key: cord-0839262-sducwb2w authors: Hirshberg, Jonathan S.; Huysman, Bridget C.; Oakes, Megan C.; Cater, Ebony B.; Odibo, Anthony O.; Raghuraman, Nandini; Kelly, Jeannie C. title: Offering onsite COVID-19 vaccination to high-risk obstetric patients: Initial Findings date: 2021-09-02 journal: Am J Obstet Gynecol MFM DOI: 10.1016/j.ajogmf.2021.100478 sha: 3f6d9923ad5da3f96800e397305ce9cb1dbb4710 doc_id: 839262 cord_uid: sducwb2w OBJECTIVE: The COVID-19 pandemic has had a disproportionate effect on pregnant women, with higher rates of viral infection and disease severity.1 The development of highly effective vaccines has significantly reduced SARS-CoV-2 transmission and clinical disease.2 However, vaccine uptake has been low in the pregnant population.3 The Centers for Disease Control and Prevention guidance suggests that limited vaccine access, not vaccine hesitancy, has driven the lower uptake rates in at-risk populations.4 We describe our experience with vaccination uptake rates among high-risk obstetrical patients before and after onsite BNT162b2 messenger RNA vaccination availability in outpatient clinics as part of a pilot program to improve vaccine access among pregnant patients. STUDY DESIGN: This was a quality improvement project at a single academic medical center. Onsite vaccination was available once a week at 2 high-risk obstetrical clinics staffed by obstetrical residents, maternal-fetal medicine (MFM) fellows, and MFM attendings were selected for our vaccine pilot program. Onsite vaccinations were immediately available for use in the clinic starting May 11, 2021. Data were collected over a 4-week period (April 27, 2021, to May 20, 2021), which included 4 clinic days before onsite vaccine availability (April 27, 2021 to May 10, 2021) and 4 days with onsite vaccine availability (May 11, 2021, to May 20, 2021). Patients were considered exposed to onsite vaccination if they had any clinic visits during the latter 2 weeks of the study period. All patients were counseled by providers at each visit using our institution's standardized COVID-19 vaccination discussion tool designed for pregnant and breastfeeding patients.5 Counseling was documented in each patient's chart per the American College of Obstetricians and Gynecologists. Before and throughout the study period, pregnancy was listed as a qualifying condition for priority vaccination in Missouri and Illinois. At this time, vaccinations were readily available in the local area surrounding our clinical space. Data on vaccine administration were collected via the Missouri and Illinois state databases over a period of 1 month after the pilot program was closed, allowing for the collection of data on patients who pursued vaccination offsite for scheduling or personal reasons. This project was deemed exempt by the Office for Human Research Protections. RESULTS: We reviewed data from 124 clinic visits, where a total of 93 individual patients were seen in the 4-week period; 6 had previously been vaccinated at external sites and the remaining 87 were eligible (Figure). The majority of our patient population was non-Hispanic Black women with public or no insurance (Table). Of the 32 eligible patients seen and counseled before onsite vaccination availability, 1 (3%) proceeded to receive the vaccination offsite. Of the 55 eligible patients seen and counseled after onsite vaccination availability, 2 (3%) proceeded with onsite vaccination and an additional 4 (7%) proceeded with vaccination offsite. Onsite vaccination availability did not significantly increase the vaccination rates (3% vs 11%; P=.22). Of the 55 eligible patients counseled during onsite vaccination availability, 25 were seen and counseled exclusively during the onsite vaccination pilot period and none of these patients accepted onsite vaccination or pursued vaccination offsite. CONCLUSION: Because only 3% of eligible, high-risk obstetrical patients proceeded with onsite vaccination, our experience suggests that vaccine hesitancy, not availability, is a critical driver of the low vaccination rates in this population. Although a larger sample size may have demonstrated statistical difference, the overall low vaccination uptake rate forced the closure of our pilot program over concerns for wasted vaccination doses. In a population at high risk for progression to severe COVID-19, only 14% of our study population was vaccinated, whereas Missouri reported a 41% vaccination rate during this time.6 These findings suggest that increased access alone may not improve vaccination rates in obstetrical patients even after counseling by expert clinicians. These findings are limited by the pre/post nature of the comparison, exposing the sample to bias as vaccination recommendations and population sentiment was rapidly evolving during this time period. However, the consistency of counseling and patient population provided by a single clinical setting limited other sources of bias during the study period. Vaccine hesitancy is multifactorial and complex and urgently requires more evaluation in this high-risk population. Vaccine hesitancy in pregnancy is well documented, but early reports suggest that the COVID-19 vaccination uptake rate is markedly lower than that of other vaccines during pregnancy. Our finding that none of the women who were seen exclusively during the onsite vaccination period accepted vaccination may suggest that repeat clinic visits and the associated establishment of rapport and trust is a vital part of vaccine decision making. Earlier intervention, before patient views on novel therapeutics such as vaccinations can be formulated and fixed, may aid in uptake. Further qualitative work and inclusion of pregnant women in vaccine trials is an initial step. The authors did not report any potential conflicts of interest. Offering onsite COVID-19 vaccination to high-risk obstetric patients: Initial Findings Condensation: Offering onsite vaccination failed to increase COVID-19 vaccination rates in a high risk OB clinic. COVID-19 onsite vaccination AJOG at a glance: a) Why was this study conducted? COVID-19 vaccination rates are low in pregnancy and thus we explore one possible option for increasing vaccine uptake. b) What are the key findings? Offering COVD-19 vaccination in our high-risk OB clinic did not significantly increase rates of vaccination. c) What does this study add to what is already known? These findings are contrary to the popularly held belief that vaccine access is the central limitation to vaccine uptake. The COVID-19 pandemic has had a disproportionate effect on pregnant women, with higher rates of viral infection and disease severity [1] . The development of highly effective vaccines has significantly reduced SARS-COV2 transmission and clinical disease [2] . Yet, vaccine uptake has been low in the pregnant population [3] . CDC guidance suggests that limited vaccine access, not vaccine hesitancy, has driven lower uptake rates in at risk populations [4] . We describe our experience targeting vaccine uptake in high-risk obstetric patients before and after onsite BNT162b2 mRNA vaccination availability in outpatient clinics as part of a pilot program to improve vaccine access in pregnant patients. This was a quality improvement project at a single academic medical center. Two once-weekly high-risk obstetric clinics staffed by obstetric residents, Maternal-Fetal Medicine (MFM) fellows, and MFM attendings were selected for our vaccine pilot program. Onsite vaccines were immediately available for use in the clinic starting 5/11/21. Data was collected over a four-week period (4/27/21-5/20/21) which included four clinic days prior to onsite vaccine availability (4/27/21-5/10/21), and four days with onsite vaccine availability (5/11/21-5/20/21). Patients were considered exposed to onsite vaccination if they had any clinic visits during the latter two weeks of the study period. All patients were counseled by providers at each visit using our institution's standardized COVID-19 vaccine discussion tool designed for We reviewed data from 124 clinic visits, where a total of 93 individual patients were seen during the four-week period; 6 had previously been vaccinated at external sites, and the remaining 87 were eligible. Our patient population was majority non-Hispanic Black women with public or no insurance (table 1) . Of 32 eligible patients seen and counseled prior to onsite vaccine availability, 1 (3%) proceeded with vaccination offsite. Of 55 eligible patients seen and counseled after onsite vaccine availability, 2 (3%) proceeded with onsite vaccination, and an additional 4 (7%) proceeded with vaccination offsite. Onsite vaccination availability did not significantly increase vaccination rates (3% v 11% p=0.22). Of the 55 eligible patients counseled during onsite availability, 25 were seen and counseled exclusively during the onsite vaccination pilot period, none of these patients accepted onsite vaccination or pursued vaccination offsite. As only 3% of eligible high-risk obstetric patients proceeded with onsite vaccination, our experience suggests that vaccine hesitancy, not availability, is a critical driver of low vaccination rates in this population. Although a larger sample size may have demonstrated statistical difference, the overall low vaccine uptake forced the closure of our pilot program over concerns for wasted vaccine doses. In a population at high risk for progression to severe COVID-19, only 14% of our study population was COVID-19 onsite vaccination vaccinated, while Missouri reported a 41% vaccination rate during this time [6] . These findings suggest that increased access alone may not improve vaccination rates in obstetric patients, even after counseling by expert clinicians. These findings are limited by the pre/post nature of the comparison, exposing the sample to bias as vaccine recommendations and population sentiment was rapidly evolving during this time period. Yet, the consistency of counseling and patient population provided by a single clinical setting limited other sources of bias during the study period. Vaccine hesitancy is multifactorial and complex, and urgently requires more evaluation in this high-risk population. Vaccine hesitancy in pregnancy is well documented, but early reports suggest that COVID-19 vaccine uptake is markedly lower than other vaccines in pregnancy. Our finding that none of the women who were seen exclusively during the onsite vaccination period accepted vaccination may suggest that repeat clinic visits, and the associated establishment of rapport and trust, is a vital part of vaccine decision making. Earlier intervention, before patient views on novel therapeutics such as vaccination can be formulated and fixed, may aid in uptake. Further qualitative work and inclusion of pregnant women in vaccine trials is an initial step. COVID-19 onsite vaccination Update: Characteristics of Symptomatic Women of Reproductive Age with Laboratory-Confirmed SARS-CoV-2 Infection by Pregnancy Status -United States BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Mass Vaccination Setting COVID-19 Vaccination Coverage Among Pregnant Women During Pregnancy -Eight Integrated Health Care Organizations, United States Expanding COVID-19 vaccine distribution to primary care providers to address disparities in immunization: guide for jurisdictions Our World in Data