnant and breastfeeding women from vaccination programs. In the United States, this decision has been left up to the people receiving the vaccine.

However, the absence of data is not indicative of any safety concern. In fact, it’s extremely unlikely that pregnant women react to the vaccine differently from the general population.

The RNA vaccines, such as those from Pfizer-BioNTech and Moderna, do not contain a weakened or dead virus, as has been the case so far with traditional vaccine development. Instead, these vaccines contain a bit of genetic code that instructs cells to produce a protein fragment from the coronavirus spike protein, which primes the body’s immune system against the virus if it encounters it later on.

Because RNA vaccines do not contain the virus, it is literally impossible for a person to get COVID-19 from it. What’s more, our cells break down the mRNA very quickly, so within a matter of days the only things left as a result of the vaccine are the antibodies and white blood cells produced by the immune system against the coronavirus.

Have there been any pregnant women who were vaccinated?

Yes. Of the nearly five million Americans vaccinated so far, there have been many pregnant healthcare workers who have chosen to get the vaccine. No adverse effect has been reported so far.

Can babies and children get the COVID-19 vaccine?

In the United States, the FDA has authorized the Pfizer-BioNTech and Moderna vaccines for emergency use in those 16 years and older and 18 years and older, respectively. The two companies began enrolling children and teenagers for clinical trials in September and December. It will take some time to analyze the data from these trials. If the results are encouraging, younger children will be enrolled in new clinical trials. Adolescents may be able to get a vaccine this year, but younger children and babies might have to wait until 2022. It all depends on how fast these clinical trials and the approval process can be completed.

What are the side effects of the coronavirus vaccine for pregnant women?

People who are pregnant are subjected to the same potential side effects and adverse reactions as the general population.

After vaccination, some of the most common side effects of the COVID-19 vaccine include:

• Injection site swelling
• Fever
• Chills
• Headache
• Tiredness

These mild side effects can be rather common but severe symptoms, such as allergic reactions, are very rare (one in hundreds of thousands).

Being mindful of risks

There are side effects for any medicine. Each person must weigh the risks of their decision here. But not getting a vaccine for which effects are largely unstudied in pregnant women may pose greater risks than the vaccination itself.

Pregnant women are at an increased risk of experiencing severe complications from COVID-19 due to their lower immune response compared to non-pregnant women. Pregnant women are more likely to develop severe disease, need hospitalization, require intensive care, or die. Infection with the virus may also put the baby at risk.

If you’re pregnant or breastfeeding, and you’re not a healthcare worker or a resident of a long-term care facility, you’ll have to wait your turn first. Members of the general public in the United States will probably start getting a COVID-19 vaccine by spring 2021.

This article is part of a series by the ZME Science editorial staff meant to inform and educate the public concerning the coronavirus vaccines. This is not medical advice. You should consult your doctor before making a health decision based on information you read online.

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