Should I get the COVID-19 vaccine if I am pregnant or nursing?
What we know, and don’t know, about pregnancy and COVID vaccination
What we know, and don’t know, about pregnancy and COVID vaccination
One of the most common questions that I have received since I wrote about why I was planning on getting the COVID vaccine is “What if I am pregnant? Should I get the vaccine?” It’s an important question that unfortunately doesn’t have a clear answer just yet. I know that this is frustrating for many people who are trying to make a decision about the vaccine. As the vaccine becomes available to more people, this question will become all the more relevant.
In an effort to help people make this decision, I wanted to work through several common questions to give some more information about what we know and what we don’t know about the COVID-19 vaccination during pregnancy.
Why is there not a clear recommendation about pregnancy and the vaccine?
The answer to this first question is quite simple. There just isn’t much data on pregnancy and COVID vaccines. Despite multiple calls from medical professionals to include pregnant women, the major early vaccine trials have specifically excluded pregnant women for reasons that we will discuss below. Without data, we cannot make an evidence-based recommendation.
Why did the trials not include pregnant or nursing women? Isn’t that concerning?
Due to federal regulations, pregnant women, fetuses, and neonates are considered a vulnerable population in clinical trials and thus require extra protection. NIH states, “The existence of additional protections should not discourage research with vulnerable populations or those requiring special considerations.”
However, there are still logistical and ethical issues that must be dealt with to include pregnant women in a clinical trial. Research in vulnerable populations takes more time, is more expensive, and can have higher liability/public relations risks associated with them. These reasons discourage the inclusion of pregnant and nursing women in clinical trials.
These issues are particularly relevant for the COVID-19 vaccine trials, as they are being conducted at unprecedented speeds. It is really not hard to understand why a company would exclude this vulnerable class of people from a vaccine trial that is designed to proceed at such speeds, especially with competition from more than 60 other vaccine trials. Including pregnant women in the trials would put the company at too high a risk and make their trial proceed slower than their competition.
Though this is unfortunate and physicians/researchers have repeatedly called for the inclusion of pregnant women in clinical trials, their exclusion from current trials should not raise the concern that these companies have a specific theoretical reason why it might be dangerous for pregnant women to get their COVID vaccine.
Is there any reason we should be concerned about pregnant women getting the vaccine?
There is no theoretical reason why the leading COVID vaccines pose any risk to pregnant or nursing women. Exclusion from clinical trials is based on unknown risks, not actual theoretical concerns. Pregnant women have been historically considered a vulnerable class because the body behaves and reacts differently while pregnant, and a developing fetus can be more vulnerable to medical interventions. Thus, there are higher risks involved for pregnant participants. However, these risks are unknown, and they are a reality for any clinical trial that would include this class of people.
The good news is, COVID-19 seems to spare young children, affecting them the least. Further, it is completely natural and normal for maternal antibodies to pass from mom to fetus (and to an infant who is getting breastmilk), providing protection for the fetus (or infant). This happens naturally if the mother gets a cold while pregnant or nursing, and it would happen naturally if the mother got COVID. It should also be noted that the CDC recommends that pregnant women get the flu and the TDAP vaccines, indicating that vaccination itself is not inherently risky during pregnancy.
Thus, in theory, there is no reason to believe that the vaccine would be dangerous to the mother’s child if received during pregnancy or while nursing.
I heard the vaccine can cause fertility issues, is this true?
No, there is no evidence to indicate or a theoretical reason to believe that the COVID vaccines will cause fertility issues. This is just a piece of misinformation that has been asserted by individuals and groups that are against the vaccine. If the vaccine were to pose a risk to fertility, then COVID infection itself would pose a risk to fertility, which has not been demonstrated. And we certainly have much more data on pregnant women with COVID than pregnant women receiving the vaccine.
Is there any positive data about pregnancy and the COVID vaccine?
Though all the clinical trials for COVID vaccines have specifically excluded pregnant women, at least one trial does have a small data set of pregnant women who received their vaccine (presumably because they didn’t know they were pregnant when they got the vaccine, or they failed to tell the trial registrants that they were pregnant).
In their report to the FDA for emergency approval, Moderna disclosed that they did have a small subset of trial participants that were pregnant (6 in the vaccine group and 7 in the placebo group). Though this group was too small to give valid statistical evidence for vaccine safety in pregnant women, the only adverse events (1 spontaneous abortion and 1 elective abortion) reported occurred in the placebo group. Further, Moderna did a preclinical study of their vaccine in pregnant rats and concluded that their vaccine did not have any adverse effects on the mother or fetus/pups in the trial.
Again, these studies are too small to be anywhere near definitive, but they do give positive indications that at least mRNA vaccines pose little threat to pregnant and nursing women and their children.
Would there be any benefit to getting the vaccine that I might consider in light of unknown risks?
Even though there are unknown risks for getting the vaccine if you are pregnant, there are known risks of COVID to weigh against when making your decision. According to the CDC and the WHO, pregnant women are at a higher risk for developing severe illness from COVID-19, being more likely to be placed in the ICU or require a ventilator. Some evidence suggests that COVID-19 might also place pregnant women at higher risk for preterm birth, which can negatively affect their children. Although the risks of these events are still low, they do seem to be heightened among pregnant women, indicating that the vaccine might be beneficial for pregnant women.
What do relevant public health and medical associations say about the vaccine and pregnancy?
Even though there haven’t been explicit recommendations for pregnant women to get the vaccine due to the reasons outlined above, different public health and medical agencies have made statements about the topic, at least suggesting that pregnant women should consider getting the vaccine.
The American College of Obstetricians and Gynecologists has recommended that the mRNA vaccines not be withheld from pregnant and nursing women and that they should be considered for the vaccine if they meet the criteria for the current recommendations.
The CDC says that it should be a personal choice for pregnant women to get the vaccine after talking with their primary care physician with the reminder that this group could be at a heightened risk of severe illness if they contract COVID.
While the WHO does not recommend the vaccine for pregnant or nursing women, they do concede that vaccination may be considered after consultation with their physician.
The American Academy of Pediatrics acknowledges the lack of clinical trial data for pregnant women but says that pregnancy and nursing are not considered risk factors for vaccination and that it is unlikely that there is any risk to the child if the mother is vaccinated. They say that this group of women will be able to choose to get the vaccine when they fall into the recommended vaccine rollout phases.
Should I get the vaccine if I am pregnant or nursing?
Ultimately, the decision to get the vaccine if you are pregnant or nursing must be made by you. I cannot make a recommendation based on evidence, because there simply is little evidence to consider. However, what little data we have is promising, and there is no theoretical reason to believe that the vaccine is unsafe for pregnant women. Further, the vaccine has a real potential benefit for pregnant women as pregnancy might put women at higher risk for severe COVID-19 and preterm labor. Any risks of the vaccine during pregnancy are unknown risks that are considered with any new vaccine or therapy, not clinical observations or theoretical concerns.
If you are pregnant or nursing and trying to figure out if you should get the vaccine or not, I understand the frustration that you must feel in not having a clear answer. I recommend seeking the advice of your primary care physician when considering whether or not to get the vaccine. I hope this discussion has given you an idea of where we stand right now in our knowledge about this subject and helps you make an informed decision.