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1.
Antimicrobial Stewardship and Healthcare Epidemiology ; 2(S1):s8-s9, 2022.
Article in English | ProQuest Central | ID: covidwho-2184926

ABSTRACT

Background: Healthcare facilities have experienced many challenges during the COVID-19 pandemic, including limited personal protective equipment (PPE) supplies. Healthcare personnel (HCP) rely on PPE, vaccines, and other infection control measures to prevent SARS-CoV-2 infections. We describe PPE concerns reported by HCP who had close contact with COVID-19 patients in the workplace and tested positive for SARS-CoV-2. Method: The CDC collaborated with Emerging Infections Program (EIP) sites in 10 states to conduct surveillance for SARS-CoV-2 infections in HCP. EIP staff interviewed HCP with positive SARS-CoV-2 viral tests (ie, cases) to collect data on demographics, healthcare roles, exposures, PPE use, and concerns about their PPE use during COVID-19 patient care in the 14 days before the HCP's SARS-CoV-2 positive test. PPE concerns were qualitatively coded as being related to supply (eg, low quality, shortages);use (eg, extended use, reuse, lack of fit test);or facility policy (eg, lack of guidance). We calculated and compared the percentages of cases reporting each concern type during the initial phase of the pandemic (April–May 2020), during the first US peak of daily COVID-19 cases (June–August 2020), and during the second US peak (September 2020–January 2021). We compared percentages using mid-P or Fisher exact tests (α = 0.05). Results: Among 1,998 HCP cases occurring during April 2020–January 2021 who had close contact with COVID-19 patients, 613 (30.7%) reported ≥1 PPE concern (Table 1). The percentage of cases reporting supply or use concerns was higher during the first peak period than the second peak period (supply concerns: 12.5% vs 7.5%;use concerns: 25.5% vs 18.2%;p Conclusions: Although lower percentages of HCP cases overall reported PPE concerns after the first US peak, our results highlight the importance of developing capacity to produce and distribute PPE during times of increased demand. The difference we observed among selected groups of cases may indicate that PPE access and use were more challenging for some, such as nonphysicians and nursing home HCP. These findings underscore the need to ensure that PPE is accessible and used correctly by HCP for whom use is recommended.Funding: NoneDisclosures: None

2.
MMWR Recomm Rep ; 71(4): 1-14, 2022 12 16.
Article in English | MEDLINE | ID: covidwho-2164343

ABSTRACT

This report summarizes the evidence and rationale supporting the components of the CSTE/CDC MIS-C surveillance case definition and describes the methods used to develop the definition. These methods included convening MIS-C clinical experts (i.e., consultants): regarding identification of MIS-C and its distinction from other pediatric conditions, a review of available literature comparing MIS-C phenotype with that of pediatric COVID-19 and other hyperinflammatory syndromes, and retrospective application of different criteria to data from MIS-C cases previously reported to CDC.


Subject(s)
COVID-19 , United States/epidemiology , Humans , COVID-19/diagnosis , Epidemiologists , Retrospective Studies , SARS-CoV-2 , Centers for Disease Control and Prevention, U.S. , Population Surveillance
3.
Case Rep Transplant ; 2022: 9426175, 2022.
Article in English | MEDLINE | ID: covidwho-2112962

ABSTRACT

Background: Since October 2021, there have been more than 500 cases of severe hepatitis of unknown origin in children reported worldwide, including 180 cases in the U.S. The most frequently detected potential pathogen to date has been adenovirus, typically serotype 41. Adenovirus is known to cause a self-limited infection in the immunocompetent host. However, in immunosuppressed individuals, severe or disseminated infections may occur. Method: We present the case of a two-year-old female who presented with cholestatic hepatitis and acute liver failure (ALF). Work up for etiologies of ALF was significant for adenovirus viremia, but liver biopsy was consistently negative for the virus. The risk for severe adenoviral infection in the setting of anticipated immunosuppression prompted us to initiate cidofovir to decrease viral load prior to undergoing liver transplantation. Result: Our patient received a successful liver transplant, cleared the viremia after 5 doses of cidofovir, and continues to maintain allograft function without signs of infection at the time of this report, 5 months posttransplant. Conclusion: Recent reports of pediatric hepatitis cases may be associated with adenoviral infection although the exact relationship is unclear. There is the possibility of the ongoing SARS-CoV-2 environment, or other immunologic modifying factors. All patients presenting with hepatitis or acute liver failure should be screened for adenovirus and reported to state health departments. Cidofovir may be used to decrease viral load prior to liver transplantation, to decrease risk of severe adenoviral infection.

4.
Clin Infect Dis ; 75(1): e741-e748, 2022 08 24.
Article in English | MEDLINE | ID: covidwho-2017777

ABSTRACT

BACKGROUND: Multisystem inflammatory syndrome in adults (MIS-A) was reported in association with the coronavirus disease 2019 (COVID-19) pandemic. MIS-A was included in the list of adverse events to be monitored as part of the emergency use authorizations issued for COVID-19 vaccines. METHODS: Reports of MIS-A patients received by the Centers for Disease Control and Prevention (CDC) after COVID-19 vaccines became available were assessed. Data collected on the patients included clinical and demographic characteristics and their vaccine status. The Vaccine Adverse Events Reporting System (VAERS) was also reviewed for possible cases of MIS-A. RESULTS: From 14 December 2020 to 30 April 2021, 20 patients who met the case definition for MIS-A were reported to CDC. Their median age was 35 years (range, 21-66 years), and 13 (65%) were male. Overall, 16 (80%) patients had a preceding COVID-19-like illness a median of 26 days (range 11-78 days) before MIS-A onset. All 20 patients had laboratory evidence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Seven MIS-A patients (35%) received COVID-19 vaccine a median of 10 days (range, 6-45 days) before MIS-A onset; 3 patients received a second dose of COVID-19 vaccine 4, 17, and 22 days before MIS-A onset. Patients with MIS-A predominantly had gastrointestinal and cardiac manifestations and hypotension or shock. CONCLUSIONS: Although 7 patients were reported to have received COVID-19 vaccine, all had evidence of prior SARS-CoV-2 infection. Given the widespread use of COVID-19 vaccines, the lack of reporting of MIS-A associated with vaccination alone, without evidence of underlying SARS-CoV-2 infection, is reassuring.


Subject(s)
COVID-19 Vaccines , COVID-19 , Connective Tissue Diseases , Adult , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Female , Humans , Male , SARS-CoV-2 , Systemic Inflammatory Response Syndrome/epidemiology , Systemic Inflammatory Response Syndrome/etiology , Vaccination/adverse effects
5.
Open Forum Infect Dis ; 9(8): ofac389, 2022 Aug.
Article in English | MEDLINE | ID: covidwho-2001404

ABSTRACT

This analysis describes the prevalence of contraindications to nirmatrelvir/ritonavir among 66 007 patients with coronavirus disease 2019 in a large health care system. A possible contradiction was present in 9830 patients (14.8%), with the prevalence of contraindications increasing with higher acuity of illness.

6.
Open forum infectious diseases ; 2022.
Article in English | EuropePMC | ID: covidwho-1999020

ABSTRACT

This analysis describes the prevalence of contraindications to nirmatrelvir/ritonavir among 66,007 patients with COVID-19 in a large health care system. A possible contradiction was present in 9,830 patients (14.8%), with the prevalence of contraindications increasing with higher acuity of illness.

7.
Infect Control Hosp Epidemiol ; 43(8): 1058-1062, 2022 08.
Article in English | MEDLINE | ID: covidwho-1747338

ABSTRACT

Healthcare personnel with severe acute respiratory coronavirus virus 2 (SARS-CoV-2) infection were interviewed to describe activities and practices in and outside the workplace. Among 2,625 healthcare personnel, workplace-related factors that may increase infection risk were more common among nursing-home personnel than hospital personnel, whereas selected factors outside the workplace were more common among hospital personnel.


Subject(s)
COVID-19 , SARS-CoV-2 , COVID-19/epidemiology , Delivery of Health Care , Health Personnel , Humans , Personnel, Hospital , Skilled Nursing Facilities
8.
Open forum infectious diseases ; 8(Suppl 1):S364-S364, 2021.
Article in English | EuropePMC | ID: covidwho-1564427

ABSTRACT

Background Remdesivir (RDV) was approved by FDA in October 2020 for use in hospitalized patients with COVID-19. We examined the association between RDV treatment and ICU admission in patients hospitalized with COVID-19 pneumonia requiring supplemental oxygen (but not advanced respiratory support) in MN. Methods COVID-19-Associated Hospitalization Surveillance Network (COVID-NET) is population-based surveillance of hospitalized laboratory confirmed cases of COVID-19. We analyzed COVID-NET cases ≥18 years hospitalized between Mar 23, 2020 and Jan 23, 2021 in MN for which medical record reviews were complete. On admission, included cases had evidence of COVID-19 pneumonia on chest imaging with oxygen saturation < 94% on room air or requiring supplemental oxygen. Cases were excluded if treated with RDV after ICU admission. Multivariable logistic regression was performed to assess the association between RDV treatment and ICU admission. Results Complete records were available for 8,666 cases (36% of admissions statewide). 1,996 cases were included in the analysis, of which 908 were treated with RDV. 83% of cases were residents of the 7-county metro area of Minneapolis-St. Paul. Mean age was 59.7 years (IQR 48-72), 55% were male, and the mean RDV treatment duration was 4.8 days (range 2-15). The proportion of cardiovascular disease (30.6% vs 23.9%, p=.003), renal disease (16.6% vs 7.6%, p< .001), and diabetes (34.7% vs 29.5%, p=0.01) was higher in the RDV untreated group, while obesity (22.3% vs 8.4%, p< .001) and dexamethasone use (54.7% vs 15%, p< .001) was more common in the RDV treated group. RDV untreated patients were more likely to be admitted to an ICU (18% vs 8.9%, p< .001) and had higher inpatient mortality than those treated with RDV (11% vs 4.4%, p< .001). After adjustment for dexamethasone use, age, sex and diabetes, treatment with RDV was associated with 48% lower odds of ICU admission (OR 0.52, 0.39-0.7, p< .001). Conclusion We found RDV treatment associated with a significantly lower risk of ICU admission in patients admitted to hospital requiring supplemental oxygen, suggesting that treatment may prevent disease progression in this group. Further studies should assess the potential benefit of RDV combination treatment with dexamethasone. Disclosures Ruth Lynfield, MD, Nothing to disclose

9.
Emerg Infect Dis ; 28(1): 95-103, 2022 01.
Article in English | MEDLINE | ID: covidwho-1547206

ABSTRACT

To determine risk factors for coronavirus disease (COVID-19) among US healthcare personnel (HCP), we conducted a case-control analysis. We collected data about activities outside the workplace and COVID-19 patient care activities from HCP with positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test results (cases) and from HCP with negative test results (controls) in healthcare facilities in 5 US states. We used conditional logistic regression to calculate adjusted matched odds ratios and 95% CIs for exposures. Among 345 cases and 622 controls, factors associated with risk were having close contact with persons with COVID-19 outside the workplace, having close contact with COVID-19 patients in the workplace, and assisting COVID-19 patients with activities of daily living. Protecting HCP from COVID-19 may require interventions that reduce their exposures outside the workplace and improve their ability to more safely assist COVID-19 patients with activities of daily living.


Subject(s)
COVID-19 , Occupational Exposure , Activities of Daily Living , Delivery of Health Care , Health Personnel , Humans , Risk Factors , SARS-CoV-2
10.
N Engl J Med ; 385(25): e90, 2021 12 16.
Article in English | MEDLINE | ID: covidwho-1434203

ABSTRACT

BACKGROUND: The prioritization of U.S. health care personnel for early receipt of messenger RNA (mRNA) vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes coronavirus disease 2019 (Covid-19), allowed for the evaluation of the effectiveness of these new vaccines in a real-world setting. METHODS: We conducted a test-negative case-control study involving health care personnel across 25 U.S. states. Cases were defined on the basis of a positive polymerase-chain-reaction (PCR) or antigen-based test for SARS-CoV-2 and at least one Covid-19-like symptom. Controls were defined on the basis of a negative PCR test for SARS-CoV-2, regardless of symptoms, and were matched to cases according to the week of the test date and site. Using conditional logistic regression with adjustment for age, race and ethnic group, underlying conditions, and exposures to persons with Covid-19, we estimated vaccine effectiveness for partial vaccination (assessed 14 days after receipt of the first dose through 6 days after receipt of the second dose) and complete vaccination (assessed ≥7 days after receipt of the second dose). RESULTS: The study included 1482 case participants and 3449 control participants. Vaccine effectiveness for partial vaccination was 77.6% (95% confidence interval [CI], 70.9 to 82.7) with the BNT162b2 vaccine (Pfizer-BioNTech) and 88.9% (95% CI, 78.7 to 94.2) with the mRNA-1273 vaccine (Moderna); for complete vaccination, vaccine effectiveness was 88.8% (95% CI, 84.6 to 91.8) and 96.3% (95% CI, 91.3 to 98.4), respectively. Vaccine effectiveness was similar in subgroups defined according to age (<50 years or ≥50 years), race and ethnic group, presence of underlying conditions, and level of patient contact. Estimates of vaccine effectiveness were lower during weeks 9 through 14 than during weeks 3 through 8 after receipt of the second dose, but confidence intervals overlapped widely. CONCLUSIONS: The BNT162b2 and mRNA-1273 vaccines were highly effective under real-world conditions in preventing symptomatic Covid-19 in health care personnel, including those at risk for severe Covid-19 and those in racial and ethnic groups that have been disproportionately affected by the pandemic. (Funded by the Centers for Disease Control and Prevention.).


Subject(s)
2019-nCoV Vaccine mRNA-1273 , BNT162 Vaccine , COVID-19/prevention & control , Health Personnel , Vaccine Efficacy , 2019-nCoV Vaccine mRNA-1273/administration & dosage , Adolescent , Adult , Aged , BNT162 Vaccine/administration & dosage , COVID-19/diagnosis , COVID-19/ethnology , COVID-19 Serological Testing , Case-Control Studies , Female , Humans , Immunization, Secondary , Male , Middle Aged , Polymerase Chain Reaction , United States
11.
MMWR Morb Mortal Wkly Rep ; 69(40): 1450-1456, 2020 Oct 09.
Article in English | MEDLINE | ID: covidwho-1389856

ABSTRACT

During the course of the coronavirus disease 2019 (COVID-19) pandemic, reports of a new multisystem inflammatory syndrome in children (MIS-C) have been increasing in Europe and the United States (1-3). Clinical features in children have varied but predominantly include shock, cardiac dysfunction, abdominal pain, and elevated inflammatory markers, including C-reactive protein (CRP), ferritin, D-dimer, and interleukin-6 (1). Since June 2020, several case reports have described a similar syndrome in adults; this review describes in detail nine patients reported to CDC, seven from published case reports, and summarizes the findings in 11 patients described in three case series in peer-reviewed journals (4-6). These 27 patients had cardiovascular, gastrointestinal, dermatologic, and neurologic symptoms without severe respiratory illness and concurrently received positive test results for SARS-CoV-2, the virus that causes COVID-19, by polymerase chain reaction (PCR) or antibody assays indicating recent infection. Reports of these patients highlight the recognition of an illness referred to here as multisystem inflammatory syndrome in adults (MIS-A), the heterogeneity of clinical signs and symptoms, and the role for antibody testing in identifying similar cases among adults. Clinicians and health departments should consider MIS-A in adults with compatible signs and symptoms. These patients might not have positive SARS-CoV-2 PCR or antigen test results, and antibody testing might be needed to confirm previous SARS-CoV-2 infection. Because of the temporal association between MIS-A and SARS-CoV-2 infections, interventions that prevent COVID-19 might prevent MIS-A. Further research is needed to understand the pathogenesis and long-term effects of this newly described condition.


Subject(s)
Coronavirus Infections/complications , Pneumonia, Viral/complications , Systemic Inflammatory Response Syndrome/diagnosis , Systemic Inflammatory Response Syndrome/virology , Adult , COVID-19 , Coronavirus Infections/epidemiology , Female , Humans , Male , Middle Aged , Pandemics , Pneumonia, Viral/epidemiology , United Kingdom/epidemiology , United States/epidemiology , Young Adult
12.
Pediatr Infect Dis J ; 40(11): e400-e406, 2021 11 01.
Article in English | MEDLINE | ID: covidwho-1354322

ABSTRACT

BACKGROUND: The incidence of multisystem inflammatory syndrome in children (MIS-C) varies by race and ethnicity. This study assessed whether disparities in MIS-C in the United States by race and ethnicity exceed known disparities in coronavirus disease 2019 (COVID-19) incidence. METHODS: We compared the distribution of race and ethnicity among patients with MIS-C (<21 years of age, termed children) with onset March 2020 to February 2021 to that of children with COVID-19 and in the general population. Analysis was restricted to 369 counties with high completeness of race and ethnicity reporting for MIS-C and COVID-19. For each racial and ethnic group, observed numbers of patients with MIS-C were compared with expected numbers (observed/expected ratio) in children with COVID-19 and in the general population within these counties. RESULTS: Compared with children in the general population, MIS-C was more frequent among Hispanic (139% of expected) and non-Hispanic Black children (183%) and less frequent among non-Hispanic White (64%) and non-Hispanic Asian children (48%). Compared with children with COVID-19, MIS-C was more frequent in non-Hispanic Black children (207% of expected) and less frequent in non-Hispanic White children (68%); however, frequency was not different among Hispanic (102%) and non-Hispanic Asian (74%) children. CONCLUSIONS: Disparities in MIS-C by race and ethnicity exist, even after controlling for COVID-19 disparities and geographic variations. The high proportion of MIS-C among Hispanic children and low proportion among non-Hispanic Asian children align with COVID-19 rates, while the high proportion among non-Hispanic Black children and low proportion among non-Hispanic White children are not explainable by COVID-19 rates.


Subject(s)
COVID-19/complications , COVID-19/epidemiology , Ethnicity/statistics & numerical data , SARS-CoV-2 , Systemic Inflammatory Response Syndrome/epidemiology , Systemic Inflammatory Response Syndrome/etiology , Adolescent , Adult , COVID-19/etiology , COVID-19/history , COVID-19/virology , Child , Child, Preschool , Female , History, 21st Century , Humans , Incidence , Infant , Male , Public Health Surveillance , Systemic Inflammatory Response Syndrome/history , United States/epidemiology , United States/ethnology , Young Adult
13.
MMWR Morb Mortal Wkly Rep ; 70(20): 753-758, 2021 May 21.
Article in English | MEDLINE | ID: covidwho-1237005

ABSTRACT

Throughout the COVID-19 pandemic, health care personnel (HCP) have been at high risk for exposure to SARS-CoV-2, the virus that causes COVID-19, through patient interactions and community exposure (1). The Advisory Committee on Immunization Practices recommended prioritization of HCP for COVID-19 vaccination to maintain provision of critical services and reduce spread of infection in health care settings (2). Early distribution of two mRNA COVID-19 vaccines (Pfizer-BioNTech and Moderna) to HCP allowed assessment of the effectiveness of these vaccines in a real-world setting. A test-negative case-control study is underway to evaluate mRNA COVID-19 vaccine effectiveness (VE) against symptomatic illness among HCP at 33 U.S. sites across 25 U.S. states. Interim analyses indicated that the VE of a single dose (measured 14 days after the first dose through 6 days after the second dose) was 82% (95% confidence interval [CI] = 74%-87%), adjusted for age, race/ethnicity, and underlying medical conditions. The adjusted VE of 2 doses (measured ≥7 days after the second dose) was 94% (95% CI = 87%-97%). VE of partial (1-dose) and complete (2-dose) vaccination in this population is comparable to that reported from clinical trials and recent observational studies, supporting the effectiveness of mRNA COVID-19 vaccines against symptomatic disease in adults, with strong 2-dose protection.


Subject(s)
COVID-19 Vaccines/immunology , COVID-19/prevention & control , Health Personnel/statistics & numerical data , Occupational Diseases/prevention & control , Adult , Aged , COVID-19/epidemiology , COVID-19 Testing , COVID-19 Vaccines/administration & dosage , Case-Control Studies , Female , Humans , Immunization Schedule , Male , Middle Aged , Occupational Diseases/epidemiology , United States/epidemiology , Young Adult
14.
Pediatr Infect Dis J ; 40(7): 601-605, 2021 07 01.
Article in English | MEDLINE | ID: covidwho-1192569

ABSTRACT

BACKGROUND: Multisystem inflammatory syndrome in children (MIS-C), temporally associated with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has been identified in infants <12 months old. Clinical characteristics and follow-up data of MIS-C in infants have not been well described. We sought to describe the clinical course, laboratory findings, therapeutics and outcomes among infants diagnosed with MIS-C. METHODS: Infants of age <12 months with MIS-C were identified by reports to the CDC's MIS-C national surveillance system. Data were obtained on clinical signs and symptoms, complications, treatment, laboratory and imaging findings, and diagnostic SARS-CoV-2 testing. Jurisdictions that reported 2 or more infants were approached to participate in evaluation of outcomes of MIS-C. RESULTS: Eighty-five infants with MIS-C were identified and 83 (97.6%) tested positive for SARS-CoV-2 infection; median age was 7.7 months. Rash (62.4%), diarrhea (55.3%) and vomiting (55.3%) were the most common signs and symptoms reported. Other clinical findings included hypotension (21.2%), pneumonia (21.2%) and coronary artery dilatation or aneurysm (13.9%). Laboratory abnormalities included elevated C-reactive protein, ferritin, d-dimer and fibrinogen. Twenty-three infants had follow-up data; 3 of the 14 patients who received a follow-up echocardiogram had cardiac abnormalities during or after hospitalization. Nine infants had elevated inflammatory markers up to 98 days postdischarge. One infant (1.2%) died after experiencing multisystem organ failure secondary to MIS-C. CONCLUSIONS: Infants appear to have a milder course of MIS-C than older children with resolution of their illness after hospital discharge. The full clinical picture of MIS-C across the pediatric age spectrum is evolving.


Subject(s)
COVID-19/epidemiology , Hospitalization/statistics & numerical data , Systemic Inflammatory Response Syndrome/epidemiology , COVID-19/diagnosis , COVID-19/therapy , COVID-19 Testing/statistics & numerical data , Epidemiological Monitoring , Female , Follow-Up Studies , Humans , Infant , Infant, Newborn , Male , Systemic Inflammatory Response Syndrome/diagnosis , Systemic Inflammatory Response Syndrome/therapy , United States/epidemiology
15.
MMWR Morb Mortal Wkly Rep ; 69(32): 1074-1080, 2020 08 14.
Article in English | MEDLINE | ID: covidwho-695725

ABSTRACT

In April 2020, during the peak of the coronavirus disease 2019 (COVID-19) pandemic in Europe, a cluster of children with hyperinflammatory shock with features similar to Kawasaki disease and toxic shock syndrome was reported in England* (1). The patients' signs and symptoms were temporally associated with COVID-19 but presumed to have developed 2-4 weeks after acute COVID-19; all children had serologic evidence of infection with SARS-CoV-2, the virus that causes COVID-19 (1). The clinical signs and symptoms present in this first cluster included fever, rash, conjunctivitis, peripheral edema, gastrointestinal symptoms, shock, and elevated markers of inflammation and cardiac damage (1). On May 14, 2020, CDC published an online Health Advisory that summarized the manifestations of reported multisystem inflammatory syndrome in children (MIS-C), outlined a case definition,† and asked clinicians to report suspected U.S. cases to local and state health departments. As of July 29, a total of 570 U.S. MIS-C patients who met the case definition had been reported to CDC. A total of 203 (35.6%) of the patients had a clinical course consistent with previously published MIS-C reports, characterized predominantly by shock, cardiac dysfunction, abdominal pain, and markedly elevated inflammatory markers, and almost all had positive SARS-CoV-2 test results. The remaining 367 (64.4%) of MIS-C patients had manifestations that appeared to overlap with acute COVID-19 (2-4), had a less severe clinical course, or had features of Kawasaki disease.§ Median duration of hospitalization was 6 days; 364 patients (63.9%) required care in an intensive care unit (ICU), and 10 patients (1.8%) died. As the COVID-19 pandemic continues to expand in many jurisdictions, clinicians should be aware of the signs and symptoms of MIS-C and report suspected cases to their state or local health departments; analysis of reported cases can enhance understanding of MIS-C and improve characterization of the illness for early detection and treatment.


Subject(s)
Coronavirus Infections/complications , Pneumonia, Viral/complications , Systemic Inflammatory Response Syndrome/epidemiology , Systemic Inflammatory Response Syndrome/virology , Adolescent , COVID-19 , Child , Child, Preschool , Coronavirus Infections/epidemiology , Female , Humans , Male , Pandemics , Pneumonia, Viral/epidemiology , United States/epidemiology
16.
Mayo Clin Proc ; 95(9): 1946-1954, 2020 09.
Article in English | MEDLINE | ID: covidwho-609276

ABSTRACT

On May 1, 2020, the US Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) to allow use of the antiviral drug remdesivir to treat patients with severe coronavirus disease-2019 (COVID-19). Remdesivir is an investigational drug studied in clinical trials for COVID-19 and is available to children and pregnant women through compassionate-use access but is not yet FDA approved. In early May, the US Department of Health and Human Services began to distribute remdesivir, donated by Gilead Sciences, Inc., to hospitals and state health departments for emergency use; multiple shipments have since been distributed. This process has raised questions of how remdesivir should be allocated. The Minnesota Department of Health has collaborated with the Minnesota COVID Ethics Collaborative and multiple clinical experts to issue an Ethical Framework for May 2020 Allocation of Remdesivir in the COVID-19 Pandemic. The framework builds on extensive ethical guidance developed for public health emergencies in Minnesota before the COVID-19 crisis. The Minnesota remdesivir allocation framework specifies an ethical approach to distributing the drug to facilities across the state and then among COVID-19 patients within each facility. This article describes the process of developing the framework and adjustments in the framework over time with emergence of new data, analyzes key issues addressed, and suggests next steps. Sharing this framework and the development process can encourage transparency and may be useful to other states formulating and refining their approach to remdesivir EUA allocation.


Subject(s)
Adenosine Monophosphate/analogs & derivatives , Alanine/analogs & derivatives , Antiviral Agents/supply & distribution , Coronavirus Infections/drug therapy , Health Care Rationing/ethics , Pneumonia, Viral/drug therapy , Adenosine Monophosphate/supply & distribution , Alanine/supply & distribution , Betacoronavirus , COVID-19 , Drugs, Investigational/supply & distribution , Humans , Minnesota , Pandemics , SARS-CoV-2 , United States , United States Food and Drug Administration
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