“Can I ask a maybe-inappropriate, slightly personal question?” one of the emergency medicine residents paused to ask me. “Are you going to get the COVID vaccine? My wife is also a pregnant physician, and I value your opinion.” We were in the doc box, my growing belly no longer hidden by baggy scrub-tops. This wasn’t the first time that a colleague had asked me this question, and it wouldn’t be the last.
“Yes, I got it last week,” I replied. Although I felt like I was shouting through my N95, my voice was probably barely audible over the buzz of conversations and music playing around us. As usual, we were in the middle of a busy shift with lots of patients to see, so I tried to keep my explanation concise and to the point, quickly summarizing the biochemistry behind mRNA vaccines and statements from professional organizations such as ACOG.
And as he and his wife were physicians, I didn’t need to convince them of the hell that the pandemic had caused; they too had worked when patients with COVID-19 were quickly filling our hospital beds to capacity, when we were told to limit our mask use because our hospital faced shortages of personal protective equipment. Had felt impotent as they watched critically ill patients crash over the edge, as we had no cure to offer; had felt the heartbreak of telling family members that their loved ones were about to die, yet they were not allowed into the hospital to say goodbye. Lived under the constant fear of contracting this novel disease and bringing it home. They already knew how this vaccine felt like our only way out of this crisis.
Yet, there was so much more that I did want to tell his wife, so much more than the immunologic theories and scientific data. As this decision was an intimately personal one, it required a personal response, one that was more substantial than a list of talking points. For me, my real answer began back in the summer, back when COVID-19 cases were peaking, our nearby mountain range was engulfed in bright orange flames, and we were in the middle of the driest summer on record. Back when it felt like my world teetered on the precipice of a fiery, apocalyptic collapse.
It was also during this time that a small opening appeared; in July, emails started to circulate about a local vaccine trial looking for volunteers. Participants would receive either a placebo or the Moderna mRNA vaccine. Many of my coworkers were eagerly signing up, and I followed their lead. We couldn’t exactly follow the advice of staying home or avoiding sick people, and a vaccine felt like an added layer of protection needed to bolster our PPE. I filled out the online query, twice, but it wasn’t until August that I received the call. “Would you like to be a participant in our study?” the woman on the other end of the line asked.
By then, I was four weeks pregnant, but when the woman from the vaccine trial told me that pregnant patients were not allowed in the study, I said that wasn’t a problem; I was prepared to lie. Although I didn’t know the specifics of how this virus might affect pregnant women or a fetus — nobody did –I did know the havoc that this virus had rampaged in the lives of my patients, and I didn’t want that for my family or me.
Despite my initial concern about the newness of the technology behind the Moderna vaccine – no other vaccine on the market used mRNA — the more I read, the more reassured I felt. First of all, they were not actually that new; mRNA vaccines had been in development for decades and had been tested in vaccine trials for other viruses, including rabies and Zika. And secondly, mRNA vaccines were much more elegant conceptually when compared to traditional vaccines, and thus, theoretically, should be safer. Instead of injecting the virus or a bulky viral component, only a minuscule nucleotide segment was administered. The mRNA segment entered into our cells (but not our DNA), and our ribosomes translated it into a small protein, the spike protein that SARS-CoV-2 used to infect us. Our bodies then produced antibodies to this spike, and the vaccine’s mRNA quickly left our system. In pregnancy, inactivated vaccines were generally considered safe and even beneficial, conferring immunity to both mom and newborn; why would this vaccine be any different?
And to be honest, at that point, my pregnancy didn’t feel entirely real. The blastocyst in my ovary was just a ball of cells, smaller than a grain of rice. If the vaccine caused a miscarriage, we could just try again, and next time, the baby and I would be protected from any future harm caused by infection. Thus, I felt like the benefit of potentially receiving the vaccine outweighed any risks. After our phone call, the woman from the trial quickly emailed over the consent forms, which included the study protocol. My eyes raced through the small print, looking for the detail that might ruin my plans. And there it was. I would be required to take a pregnancy test. I couldn’t lie my way through that.
I canceled my intake appointment, tapping loudly on my keyboard from anger. Sure, entering the trial didn’t guarantee that I would get the vaccine, but it at least gave me the possibility. I was a front-line worker, exposed to this virus every day — why couldn’t I make my own decision about what was best for me and my family? The American College of Obstetrics and Gynecology (ACOG) had been advocating for the inclusion of pregnant women in the COVID-19 vaccine trials, so why had we systematically been excluded? When I vociferously complained about this to my partner over dinner, our toddler loudly banging the butt of her fork on the table, his less-than-furious response made me wonder if my sense of unjustness was misplaced. Was I over-reacting? Maybe the researchers did have my best interest in mind.
So I did a little research of my own, and found that the history of exclusion went back decades. In the first half of the 20th century, there was very little regulation around the testing and licensing of drugs. Pharmaceutical companies only needed to perform minimal animal testing before marketing a drug as safe in humans. And that’s how thalidomide made it to women around the world, advertised as a safe cure for morning sickness, even though it had never been researched in pregnant women.
Several years later, scientists realized that thalidomide taken during pregnancy was responsible for the birth defects, and even deaths, suffered by thousands of children. Although I had heard of the thalidomide tragedy, I didn’t realize just how severe the effects were until I clicked on the black and white photos returned by my internet search – a girl with only stubs for arms, using her foot to play with a small wooden toy similar to one that my daughter has; a newborn with short, twisting legs, her feet angling in the wrong directions.
Although this tragedy led to some positive regulatory changes, it also led to the paternalistic belief that women, especially pregnant women, needed to be protected from the dangers of clinical trials. In 1975, The National Commission for the Protection of Human Subjects and Biomedical and Behavioral Research designated pregnant women as vulnerable research subjects, in the same category as individuals without the capacity to give informed consent. In 1977, an FDA guideline essentially banned women of “child-bearing potential” from participating in early phase clinical research, and researchers tended to extend the policy to include all phases of drug trials. It was believed that if a drug was found effective and safe for a man, the same would hold true for a woman. Men, especially white ones, were seen as the physiologic norm.
Subsequent progress can partially be attributed to the work of AIDS activists, a group who became one of the most influential patient advocacy groups in history and revolutionized medical research. Sometimes their methods were controversial: locking themselves to politicians’ desks, covering officials’ computers with fake blood, and flipping over the shrimp cocktail tables in the middle of pharmaceutical company meetings. But it worked. One of their positions was that women should not be excluded from HIV drug trials, as the stakes from such a life-threatening illness were too high. They also advocated to replace the prevailing practice of testing drugs on a small number of people over a long period of time with testing a huge sample of people over a much shorter period — significantly speeding up the time it took to conduct drug trials. Such a timeline was key to the record speed in which the initial vaccines for COVID-19 were authorized for emergency use.
In 1986, the NIH established a policy that encouraged researchers to include women in studies, yet it wasn’t until 1993 that the FDA lifted the ban of young women from participating in early phase research. That same year, Congress passed an act requiring the NIH to ensure that women and minorities were included in all clinical research. Nonetheless, when it comes to including pregnant women, little progress has been made. It is still the norm for us to be excluded from clinical trials.
As ACOG wrote in a 2015 Committee Opinion article, “Although there is a cognitive bias toward considering the risks of intervention, including the risk of inclusion in research, there is also a risk associated with failing to intervene and exclusion from research. Pursuit of zero risk to the fetus may come at a cost.” Although more than 60% of pregnant women use at least one prescription medication during their pregnancy, especially now that pregnancy is becoming increasingly common in older women such as myself, most of these medications have not been studied in pregnancy. This places the fetus at risk, and means that physicians and pregnant women must make complex health care decisions based on insufficient data.
An article recently published in The Lancet Global Health showed that over 70% of COVID-19 treatment studies specifically excluded pregnant women, even though the CDC now considers us a high-risk population for COVID complications. Furthermore, the researchers found that the exclusion was rarely scientifically justified, as many of the treatments being evaluated had already been shown to be safe in pregnancy. Meaning, it was just easier to exclude pregnant women. Less liability. Faster IRB approval. Cheaper.
Fast forward to October, two months after I had been rejected from the Moderna trial. I was now in the early weeks of my second trimester, just starting to emerge from the constant nausea and fatigue of early pregnancy, and was juggling the demands of a hectic ED shift when I got a text from my toddler’s babysitter, “Hi guys I hope you’re doing good, I just wanted to let you know that my husband was feeling a little sick and he went to take the test, and it seems like he’s positive.”
My stomach cinched and my ears filled with the reverberations of my heart pounding against my eardrums. Just two days ago, she had watched our daughter in their apartment. Studies were showing that people were most infectious right before they developed symptoms, meaning our daughter had been there at the worst possible time. Within seconds, my partner and I were on the phone, panicking together. We had been so careful, and yet, here we were.
It wasn’t long before the three of us also tested positive. My first symptom was an aching pressure in the back of my nose, followed by the bizarre absence of all taste and smell. It took a few days for the fever to arrive, and with it came the bleeding. I worried that my placenta had been infected, that I might miscarry. Or even if I didn’t, would the infection cause some irreversible damage to the baby? I turned to medical journals for reassurance, but found none. The disease was too new. That same week, the CDC added pregnancy to the list of conditions that portended a worse prognosis if infected with COVID. There was increasing evidence that pregnant women infected with COVID-19 were more likely to be hospitalized, admitted to an ICU, or intubated than other women, and that infection might increase rates of preterm birth.
Our toddler remained as high-energy as always, so we took turns napping and watching with febrile exhaustion as she jumped from cushion to cushion on the couch or littered her toys around the house. Although I was painfully tired, the worry kept me from sleeping well at night. I knew that statistics showed that our age, money, whiteness, and overall good health were protective, but I had seen even young patients succumb to severe illness. And because it usually took at least a week for the dangerous hypoxia to develop, we had several days of suspenseful waiting. Plus, survival was not the only thing to worry about; I had seen patients who continued to suffer for months due to scarring from cardiac and pulmonary inflammation. Accustomed to hiking and biking, how much would our lives change if we became “long haulers,” if we could no longer do the things we loved?
Luckily, everything turned out okay for us. Although my partner’s fatigue dragged on for over a month, it eventually went away. We never had to visit a hospital. We never needed oxygen. We recovered. In November, I went for my second trimester anatomy scan, and relief seeped into my tense shoulders each time the ultrasonographer told me that a measurement looked normal. The baby was developing as expected, everything looked right on target. Of course, problems could still show up later, and it was too early to know with certainty that everything was ok, but still, I welcomed any good news.
In December, COVID cases again surged, pushing our hospital system once again to the brink of collapse. It felt like some sick kind of déjà vu, one that scientists had predicted with frightening accuracy; we had been here before, but this time, there were even more patients; our state had the highest infection rate per capita in the U.S.
But for the first time since the pandemic’s arrival, hope was also on the horizon. That same month, less than a year after COVID-19 reached our shores, the FDA convened to approve an Emergency Use Authorization for the Pfizer mRNA vaccine. This was a monumental event, a big freaking deal: the fastest vaccine development in history, and one that seemed to be extremely effective. I followed the FDA’s proceedings closely, as there was debate as to whether the FDA would allow pregnant and breastfeeding women to receive the vaccine. Although I likely had some protection from the antibodies I gained during my infection, it was the other women I was more worried about. Around three-quarters of healthcare workers were women, and the CDC estimated that 330,000 healthcare workers could be pregnant or breastfeeding at the time of vaccine rollout. I was pessimistic — I knew that history was not on our side.
On December 11th, the FDA granted the emergency use authorization. Amazingly, it did not exclude pregnant women, marking a significant historical achievement in women’s health. A week later, a similar authorization was granted for the Moderna mRNA vaccine. But instead of the elation I expected to feel, anxiety raced in. The heavy responsibility of the decision had become my own; I could no longer blame someone else if something went wrong. Before, when the baby was just a blob, producing barely enough hormones to manifest a faintly blue line on a pregnancy test, the decision seemed easy; now she was a fully formed human being whose kicks I felt against my belly, whose fingers and toes I watched with awe on the grayscale of the hospital ultrasound. If she later developed some life-altering complication, I would always wonder if my decision was to blame. Of course, it would be more likely that my COVID infection itself had been the problem, but still, that wasn’t something I had chosen. This would be.
Again, I wished that the trials had included pregnant women, so at least I would have some clinical data to rely on. After nights of pouring through articles explaining the vaccines’ molecular effects, official statements from professional societies, and discussions with other pregnant physicians, I concluded that yes, I would get vaccinated. Soon. Anecdotally, it seemed like people were getting COVID twice. And as I knew from experience, you could still get sick despite taking almost every precaution possible. What would happen if I got COVID during the end of my third trimester, when my lungs were already diminished by the giant belly squishing against them? Or if I transmitted the infection to my baby when she was only a few weeks old? For me and the baby, I believed that the benefits of the vaccine outweighed the risks. I hoped I was right.
When I got into my car to drive to the vaccine site, doubts about my decision still coursed through my body like nervous adrenaline. But then the mood shifted; it was a little after noon, a warm winter day in the desert, and the sun warmed my arms through the open car window. Ozuna’s Caramelo was on the radio, its upbeat melody reverberating through the air. Before me flashed the faces of my patients and colleagues who did not live to experience this opportunity, the ones I had been trying to forget. But now, their memory felt encouraging. I wished they were here to see this, could have made it just a little longer.
As the fear started to melt away, I finally recognized how tightly it had clenched my core for months. And for the first time almost a year, I also remembered the way that hope could lift you up, make you notice the bright green of the palm trees, appreciate the electric blue of the infinite desert sky or the feathery wisps of white clouds extending towards the jagged mountains of the horizon. A sob started to shake my chest, rising upward and constricting my throat as tears rolled down my cheeks, cheeks stretching into a huge smile.
Links to Professional Statements Around the Vaccine: