Durability analysis of the highly effective mRNA-1273 vaccine against COVID-19.

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 ORNon-COVID Hospitalization: 0.68, 95% CI: 0.47-1.0; Day 250 ORNon-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.

Durability analysis of the highly effective BNT162b2 vaccine against COVID-19.

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.

Psychologic wellness of PA, NP, and physician hospitalists during the COVID-19 pandemic.

OBJECTIVES: Hospitalists, comprising PAs, NPs, and physicians, manage patients hospitalized with COVID-19. To guide the development of support programs, this study compared the psychologic wellness of hospitalist PAs, NPs, and physicians during the COVID-19 pandemic. METHODS: We surveyed hospitalists in 16 hospitals at Mayo Clinic, from May 4 to 25, 2020. We used PROMIS surveys for self-reported global well-being (two single-item measures), anxiety, social isolation, and emotional support, before and during the pandemic. Linear and logistic regression models were adjusted for personal and professional factors. RESULTS: The response rate was 52.2% (N = 154/295). In adjusted linear regression models, the change in scores (before minus during pandemic) for anxiety, social isolation, and emotional support was similar for PAs and NPs compared with physicians. In adjusted logistic regression models, physicians, compared with PAs and NPs, had a higher odds of top global well-being for mental health (adjusted odds ratio [95% confidence interval]: 2.82 [1.12, 7.13]; P = .03) and top global well-being for social activities and relationships (adjusted odds ratio 4.08 [1.38, 12.08]; P = .01). CONCLUSIONS: During the COVID-19 pandemic, global well-being was lower for PAs and NPs compared with physician hospitalists. These results can guide support programs for hospitalists.

Surveillance of Safety of 3 Doses of COVID-19 mRNA Vaccination Using Electronic Health Records.

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.

Wellness of hospitalists and hospital medicine advanced practice providers during the COVID-19 pandemic, 2020-2021.

BACKGROUND: The early phase of the coronavirus disease 2019 (COVID-19) pandemic had a negative impact on the wellness of hospitalists and hospital medicine advanced practice providers (APPs). However, the burden of the pandemic has evolved and the change in hospitalist and hospital medicine APP wellness is unknown. OBJECTIVE: To evaluate the longitudinal trend in wellness of hospitalists and hospital medicine APPs during the COVID-19 pandemic and guide wellness interventions. DESIGN, SETTING AND PARTICIPANTS: Between May 4, 2020, and June 6, 2021, we administered three surveys to Internal Medicine hospitalists (physicians) and hospital medicine APPs (nurse practitioners and physician assistants) at 16 Mayo Clinic hospitals in four U.S. states. MEASUREMENTS: We evaluated the association of hospitalist and hospital medicine APP characteristics with PROMIS® measures of global wellbeing-mental health, global wellbeing-social activities and relationships, anxiety, social isolation, and emotional support, using logistic and linear regression models. RESULTS: The response rates were 52.2% (n=154/295; May 2020), 37.1% (n=111/299; October 2020) and 35.5% (n=114/321; May 2021). In mixed models that included hospitalist and hospital medicine APP characteristics and survey period, APPs, compared with physicians, had lower odds of top global wellbeing-social activities and relationships (adjusted odds ratio 0.42 [0.22-0.82]; p = .01), whereas survey period showed no association. The survey period showed an independent association with higher anxiety (May 2020 vs. others) and higher social isolation (October 2020 vs. others), whereas profession showed no association. Concern about contracting COVID-19 at work was significantly associated with lower odds of top global wellbeing-mental health and global wellbeing-social activities and relationships, and with higher anxiety and social isolation. Hospitalist and hospital medicine APP characteristics showed no association with levels of emotional support. CONCLUSIONS: In this longitudinal assessment of hospitalists and hospital medicine APPs, concern about contracting COVID-19 at work remained a determinant of wellness. The trend for global wellbeing, anxiety, and social isolation may guide wellness interventions.

Comparative effectiveness of mRNA-1273 and BNT162b2 against symptomatic SARS-CoV-2 infection.

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 (VEmRNA-1273: 84.1%, 95% confidence interval [CI]: 81.6%-86.2%; VEBNT162b2: 75.6%, 95% CI: 72.2%-78.7%), but their effectiveness was reduced during July-September (VEmRNA-1273: 75.6%, 95% CI: 70.1%-80%; VEBNT162b2: 63.5%, 95% CI: 55.8%-69.9%) as compared to December-May (VEmRNA-1273: 93.7%, 95% CI: 90.4%-95.9%; VEBNT162b2: 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.

Hospitalist perspectives on barriers to recommend and potential benefit of the COVID-19 vaccine.

Background: Hospitalists, comprised of nurse practitioners and physician assistants (collectively, advanced practice providers [APPs]) and physicians, have opportunities to counsel patients and reduce SARS-CoV-2 related coronavirus disease 2019 (COVID-19) vaccine hesitancy. However, hospitalist perspectives on the COVID-19 vaccine and potential differences between APPs and physicians are unknown. Understanding hospitalist perspectives could help to address vaccine hesitancy among patients.Methods: We conducted an online survey of hospitalists at Mayo Clinic sites in Arizona, Florida, Minnesota, and Wisconsin from 14 December 2020 through 4 January 2021. We collected demographic information and assessed perspectives on the COVID-19 vaccine and, for comparison, on the influenza vaccine. Descriptive statistics were used to compare responses between APPs and physicians.Results: The overall response rate was 42.7% (n = 128/300) and comprised of 53.9% women (n = 69/128) and 41.4% APPs (n = 53/128). Most hospitalists reported receiving or planning to receive vaccination against COVID-19 (93.7%; n = 119/128) and influenza (97.7%; n = 125/128). Most hospitalists reported they would advise 100% of patients to receive the COVID-19 vaccine (66% for APPs; 74.7% for physicians) and influenza vaccine (83% for APPs; 80% for physicians). Barriers to recommending the COVID-19 vaccine included patient health status and vaccine safety profile. Hospitalists reported that patients and coworkers receiving the COVID-19 vaccine would reduce their anxiety (~80% of hospitalists), social isolation (~64% of hospitalists), and improve their emotional support (~40% of hospitalists). APP and physician responses were similar. The possible reduction in social isolation was associated with higher odds of hospitalists advising all patients to receive the COVID-19 vaccine (adjusted odds ratio 2.95 [95% confidence interval, 1.32-6.59]; P< .008), whereas hospitalist age, gender, and profession showed no association.Conclusion: Most hospitalists would reportedly advise patients to receive the COVID-19 vaccine. Barriers to this recommendation included patient health status and vaccine safety. Hospitalists are an important resource to provide patient education and reduce COVID-19 vaccine hesitancy.

Prevalence of SARS-CoV-2 Antibodies in a Multistate Academic Medical Center.

OBJECTIVE: To estimate the seroprevalence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies in health care personnel. METHODS: The Mayo Clinic Serology Screening Program was created to provide a voluntary, two-stage testing program for SARS-CoV-2 antibodies to health care personnel. The first stage used a dried blood spot screening test initiated on June 15, 2020. Those participants identified as reactive were advised to have confirmatory testing via a venipuncture. Venipuncture results through August 8, 2020, were considered. Consent and authorization for testing was required to participate in the screening program. This report, which was conducted under an institutional review board-approved protocol, only includes employees who have further authorized their records for use in research. RESULTS: A total of 81,113 health care personnel were eligible for the program, and of these 29,606 participated in the screening program. A total of 4284 (14.5%) of the dried blood spot test results were "reactive" and warranted confirmatory testing. Confirmatory testing was completed on 4094 (95.6%) of the screen reactive with an overall seroprevalence rate of 0.60% (95% CI, 0.52% to 0.69%). Significant variation in seroprevalence was observed by region of the country and age group. CONCLUSION: The seroprevalence for SARS-CoV-2 antibodies through August 8, 2020, was found to be lower than previously reported in other health care organizations. There was an observation that seroprevalence may be associated with community disease burden.

Psychological wellness of internal medicine hospitalists during the COVID-19 pandemic.

BACKGROUND: Patients with COVID-19 infection requiring in-hospital care are frequently managed by Internal Medicine hospitalists, comprised of physicians, nurse practitioners and physician assistants. There is sparse information on the psychological impact of the COVID-19 pandemic on Internal Medicine hospitalists. METHODS: We surveyed Internal Medicine hospitalists at Mayo Clinic sites in four states (Arizona, Florida, Minnesota, and Wisconsin). We collected demographic information, and used Patient-Reported Outcomes Measurement Information System (PROMIS®) measures to assess global well-being, anxiety, social isolation, and emotional support. Descriptive statistics were used to compare responses between two periods: prior to the pandemic (before March 15th, 2020), and during the pandemic (March 15 through 30 April 2020). The survey was conducted from May 4-25, 2020. RESULTS: Of 295 Internal Medicine hospitalists, 154 (52%) responded. Fifty-six percent were women (n = 85/154) and 54% were physicians (n = 84/154). Most hospitalists (75%; n = 115/154) reported concerns about contracting COVID-19 infection at work, and 5% (n = 8/154) reported changing where they lived during the pandemic. Most hospitalists (73%; n = 112/154) reported relying primarily on institutional resources for COVID-19 information. During the pandemic, the percentage of participants with excellent or very good global well-being decreased (90% prior to pandemic vs. 53% during pandemic), with increases in mean anxiety (-4.88 [95% confidence interval, - 5.61 to - 4.16]; P<.001) and social isolation (-3.91[95% confidence interval, - 4.68 to - 3.13]; P<.001). During the same period, there was a small decrease in mean emotional support (1.46 [95% confidence interval, 0.83 to 2.09]; P<.001). CONCLUSION: During the COVID-19 pandemic, Internal Medicine hospitalists reported lower global well-being, higher anxiety and social isolation, and a small decrease in emotional support. These results provide a framework to develop programs to support hospitalists and potentially mitigate long-term psychological sequelae including burnout.