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Article ; Online: Effectiveness of the 2023-2024 Formulation of the Coronavirus Disease 2019 mRNA Vaccine.

Shrestha, Nabin K / Burke, Patrick C / Nowacki, Amy S / Gordon, Steven M

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

2024

Abstract: ... before the JN.1 lineage became dominant (HR, .58; 95% C.I., .49-.68, p-value < .001), and lower risk but one ... that did not reach statistical significance after (HR, .81; 95% C.I., .65-1.01, p-value 0.06). Estimated ... vaccine effectiveness (VE) was 42% (95% C.I., 32%-51%) before the JN.1 lineage became dominant, and 19% (C ...

Abstract	Background: The purpose of this study was to evaluate whether the 2023-2024 formulation of the COVID-19 mRNA vaccine protects against COVID-19. Methods: Employees of Cleveland Clinic in employment when the 2023-2024 formulation of the COVID-19 mRNA vaccine became available to employees, were included. Cumulative incidence of COVID-19 over the following 17 weeks was examined prospectively. Protection provided by vaccination (analyzed as a time-dependent covariate) was evaluated using Cox proportional hazards regression, with time-dependent coefficients used to separate effects before and after the JN.1 lineage became dominant. The analysis was adjusted for the propensity to get tested, age, sex, pandemic phase when the last prior COVID-19 episode occurred, and the number of prior vaccine doses. Results: Among 48210 employees, COVID-19 occurred in 2462 (5.1%) during the 17 weeks of observation. In multivariable analysis, the 2023-2024 formula vaccinated state was associated with a significantly lower risk of COVID-19 before the JN.1 lineage became dominant (HR, .58; 95% C.I., .49-.68, p-value < .001), and lower risk but one that did not reach statistical significance after (HR, .81; 95% C.I., .65-1.01, p-value 0.06). Estimated vaccine effectiveness (VE) was 42% (95% C.I., 32%-51%) before the JN.1 lineage became dominant, and 19% (C.I., -1%-35%) after. Risk of COVID-19 was lower among those previously infected with an XBB or more recent lineage, and increased with the number of vaccine doses previously received. Conclusions: The 2023-2024 formula COVID-19 vaccine given to working-aged adults afforded modest protection overall against COVID-19 before the JN.1 lineage became dominant, and less protection after.
Language	English
Publishing date	2024-03-11
Publishing country	United States
Document type	Journal Article
ZDB-ID	1099781-7
ISSN	1537-6591 ; 1058-4838
ISSN (online)	1537-6591
ISSN	1058-4838
DOI	10.1093/cid/ciae132
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Article ; Online: Descriptive, real-world treatment patterns, resource use, and total cost of care among eculizumab- and ravulizumab-treated members with paroxysmal nocturnal hemoglobinuria.

Broderick, Kelly C / Burke, James P / Fishman, Jesse / Gleason, Patrick P

Journal of managed care & specialty pharmacy

2023 Volume 29, Issue 8, Page(s) 941–951

Abstract: BACKGROUND: ...

Abstract	BACKGROUND:
MeSH term(s)	Adult ; Female ; Humans ; Male ; Health Care Costs ; Hemoglobinuria, Paroxysmal/drug therapy ; Retrospective Studies ; United States
Chemical Substances	eculizumab (A3ULP0F556) ; ravulizumab (C3VX249T6L)
Language	English
Publishing date	2023-07-31
Publishing country	United States
Document type	Journal Article
ISSN	2376-1032
ISSN (online)	2376-1032
DOI	10.18553/jmcp.2023.29.8.941
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Article ; Online: Risk of Coronavirus Disease 2019 (COVID-19) among those up-to-date and not up-to-date on COVID-19 vaccination by US CDC criteria.

Shrestha, Nabin K / Burke, Patrick C / Nowacki, Amy S / Gordon, Steven M

PloS one

2023 Volume 18, Issue 11, Page(s) e0293449

Abstract: ... with lower risk of COVID-19 (HR, 1.05; 95% C.I., 0.88-1.25; P-value, 0.58). Results were very similar ...

Abstract	Background: The CDC recently defined being "up-to-date" on COVID-19 vaccination as having received at least one dose of a COVID-19 bivalent vaccine. The purpose of this study was to compare the risk of COVID-19 among those "up-to-date" and "not up-to-date". Methods: Employees of Cleveland Clinic in Ohio, USA, in employment when the COVID-19 bivalent vaccine first became available, and still employed when the XBB lineages became dominant, were included. Cumulative incidence of COVID-19 since the XBB lineages became dominant was compared across the"up-to-date" and "not up-to-date" states, by treating COVID-19 bivalent vaccination as a time-dependent covariate whose value changed on receipt of the vaccine. Risk of COVID-19 by vaccination status was also evaluated using multivariable Cox proportional hazards regression adjusting for propensity to get tested for COVID-19, age, sex, most recent prior SARS-CoV-2 infection, and number of prior vaccine doses. Results: COVID-19 occurred in 1475 (3%) of 48 344 employees during the 100-day study period. The cumulative incidence of COVID-19 was lower in the "not up-to-date" than the "up-to-date" state. On multivariable analysis, being "up-to-date" was not associated with lower risk of COVID-19 (HR, 1.05; 95% C.I., 0.88-1.25; P-value, 0.58). Results were very similar when those 65 years and older were only considered "up-to-date" after 2 doses of the bivalent vaccine. Conclusions: Since the XBB lineages became dominant, adults "up-to-date" on COVID-19 vaccination by the CDC definition do not have a lower risk of COVID-19 than those "not up-to-date", bringing into question the value of this risk classification definition.
MeSH term(s)	Adult ; Humans ; United States/epidemiology ; COVID-19/epidemiology ; COVID-19/prevention & control ; COVID-19 Vaccines ; SARS-CoV-2 ; Vaccination ; Vaccines, Combined ; Centers for Disease Control and Prevention, U.S.
Chemical Substances	COVID-19 Vaccines ; Vaccines, Combined
Language	English
Publishing date	2023-11-08
Publishing country	United States
Document type	Journal Article
ZDB-ID	2267670-3
ISSN	1932-6203 ; 1932-6203
ISSN (online)	1932-6203
ISSN	1932-6203
DOI	10.1371/journal.pone.0293449
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Risk of Coronavirus Disease 2019 (COVID-19) among those up-to-date and not up-to-date on COVID-19 vaccination by US CDC criteria

Nabin K. Shrestha / Patrick C. Burke / Amy S. Nowacki / Steven M. Gordon

PLoS ONE, Vol 18, Iss

2023 Volume 11

Keywords	Medicine ; R ; Science ; Q
Language	English
Publishing date	2023-01-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Risk of Coronavirus Disease 2019 (COVID-19) among those up-to-date and not up-to-date on COVID-19 vaccination by US CDC criteria.

Nabin K Shrestha / Patrick C Burke / Amy S Nowacki / Steven M Gordon

PLoS ONE, Vol 18, Iss 11, p e

2023 Volume 0293449

Abstract: ... of COVID-19 (HR, 1.05; 95% C.I., 0.88-1.25; P-value, 0.58). Results were very similar when those 65 years ...

Abstract	Background The CDC recently defined being "up-to-date" on COVID-19 vaccination as having received at least one dose of a COVID-19 bivalent vaccine. The purpose of this study was to compare the risk of COVID-19 among those "up-to-date" and "not up-to-date". Methods Employees of Cleveland Clinic in Ohio, USA, in employment when the COVID-19 bivalent vaccine first became available, and still employed when the XBB lineages became dominant, were included. Cumulative incidence of COVID-19 since the XBB lineages became dominant was compared across the"up-to-date" and "not up-to-date" states, by treating COVID-19 bivalent vaccination as a time-dependent covariate whose value changed on receipt of the vaccine. Risk of COVID-19 by vaccination status was also evaluated using multivariable Cox proportional hazards regression adjusting for propensity to get tested for COVID-19, age, sex, most recent prior SARS-CoV-2 infection, and number of prior vaccine doses. Results COVID-19 occurred in 1475 (3%) of 48 344 employees during the 100-day study period. The cumulative incidence of COVID-19 was lower in the "not up-to-date" than the "up-to-date" state. On multivariable analysis, being "up-to-date" was not associated with lower risk of COVID-19 (HR, 1.05; 95% C.I., 0.88-1.25; P-value, 0.58). Results were very similar when those 65 years and older were only considered "up-to-date" after 2 doses of the bivalent vaccine. Conclusions Since the XBB lineages became dominant, adults "up-to-date" on COVID-19 vaccination by the CDC definition do not have a lower risk of COVID-19 than those "not up-to-date", bringing into question the value of this risk classification definition.
Keywords	Medicine ; R ; Science ; Q
Subject code	610
Language	English
Publishing date	2023-01-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Risk of Coronavirus Disease 2019 (COVID-19) among Those Up-to-Date and Not Up-to-Date on COVID-19 Vaccination

Shrestha, Nabin K. / Burke, Patrick C. / Nowacki, Amy S. / Gordon, Steven M.

medRxiv

Abstract: ... 0.77; 95% C.I., 0.69-0.86; P-value, <0.001). Results were very similar when those 65 years and older ...

Abstract	Background. The CDC recently defined being 9up-to-date9 on COVID-19 vaccination as having received at least one dose of a COVID-19 bivalent vaccine. The purpose of this study was to compare the risk of COVID-19 among those 9up-to-date9 and 9not up-to-date9 on COVID-19 vaccination. Methods. Employees of Cleveland Clinic in employment when the bivalent COVID-19 vaccine first became available, and still employed when the XBB lineages became dominant, were included. Cumulative incidence of COVID-19 since the XBB lineages became dominant was compared across the 9up-to-date9 and 9not up-to-date9 states, by treating COVID-19 bivalent vaccination as a time-dependent covariate whose value changed on receipt of the vaccine. Risk of COVID-19 by vaccination status was also compared using multivariable Cox proportional hazards regression adjusting for propensity to get tested for COVID-19, age, sex, and phase of most recent prior SARS-CoV-2 infection. Results. COVID-19 occurred in 1475 (3%) of 48344 employees during the 100-day study period. The cumulative incidence of COVID-19 was lower in the 9not up-to-date9 than in the 9up-to-date9 state. On multivariable analysis, not being 9up-to-date9 with COVID-19 vaccination was associated with lower risk of COVID-19 (HR, 0.77; 95% C.I., 0.69-0.86; P-value, <0.001). Results were very similar when those 65 years and older were only considered 9up-to-date9 after receiving 2 doses of the bivalent vaccine. Conclusions. Since the XBB lineages became dominant, adults 9not up-to-date9 by the CDC definition have a lower risk of COVID-19 than those 9up-to-date9 on COVID-19 vaccination, bringing into question the value of this risk classification definition.
Keywords	covid19
Language	English
Publishing date	2023-06-12
Publisher	Cold Spring Harbor Laboratory Press
Document type	Article ; Online
DOI	10.1101/2023.06.09.23290893
Database	COVID19

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Article ; Online: Coronavirus Disease 2019 (COVID-19) Vaccine Boosting in Previously Infected or Vaccinated Individuals.

Shrestha, Nabin K / Shrestha, Priyanka / Burke, Patrick C / Nowacki, Amy S / Terpeluk, Paul / Gordon, Steven M

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

2022

Abstract: Background: The purpose of this study was to evaluate whether boosting previously infected or vaccinated healthcare personnel with a vaccine developed for an earlier variant of SARS-CoV-2 protects against the Omicron variant.: Methods: Employees of ... ...

Abstract	Background: The purpose of this study was to evaluate whether boosting previously infected or vaccinated healthcare personnel with a vaccine developed for an earlier variant of SARS-CoV-2 protects against the Omicron variant. Methods: Employees of Cleveland Clinic previously infected with or vaccinated against COVID-19, and working in Ohio the day the Omicron variant was declared a variant of concern, were included. The cumulative incidence of COVID-19 was examined over two months during an Omicron variant surge. Protection provided by boosting (analyzed as a time-dependent covariate) was evaluated using Cox proportional hazards regression. Analyses were adjusted for time since proximate SARS-CoV-2 exposure as a time-dependent covariate. Results: Among 39 766 employees, 8037 (20%) previously infected and the remaining previously vaccinated, COVID-19 occurred in 6230 (16%) during the study. Risk of COVID-19 increased with time since proximate SARS-CoV-2 exposure, and boosting protected those >6 months since prior infection or vaccination. In multivariable analysis, boosting was independently associated with lower risk of COVID-19 among those vaccinated but not previously infected (HR, .43; 95% CI, .41-.46) as well as those previously infected (HR, .66; 95% CI, .58-.76). Among those previously infected, receiving 2 compared to 1 dose of vaccine was associated with higher risk of COVID-19 (HR, 1.54; 95% CI, 1.21-1.97). Conclusions: Administering a COVID-19 vaccine not designed for the Omicron variant, >6 months after prior infection or vaccination, protects against Omicron variant infection in those previously infected or vaccinated. There is no evidence of an advantage to administering more than 1 dose of vaccine to previously infected persons.
Language	English
Publishing date	2022-04-27
Publishing country	United States
Document type	Journal Article
ZDB-ID	1099781-7
ISSN	1537-6591 ; 1058-4838
ISSN (online)	1537-6591
ISSN	1058-4838
DOI	10.1093/cid/ciac327
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article: Effectiveness of the Coronavirus Disease 2019 Bivalent Vaccine.

Shrestha, Nabin K / Burke, Patrick C / Nowacki, Amy S / Simon, James F / Hagen, Amanda / Gordon, Steven M

Open forum infectious diseases

2023 Volume 10, Issue 6, Page(s) ofad209

Abstract: Background: The purpose of this study was to evaluate whether a bivalent coronavirus disease 2019 (COVID-19) vaccine protects against COVID-19.: Methods: The study included employees of Cleveland Clinic in employment when the bivalent COVID-19 ... ...

Abstract	Background: The purpose of this study was to evaluate whether a bivalent coronavirus disease 2019 (COVID-19) vaccine protects against COVID-19. Methods: The study included employees of Cleveland Clinic in employment when the bivalent COVID-19 vaccine first became available. Cumulative incidence of COVID-19 over the following 26 weeks was examined. Protection provided by vaccination (analyzed as a time-dependent covariate) was evaluated using Cox proportional hazards regression, with change in dominant circulating lineages over time accounted for by time-dependent coefficients. The analysis was adjusted for the pandemic phase when the last prior COVID-19 episode occurred and the number of prior vaccine doses. Results: Among 51 017 employees, COVID-19 occurred in 4424 (8.7%) during the study. In multivariable analysis, the bivalent-vaccinated state was associated with lower risk of COVID-19 during the BA.4/5-dominant (hazard ratio, 0.71 [95% confidence interval, .63-79]) and the BQ-dominant (0.80 [.69-.94]) phases, but decreased risk was not found during the XBB-dominant phase (0.96 [.82-.1.12]). The estimated vaccine effectiveness was 29% (95% confidence interval, 21%-37%), 20% (6%-31%), and 4% (-12% to 18%), during the BA.4/5-, BQ-, and XBB-dominant phases, respectively. The risk of COVID-19 also increased with time since the most recent prior COVID-19 episode and with the number of vaccine doses previously received. Conclusions: The bivalent COVID-19 vaccine given to working-aged adults afforded modest protection overall against COVID-19 while the BA.4/5 lineages were the dominant circulating strains, afforded less protection when the BQ lineages were dominant, and effectiveness was not demonstrated when the XBB lineages were dominant.
Language	English
Publishing date	2023-04-19
Publishing country	United States
Document type	Journal Article
ZDB-ID	2757767-3
ISSN	2328-8957
ISSN	2328-8957
DOI	10.1093/ofid/ofad209
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Article ; Online: Performance of OC-Auto Micro 80 Fecal Immunochemical Test in an Integrated Academic-Community Health System.

Durowoju, Lindsey / Mathias, Patrick C / Bell-Brown, Ari / Breit, Nathan / Liao, Hsuan-Chieh / Burke, Wynn / Issaka, Rachel B

Journal of clinical gastroenterology

2023

Abstract: Goals: We aimed to determine the performance of the OC-Auto Micro 80 fecal immunochemical test (FIT) in an average-risk population receiving care in an integrated, academic-community health system.: Background: The FIT is the most used colorectal ... ...

Abstract	Goals: We aimed to determine the performance of the OC-Auto Micro 80 fecal immunochemical test (FIT) in an average-risk population receiving care in an integrated, academic-community health system. Background: The FIT is the most used colorectal cancer (CRC) screening test worldwide. However, many Food and Drug Administration-cleared FIT products have not been evaluated in clinical settings. Study: We performed a retrospective cohort study of patients (50 to 75 y old) in the University of Washington Medicine health care system who were screened for CRC by OC-Auto Micro 80 FIT between March 2016 and September 2021. We used electronic health records to extract patient-level and clinic-level factors, FIT use, colonoscopy, and pathology findings. The primary outcomes were the FIT positivity rate and neoplasms detected at colonoscopy. Secondary outcomes were FIT positivity by sex and safety-net versus non-safety-net clinical settings. Results: We identified 39,984 FITs completed by 26,384 patients; 2411 (6.0%) had a positive FIT result (>100 ng/mL of hemoglobin in buffer), and 1246 (51.7%) completed a follow-up colonoscopy. The FIT positive rate was 7.0% in men and 5.2% in women (P <0.01). Among those who completed a colonoscopy after an abnormal FIT result, the positive predictive value for CRC, advanced adenoma, and advanced neoplasia was 3.0%, 20.9%, and 23.9%, respectively. Conclusions: In a retrospective analysis of a large heterogeneous population, the OC-Auto Micro 80 FIT for CRC screening demonstrated a positivity rate of 6.0% and a positive predictive value for CRC of 3.0%.
Language	English
Publishing date	2023-09-26
Publishing country	United States
Document type	Journal Article
ZDB-ID	448460-5
ISSN	1539-2031 ; 0192-0790
ISSN (online)	1539-2031
ISSN	0192-0790
DOI	10.1097/MCG.0000000000001928
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Article ; Online: Necessity of Coronavirus Disease 2019 (COVID-19) Vaccination in Persons Who Have Already Had COVID-19.

Shrestha, Nabin K / Burke, Patrick C / Nowacki, Amy S / Terpeluk, Paul / Gordon, Steven M

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

2022 Volume 75, Issue 1, Page(s) e662–e671

Abstract: Background: The aim was to evaluate the necessity of coronavirus disease 2019 (COVID-19) vaccination in persons with prior COVID-19.: Methods: Employees of the Cleveland Clinic working in Ohio on 16 December 2020, the day COVID-19 vaccination was ... ...

Abstract	Background: The aim was to evaluate the necessity of coronavirus disease 2019 (COVID-19) vaccination in persons with prior COVID-19. Methods: Employees of the Cleveland Clinic working in Ohio on 16 December 2020, the day COVID-19 vaccination was started, were included. Anyone who tested positive for COVID-19 at least once before the study start date was considered previously infected. One was considered vaccinated 14 days after receiving the second dose of COVID-19 mRNA vaccine. Cumulative incidences of COVID-19, symptomatic COVID-19, and hospitalizations for COVID-19 were examined over the next year. Results: Among 52 238 employees, 4718 (9%) were previously infected and 36 922 (71%) were vaccinated by the study's end. Cumulative incidence of COVID-19 was substantially higher throughout for those previously uninfected who remained unvaccinated than for all other groups, lower for the vaccinated than unvaccinated, and lower for those previously infected than those not. Incidence of COVID-19 increased dramatically in all groups after the Omicron variant emerged. In multivariable Cox proportional hazards regression, both prior COVID-19 and vaccination were independently associated with significantly lower risk of COVID-19. Among previously infected subjects, a lower risk of COVID-19 overall was not demonstrated, but vaccination was associated with a significantly lower risk of symptomatic COVID-19 in both pre-Omicron (HR, .60; 95% CI, .40-.90) and Omicron (HR, .36; 95% CI, .23-.57) phases. Conclusions: Both previous infection and vaccination provide substantial protection against COVID-19. Vaccination of previously infected individuals does not provide additional protection against COVID-19 for several months, but after that provides significant protection at least against symptomatic COVID-19.
MeSH term(s)	COVID-19/epidemiology ; COVID-19/prevention & control ; COVID-19 Vaccines ; Humans ; SARS-CoV-2 ; Vaccination ; Vaccines, Synthetic ; mRNA Vaccines
Chemical Substances	COVID-19 Vaccines ; Vaccines, Synthetic ; mRNA Vaccines
Language	English
Publishing date	2022-01-13
Publishing country	United States
Document type	Journal Article
ZDB-ID	1099781-7
ISSN	1537-6591 ; 1058-4838
ISSN (online)	1537-6591
ISSN	1058-4838
DOI	10.1093/cid/ciac022
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