“The world isn’t made up of good people and death eaters.” -JK Rowling
The world isn’t made up of people who choose to vaccinate and those who are vehemently opposed. With the evolution of the COVID-19 pandemic, understanding has changed rapidly. With the development of three effective vaccinations, there has emerged a group of people that exhibit what has been dubbed “vaccine hesitancy.” This is a relatively new phenomenon in terms of new vaccination–the uptake, for example, of the polio vaccination in the early 1950s, was more immediate and widespread. The Zika epidemic also provides an interesting contrast to the current situation as well. I use these examples simply as a foil to the current pandemic and draw a number of interesting similarities and differences.
As an OBGYN in a large academic medical center in Wisconsin, United States of America, I work with a hesitant and vulnerable patient population–expectant mothers. Patients use pregnancy as an opportunity to improve their diet, begin exercising, drink only organic juices, etc. in an effort to be the best “home” for a baby. Women understand that their developing child experiences all of which they take in and so appropriately are more cautious during pregnancy about their own physical health. The effort to encourage vaccination for COVID-19 in the pregnant population has been interesting from a sociological and psychological perspective but for me has been difficult, frustrating and a source of burnout. The contrast of the COVID-19 vaccination development with the polio vaccination is stark–in the Salk Poliomyelitis Vaccine Field Trial in the early 1950s people volunteered their healthy children for participation in the vaccine trial (1). This was a disease that was significantly more morbid for children than COVID-19 has proven to be but represents another modern study on the evolution of disease, vaccination, and public health. One would think that the mothers of the 1950s would have been more cautious about exposing their children to an untested vaccination for a disease that caused significant morbidity and mortality. What has changed such that pregnant patients are more worried about the vaccine than the disease it’s meant to prevent? More recently, the Zika epidemic presents another contrast to the current COVID pandemic. While there are some striking differences- the severity of impact on unborn children, the largely unaffected population outside of warm, tropical climates and that this represented a zoonotic disease- the response to this virus in my patient population was vastly different. I had many patients change travel plans, including expensive vacations and weddings to avoid exposure to the virus. The effort to encourage vaccination for COVID-19 in the pregnant population has been interesting from a sociological and psychological perspective. Personally, for me has also been difficult, frustrating and a source of burnout.
“There just isn’t enough data about this vaccine in pregnancy.”
As an academic generalist OBGYN, I see about 25 patients in a typical eight-hour clinic day–pregnant patients, teenagers looking to discuss contraception and sexual health, menopausal patients struggling with hot flashes, and pre- and postoperative patients for hysterectomy and ovarian surgery. During a recent busy clinic, I spoke about the vaccination with four young pregnant patients in different stages of pregnancy–each of whom became defensive about choosing to not be vaccinated while pregnant. Some don’t even want to have a conversation about getting vaccinated. It’s exhausting to feel like an adversary with my patients in regards to this. I discuss with them that I would be a bad physician if I didn’t bring it up and at least review the risks and benefits together. Pregnant patients were not included in trials for approval of any of the current vaccinations, which is touted by many as the reason for not choosing vaccination while pregnant or breastfeeding. Non-inclusion in the vaccination development process for the COVID-19 vaccinations is not unique–pregnant women are considered a special population with regard to research and have not been included in a large body of experimental research for many vaccinations and medications. Vulnerable populations are defined as social groups who have an increased relative risk or susceptibility to adverse health outcomes (5). Pregnant patients have been included in this definition secondary to the risk of the unborn fetus with any maternal exposure. As the debate on maternal decision-making regarding maternal bodily autonomy in contrast with protection for the fetus rages on, many feel that this inclusion is problematic and the American College of Obstetrics and Gynecology (ACOG) has encouraged pregnant patients to be considered a “medically complex” population rather than a vulnerable one. A 2011 study on all medications approved by the United States Food and Drug Administration (FDA) from 1980 to 2010 found that 91% of the medications approved for use by adults did not have sufficient data on safety, efficacy, and fetal risk of medication taken during pregnancy (2). Erring on the side of caution may aim to protect women, but it actually puts them at a disadvantage–excluding pregnant women from studies means that we have less data for patients in order to make good health choices. Many physicians and researchers in maternal-fetal health have felt even before a global pandemic that this research policy is due for significant changes and have pushed for more pregnant patients to be included in research and drug and vaccine trials. Some researchers have proposed “fair inclusion” rather than routine exclusion as a practice (4). This means fair, ethical, and appropriately protected inclusion of pregnant women in research rather than routine exclusion (4).
My personal hope is that more public awareness regarding this lack of information will provide the impetus we need to broaden our scientific definitions of a vulnerable population in research to include more pregnant patients in studies. Despite the lack of inclusion in initial studies, multiple large trials have now been published detailing the experiences of women who did choose to become vaccinated and the outcomes for pregnancy. The data is largely reassuring. In addition, the data is clear that vaccination is far superior to contracting the disease–COVID-19 is associated with increased morbidity and mortality in the pregnant population (3). I want to belabor this point, which often seems to be lost in the shuffle–overwhelmingly the conversation seems to be about the vaccine and its safety, not the safety of acquiring a novel virus during pregnancy and how that may impact maternal and fetal health. We have the same or less information on long-term outcomes and sequelae from the virus than the vaccination. Furthermore, how much data is enough data to make women feel comfortable? Are patients waiting to hear a magic number or a certain fact that will tip the scale? If so, this should be a subject of scrutiny and the information should be disseminated. My personal belief is that it is not actually an issue with data, it’s an issue with dissemination and communication. The public health communication about vaccination in pregnancy has been small and non-unified and patients are inundated with multiple sources of misinformation. Physicians counsel patients individually about the benefits of COVID-19 vaccination in pregnancy and the data behind this recommendation. As a physician, I can say that the task of discussing the vaccination on a one-by-one basis with my whole patient population is daunting and feels insurmountable. It feels insurmountable as a single physician talking with my private patient population.
“Is it safe to travel?”
Perhaps most frustrating for me is the new phase we have entered in which unvaccinated persons are comfortable returning to “normal.” As healthcare workers, many of us may never return to normal after the trauma of this past year. Personally, this event has changed my outlook on my life, my career, and my family. And yet, so many just want to return to life before the pandemic–a life without masking, social distancing, caution about large groups, and the divisiveness associated with different beliefs and values. Patients are yearning to celebrate with family, go about daily business unencumbered by concerns about transmission, and have fun—often in the company of large groups of people. I have spoken with many patients about the COVID-19 vaccine in pregnancy and their reluctance about vaccination. Often, they would then follow up with a question about whether or not it is safe to travel to Tennessee for their cousin’s wedding, for example. I often point out the incongruous nature of this–vaccinated persons can return to normal life but if you have chosen not to then you need to continue to live cautiously–wearing masks, distancing from others, washing hands. It is hard to observe the fear of the vaccination being stronger than the fear of the actual disease that I have firsthand seen killing our most vulnerable. As the delta variant now sweeps across the country, many healthcare workers are feeling more frustrated at the knowledge that this was preventable had more people more rapidly up-taken vaccination.
“I’m not an anti-vaxxer, I just don’t want this vaccine.”
Of course, it feels like these vaccinations were rushed to the market. They were. A lot of resources were poured into the development of a vaccination for a virus that had caused a deadly worldwide pandemic. One would expect that the vaccination development and approval for human use moved through the bureaucratic process more swiftly. However, this was not at a cost to safety. When patients feel like this particular vaccine feels like it’s different, I honor that sentiment—of course, this feels different because life is now different. There aren’t living people on Earth who have experienced a pandemic of this nature and the subsequent healing from such. I’m at a loss about how to respond when people feel that this vaccination is so different than other recommendations we have in pregnancy. There has gotten to be a collective feeling that this vaccination is somehow different than many vaccines that we recommend including the influenza vaccine and the Tdap (tetanus, diphtheria, and pertussis). I struggle to understand why patients will accept these vaccines and not the COVID-19 vaccination while pregnant.
“Now what do I do?”
The majority of our population is now feeling the burden lifted: the vaccination for COVID-19 is available to anyone who chooses to accept it. We are collectively navigating the recovery from this pandemic–physically, emotionally, and economically. As an OBGYN, I’m struggling with where to go from here. I’m feeling downtrodden as the delta variant has caused case numbers to rise and the hope that I was feeling is diminished. How do we deal with the frustration that we feel now when patients come in with COVID-19 and could have chosen to get the vaccine? The healthcare resources that they utilize take away from other patients and expose vulnerable patients to preventable disease. How do we maintain therapeutic relationships with patients who won’t trust our recommendations and continue to risk public health due to their choices? We teach medical students how to deal with difficult patients and never before have I had to utilize those skills so routinely. I will be honest that I don’t know the answers to these aforementioned questions, but I do know that we need to work to navigate through “pandexit” and collectively recover from how this has affected the healthcare system and healthcare workers. As I wrote this post, I reflected on my feelings as a physician and how to foster resilience after this difficult year. One of the four patients that I spoke with sent me a message that buoyed me for another day and made me feel like I was indeed making a difference: “Doc, after talking with you I decided to get the vaccine. Do you know where I can schedule it?”
And so I continue. I continue to talk to my patients, I continue to gently encourage women to focus on data and work to continue to ensure that we have a relationship that allows them to explore their thoughts about the vaccine and continue to see me as their advocate and ally. My hope is that even if a handful of my patients choose to vaccinate based on our discussion that it will make a meaningful difference.
1. Lambert SM, Markel H. Making history: Thomas Francis, Jr, MD, and the 1954 Salk Poliomyelitis Vaccine Field Trial. Arch Pediatr Adolesc Med. 2000 May;154(5):512-7. doi: 10.1001/archpedi.154.5.512. PMID: 10807305.
2. Adam MP , Polifka JE , Friedman JM . Evolving knowledge of the teratogenicity of medications in human pregnancy. Am J Med Genet Part C Semin Med Genet 2011;157:175–82. doi:10.1002/ajmg.c.30313.
3. Moore KM, Suthar MS. Comprehensive analysis of COVID-19 during pregnancy. Biochem Biophys Res Commun. 2021 Jan 29;538:180-186. doi: 10.1016/j.bbrc.2020.12.064. Epub 2020 Dec 24. PMID: 33384142; PMCID: PMC7759124.
4. Payne P. Including Pregnant Women in Clinical Research: Practical Guidance for Institutional Review Boards. Ethics Hum Res. 2019 Nov;41(6):35-40. doi: 10.1002/eahr.500036. PMID: 31743630.
5. Flaskerud, Jacquelyn H.; Winslow, Betty J. Conceptualizing Vulnerable Populations Health-Related Research, Nursing Research: March 1998 – Volume 47 – Issue 2 – p 69-78.