Impact of the COVID-19 pandemic on human papillomavirus (HPV) vaccination among a national sample of United States adults ages 18–45: A cross-sectional study

To assess how the COVID-19 pandemic affected catch-up HPV vaccination among age-eligible adults (ages 18–45). The current study leverages a national, cross-sectional sample of US adults ages 18–45 years to assess the prevalence and determinants of COVID-19 pandemic-related disruptions to catch-up HPV vaccination in 2021. The sample was restricted to adults intending to receive the HPV vaccine. Multinomial logistic regression analysis was conducted to assess the probability of 1) pandemic-related HPV vaccination disruption and 2) uncertainty about pandemic-related HPV vaccination disruption. Report of ‘no pandemic-related HPV vaccination disruption' served as the reference category. Among adults intending to get the HPV vaccine (n = 1,683), 8.6 % reported pandemic-related HPV vaccination disruption, 14.7 % reported uncertainty about vaccination disruption, and 76.7 % reported no disruption. Factors associated with higher odds of pandemic-related vaccination disruption included non-English language preference (OR: 3.20;95 % CI: 1.99–5.13), being a parent/guardian (OR: 1.77;95 % CI: 1.18–2.66), having at least one healthcare visit in the past year (OR: 1.97;95 % CI: 1.10–3.53), being up-to-date on the tetanus vaccine (OR: 1.81;95 % CI: 1.19–2.75), and being a cancer survivor (OR: 2.57;95 % CI: 1.52–4.34). Catch-up HPV vaccination for age-eligible adults is a critical public health strategy for reducing HPV-related cancers. While a small percentage of adults reported pandemic-related disruptions to HPV vaccination, certain adults (e.g., individuals with a non-English language preference and cancer survivors) were more likely to report a disruption. Interventions may be needed that increase accessibility of catch-up HPV vaccination among populations with reduced healthcare access during the pandemic. © 2022 The Authors

Quick Thinking: How the Pediatric Intensive Care Unit Adapted Simulation for the Pandemic

Purpose/Objectives: The creation of a biocontainment unit (BCU) team was established for the preparation of care for patients with highly infectious diseases in 2014. When the COVID-19 pandemic surfaced, the nursing and physician leadership from the BCU and the MICU designed simulations around the safe provision of care during aerosol generating procedures (AGPs) in emergent situations. These low fidelity simulation sessions helped to prepare clinicians based on real life scenarios when intubating and coding a patient with COVID-19. The purpose of this was to successfully prepare PICU staff to safely care for patients receiving AGPs during an emergency through quick 30- minute simulations in situ. The goal of these simulations was to practice limiting the number of people in the patient room to minimize exposure risk to staff, while still maintaining highquality communication among all team members during emergency situations. Design/Methods: The simulation sessions occurred on the PICU in an empty bed space with ICU team members during their shift. Simulation offerings occurred during the day and night shifts. For each simulation session, feedback from the multidisciplinary team allowed for iterative changes to be made to the procedural checklist used in everyday practice for intubation. These sessions also identified multiple communication barriers from occurring both inside and outside of the patient room. These communication issues were addressed through real time debriefing and by trialing creative, thoughtful solutions during subsequent simulation sessions such as using wireless headsets and scannable QR codes to zoom calls. A survey sent by the Survey Monkey™ software was given to all participants to determine the effectiveness of these simulations and changes that needed to take place in the future. Results: Survey responses were received from 21 of 42 clinicians who attended the simulations. 90% of clinicians indicated they felt comfortable with the intubation checklist modifications with regard to intubation being considered an AGP. The clinicians all indicated they were comfortable with the new techniques being taught to them in the scenarios. 90% of clinicians understood their roles in the emergency situation and felt they were more prepared for critical care situations involving patients on or receiving AGPs. Conclusion/Discussion: In the event, that the PICU is faced with the inability to utilize simulation spaces in the future, there is an ability now to offer simulation in situ on the PICU itself. The use of Zoom calls to an iPad into the room of a critically ill patient on airborne precautions has been extremely useful in maintaining communication with the rest of the PICU team outside of the room, while minimizing the clinicians required in the room.

Immunogenicity of Sars-Cov-2 mRNA 1273 Vaccine in Patients with Lymphoid Malignancies

Introduction: Patients (pts) with hematological malignancies (HMs) are at increased risk for severe COVID19 infection and death (Grivas, 2021). Currently, vaccination represents the most effective prevention approach. HM pts have been shown to have lower immune responses to COVID19 vaccine, particularly those with lymphoid malignancies (LMs) (Herishanu, 2021;Thakkar 2021;Tzarfari 2021). We conducted an observational cohort study at Moffitt Cancer Center (MCC) to evaluate the immune response following one and two doses of the mRNA1273 (Moderna) vaccine in cancer pts. Here we report the results for pts with LMs and assessed associated factors. Methods: MCC pts who presented for the first mRNA-1273 vaccine dose from 1/12/2021-1/25/2021 and who provided consent were enrolled. Blood samples were collected prior to the 1 st and 2 nd doses (Days 1 and 29) and ~28 days after the 2 nd dose (Day 57). The IgG response against the SARS-CoV-2 spike (S) protein was measured using a two-step ELISA adapted from the Krammer (Icahn School of Medicine at Mount Sinai) protocol. The total 103 LM pts who received both vaccine doses and had samples at all time points were included in analyses. The 214 pts with solid tumors (ST) were included as comparison. Associations of seroconversion (SV) rates with pt characteristics were evaluated using the Fisher exact test or Chi-square test as appropriate. Associations of antibody (Ab) titers with pt characteristics were examined using Kruskal Wallis test. Factors independently associated with SV rates were evaluated using multivariable logistic regression. All analyses were performed using SAS 9.4 and R studio. Results: Baseline characteristics, cancer treatments and SV rates by these factors are listed in Tables 1 and 2. 55 pts had B-cell non-Hodgkin lymphoma (B-NHL), 23 had chronic lymphocytic leukemia (CLL), 15 had T- or NK-cell lymphoma (T/NK lymphoma) and 10 had Hodgkin lymphoma (HL). SV rates were significantly lower for LM pts compared to ST pts (49.5% vs 86.9% after the 1st dose and 68.9% vs 98.1% after the 2 nd dose, respectively, p<0.0001 for both doses). Pts with CLL and B-NHL had the lowest SV rates (21.7% and 43.6% after dose 1 and 65.2% and 58.2% after dose 2, respectively). None of the 11 pts on anti-CD20 monoclonal Ab (mAb) seroconverted after 2 doses. Pts on BTK inhibitors (BTKi) or PI3K inhibitors (PI3Ki) or venetoclax also had low SV rates [4/12 (33.3%) after 2 doses]. Only 1 out of the 8 pts post CAR-T seroconverted, despite the fact that 6 pts had CAR-T >12 months ago and 6 pts were in remission and have not received any cancer treatment after CAR-T. Pts with CLL and B-NHL but not on CD20 mAb/BTKi/PI3Ki/venetoclax or post CAR-T had much higher SV rates (31.3-60.5% after dose 1 and 79.0-81.3% after dose 2, Table 3). Other factors associated with lack of SV after 2 doses included: lymphocyte <1 x 10 9/L, low IgG level and on anticancer treatment within 3 months. Multivariate analyses showed that diagnosis of CLL or B-NHL compared to ST, CAR-T and CD20 mAb/BTKi/PI3Ki/venetoclax were independently associated with decreased SV after 2 doses (Table 4). In the univariate model, Ab titers after 1 and 2 doses were significantly lower in pts with diagnosis of CLL/B-NHL, low lymphocyte count, low IgG and on cancer treatment (Figures 1-3). HL and T/NK lymphoma had titers comparable to solid tumors (Figure 1). Conclusions: Pts with CLL and B-NHL had low SV rates and Ab titers after receiving the mRNA-1273 vaccine when compared with ST, HL and T/NK-lymphoma. Current or past treatments with CD20 mAb/BTKi/PI3Ki/venetoclax and CAR-T were associated with lower immune response, with pooled SV rates of 16.7% after 2 doses. In general, LM pts had lower SV rates and Ab titers after the 1 st dose vs ST, but responses improved after the 2 nd dose. Further studies are needed to improve immune responses to COVID19 vaccines in LM pts, including the potential role of a 3 rd booster dose. [Formula presented] Disclosures: Gaballa: Adaptive Biotechnologies: Research Funding;Epizyme: Consultancy, Resear h Funding;TG therapeutics: Consultancy, Speakers Bureau;Beigene: Consultancy;ADC Therapeutics: Consultancy. Saeed: Bristol-Myers Squibb Company: Consultancy;sano-aventis U.S.: Consultancy, Membership on an entity's Board of Directors or advisory committees;Janssen Pharmaceutica Products, LP: Consultancy, Other: investigator;Celgene Corporation: Consultancy, Other: investigator;MEI Pharma Inc: Consultancy, Other: investigator;Kite Pharma: Consultancy, Other: investigator;Other-TG therapeutics: Consultancy, Other: investigator;Nektar Therapeutics: Consultancy, Other: research investigator;MorphoSys AG: Consultancy, Membership on an entity's Board of Directors or advisory committees;Other-Epizyme, Inc.: Consultancy;Other-Secura Bio, Inc.: Consultancy;Seattle Genetics, Inc.: Consultancy, Membership on an entity's Board of Directors or advisory committees. Shah: Pharmacyclics/Janssen: Honoraria, Other: Expenses;Pfizer: Consultancy, Other: Expenses;BeiGene: Consultancy, Honoraria;Servier Genetics: Other;Jazz Pharmaceuticals: Research Funding;Precision Biosciences: Consultancy;Amgen: Consultancy;Kite, a Gilead Company: Consultancy, Honoraria, Other: Expenses, Research Funding;Acrotech/Spectrum: Honoraria;Novartis: Consultancy, Other: Expenses;Bristol-Myers Squibb/Celgene: Consultancy, Other: Expenses;Adaptive Biotechnologies: Consultancy;Incyte: Research Funding. Locke: Janssen: Consultancy, Other: Scientific Advisory Role;BMS/Celgene: Consultancy, Other: Scientific Advisory Role;EcoR1: Consultancy;Allogene Therapeutics: Consultancy, Other: Scientific Advisory Role, Research Funding;Calibr: Consultancy, Other: Scientific Advisory Role;Amgen: Consultancy, Other: Scientific Advisory Role;Bluebird Bio: Consultancy, Other: Scientific Advisory Role;Umoja: Consultancy, Other;Cowen: Consultancy;Kite, a Gilead Company: Consultancy, Other: Scientific Advisory Role, Research Funding;Emerging Therapy Solutions: Consultancy;Gerson Lehrman Group: Consultancy;Moffitt Cancer Center: Patents & Royalties: field of cellular immunotherapy;Iovance Biotherapeutics: Consultancy, Other: Scientific Advisory Role;GammaDelta Therapeutics: Consultancy, Other: Scientific Advisory Role;Cellular Biomedicine Group: Consultancy, Other: Scientific Advisory Role;Wugen: Consultancy, Other;Takeda: Consultancy, Other;Novartis: Consultancy, Other, Research Funding;Legend Biotech: Consultancy, Other. Chavez: Abbvie: Consultancy;AstraZeneca: Research Funding;Kite/Gilead: Consultancy;Karyopharm Therapeutics: Consultancy;MorphoSys: Speakers Bureau;Epizyme: Speakers Bureau;Bristol Myers Squibb: Speakers Bureau;Merck: Research Funding;Adaptive: Research Funding;BeiGene: Speakers Bureau;Novartis: Consultancy;ADC Therapeutics: Membership on an entity's Board of Directors or advisory committees, Research Funding. Lancet: AbbVie: Consultancy;ElevateBio Management: Consultancy;Daiichi Sankyo: Consultancy;Celgene/BMS: Consultancy;Millenium Pharma/Takeda: Consultancy;BerGenBio: Consultancy;Agios: Consultancy;Astellas: Consultancy;Jazz: Consultancy. Sokol: Dren Bio: Membership on an entity's Board of Directors or advisory committees;Kyowa-Kirin: Membership on an entity's Board of Directors or advisory committees. Pinilla Ibarz: AbbVie, Janssen, AstraZeneca, Novartis, TG Therapeutics, Takeda: Consultancy, Other: Advisory;Sellas: Other: ), patents/royalties/other intellectual property;MEI, Sunesis: Research Funding;AbbVie, Janssen, AstraZeneca, Takeda: Speakers Bureau. Giuliano: Merck & CO: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding.

Responses to Sars-Cov-2 Vaccines in Patients with Myelodysplastic Syndrome and Acute Myeloid Leukemia

Introduction: Patients with myeloid malignancies, including acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), are at a high risk of severe SARS-CoV-2 infection. It is uncertain whether patients with AML and MDS, who frequently have quantitative or qualitative deficiencies of neutrophils and/or lymphocytes, will develop protective immunity from SARS-CoV-2 vaccines. The primary aim of this analysis was to describe the immune response and safety profile to the mRNA-1273 vaccine amongst a cohort of patients with AML and MDS. Methods: We enrolled AML and MDS patients to a large, single-site observational study of mRNA-1273 vaccination in cancer patients during the period January 12 to January 25, 2021. Blood specimens were collected from patients prior to the first and second vaccine doses (Days 1 and 29) and ~28 days after the second vaccine dose (Day 57) for antibody analyses. Retrospective chart review was done to collect information on baseline characteristics, cancer diagnoses, treatments received, and disease status. To evaluate serostatus, a two-step ELISA was performed, measuring IgG responses. SARS-CoV-2 antibody positivity rates were compared using the Fisher exact test or Chi-square test. The association of SARS-CoV-2 antibody titer and patient characteristics was examined by using Kruskal-Wallis test. Paired t-test was used to analyze the difference of SARS-CoV-2 antibody titers among day 1, after dose 1 and dose 2. Results: A total of 46 patients, 30 patients with AML and 16 patients with MDS, were included in this study. The median age at vaccination for the entire cohort was 68 yrs (range 37-85 yrs). The majority of patients were males (58.7%) and Caucasians (95.7%). Table 1 describes the baseline characteristics of the patients. The median time from diagnosis to the start of vaccination series was 24.3 months (range 4.5-105). One third of the patients (32.6%, n=15) were on active treatment for their disease during the course of vaccination with hypomethylating agents (n=6;13%), erythroid maturation agent i.e. luspatercept (n=2, 4.3%), immunomodulatory drugs i.e. lenalidomide (n=1;2.2%) and targeted therapy (6;13%). Targeted therapy included patients on enasidenib (n=4), midostaurin (n=1) and gilteritinib (n=1). A total of 32 patients (69.6%) were post allogeneic stem cell transplantation for their disease. The median time since allo-SCT for the entire cohort was 17 months (4.9-75.8 mos). The majority of the patients (n=40, 87%) were in remission at the time of vaccination. We found that two patients with AML relapsed post vaccination. Overall, 69.6% patients were seropositive at day 29 (after first vaccine dose) and 95.7% patients were seropositive on day 57 (after 2 vaccine doses). Table 2 describes response to the vaccine in our cohort and the differences in seropositivity rate after one and two doses of vaccine, based upon disease characteristics. Age, gender, race, disease status, time to vaccination from disease diagnosis, number of prior lines of therapy, whether on active treatment, laboratory parameters (including ALC and ANC), whether the patient had undergone allo-SCT, and therapy at time of vaccination did not significantly affect the seropositivity rate. Antibody titer levels were significantly higher after the 2 nd vaccine dose than after 1 st dose (mean 3806.5 vs 315, p<0.0001), a difference that was observed across the different variables and patient subsets (Figure 1). Mild injection site pain, fatigue, headache and arm swelling were the most common adverse events post vaccination. Conclusion: In this observational study, the largest reported to date amongst AML and MDS patients with serial serologic data following 2 vaccine doses, we found that the vast majority of patients with AML and MDS converted to seropositivity after two doses of the vaccine. Although the overall sample size was relatively small, most clinical and laboratory variables (including neutropenia and lymphopenia) did not affect the seropositivity rate. Antibody titer levels increased dramatically follo ing the 2 nd vaccine dose, indicating the potential utility for serial vaccination (i.e. additional dosing) in poorly-responsive patients. While these findings should be substantiated in a larger cohort, mRNA-273 SARS-CoV-2 vaccine appears to induce a strong humoral response in this population of patients with AML and MDS. [Formula presented] Disclosures: Komrokji: PharmaEssentia: Membership on an entity's Board of Directors or advisory committees;Geron: Consultancy;Novartis: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees;Acceleron: Consultancy;Jazz: Consultancy, Speakers Bureau;Taiho Oncology: Membership on an entity's Board of Directors or advisory committees;AbbVie: Consultancy;BMSCelgene: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Sweet: Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees;AROG: Membership on an entity's Board of Directors or advisory committees;Gilead: Membership on an entity's Board of Directors or advisory committees;Astellas: Consultancy, Membership on an entity's Board of Directors or advisory committees;Bristol Meyers Squibb: Honoraria, Membership on an entity's Board of Directors or advisory committees. Sallman: Incyte: Speakers Bureau;AbbVie: Membership on an entity's Board of Directors or advisory committees;Aprea: Membership on an entity's Board of Directors or advisory committees, Research Funding;Bristol-Myers Squibb: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau;Agios: Membership on an entity's Board of Directors or advisory committees;Intellia: Membership on an entity's Board of Directors or advisory committees;Kite: Membership on an entity's Board of Directors or advisory committees;Magenta: Consultancy;Novartis: Consultancy, Membership on an entity's Board of Directors or advisory committees;Syndax: Membership on an entity's Board of Directors or advisory committees;Shattuck Labs: Membership on an entity's Board of Directors or advisory committees;Takeda: Consultancy. Padron: Taiho: Honoraria;Kura: Research Funding;BMS: Research Funding;Blueprint: Honoraria;Incyte: Research Funding;Stemline: Honoraria. Kuykendall: BluePrint Medicines: Honoraria, Speakers Bureau;Abbvie: Honoraria;Celgene/BMS: Honoraria, Speakers Bureau;CTI Biopharma: Honoraria;Incyte: Consultancy;Novartis: Honoraria, Speakers Bureau;Protagonist: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding;Prelude: Research Funding;PharmaEssentia: Honoraria. Giuliano: Merck & CO: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding. Lancet: Daiichi Sankyo: Consultancy;BerGenBio: Consultancy;Celgene/BMS: Consultancy;Millenium Pharma/Takeda: Consultancy;Agios: Consultancy;ElevateBio Management: Consultancy;AbbVie: Consultancy;Astellas: Consultancy;Jazz: Consultancy.