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Objective: To evaluate the magnitude of humoral response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) messenger RNA (mRNA) vaccines in patients with cancer receiving active therapies. Patients and Methods: Patients 18 years or older in whom SARS-CoV-2 spike antibody (anti-S Ab) levels were measured after 2 doses of SARS-CoV-2 mRNA vaccines were included. Patients with prior coronavirus disease 2019 (COVID-19) infection or receiving other immunosuppressive therapy were excluded. Results: Among 201 patients who met the criteria, 61 were immunocompetent, 91 had a hematologic malignancy, and 49 had a solid malignancy while receiving treatments associated with cytopenia, including chemotherapy or cyclin-dependent kinase 4 and 6 inhibitors. A significantly greater proportion of immunocompetent patients (96.7% [59 of 61]) had anti-S Ab titers of 500 U/mL or greater compared to patients with hematologic (7.7% [7 of 91) and solid (55.1% [27 of 49]) malignancy (P

Summary:. Injection therapies for cosmetic enhancement, particularly antiaging treatments, are increasingly popular. However, once the needle has penetrated the skin, the injector is “blind” to the depth and exact location of the needle tip. Duplex ultrasound use before and after treatment can allow the injector to visualize in real time the individual anatomy, thereby improving and confirming the accuracy of the injections through visualization of both the target layer and the vital structures to be avoided. Previously injected permanent filler treatments can also be visualized. In this way, ultrasound use becomes an important educational tool in promoting “safer” facial injection therapy. It shifts static anatomy to mobile real-time facial anatomy, thereby establishing itself as an invaluable learning tool through follow-up imaging, with subsequent optimization in techniques and patient outcomes.

This study reports on the relationship between timing of initial hepatitis B virus (HBV) vaccine series and HBV antibody immunity in healthcare personnel (HCP) screened prior to employment. HCPs vaccinated as neonates were significantly more likely to have negative or indeterminate antibodies. An alternative screening approach is considered.

Background: Uncertainty exists regarding the effectiveness of COVID-19 vaccine to prevent postacute sequelae of COVID-19 (PASC) following a breakthrough infection. While most studies based on symptom surveys found an association between preinfection vaccination status and PASC symptoms, studies of medically attended PASC are less common and have reported conflicting findings., Methods: In this retrospective cohort of patients with an initial SARS-CoV-2 infection who were continually empaneled for primary care in a large US health system, the electronic health record was queried for preinfection vaccination status, demographics, comorbidity index, and diagnosed conditions. Multivariable logistic regression was used to model the outcome of a medically attended PASC diagnosis within 6 months of SARS-CoV-2 infection. Likelihood ratio tests were used to assess the interaction between vaccination status and prevalent variant at the time of infection and between vaccination status and hospitalization for SARS-CoV-2 infection., Results: During the observation period, 6.9% of patients experienced medically attended and diagnosed PASC. A diagnosis of PASC was associated with older age, female sex, hospitalization for the initial infection, and an increased severity-weighted comorbidity index and was inversely associated with infection during the Omicron period. No difference in the development of diagnosed PASC was observed between unvaccinated patients and those vaccinated with either 2 doses of an mRNA vaccine or >2 doses., Conclusions: We found no association between vaccination status at the time of infection and development of medically diagnosed PASC. Vaccine remains an important measure to prevent SARS-CoV-2 infection and severity. Further research is needed to identify effective measures to prevent and treat PASC., Competing Interests: Potential conflicts of interest. M. D. S. discloses a current unpaid elected position on the American College of Occupational and Environmental Medicine Board of Directors. All other authors report no potential conflicts., (© The Author(s) 2024. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)

This article is the third of 3 articles in a series about managing the care of physicians as patients. In part 1, the authors reviewed unique characteristics of physicians as patients with some general guidance for how to approach their care. Part 2 highlighted role clarity for the treating physician with discussion of the physical and cognitive issues that commonly arise when treating physician-patients along with licensure issues and reporting requirements. This final installment will focus on physician mental health and work-related stress., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

This second installment in a 3-part series about physicians as patients explores challenges in communication and role definition while managing their care and safe return to work. In the first article of the series, authors reviewed unique characteristics that make physicians different as patients, with some general guidance about how to approach their care. Although most treating physicians receive little occupational training, health issues commonly have an impact on work with imperative to address work issues promptly for best outcome. This paper demystifies the challenge of managing work status and discusses navigating common physical and cognitive issues while maintaining role clarity. The treating clinician reading this paper will learn to avoid common pitfalls and be better equipped to provide initial assessments and interventions to keep physicians working safely, keeping in mind licensure issues and reporting requirements. Part Three of the series will focus on the most common mental health issues seen in physicians., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

This is the first article of a 3-part series about physician health. In this installment, we outline the unique characteristics of physicians as patients, challenges and opportunities presented by physician-patients, and recommendations for treating physicians. Future articles will delve into role clarity, occupational considerations, mental health, and interactions with third parties such as the physician's employer or licensing board. Ultimately, this series will help treating clinicians provide the best care to their physician-patients and successfully navigate the unique challenges that may arise, especially when the diagnosis may have an impact on their ability to practice medicine., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

This retrospective cohort study describes the population of physicians seeking medical evaluation in a dedicated physician health center and identifies factors associated with needing practice restrictions. Participants had an initial evaluation between January 1, 2016, and December 31, 2022. We report personal and professional demographics and types of medical conditions in this cohort. An ordinal logistic regression analysis was used to identify factors associated with occupational outcomes. Physicians in a wide variety of specialties from 34 different states presented for evaluation of diverse medical problems. More than half of the participants presented with occupational concerns. The presence of a neurologic or psychiatric illness were the only factors associated with temporary or permanent restrictions. Physicians with medical conditions impacting their ability to practice have a professional obligation to obtain a thorough, objective medical evaluation. Such evaluations should support and protect patients, employers, and the physicians themselves., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Some patients with inflammatory bowel disease (IBD) on immunosuppressive therapies may have a blunted response to certain vaccines, including the messenger RNA (mRNA) coronavirus disease 2019 (COVID-19) vaccines. However, few studies have evaluated the cell-mediated immune response (CMIR), which is critical to host defense after COVID-19 infection. The aim of this study was to evaluate the humoral immune response and CMIR after mRNA COVID-19 vaccination in patients with IBD., Methods: This prospective study (HERCULES [HumoRal and CellULar initial and Sustained immunogenicity in patients with IBD] study) evaluated humoral immune response and CMIR after completion of 2 doses of mRNA COVID-19 vaccines in 158 IBD patients and 20 healthy control (HC) subjects. The primary outcome was the CMIR to mRNA COVID-19 vaccines in patients with IBD. The secondary outcomes were a comparison of (1) the CMIR in patients with IBD and HC subjects, (2) CMIR and humoral immune response in all participants, and (3) correlation between CMIR and humoral immune response., Results: The majority (89%) of patients with IBD developed a CMIR, which was not different vs HC subjects (94%) (P = .6667). There was no significant difference (P = .5488) in CMIR between immunocompetent (median 255 [interquartile range, 146-958] spike T cells per million peripheral blood mononuclear cells) and immunosuppressed patients (median 377 [interquartile range, 123-1440]). There was no correlation between humoral and cell-mediated immunity after vaccination (P = .5215). In univariable analysis, anti-tumor necrosis factor therapy was associated with a higher CMIRs (P = .02) and confirmed in a multivariable model (P = .02). No other variables were associated with CMIR., Conclusions: Most patients with IBD achieved CMIR to a COVID-19 vaccine. Future studies are needed evaluating sustained CMIR and clinical outcomes., (© The Author(s) 2022. Published by Oxford University Press on behalf of Crohn’s & Colitis Foundation. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Objective: The aim of the study is to identify lessons learned implementing JYNNEOS vaccination for laboratory workers exposed to orthopoxviruses such as mpox., Methods: Workers at risk of laboratory exposure were offered vaccine in a carefully planned occupational health program. Vaccine was procured from the Centers for Disease Control and Prevention (CDC) Drug Service, which has special requirements. Reasons for accepting or declining vaccine and adverse effects were obtained by survey., Results: Most workers accepted JYNNEOS, and occupational risk was the most commonly cited reason for acceptance. Most experienced mild local adverse effects. The administrative requirements of the Centers for Disease Control and Prevention Drug Service are documented., Conclusions: Occupational health programs caring for laboratory workers handling unusual biological agents require careful planning and coordination to facilitate access to vaccines that are not commercially available, anticipate and mitigate barriers to vaccination, and comply with special Centers for Disease Control and Prevention requirements., Competing Interests: Conflict of Interest: M.D.S. reports receipt of research funds for a COVID vaccine registry from Pfizer, Inc, in 2021, and an unpaid position on the ACOEM Board of Directors. No other conflicts declared., (Copyright © 2023 American College of Occupational and Environmental Medicine.)

COVID-19 vaccination remains one of the most effective tools to reduce the risk of SARS-CoV-2 infection. Unfortunately, vaccine hesitancy has limited primary vaccination and booster uptake among the general population and HCWs. To gain a better understanding of factors associated with booster vaccine uptake, we analyzed COVID-19 vaccine booster rates among HCWs and identified risk factors associated with nonacceptance. Of the 62,387 HCWs included in our analysis, the overall booster uptake rate was 64.8%. Older age, Non-Hispanic White racial group, early initial vaccine uptake and longer duration of employment were associated with higher booster uptake. Significant differences were observed between different job categories. This persistence of vaccine hesitancy and disparities in COVID-19 booster uptake among HCWs, almost 2 years after the rollout of the COVID-19 vaccination, call for further efforts to increase vaccine confidence among HCWs and the general population in light of the continued need for further COVID-19 protection., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2023 The Author(s).)

Objective: To assess the rate and factors associated with healthcare personnel (HCP) testing positive for severe acute respiratory coronavirus virus 2 (SARS-CoV-2) after an occupational exposure., Design: Retrospective cohort study., Setting: Academic medical center with sites in Minnesota, Wisconsin, Arizona, and Florida., Participants: HCP with a high or medium risk occupational exposure to a patient or other HCP with SARS-CoV-2., Methods: We reviewed the records of HCP with significant occupational exposures from March 20, 2020, through December 31, 2020. We then performed regression analysis to assess the impact of demographic and occupational variables to assess their impact on the likelihood of testing positive for SARS-CoV-2., Results: In total, 2,253 confirmed occupational exposures occurred during the study period. Employees were the source for 57.1% of exposures. Overall, 101 HCP (4.5%) tested positive in the postexposure period. Of these, 80 had employee sources of exposure and 21 had patient sources of exposure. The postexposure infection rate was 6.2% when employees were the source, compared to 2.2% with patient sources. In a multivariate analysis, occupational exposure from an employee source had a higher risk of testing positive compared to a patient source (odds ratio [OR], 3.22; 95% confidence interval [CI], 1.72-6.04). Sex, age, high-risk exposure, and HCP role were not associated with an increased risk of testing positive., Conclusions: The risk of acquiring coronavirus disease 2019 (COVID-19) following a significant occupational exposure has remained relatively low, even in the prevaccination era. Exposure to an infectious coworker carries a higher risk than exposure to a patient. Continued vigilance and precautions remain necessary in healthcare settings.

Background: Myocarditis following coronavirus disease 2019 (COVID-19) mRNA vaccines (Pfizer-BioNTech and Moderna) has been increasingly reported. Incidence rates in the general population are lacking, with pericarditis rather than myocarditis diagnostic codes being used to estimate background rates. This comparison is critical for balancing the risk of vaccination with the risk of no vaccination., Methods: A retrospective case series was performed using the Mayo Clinic COVID-19 Vaccine Registry. We measured the incidence rate ratio (IRR) for myocarditis temporally related to COVID-19 mRNA vaccination compared with myocarditis in a comparable population from 2016 through 2020. Clinical characteristics and outcomes of the affected patients were collected. A total of 21 individuals were identified, but ultimately 7 patients met the inclusion criteria for vaccine-associated myocarditis., Results: The overall IRR of COVID-19-related myocarditis was 4.18 (95% confidence interval [CI], 1.63-8.98), which was entirely attributable to an increased IRR among adult males (IRR, 6.69; 95% CI, 2.35-15.52) compared with females (IRR 1.41; 95% CI, .03-8.45). All cases occurred within 2 weeks of a dose of the COVID-19 mRNA vaccine, with the majority occurring within 3 days (range, 1-13) following the second dose (6 of 7 patients, 86%). Overall, cases were mild, and all patients survived., Conclusions: Myocarditis is a rare adverse event associated with COVID-19 mRNA vaccines. It occurs in adult males with significantly higher incidence than in the background population. Recurrence of myocarditis after a subsequent mRNA vaccine dose is not known at this time., (© The Author(s) 2021. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.)

We report the utility of rapid antigen tests (RAgT) in a cohort of US healthcare personnel with coronavirus disease 2019 (COVID-19) infection who met symptom criteria to return to work at day 5 or later of isolation. In total, 11.9% of initial RAgT were negative. RAgT can be helpful to guide return to work decisions., (© The Author(s) 2022. Published by Oxford University Press for the Infectious Diseases Society of America.)

COVID-19 vaccines are effective, but breakthrough infections have been increasingly reported. We conducted a test-negative case-control study to assess the durability of protection after full vaccination with BNT162b2 against polymerase chain reaction (PCR)-confirmed symptomatic SARS-CoV-2 infection, in a national medical practice from January 2021 through January 2022. We fit conditional logistic regression (CLR) models stratified on residential county and calendar time of testing to assess the association between time elapsed since vaccination and the odds of symptomatic infection or non-COVID-19 hospitalization (negative control), adjusted for several covariates. There were 5,985 symptomatic individuals with a positive test after full vaccination with BNT162b2 (cases) and 32,728 negative tests contributed by 27,753 symptomatic individuals after full vaccination (controls). The adjusted odds of symptomatic infection were higher 250 days after full vaccination versus at the date of full vaccination (Odds Ratio [OR]: 3.62, 95% CI: 2.52 to 5.20). The odds of infection were still lower 285 days after the first BNT162b2 dose as compared to 4 days after the first dose (OR: 0.50, 95% CI: 0.37 to 0.67), when immune protection approximates the unvaccinated status. Low rates of COVID-19 associated hospitalization or death in this cohort precluded analyses of these severe outcomes. The odds of non-COVID-19 associated hospitalization (negative control) decreased with time since vaccination, suggesting a possible underestimation of waning protection by this approach due to confounding factors. In summary, BNT162b2 strongly protected against symptomatic SARS-CoV-2 infection for at least 8 months after full vaccination, but the degree of protection waned significantly over this period., (© The Author(s) 2022. Published by Oxford University Press on behalf of the National Academy of Sciences.)

Objective: Personal protective equipment (PPE) is a critical aspect of preventing the transmission of severe acute respiratory coronavirus virus 2 (SARS-CoV-2) in healthcare settings. We aimed to identify factors related to lapses in PPE use that may influence transmission of SARS-CoV-2 from patients to healthcare personnel (HCP)., Design: Retrospective cohort study., Setting: Tertiary-care medical center in Minnesota., Participants: In total, 345 HCP who sustained a significant occupational exposure to a patient with coronavirus disease 2019 (COVID-19) from May 13, 2020, through November 30, 2020, were evaluated., Results: Overall, 8 HCP (2.3%) were found to have SARS-CoV-2 infection during their 14-day postexposure quarantine. A lack of eye protection during the care of a patient with COVID-19 was associated with HCP testing positive for SARS-CoV-2 by reverse-transcriptase polymerase chain reaction (RT-PCR) during the postexposure quarantine (relative risk [RR], 10.25; 95% confidence interval [CI], 1.28-82.39; P = .009). Overall, the most common reason for a significant exposure was the use of a surgical face mask instead of a respirator during an aerosol-generating procedure (55.9%). However, this was not associated with HCP testing positive for SARS-CoV-2 during the postexposure quarantine (RR, 0.99; 95% CI, 0.96-1; P = 1). Notably, transmission primarily occurred in units that did not regularly care for patients with COVID-19., Conclusions: The use of universal eye protection is a critical aspect of PPE to prevent patient-to-HCP transmission of SARS-CoV-2.

COVID-19 vaccines are effective, but breakthrough infections have been increasingly reported. We conducted a test-negative case-control study to assess the durability of protection against symptomatic infection after vaccination with mRNA-1273. We fit conditional logistic regression (CLR) models stratified on residential county and calendar date of SARS-CoV-2 PCR testing to assess the association between the time elapsed since vaccination and the odds of symptomatic infection, adjusted for several covariates. There were 2,364 symptomatic individuals who had a positive SARS-CoV-2 PCR test after full vaccination with mRNA-1273 ("cases") and 12,949 symptomatic individuals who contributed 15,087 negative tests after full vaccination ("controls"). The odds of symptomatic infection were significantly higher 250 days after full vaccination compared to the date of full vaccination (Odds Ratio [OR]: 2.47, 95% confidence interval [CI]: 1.19-5.13). The odds of non-COVID-19 associated hospitalization and non-COVID-19 pneumonia (negative control outcomes) remained relatively stable over the same time interval (Day 250 OR Non-COVID Hospitalization : 0.68, 95% CI: 0.47-1.0; Day 250 OR Non-COVID Pneumonia : 1.11, 95% CI: 0.24-5.2). The odds of symptomatic infection remained significantly lower almost 300 days after the first mRNA-1273 dose as compared to 4 days after the first dose, when immune protection approximates the unvaccinated state (OR: 0.26, 95% CI: 0.17-0.39). Low rates of COVID-19 associated hospitalization or death in this cohort precluded analyses of these severe outcomes. In summary, mRNA-1273 robustly protected against symptomatic SARS-CoV-2 infection at least 8 months after full vaccination, but the degree of protection waned over this time period., (© The Author(s) 2022. Published by Oxford University Press on behalf of the National Academy of Sciences.)

Background: COVID-19 vaccine uptake by healthcare workers (HCWs) is critical to protect HCWs, the patients they care for, and the healthcare infrastructure. Our study aims to examine the actual COVID-19 vaccination rate among HCWs and identify risk factors associated with vaccine nonacceptance., Study Design and Methods: A retrospective analysis of COVID-19 vaccinations for HCWs at a large multi-site US academic medical center from 12/18/2020 through 05/04/2021. Comparisons between groups were performed using unpaired student t-test for continuous variables and the chi-square test for categorical variables. A logistic regression analysis was used to assess the associations between vaccine uptake and risk factor(s)., Results: Of the 65,270 HCWs included in our analysis, the overall vaccination rate was 78.6%. Male gender, older age, White and Asian race, and direct patient care were associated with higher vaccination rates (P <.0001). Significant differences were observed between different job categories. Physicians and advanced practice staff, and healthcare professionals were more likely to be vaccinated than nurses and support staff., Conclusions: Our data demonstrated higher initial vaccination rates among HCWs than the general population national average during the study period. We observed significant disparities among different high-risk HCWs groups, especially among different job categories, black HCWs and younger HCWs despite their high risk of contracting the infection. Interventions to address lower vaccination rate and vaccine hesitancy should be built with these disparities and differences in mind to create more targeted interventions., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2022 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Importance: Recent reports on waning of COVID-19 vaccine-induced immunity have led to the approval and rollout of additional doses and booster vaccinations. Individuals at increased risk of SARS-CoV-2 infection are receiving additional vaccine doses in addition to the regimen that was tested in clinical trials. Risks and adverse event profiles associated with additional vaccine doses are currently not well understood., Objective: To evaluate the safety of third-dose vaccination with US Food and Drug Administration (FDA)-approved COVID-19 mRNA vaccines., Design, Setting, and Participants: This cohort study was conducted using electronic health record (EHR) data from December 2020 to October 2021 from the multistate Mayo Clinic Enterprise. Participants included all 47 999 individuals receiving 3-dose COVID-19 mRNA vaccines within the study setting who met study inclusion criteria. Participants were divided into 2 cohorts by vaccine brand administered and served as their own control groups, with no comparison made between cohorts. Data were analyzed from September through November 2021., Exposures: Three doses of an FDA-authorized COVID-19 mRNA vaccine, BNT162b2 or mRNA-1273., Main Outcomes and Measures: Vaccine-associated adverse events were assessed via EHR report. Adverse event risk was quantified using the percentage of study participants who reported the adverse event within 14 days after each vaccine dose and during a 14-day control period, immediately preceding the first vaccine dose., Results: Among 47 999 individuals who received 3-dose COVID-19 mRNA vaccines, 38 094 individuals (21 835 [57.3%] women; median [IQR] age, 67.4 [52.5-76.5] years) received BNT162b2 (79.4%) and 9905 individuals (5099 [51.5%] women; median [IQR] age, 67.7 [59.5-73.9] years) received mRNA-1273 (20.6%). Reporting of severe adverse events remained low after the third vaccine dose, with rates of pericarditis (0.01%; 95% CI, 0%-0.02%), anaphylaxis (0%; 95% CI, 0%-0.01%), myocarditis (0%; 95% CI, 0%-0.01%), and cerebral venous sinus thrombosis (no individuals) consistent with results from earlier studies. Significantly more individuals reported low-severity adverse events after the third dose compared with after the second dose, including fatigue (2360 individuals [4.92%] vs 1665 individuals [3.47%]; P < .001), lymphadenopathy (1387 individuals [2.89%] vs 995 individuals [2.07%]; P < .001), nausea (1259 individuals [2.62%] vs 979 individuals [2.04%]; P < .001), headache (1185 individuals [2.47%] vs 992 individuals [2.07%]; P < .001), arthralgia (1019 individuals [2.12%] vs 816 individuals [1.70%]; P < .001), myalgia (956 individuals [1.99%] vs 784 individuals [1.63%]; P < .001), diarrhea (817 individuals [1.70%] vs 595 individuals [1.24%]; P < .001), fever (533 individuals [1.11%] vs 391 individuals [0.81%]; P < .001), vomiting (528 individuals [1.10%] vs 385 individuals [0.80%]; P < .001), and chills (224 individuals [0.47%] vs 175 individuals [0.36%]; P = .01)., Conclusions and Relevance: This study found that although third-dose vaccination against SARS-CoV-2 infection was associated with increased reporting of low-severity adverse events, risk of severe adverse events remained comparable with risk associated with the standard 2-dose regime. These findings suggest the safety of third vaccination doses in individuals who were eligible for booster vaccination at the time of this study.

Objective: To evaluate the magnitude of humoral response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) messenger RNA (mRNA) vaccines in patients with cancer receiving active therapies., Patients and Methods: Patients 18 years or older in whom SARS-CoV-2 spike antibody (anti-S Ab) levels were measured after 2 doses of SARS-CoV-2 mRNA vaccines were included. Patients with prior coronavirus disease 2019 (COVID-19) infection or receiving other immunosuppressive therapy were excluded., Results: Among 201 patients who met the criteria, 61 were immunocompetent, 91 had a hematologic malignancy, and 49 had a solid malignancy while receiving treatments associated with cytopenia, including chemotherapy or cyclin-dependent kinase 4 and 6 inhibitors. A significantly greater proportion of immunocompetent patients (96.7% [59 of 61]) had anti-S Ab titers of 500 U/mL or greater compared to patients with hematologic (7.7% [7 of 91) and solid (55.1% [27 of 49]) malignancy ( P <.001). Despite 2 doses of SARS-CoV-2 mRNA vaccines, 52.7% of patients with hematologic malignancy (48 of 91) and 8.2% of those with solid malignancy (4 of 49) receiving cytopenic therapy had no seroconversion (spike antibody titers <0.8 U/mL). Two patients subsequently had development of breakthrough COVID-19 infection after full vaccination., Conclusion: A substantial proportion of patients with hematologic and solid malignancies receiving chemotherapies and CDK4/6i had poor humoral responses after SARS-CoV-2 mRNA vaccination. Our study adds to a growing body of literature suggesting that immunosuppressed patients have a suboptimal humoral response to COVID-19 vaccination. Our study also underscores the importance of assessing antibody response after COVID-19 vaccines in these vulnerable patients., (© 2021 The Authors.)

Background: mRNA coronavirus disease 2019 (COVID-19) vaccines are safe and effective, but increasing reports of breakthrough infections highlight the need to vigilantly monitor and compare the effectiveness of these vaccines., Methods: We retrospectively compared protection against symptomatic infection conferred by mRNA-1273 and BNT162b2 at Mayo Clinic sites from December 2020 to September 2021. We used a test-negative case-control design to estimate vaccine effectiveness (VE) and to compare the odds of symptomatic infection after full vaccination with mRNA-1273 versus BNT162b2, while adjusting for age, sex, race, ethnicity, geography, comorbidities, and calendar time of vaccination and testing., Findings: Both vaccines were highly effective over the study duration (VE mRNA-1273 : 84.1%, 95% confidence interval [CI]: 81.6%-86.2%; VE BNT162b2 : 75.6%, 95% CI: 72.2%-78.7%), but their effectiveness was reduced during July-September (VE mRNA-1273 : 75.6%, 95% CI: 70.1%-80%; VE BNT162b2 : 63.5%, 95% CI: 55.8%-69.9%) as compared to December-May (VE mRNA-1273 : 93.7%, 95% CI: 90.4%-95.9%; VE BNT162b2 : 85.7%, 95% CI: 81.4%-88.9%). Adjusted for demographic characteristics, clinical comorbidities, time of vaccination, and time of testing, the odds of experiencing a symptomatic breakthrough infection were lower after full vaccination with mRNA-1273 than with BNT162b2 (odds ratio: 0.60; 95% CI: 0.55-0.67)., Conclusions: Both mRNA-1273 and BNT162b2 strongly protect against symptomatic severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. It is imperative to continue monitoring and comparing available vaccines over time and with respect to emerging variants to inform public and global health decisions., Funding: This study was funded by nference., Competing Interests: A.P., P.J.L., E.S., M.J.M.N., J.C.O., A.J.V., and V.S. are employees of nference and have financial interests in the company. nference is collaborating or has collaborated with Moderna, Pfizer, Janssen, and other bio-pharmaceutical companies on data science initiatives unrelated to this study. These collaborations had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. J.C.O. receives personal fees from Elsevier and Bates College and receives small grants from nference, Inc., outside the submitted work. A.D.B. is supported by grants from NIAID (grants AI110173 and AI120698), Amfar (no. 109593), and Mayo Clinic (HH Shieck Khalifa Bib Zayed Al-Nahyan Named Professorship of Infectious Diseases). A.D.B. is a paid consultant for Abbvie, Gilead, Freedom Tunnel, Pinetree Therapeutics, Primmune, Immunome, and Flambeau Diagnostics; is a paid member of the DSMB for Corvus Pharmaceuticals, Equilium, and Excision Biotherapeutics; has received fees for speaking for Reach MD and Medscape; owns equity for scientific advisory work in Zentalis and nference; and is founder and President of Splissen Therapeutics. M.D.S. received grant funding from Pfizer via Duke University for a vaccine side effect registry. J.C.O., A.V., M.D.S., J.E.G., L.L.S., H.L.G., W.K., J.H., and A.D.B. are employees of the Mayo Clinic. The Mayo Clinic may stand to gain financially from the successful outcome of the research. This research has been reviewed by the Mayo Clinic Conflict of Interest Review Board and is being conducted in compliance with Mayo Clinic Conflict of Interest policies., (© 2021 The Authors.)