Background: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is associated with increased morbidity and mortality in solid organ transplant (SOT) recipients. Despite exclusion from SARS-CoV-2 vaccine clinical trials, these individuals were identified as high-risk and prioritized for vaccination in public health guidelines. Methods:We prospectively evaluated humoral and cellular immune responses to two doses of the SARS-CoV-2 mRNA vaccine, BNT162b2, in 56 SOT recipients and 26 healthy controls (HCs). Blood specimens collected from participants prior to each dose and following the second dose were tested for SARS-CoV-2-specific antibodies, as well as CD4+ and CD8+ T-cell responses.Results: SOT recipients demonstrated lower mean anti-SARS-CoV-2 antibody levels compared to HCs after each dose, and only 21.6% achieved an antibody response after the second dose within the range of HC responses. Similarly, the percentage of responsive CD4+ and CD8+ T cells in SOT recipients was lower than in HCs. While most HCs showed notable humoral and cellular responses, responses were less concordant in

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Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is associated with increased morbidity and mortality in immunocompromised individuals, including solid organ transplant recipients (SOTR). Despite being excluded from phase 1-3 SARS-CoV-2 vaccine clinical trials, SOTR were identified as high-risk populations and prioritized for vaccination in public health guidelines. We aimed to evaluate the antibody response to two doses of the BNT162b2 (Pfizer-BioNTech) vaccine in SOTR as compared to healthy controls (HC). Methods SOTR and HC scheduled to receive two doses of BNT162b2 vaccine and able to complete required follow-up visits were enrolled. Blood specimens were collected from participants before receiving the first and second doses and 21-42 days after the second dose. Enzyme-linked immunosorbent assay (ELISA) was used to detect immunoglobulin G (IgG) to the SARS-CoV-2 spike receptor-binding domain (RBD). Generalized estimating equations with a working independence correlation structure were used to compare anti-RBD IgG levels between SOTR and HC at each study visit and within each group over time. All models were adjusted for age, sex, and pre-vaccination seroreactivity in the ELISA. Results A total of 54 SOTR and 26 HC were enrolled, with mean (SD) ages of 72 (3.6) and 62 (6.7) years, 61% and 35% were male, and 91% and 88% were white, respectively. The most common organ transplant types were kidney (41%) and liver (37%). All SOTR were receiving calcineurin inhibitors. The median time post-transplantation was 7 years. SOTR had markedly lower mean anti-RBD IgG levels when compared to HC with adjusted mean differences of -0.76 (95%CI: [-1.04, -0.47]; p < 0.001) ELISA units (EU) and -1.35 (95%CI [-1.68, -1.01]; p < 0.001) EU after the first and second doses, respectively (Figure 1). Both groups had a significant increase in anti-SARS-CoV-2 IgG levels after the second dose. However, the magnitude was lower in SOTR, 0.49 (95%CI [0.31, 0.69]; p < 0.001) EU than in HCs, 1.08 (95% CI [0.91, 1.24]; p < 0.001) EU. Figure 1. Anti-SARS-CoV-2 RBD IgG levels in solid organ transplant recipients and healthy controls before receiving the BNT162b2 vaccine (baseline), post-vaccine dose 1, and post-vaccine dose 2. Conclusion Our study showed SOTR mounted weaker humoral immune responses than HC to SARS-CoV-2 vaccines. Given a lower response, SOTR should continue to practice social distancing and masking until data on vaccine efficacy are available in this vulnerable population. Disclosures Natasha B. Halasa, MD, MPH, Genentech (Other Financial or Material Support, I receive an honorarium for lectures - it's a education grant, supported by genetech)Quidel (Grant/Research Support, Other Financial or Material Support, Donation of supplies/kits)Sanofi (Grant/Research Support, Other Financial or Material Support, HAI/NAI testing) Natasha B. Halasa, MD, MPH, Genentech (Individual(s) Involved: Self): I receive an honorarium for lectures - it's a education grant, supported by genetech, Other Financial or Material Support, Other Financial or Material Support; Sanofi (Individual(s) Involved: Self): Grant/Research Support, Research Grant or Support

Background Regardless of severity of acute SARS-CoV-2 illness, adults infected with SARS-CoV-2 are at risk for post-acute sequelae of COVID-19. Long COVID is typically classified as symptoms lasting greater than four weeks post-infection. We aimed to evaluate the frequency of resolved and unresolved long COVID symptoms in adults residing in greater Nashville, TN. Methods We conducted a longitudinal cohort study of SARS-CoV-2-positive and exposed individuals from March 20 to May 15, 2020. Participants for this analysis were included if: 1) ≥18 years; 2) SARS-CoV-2 positive by molecular or antibody testing; and 3) completed a one-year visit. Demographic and illness information were collected at enrollment, and long COVID symptoms were systematically collected at the one-year survey. Long COVID symptoms are defined as an adult experiencing at least one of the following symptoms four weeks post-infection: fatigue, confusion, loss of smell or taste, shortness of breath, chest pain, cough, muscle aches, inability to exercise, or heart palpitations. Unresolved symptoms are defined as an individual with long COVID still experiencing symptoms at the one-year visit. Results A total of 115 adults enrolled and completed the one-year survey, of which 63 (54.8%) were SARS-CoV-2-positive, with one asymptomatic individual. Of SARS-CoV-2-positive symptomatic adults, 32 (51%) were female, 5 (88%) were of Hispanic ethnicity, and 58 (92%) were white. At the one-year visit, 33 (52%) reported having long COVID, of which 17 (52%) reported having unresolved symptoms. Fatigue (89%), headache (89%), muscle aches (79%), and cough (77%) were the most common symptoms reported at illness onset (Figure 1). Among 33 adults with long COVID, fatigue (42%), loss of smell (39%), and loss of taste (33%) were most common (Figure 2A). In the 17 individuals with unresolved symptoms, loss of smell (29%) and loss of taste (24%) were commonly reported (Figure 2B). Figure 1. COVID-19 symptoms reported at enrollment (n=62) Figure 2. Long COVID (symptoms lasting ≥ 4 weeks) (n=33) (A) and unresolved long COVID symptoms one-year post-infection (n=17) (B) reported on the one-year survey Conclusion Half of the adults in our cohort reported long COVID symptoms, with more than quarter of symptoms persisting one-year post-illness. Our findings support that prolonged symptoms up to year after SARS-CoV-2 exposure occur, and future studies should investigate the residual impacts of long COVID symptoms and conditions. Disclosures Natasha B. Halasa, MD, MPH, Genentech (Other Financial or Material Support, I receive an honorarium for lectures - it’s a education grant, supported by genetech)Quidel (Grant/Research Support, Other Financial or Material Support, Donation of supplies/kits)Sanofi (Grant/Research Support, Other Financial or Material Support, HAI/NAI testing) Natasha B. Halasa, MD, MPH, Genentech (Individual(s) Involved: Self): I receive an honorarium for lectures - it’s a education grant, supported by genetech, Other Financial or Material Support, Other Financial or Material Support; Sanofi (Individual(s) Involved: Self): Grant/Research Support, Research Grant or Support