ABSTRACT
The COVID-19 pandemic, caused by SARS-CoV-2, has been the most significant global health crisis of the past century. The development of safe and effective vaccines has led to a reduction in COVID- 19-related hospitalizations and deaths;however, the clinical trials that led to US Food and Drug Administration Emergency Use Authorization and/or approval of the vaccines in the United States did not include individuals with inflammatory bowel disease (IBD). Because individuals with IBD are commonly treated with immunosuppressive medications, there had been concern for reduced vaccine efficacy in this population. This article provides an overview of the peer-reviewed literature addressing COVID-19 vaccination in individuals with IBD;details the perceptions of patients with IBD of COVID-19 vaccines, including how gastroenterologists can help to reduce vaccine hesitancy;and describes the humoral immune response to COVID-19 vaccines, with a majority of patients with IBD seroconverting following complete vaccination regardless of medication exposure. Additionally, low rates of IBD flare and similar rates of vaccine-related adverse events to those in the general population are described. Finally, the article provides current recommendations from the Centers for Disease Control and Prevention for COVID-19 vaccination in individuals with IBD.
ABSTRACT
Background: Current recommendations in many countries support additional COVID-19 vaccine doses in patients with inflammatory bowel disease (IBD) who are treated with immunosuppressants, yet real-world data on the effectiveness and safety of additional vaccine doses is lacking. We sought to quantify the humoral immune response to an additional (third) dose of mRNA vaccines in adolescents and adult patients with IBD. Methods: We performed a direct-to-patient, internet-based cohort study of patients with IBD in the United States who have received any SARS-CoV-2 vaccine granted EUA. Participants completed baseline and follow-up surveys and had blood work obtained approximately 8 weeks following completion of the initial vaccination series and 6 weeks following administration of an additional (third) vaccine dose. We performed quantitative measurement of antireceptor binding domain (RBD) IgG antibodies specific to SARS-CoV-2 using the LabCorp Cov2Quant IgG™ assay. Results: A total of 659 participants were included [415 participants (63%) initially received BNT162b2, 243 participants (37%) initially received mRNA-1273, and 5 participants (1%) initially received Ad26.COV2.S]. Demographic, clinical, and treatment characteristics of the study population are provided in Table 1. Over 98% of those receiving an initial mRNA vaccine received the same type additional dose. Whereas 93% had detectable antibody after the initial vaccination series, 99.5% had detectable antibodies following an additional dose. Mean (SD) increase in antibody level was 61 ug/mL (103) in those receiving BNT162b2 and 78 ug/mL (143) for those receiving mRNA-1273 (Figure 1). Importantly, of 47 of patients without initial antibody response, 45 (96%) had detectable antibodies following an additional dose. Additional vaccination was generally well tolerated in this population, with 44%, 24%, 25%, and 6% reporting no, mild, moderate, and severe side effects respectively. Discussion: These findings demonstrate robust immunogenicity to additional doses of SARS-CoV-2 vaccine, even amongst patients with undetectable antibody following the initial series. Adverse event rates were low. These data can be used to inform vaccine decisions in patients with a broad array of immune-medicated conditions frequently managed by immunosuppression. (Table Presented) (Figure Presented)
ABSTRACT
Introduction: Individuals on immunosuppression were excluded from COVID-19 vaccine clinical trials which led to their emergency use authorization (EUA). As a result, patients with inflammatory bowel disease (IBD) who are frequently treated with immune suppressing medications have questions about COVID-19 vaccine effectiveness. Data of vaccine effectiveness and immune response in the IBD population are urgently needed to guide vaccination strategies. This study aimed to assess serologic response after completion of COVID-19 vaccine series in a large IBD population across the US. Methods: Partnership to Report Effectiveness of Vaccination in populations Excluded from iNitial Trials of COVID (PREVENT-COVID) is a prospective observational cohort study of IBD patients who received any COVID-19 vaccine granted EUA in the US. Enrolled participants had the option to provide serum samples to evaluate antibody development 8 weeks following completion of COVID-19 vaccine series. Quantitative analysis of anti-receptor binding domain (RBD) IgG antibodies specific to SARS-CoV-2 was performed using the LabCorp Cov2Quant IgG assay. Qualitative assessment of nucleocapsid antibodies as an indicator of past infection was also completed. This analysis included participants who completed vaccination series and laboratory testing prior to 6/17/ 21. Individuals who reported prior COVID infection and/or had positive nucleocapsid antibody were excluded. Descriptive statistics were performed to characterize the study population and antibody response. Results: A total of 788 participants with IBD (mean age 48 yrs, 73% female) were included, and 752/ 788 [95.4%, 95% confidence interval (CI) 93.7-96.7%] had detectable anti-RBD antibodies. Additional demographic characteristics and distribution of antibody response across medication classes are shown in Table 1. Antibody response was generally similar across age group, vaccine type, and IBD medication class (Figure 1);however, individuals receiving corticosteroids (n=35) had reduced antibody response with 85.7% (95% CI 70.6-93.7) having detectable antibodies vs 95.9% (95% CI 94.2-97.1) in non-steroid users. Conclusion: A vast majority of our IBD cohort including those on immunosuppressive therapies demonstrated humoral immune response after completion of COVID-19 vaccine series. Longer term data are needed to assess durability of antibody response, but this emerging data provides reassurance that most IBD medications do not significantly diminish response to COVID-19 vaccination.