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1.
PNAS Nexus ; 1(3): pgac082, 2022 Jul.
Article in English | MEDLINE | ID: covidwho-1931892

ABSTRACT

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.

2.
Clin Infect Dis ; 2021 Nov 03.
Article in English | MEDLINE | ID: covidwho-1852978

ABSTRACT

BACKGROUND: Myocarditis following COVID-19 mRNA vaccines (Pfizer-BioNTech and Moderna) have 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 to balance the risk of vaccination with the risk of no vaccination. METHODS: A retrospective case-series was performed utilizing the Mayo Clinic COVID-19 Vaccine Registry. We measured the incidence rate ratio for myocarditis temporally related to COVID-19 mRNA vaccination compared to myocarditis in a comparable population from 2016 through 2020. Clinical characteristics and outcomes of the affected patients was collected. A total of 21 individuals were identified, but ultimately 7 patients met the inclusion criteria for vaccine-associated myocarditis. RESULTS: The overall incidence rate ratio (IRR) of COVID-19 related myocarditis was 4.18 (CI95% 1.63, 8.98) which was entirely attributable to an increased IRR among adult males (IRR 6.69, CI95% 2.35, 15.52) compared to females (IRR 1.41, CI95% 0.03, 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 days) following the second dose (6/7 patients, 86%). Overall, cases were mild, and all patients survived. CONCLUSIONS: Myocarditis is a rare adverse event associated with COVID-19 mRNA vaccines, and in adult males it occurs with significantly higher incidence than the background population rate. Recurrence of myocarditis after a subsequent mRNA vaccine dose is not known at this time.

3.
Clin Infect Dis ; 2022 Mar 30.
Article in English | MEDLINE | ID: covidwho-1852998

ABSTRACT

We report the utility of rapid antigen tests (RAgT) in a cohort of US healthcare personnel with COVID-19 infection who met symptom criteria to return to work at day 5 or later of isolation. 11.9% of initial RAgT were negative. RAgT can be helpful to guide return to work decisions.

4.
JAMA Netw Open ; 5(4): e227038, 2022 04 01.
Article in English | MEDLINE | ID: covidwho-1787607

ABSTRACT

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.


Subject(s)
COVID-19 Vaccines , COVID-19 , Aged , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Cohort Studies , Electronic Health Records , Female , Humans , Male , RNA, Messenger , SARS-CoV-2 , Vaccination/adverse effects , Vaccines, Synthetic
5.
Vaccine ; 40(19): 2749-2754, 2022 04 26.
Article in English | MEDLINE | ID: covidwho-1757920

ABSTRACT

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.


Subject(s)
COVID-19 , Vaccines , COVID-19/prevention & control , COVID-19 Vaccines , Health Personnel , Humans , Male , Retrospective Studies , SARS-CoV-2 , Vaccination
6.
Infect Control Hosp Epidemiol ; 43(6): 770-774, 2022 06.
Article in English | MEDLINE | ID: covidwho-1747341

ABSTRACT

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.


Subject(s)
COVID-19 , Virus Diseases , COVID-19/prevention & control , Delivery of Health Care , Health Personnel , Humans , Personal Protective Equipment , Retrospective Studies , SARS-CoV-2
7.
Mayo Clin Proc ; 97(5): 1021-1023, 2022 05.
Article in English | MEDLINE | ID: covidwho-1734806
8.
Infect Control Hosp Epidemiol ; : 1-5, 2022 Jan 06.
Article in English | MEDLINE | ID: covidwho-1607816

ABSTRACT

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.

9.
Mayo Clin Proc Innov Qual Outcomes ; 6(2): 120-125, 2022 Apr.
Article in English | MEDLINE | ID: covidwho-1561885

ABSTRACT

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.

10.
Med (N Y) ; 3(1): 28-41.e8, 2022 Jan 14.
Article in English | MEDLINE | ID: covidwho-1559964

ABSTRACT

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.


Subject(s)
COVID-19 , COVID-19/prevention & control , COVID-19 Vaccines/therapeutic use , Humans , Retrospective Studies , SARS-CoV-2/genetics
11.
Clin Infect Dis ; 2021 Nov 03.
Article in English | MEDLINE | ID: covidwho-1501062

ABSTRACT

BACKGROUND: Myocarditis following COVID-19 mRNA vaccines (Pfizer-BioNTech and Moderna) have 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 to balance the risk of vaccination with the risk of no vaccination. METHODS: A retrospective case-series was performed utilizing the Mayo Clinic COVID-19 Vaccine Registry. We measured the incidence rate ratio for myocarditis temporally related to COVID-19 mRNA vaccination compared to myocarditis in a comparable population from 2016 through 2020. Clinical characteristics and outcomes of the affected patients was collected. A total of 21 individuals were identified, but ultimately 7 patients met the inclusion criteria for vaccine-associated myocarditis. RESULTS: The overall incidence rate ratio (IRR) of COVID-19 related myocarditis was 4.18 (CI95% 1.63, 8.98) which was entirely attributable to an increased IRR among adult males (IRR 6.69, CI95% 2.35, 15.52) compared to females (IRR 1.41, CI95% 0.03, 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 days) following the second dose (6/7 patients, 86%). Overall, cases were mild, and all patients survived. CONCLUSIONS: Myocarditis is a rare adverse event associated with COVID-19 mRNA vaccines, and in adult males it occurs with significantly higher incidence than the background population rate. Recurrence of myocarditis after a subsequent mRNA vaccine dose is not known at this time.

12.
JAMA Netw Open ; 4(11): e2132540, 2021 11 01.
Article in English | MEDLINE | ID: covidwho-1490645

ABSTRACT

Importance: Continuous assessment of the effectiveness and safety of the US Food and Drug Administration-authorized SARS-CoV-2 vaccines is critical to amplify transparency, build public trust, and ultimately improve overall health outcomes. Objective: To evaluate the effectiveness of the Johnson & Johnson Ad26.COV2.S vaccine for preventing SARS-CoV-2 infection. Design, Setting, and Participants: This comparative effectiveness research study used large-scale longitudinal curation of electronic health records from the multistate Mayo Clinic Health System (Minnesota, Arizona, Florida, Wisconsin, and Iowa) to identify vaccinated and unvaccinated adults between February 27 and July 22, 2021. The unvaccinated cohort was matched on a propensity score derived from age, sex, zip code, race, ethnicity, and previous number of SARS-CoV-2 polymerase chain reaction tests. The final study cohort consisted of 8889 patients in the vaccinated group and 88 898 unvaccinated matched patients. Exposure: Single dose of the Ad26.COV2.S vaccine. Main Outcomes and Measures: The incidence rate ratio of SARS-CoV-2 infection in the vaccinated vs unvaccinated control cohorts, measured by SARS-CoV-2 polymerase chain reaction testing. Results: The study was composed of 8889 vaccinated patients (4491 men [50.5%]; mean [SD] age, 52.4 [16.9] years) and 88 898 unvaccinated patients (44 748 men [50.3%]; mean [SD] age, 51.7 [16.7] years). The incidence rate ratio of SARS-CoV-2 infection in the vaccinated vs unvaccinated control cohorts was 0.26 (95% CI, 0.20-0.34) (60 of 8889 vaccinated patients vs 2236 of 88 898 unvaccinated individuals), which corresponds to an effectiveness of 73.6% (95% CI, 65.9%-79.9%) and a 3.73-fold reduction in SARS-CoV-2 infections. Conclusions and Relevance: This study's findings are consistent with the clinical trial-reported efficacy of Ad26.COV2.S and the first retrospective analysis, suggesting that the vaccine is effective at reducing SARS-CoV-2 infection, even with the spread of variants such as Alpha or Delta that were not present in the original studies, and reaffirm the urgent need to continue mass vaccination efforts globally.


Subject(s)
COVID-19 Vaccines/immunology , COVID-19/prevention & control , Adolescent , Adult , Aged , COVID-19/diagnosis , COVID-19/epidemiology , COVID-19/immunology , COVID-19 Nucleic Acid Testing , COVID-19 Vaccines/administration & dosage , Drug Evaluation , Female , Humans , Incidence , Male , Middle Aged , Pandemics , Propensity Score , Retrospective Studies , SARS-CoV-2 , Severity of Illness Index , Time Factors , United States/epidemiology , Vaccination/statistics & numerical data , Young Adult
13.
Clin Infect Dis ; 73(6): e1376-e1379, 2021 09 15.
Article in English | MEDLINE | ID: covidwho-1413850

ABSTRACT

In a large cohort of United States healthcare personnel without prior coronavirus disease 2019 (COVID-19) infection, 94 382 doses of messenger RNA (mRNA) COVID-19 vaccine were administered to 49 220 individuals. The adjusted vaccine effectiveness following 2 doses of each of the 2 available brands of mRNA vaccine exceeded 96%.


Subject(s)
COVID-19 , Vaccines , COVID-19 Vaccines , Delivery of Health Care , Humans , RNA, Messenger , SARS-CoV-2 , United States/epidemiology
15.
J Stroke Cerebrovasc Dis ; 30(10): 105923, 2021 Oct.
Article in English | MEDLINE | ID: covidwho-1300924

ABSTRACT

OBJECTIVE: To assess the association of COVID-19 vaccines and non-COVID-19 vaccines with cerebral venous sinus thrombosis (CVST). MATERIALS AND METHOD: We retrospectively analyzed a cohort of 771,805 vaccination events across 266,094 patients in the Mayo Clinic Health System between 01/01/2017 and 03/15/2021. The primary outcome was a positive diagnosis of CVST, identified either by the presence of a corresponding ICD code or by an NLP algorithm which detected positive diagnosis of CVST within free-text clinical notes. For each vaccine we calculated the relative risk by dividing the incidence of CVST in the 30 days following vaccination to that in the 30 days preceding vaccination. RESULTS: We identified vaccination events for all FDA-approved COVID-19 vaccines including Pfizer-BioNTech (n = 94,818 doses), Moderna (n = 36,350 doses) and Johnson & Johnson - J&J (n = 1,745 doses). We also identified vaccinations events for 10 common FDA-approved non-COVID-19 vaccines (n = 771,805 doses). There was no statistically significant difference in the incidence rate of CVST in 30-days before and after vaccination for any vaccine in this population. We further found the baseline CVST incidence in the study population between 2017 and 2021 to be 45 to 98 per million patient years. CONCLUSIONS: This real-world evidence-based study finds that CVST is rare and is not significantly associated with COVID-19 vaccination in our patient cohort. Limitations include the rarity of CVST in our dataset, a relatively small number of J&J COVID-19 vaccination events, and the use of a population drawn from recipients of a SARS-CoV-2 PCR test in a single health system.


Subject(s)
COVID-19 Vaccines/adverse effects , COVID-19/prevention & control , Sinus Thrombosis, Intracranial/epidemiology , Vaccination/adverse effects , COVID-19/immunology , COVID-19/virology , Electronic Health Records , Humans , Incidence , Retrospective Studies , Risk Assessment , Risk Factors , Sinus Thrombosis, Intracranial/diagnosis , Time Factors , United States/epidemiology
16.
Med (N Y) ; 2(8): 965-978.e5, 2021 08 13.
Article in English | MEDLINE | ID: covidwho-1294062

ABSTRACT

BACKGROUND: As the coronavirus disease 2019 (COVID-19) vaccination campaign unfolds, it is important to continuously assess the real-world safety of Food and Drug Administration (FDA)-authorized vaccines. Curation of large-scale electronic health records (EHRs) enables near-real-time safety evaluations that were not previously possible. METHODS: In this retrospective study, we deployed deep neural networks over a large EHR system to automatically curate the adverse effects mentioned by physicians in over 1.2 million clinical notes between December 1, 2020 and April 20, 2021. We compared notes from 68,266 individuals who received at least one dose of BNT162b2 (n = 51,795) or mRNA-1273 (n = 16,471) to notes from 68,266 unvaccinated individuals who were matched by demographic, geographic, and clinical features. FINDINGS: Individuals vaccinated with BNT162b2 or mRNA-1273 had a higher rate of return to the clinic, but not the emergency department, after both doses compared to unvaccinated controls. The most frequently documented adverse effects within 7 days of each vaccine dose included myalgia, headache, and fatigue, but the rates of EHR documentation for each side effect were remarkably low compared to those derived from active solicitation during clinical trials. Severe events, including anaphylaxis, facial paralysis, and cerebral venous sinus thrombosis, were rare and occurred at similar frequencies in vaccinated and unvaccinated individuals. CONCLUSIONS: This analysis of vaccine-related adverse effects from over 1.2 million EHR notes of more than 130,000 individuals reaffirms the safety and tolerability of the FDA-authorized mRNA COVID-19 vaccines in practice. FUNDING: This study was funded by nference.


Subject(s)
COVID-19 , Drug-Related Side Effects and Adverse Reactions , BNT162 Vaccine , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Humans , Mass Vaccination , RNA, Messenger , Retrospective Studies , SARS-CoV-2 , United States , United States Food and Drug Administration
17.
Med (N Y) ; 2(8): 979-992.e8, 2021 08 13.
Article in English | MEDLINE | ID: covidwho-1284376

ABSTRACT

BACKGROUND: Two US Food and Drug Administration (FDA)-authorized coronavirus disease 2019 (COVID-19) mRNA vaccines, BNT162b2 (Pfizer/BioNTech) and mRNA-1273 (Moderna), have demonstrated high efficacy in large phase 3 randomized clinical trials. It is important to assess their effectiveness in a real-world setting. METHODS: This is a retrospective analysis of 136,532 individuals in the Mayo Clinic health system (Arizona, Florida, Iowa, Minnesota, and Wisconsin) with PCR testing data between December 1, 2020 and April 20, 2021. We compared clinical outcomes for a vaccinated cohort of 68,266 individuals who received at least one dose of either vaccine (nBNT162b2 = 51,795; nmRNA-1273 = 16,471) and an unvaccinated control cohort of 68,266 individuals propensity matched based on relevant demographic, clinical, and geographic features. We estimated real-world vaccine effectiveness by comparing incidence rates of positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) PCR testing and COVID-19-associated hospitalization and intensive care unit (ICU) admission starting 7 days after the second vaccine dose. FINDINGS: The real-world vaccine effectiveness of preventing SARS-CoV-2 infection was 86.1% (95% confidence interval [CI]: 82.4%-89.1%) for BNT162b2 and 93.3% (95% CI: 85.7%-97.4%) for mRNA-1273. BNT162b2 and mRNA-1273 were 88.8% (95% CI: 75.5%-95.7%) and 86.0% (95% CI: 71.6%-93.9%) effective in preventing COVID-19-associated hospitalization. Both vaccines were 100% effective (95% CIBNT162b2: 51.4%-100%; 95% CImRNA-1273: 43.3%-100%) in preventing COVID-19-associated ICU admission. CONCLUSIONS: BNT162b2 and mRNA-1273 are effective in a real-world setting and are associated with reduced rates of SARS-CoV-2 infection and decreased burden of COVID-19 on the healthcare system. FUNDING: This study was funded by nference.


Subject(s)
COVID-19 Vaccines , COVID-19 , COVID-19/epidemiology , COVID-19/prevention & control , Clinical Trials, Phase III as Topic , Humans , Retrospective Studies , SARS-CoV-2/genetics , United States/epidemiology , United States Food and Drug Administration
18.
Infect Control Hosp Epidemiol ; 43(6): 770-774, 2022 06.
Article in English | MEDLINE | ID: covidwho-1225468

ABSTRACT

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.


Subject(s)
COVID-19 , Virus Diseases , COVID-19/prevention & control , Delivery of Health Care , Health Personnel , Humans , Personal Protective Equipment , Retrospective Studies , SARS-CoV-2
19.
Mayo Clin Proc ; 96(5): 1165-1174, 2021 05.
Article in English | MEDLINE | ID: covidwho-1157598

ABSTRACT

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.


Subject(s)
Antibodies, Viral/blood , COVID-19 Serological Testing , COVID-19 , Disease Transmission, Infectious/statistics & numerical data , Health Personnel/statistics & numerical data , SARS-CoV-2 , Academic Medical Centers , Adult , COVID-19/blood , COVID-19/epidemiology , COVID-19/therapy , COVID-19 Serological Testing/methods , COVID-19 Serological Testing/statistics & numerical data , Female , Humans , Immunoglobulin G/blood , Male , Middle Aged , Public Health/methods , SARS-CoV-2/immunology , SARS-CoV-2/isolation & purification , Seroepidemiologic Studies , Spatio-Temporal Analysis , United States/epidemiology
20.
Mayo Clin Proc ; 96(3): 699-707, 2021 03.
Article in English | MEDLINE | ID: covidwho-1002867

ABSTRACT

The success of vaccination programs is contingent upon irrefutable scientific safety data combined with high rates of public acceptance and population coverage. Vaccine hesitancy, characterized by lack of confidence in vaccination and/or complacency about vaccination that may lead to delay or refusal of vaccination despite the availability of services, threatens to undermine the success of coronavirus disease 2019 (COVID-19) vaccination programs. The rapid pace of vaccine development, misinformation in popular and social media, the polarized sociopolitical environment, and the inherent complexities of large-scale vaccination efforts may undermine vaccination confidence and increase complacency about COVID-19 vaccination. Although the experience of recent lethal surges of COVID-19 infections has underscored the value of COVID-19 vaccines, ensuring population uptake of COVID-19 vaccination will require application of multilevel, evidence-based strategies to influence behavior change and address vaccine hesitancy. Recent survey research evaluating public attitudes in the United States toward the COVID-19 vaccine reveals substantial vaccine hesitancy. Building upon efforts at the policy and community level to ensure population access to COVID-19 vaccination, a strong health care system response is critical to address vaccine hesitancy. Drawing on the evidence base in social, behavioral, communication, and implementation science, we review, summarize, and encourage use of interpersonal, individual-level, and organizational interventions within clinical organizations to address this critical gap and improve population adoption of COVID-19 vaccination.


Subject(s)
COVID-19 Vaccines/pharmacology , COVID-19/prevention & control , Health Knowledge, Attitudes, Practice , Patient Acceptance of Health Care , SARS-CoV-2/immunology , Social Media , Vaccination/statistics & numerical data , COVID-19/epidemiology , Humans , Pandemics
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