That’s a question that two Baystate Medical Center doctors contemplated together recently—one a primary care physician at Baystate Mason Square Neighborhood Health Center, who is also board certified in infectious diseases—and the other an OBGYN.
“When the pandemic began to surge in March, the hospital’s chief of infectious diseases reached out to others like me with additional training in the specialty to help with the influx of COVID patients,” said Dr. Amanda Westlake, who learned in September that she was expecting her third child.
Physicians are constantly reading to stay up to date on the latest medical information in their field, especially now to keep informed on the ever-changing treatments and data on coronavirus. So, it is not surprising that when Dr. Westlake visited with her OBGYN, Dr. Katie Barker of Baystate Wesson Women’s Group, she was already familiar with much of the emerging literature on pregnancy and COVID-19. However, there is no scientific study on whether or not the vaccine is safe for pregnant women.
Pregnant People at Increased Risk for Severe Illness from COVID-19
Both doctors – who are long familiar with one another since Dr. Westlake as a medical student had done a clinical rotation at Brown University under Dr. Barker, who was a third-year resident at the time – knew what the Centers for Disease Control and Prevention (CDC) now clearly states on its website:
“Based on what we know at this time, pregnant people are at an increased risk for severe illness from COVID-19 compared to non-pregnant people. Additionally, pregnant people with COVID-19 might be at increased risk for other adverse outcomes, such as preterm birth.”
What is also known is that 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. And pregnant women are more likely to die of COVID than non-pregnant women of the same age with COVID.
But when the two doctors came together to discuss whether Dr. Westlake should get the coronavirus vaccine, the answer wasn’t that simple.
No Simple Answer
“Pfizer did not include pregnant women in its clinical trials to establish the safety and efficacy of their vaccine (it is common in clinical trials to exclude pregnant women). That was unfortunate because our professional organization, the American College of Obstetricians and Gynecologists (ACOG) has long advocated for women to be involved in vaccine trials,” said Dr. Barker.
“As a result, we do not have specific data on which to make a decision about pregnant women receiving the vaccine. However, we have no reason now to suspect that it would work differently or be harmful to pregnant women, which is something I tell my patients every day,” she added.
And, when studies are completed on the vaccine’s effects on pregnant women now being inoculated against the virus, Dr. Barker said she would be surprised if they discover anything unexpected.
For Dr. Westlake, her personal answer was clear: the benefits of receiving the vaccine far outweigh the risks. And, as a frontline healthcare worker, she was vaccinated in December as Baystate rolled out the Pfizer vaccine to employees.
As the Pfizer vaccine came closer to receiving Emergency Use Authorization from the Food and Drug Administration (FDA), the two doctors wanted to share what they knew to help other pregnant healthcare workers make an informed decision about getting the coronavirus vaccine.
That’s when Dr. Barker received a precipitous call from Dr. Lauren Westafer an Emergency Medicine physician at Baystate, who was looking to find out how obstetricians at Baystate were counseling pregnant doctors who would soon be eligible for the vaccine. Recognizing that this guidance would be widely needed, the Shared Decision-Making: COVID Vaccination in Pregnancy working group at the University of Massachusetts Medical School – Baystate was created under the leadership of Dr. Elizabeth Schoenfeld, another Emergency Medicine physician at Baystate.
Dr. Schoenfeld, a shared decision-making researcher in the hospital’s Institute for Healthcare Delivery and Population Science, has experience making decision aids to help patients make decisions together with their doctors. Because of the lack of evidence to guide recommendations for pregnant women, a shared decision aid was needed to help women understand the risks and benefits and the unknowns. Dr. Schoenfeld was asked to make a decision aid by Dr. Andrew Artenstein, chief physician executive and chief academic officer for Baystate Health. As the health system’s COVID-19 incident commander, Dr. Artenstein at the time of the call was planning Baystate’s vaccine distribution.
“Shared decision-making helps patients understand their choices and come to an informed decision with their doctors about their care. It is a way for patients to have their voices heard when deciding what the next step in their medical care will be. And a decision aid is a tool to help facilitate a discussion between a doctor and patient such as, “Should I get the coronavirus vaccine,” said Dr. Schoenfeld.
The clinical researcher noted that “in general the vaccine is highly recommended and safe” and although there was no hard data available on pregnancy and the vaccine, it wasn’t as if “there was no evidence at all about the vaccine to share in an aid.”
“Certainly, for many pregnant women the pros outweigh the cons,” said Dr. Schoenfeld, who noted that when putting together the decision aid it was important to involve multiple stakeholders, such as maternal-fetal medicine experts, COVID experts, and pregnant healthcare workers.
I'm Pregnant. Should I Get the COVID Vaccine?
The result is a 6-page decision aid (pdf) on the Pfizer and Moderna vaccines that starts with the basics: “I’m pregnant. Should I get a COVID vaccine?” It discusses a woman’s options, the benefits and risks of getting an mRNA COVID vaccine, and other information to help pregnant women make an informed decision. There are also additional details about breastfeeding, noting the Society for Maternal-Fetal Medicine (SMFM) and the Academy of Breastfeeding Medicine (ABM) report that there is no reason to believe that the vaccine affects the safety of breastmilk.
You can also access the guide online here.
So, what are the main points in the shared decision-making tool from experts for pregnant women thinking about getting the coronavirus vaccine?
- Because COVID is dangerous and easily spread, the CDC says that the mRNA vaccines for COVID-19 are recommended for adults.
- However, because there are no studies of pregnant women yet, there are no clear recommendations for pregnant women. This is standard for a new drug and is not due to any particular concern with this vaccine.
- Women will want to think about their own risk of getting COVID or getting severe COVID and balance that risk with the risks of the vaccine – which are thought to be small, but are relatively unknown.
Download the decision aid:
What is mRNA?
mRNA vaccines are a new type of vaccine to protect against infectious diseases. To trigger an immune response, many vaccines put a weakened or inactivated germ into our bodies. Not mRNA vaccines. Instead, they teach our cells how to make a protein—or even just a piece of a protein—that triggers an immune response inside our bodies. That immune response, which produces antibodies, is what protects us from getting infected if the real virus enters our bodies.
The tool—which is now aimed at all pregnant women, not just healthcare workers—was ultimately created under the auspices of the Shared Decision-Making: COVID Vaccination in Pregnancy working group at the University of Massachusetts Medical School – Baystate. The group consists of experts from Baystate in the fields of OBGYN, maternal-fetal medicine, emergency medicine, shared decision making and risk communications.
Sharing the Decision Aid Widely
Since completing the aid, it has been shared via Twitter and with various national professional networks such as maternal fetal medicine doctors, obstetricians, emergency medicine doctors, and medical informatics leaders. Based on feedback from those who have received the aid, it is being used at Boston Medical Center, Kaiser Southern California, Mass General Hospital, and in multiple other practices including Texas, and all around the country.
“We have received so much positive feedback. In fact, one woman from Costa Rica asked if we had a Spanish version of the document. We were able to quickly create Spanish and Russian versions and have made them available as well,” said Dr. Schoenfeld.
She noted there are a few things about the vaccine that don't fit in the decision aid.
“First, it gives us hope - that we will eventually get to go back to the social world we miss so much. Second, it lets us front line workers feel better about spending more time at the bedside—I am more comfortable holding a patient's hand and lingering than I was 6 months ago. That's a nice holiday gift for both me and my patients," said Dr. Schoenfeld.
Learn more about the COVID-19 vaccine.
Photo by Doug Hook, MassLive.