The morning after the Food and Drug Administration approved the emergency clearance for the first coronavirus vaccine, I woke up to a message from my hospital asking me to register for a vaccination appointment.
It brought tears to my eyes. As a family doctor, I wasn’t at the forefront of the Covid-19 fight, but it changed my life and that of my patients. With the approval of the vaccine – and now a second – we finally have an end in sight. Within a few hours, my colleagues texted each other and were thrilled with the excitement of scheduling their vaccination appointments.
But I quickly learned that I had an impossible choice before me.
I am pregnant and all clinical trials with Covid-19 vaccines excluded pregnant people. This comes as no surprise: pregnant women are often excluded from clinical research because of the complexities of pregnancy, including concerns about possible harm to the fetus. We have little data to help us make drug and vaccine decisions.
Instead, we are alone, fueling it at an already vulnerable time. And as I care for a growing number of coronavirus-positive patients every day, my decision about the vaccine seems more urgent than ever.
The news of my pregnancy was a joyful moment for my family in a difficult year, but Covid-19 was a terrible backdrop. I am practicing in Camden, New Jersey and our community is badly affected. Infections rise above the spring peak. My inbox has positive cases after positive cases.
My patients are the most important workers – housekeeping, warehouse workers, janitors – even after everything we’ve learned this year, with poor job security, minimal paid sick leave, and inadequate personal protective equipment. And when my patients are exposed to the virus, so am I.
The data on coronavirus infection during pregnancy are not reassuring. Pregnant women who get the virus appear to be at a higher risk of severe symptoms and complications, and there may also be a slightly increased risk of premature delivery. Every day when I go to my clinic I ask myself, “Will this be the day I get it?”
The first news about the effectiveness of the vaccines was exciting. However, there is little data on how the vaccine affects pregnant people. Pregnant patients were not included in the early studies, although some people became pregnant during the study. Researchers are monitoring them to see how they are doing.
Ruth Faden, a Johns Hopkins bioethicist who studies vaccine policy, has a long history of reluctance to include pregnant subjects in clinical trials.
“There is indolence that sets in,” she told me. Studying pregnant people requires extra effort for safe study design and recruiting efforts. Instead of doing hard work, pregnant women are often just left out entirely.
“It’s an ethically complex situation,” she added. “Pregnancy is like nothing else. Anything you do to a pregnant woman can affect the developing offspring as well. “
Researchers estimate that we have adequate data on the risk of birth defects in less than 10 percent of the drugs approved by the Food and Drug Administration since 1980. This means that every time a pregnant person thinks about using a drug or vaccine, they feel like they are making a random decision, with no rigorous information to guide them.
This is how I feel now. Through my medical training I have learned to respect the autonomy of my patients. My job is to guide them through confusing medical information and help them make decisions without making decisions for them. Patient autonomy is a major value in medicine.
I was happy to see the FDA left the decision on whether or not the Covid-19 vaccine should be given to pregnant women, rather than excluding us from approval altogether. For a pregnant nursing home worker or intensive care nurse, the risk of developing Covid-19 may be higher than the risk of potential side effects from the vaccine.
This is not a theoretical exercise for hundreds of thousands of healthcare workers. Women make up an estimated 76 percent of healthcare workers, many of us of childbearing age. I have texting chains with several doctor friends who are pregnant and breastfeeding, all of whom are trying to sort through the limited information we have.
But without data to guide me, my autonomy to make the decision doesn’t feel so useful. The American College of Obstetricians and Gynecologists made this extremely unsatisfactory recommendation: “Covid-19 vaccines should not be withheld from pregnant individuals who meet the criteria for vaccination.” The Centers for Disease Control and Prevention also issued non-binding guidelines: “Pregnant health care workers can opt for a vaccination.” Both organizations are far from the enthusiastic support of the two organizations for the flu vaccine, for example during pregnancy.
So it’s up to me and my midwife nurse, we’re both smart clinicians, but not vaccine experts. I asked her what she thought and she said to me, “Honestly, I have no idea.”
I try to weigh the costs and benefits: I care for positive patients, but it’s not like I’m an intensive care doctor. Many vaccines are safe to use during pregnancy – I was happy to have my flu shot early – but other vaccines are not. How can I weigh up costs and benefits if I don’t know the costs?
The two vaccines now approved use a novel messenger RNA technology that has not been studied in pregnancy. According to Dr. Michal Elovitz, a premature infant researcher and obstetrician at the University of Pennsylvania, it is possible for the mRNA and the bubble of lipid nanoparticles to cross the placenta. This could theoretically lead to inflammation in the uterus that could be harmful to the developing fetal brain.
Or the lipid nanoparticles might not pass the placenta, says Dr. Elovitz. It is also possible that the new vaccines, like the flu shot, will be perfectly safe during pregnancy. We just don’t have any data yet.
“To avoid pregnant people guessing, we should advocate more preclinical and clinical research that focuses on pregnant patients,” she told me.
My conclusion: if I have the chance, I would be happy to take part in a clinical study with a Covid-19 vaccine for pregnant women. It’s a decision that feels way more informed in science than figuring this out for myself because I would make it alongside the expertise of the scientists who are designing the study.
I would feel reassured that immunology and pregnancy physiology experts had determined the safest trimester for the vaccine. I would feel reassured that they did this using evidence from animal testing, and I would feel reassured by the ethics committee that approved the experiment. It wouldn’t be a risk free decision, but I would feel like it is not a completely reckless decision.
Until then, I’ll be taking care of my patients with my mask, face shield, and gloves on, hoping I won’t get infected, and thinking about my health and the health of my baby every day.
Dr. Mara Gordon is a family doctor in Camden, NJ