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1.
MMWR Morb Mortal Wkly Rep ; 70(45): 1579-1583, 2021 Nov 12.
Artigo em Inglês | MEDLINE | ID: mdl-34758012

RESUMO

The Pfizer-BioNTech COVID-19 (BNT162b2) vaccine is a lipid nanoparticle-formulated, nucleoside-modified mRNA vaccine encoding the prefusion spike glycoprotein of SARS-CoV-2, the virus that causes COVID-19. On August 23, 2021, the Food and Drug Administration (FDA) approved a Biologics License Application (BLA) for use of the Pfizer-BioNTech COVID-19 vaccine, marketed as Comirnaty (Pfizer, Inc.), in persons aged ≥16 years (1). The Pfizer-BioNTech COVID-19 vaccine is also recommended for adolescents aged 12-15 years under an Emergency Use Authorization (EUA) (1). All persons aged ≥12 years are recommended to receive 2 doses (30 µg, 0.3 mL each), administered 3 weeks apart (2,3). As of November 2, 2021, approximately 248 million doses of the Pfizer-BioNTech COVID-19 vaccine had been administered to persons aged ≥12 years in the United States.* On October 29, 2021, FDA issued an EUA amendment for a new formulation of Pfizer-BioNTech COVID-19 vaccine for use in children aged 5-11 years, administered as 2 doses (10 µg, 0.2 mL each), 3 weeks apart (Table) (1). On November 2, 2021, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation† for use of the Pfizer-BioNTech COVID-19 vaccine in children aged 5-11 years for the prevention of COVID-19. To guide its deliberations regarding recommendations for the vaccine, ACIP used the Evidence to Recommendation (EtR) Framework§ and incorporated a Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach.¶ The ACIP recommendation for the use of the Pfizer-BioNTech COVID-19 vaccine in children aged 5-11 years under an EUA is interim and will be updated as additional information becomes available. The Pfizer-BioNTech COVID-19 vaccine has high efficacy (>90%) against COVID-19 in children aged 5-11 years, and ACIP determined benefits outweigh risks for vaccination. Vaccination is important to protect children against COVID-19 and reduce community transmission of SARS-CoV-2.


Assuntos
Vacinas contra COVID-19/administração & dosagem , Guias de Prática Clínica como Assunto , Comitês Consultivos , COVID-19/epidemiologia , COVID-19/prevenção & controle , Centers for Disease Control and Prevention, U.S. , Criança , Aprovação de Drogas , Humanos , Imunização/normas , Esquemas de Imunização , Estados Unidos/epidemiologia , United States Food and Drug Administration
2.
MMWR Morb Mortal Wkly Rep ; 70(44): 1545-1552, 2021 Nov 05.
Artigo em Inglês | MEDLINE | ID: mdl-34735422

RESUMO

Three COVID-19 vaccines are currently approved under a Biologics License Application (BLA) or authorized under an Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA) and recommended for primary vaccination by the Advisory Committee on Immunization Practices (ACIP) in the United States: the 2-dose mRNA-based Pfizer-BioNTech/Comirnaty and Moderna COVID-19 vaccines and the single-dose adenovirus vector-based Janssen (Johnson & Johnson) COVID-19 vaccine (1,2) (Box 1). In August 2021, FDA amended the EUAs for the two mRNA COVID-19 vaccines to allow for an additional primary dose in certain immunocompromised recipients of an initial mRNA COVID-19 vaccination series (1). During September-October 2021, FDA amended the EUAs to allow for a COVID-19 vaccine booster dose following a primary mRNA COVID-19 vaccination series in certain recipients aged ≥18 years who are at increased risk for serious complications of COVID-19 or exposure to SARS-CoV-2 (the virus that causes COVID-19), as well as in recipients aged ≥18 years of Janssen COVID-19 vaccine (1) (Table). For the purposes of these recommendations, an additional primary (hereafter additional) dose refers to a dose of vaccine administered to persons who likely did not mount a protective immune response after initial vaccination. A booster dose refers to a dose of vaccine administered to enhance or restore protection by the primary vaccination, which might have waned over time. Health care professionals play a critical role in COVID-19 vaccination efforts, including for primary, additional, and booster vaccination, particularly to protect patients who are at increased risk for severe illness and death.


Assuntos
Comitês Consultivos , Vacinas contra COVID-19/administração & dosagem , Imunização/normas , Guias de Prática Clínica como Assunto , Adolescente , Adulto , Sistemas de Notificação de Reações Adversas a Medicamentos , Idoso , COVID-19/epidemiologia , COVID-19/prevenção & controle , Vacinas contra COVID-19/efeitos adversos , Centers for Disease Control and Prevention, U.S. , Aprovação de Drogas , Humanos , Pessoa de Meia-Idade , Estados Unidos/epidemiologia , United States Food and Drug Administration , Adulto Jovem
3.
MMWR Morb Mortal Wkly Rep ; 70(38): 1332-1336, 2021 Sep 24.
Artigo em Inglês | MEDLINE | ID: mdl-34555002

RESUMO

Foodborne illnesses are a substantial and largely preventable public health problem; before 2020 the incidence of most infections transmitted commonly through food had not declined for many years. To evaluate progress toward prevention of foodborne illnesses in the United States, the Foodborne Diseases Active Surveillance Network (FoodNet) of CDC's Emerging Infections Program monitors the incidence of laboratory-diagnosed infections caused by eight pathogens transmitted commonly through food reported by 10 U.S. sites.* FoodNet is a collaboration among CDC, 10 state health departments, the U.S. Department of Agriculture's Food Safety and Inspection Service (USDA-FSIS), and the Food and Drug Administration. This report summarizes preliminary 2020 data and describes changes in incidence with those during 2017-2019. During 2020, observed incidences of infections caused by enteric pathogens decreased 26% compared with 2017-2019; infections associated with international travel decreased markedly. The extent to which these reductions reflect actual decreases in illness or decreases in case detection is unknown. On March 13, 2020, the United States declared a national emergency in response to the COVID-19 pandemic. After the declaration, state and local officials implemented stay-at-home orders, restaurant closures, school and child care center closures, and other public health interventions to slow the spread of SARS-CoV-2, the virus that causes COVID-19 (1). Federal travel restrictions were declared (1). These widespread interventions as well as other changes to daily life and hygiene behaviors, including increased handwashing, have likely changed exposures to foodborne pathogens. Other factors, such as changes in health care delivery, health care-seeking behaviors, and laboratory testing practices, might have decreased the detection of enteric infections. As the pandemic continues, surveillance of illness combined with data from other sources might help to elucidate the factors that led to the large changes in 2020; this understanding could lead to improved strategies to prevent illness. To reduce the incidence of these infections concerted efforts are needed, from farm to processing plant to restaurants and homes. Consumers can reduce their risk of foodborne illness by following safe food-handling and preparation recommendations.


Assuntos
COVID-19/epidemiologia , Microbiologia de Alimentos/estatística & dados numéricos , Parasitologia de Alimentos/estatística & dados numéricos , Doenças Transmitidas por Alimentos/epidemiologia , Pandemias , Conduta Expectante , Adolescente , Criança , Pré-Escolar , Doenças Transmitidas por Alimentos/microbiologia , Doenças Transmitidas por Alimentos/parasitologia , Humanos , Incidência , Lactente , Estados Unidos/epidemiologia
4.
MMWR Morb Mortal Wkly Rep ; 70(38): 1344-1348, 2021 Sep 24.
Artigo em Inglês | MEDLINE | ID: mdl-34555007

RESUMO

The Pfizer-BioNTech COVID-19 vaccine (BNT162b2) is a lipid nanoparticle-formulated, nucleoside mRNA vaccine encoding the prefusion spike glycoprotein of SARS-CoV-2, the virus that causes COVID-19. Vaccination with the Pfizer-BioNTech COVID-19 vaccine consists of 2 intramuscular doses (30 µg, 0.3 mL each) administered 3 weeks apart. In December 2020, the vaccine was granted Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA) as well as an interim recommendation for use among persons aged ≥16 years by the Advisory Committee on Immunization Practices (ACIP) (1). In May 2021, the EUA and interim ACIP recommendations for Pfizer-BioNTech COVID-19 vaccine were extended to adolescents aged 12-15 years (2). During December 14, 2020-September 1, 2021, approximately 211 million doses of Pfizer-BioNTech COVID-19 vaccine were administered in the United States.* On August 23, 2021, FDA approved a Biologics License Application for use of the Pfizer-BioNTech COVID-19 vaccine, Comirnaty (Pfizer, Inc.), in persons aged ≥16 years (3). The ACIP COVID-19 Vaccines Work Group's conclusions regarding the evidence for the Pfizer-BioNTech COVID-19 vaccine were presented to ACIP at a public meeting on August 30, 2021. To guide its deliberations regarding the Pfizer-BioNTech COVID-19 vaccine, ACIP used the Evidence to Recommendation (EtR) Framework,† and incorporated a Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach.§ In addition to initial clinical trial data, ACIP considered new information gathered in the 8 months since issuance of the interim recommendation for Pfizer-BioNTech COVID-19 vaccine, including additional follow-up time in the clinical trial, real-world vaccine effectiveness studies, and postauthorization vaccine safety monitoring. The additional information increased certainty that benefits from prevention of asymptomatic infection, COVID-19, and associated hospitalization and death outweighs vaccine-associated risks. On August 30, 2021, ACIP issued a recommendation¶ for use of the Pfizer-BioNTech COVID-19 vaccine in persons aged ≥16 years for the prevention of COVID-19.


Assuntos
Vacinas contra COVID-19/administração & dosagem , COVID-19/prevenção & controle , Imunização/normas , Guias de Prática Clínica como Assunto , Adolescente , Adulto , Comitês Consultivos , COVID-19/epidemiologia , Vacinas contra COVID-19/efeitos adversos , Centers for Disease Control and Prevention, U.S. , Aprovação de Drogas , Feminino , Humanos , Masculino , Estados Unidos/epidemiologia , Vacinas Sintéticas/administração & dosagem , Adulto Jovem
5.
Clin Infect Dis ; 2021 May 16.
Artigo em Inglês | MEDLINE | ID: mdl-33993224

RESUMO

BACKGROUND: In 2018, CDC and the Vermont Department of Health investigated an outbreak of multidrug-resistant Shigella sonnei infections in a retirement community that offered a continuum of care from independent living through skilled nursing care. The investigation identified 24 culture-confirmed cases. Isolates were resistant to trimethoprim-sulfamethoxazole, ampicillin, and ceftriaxone, and had decreased susceptibility to azithromycin and ciprofloxacin. METHODS: To evaluate clinical and microbiologic response, we reviewed inpatient and outpatient medical records for treatment outcomes among the 24 patients with culture-confirmed S. sonnei infection. We defined clinical failure as diarrhea (≥3 loose stools per day) for ≥1 day after treatment finished, and microbiologic failure as a stool culture that yielded S. sonnei after treatment finished. We used broth microdilution to perform antimicrobial susceptibility testing, and whole genome sequencing to identify resistance mechanisms. RESULTS: Isolates contained macrolide resistance genes mph(A) and erm(B) and had azithromycin minimum inhibitory concentrations above the Clinical and Laboratory Standards Institute epidemiological cutoff value of ≤16 µg/mL. Among 24 patients with culture-confirmed Shigella infection, four were treated with azithromycin; all had clinical treatment failure and two also had microbiologic treatment failure. Isolates were susceptible to ciprofloxacin but contained a gyrA mutation; two patients failed treatment with ciprofloxacin. CONCLUSIONS: These azithromycin treatment failures demonstrate the importance of clinical breakpoints to aid clinicians in identifying alternative treatment options for resistant strains. Additionally, these treatment failures highlight a need for comprehensive susceptibility testing and systematic outcome studies, particularly given the emergence of multidrug-resistant Shigella among an expanding range of patient populations.

6.
N Engl J Med ; 383(4): 334-346, 2020 07 23.
Artigo em Inglês | MEDLINE | ID: mdl-32598831

RESUMO

BACKGROUND: Understanding the epidemiology and clinical course of multisystem inflammatory syndrome in children (MIS-C) and its temporal association with coronavirus disease 2019 (Covid-19) is important, given the clinical and public health implications of the syndrome. METHODS: We conducted targeted surveillance for MIS-C from March 15 to May 20, 2020, in pediatric health centers across the United States. The case definition included six criteria: serious illness leading to hospitalization, an age of less than 21 years, fever that lasted for at least 24 hours, laboratory evidence of inflammation, multisystem organ involvement, and evidence of infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) based on reverse-transcriptase polymerase chain reaction (RT-PCR), antibody testing, or exposure to persons with Covid-19 in the past month. Clinicians abstracted the data onto standardized forms. RESULTS: We report on 186 patients with MIS-C in 26 states. The median age was 8.3 years, 115 patients (62%) were male, 135 (73%) had previously been healthy, 131 (70%) were positive for SARS-CoV-2 by RT-PCR or antibody testing, and 164 (88%) were hospitalized after April 16, 2020. Organ-system involvement included the gastrointestinal system in 171 patients (92%), cardiovascular in 149 (80%), hematologic in 142 (76%), mucocutaneous in 137 (74%), and respiratory in 131 (70%). The median duration of hospitalization was 7 days (interquartile range, 4 to 10); 148 patients (80%) received intensive care, 37 (20%) received mechanical ventilation, 90 (48%) received vasoactive support, and 4 (2%) died. Coronary-artery aneurysms (z scores ≥2.5) were documented in 15 patients (8%), and Kawasaki's disease-like features were documented in 74 (40%). Most patients (171 [92%]) had elevations in at least four biomarkers indicating inflammation. The use of immunomodulating therapies was common: intravenous immune globulin was used in 144 (77%), glucocorticoids in 91 (49%), and interleukin-6 or 1RA inhibitors in 38 (20%). CONCLUSIONS: Multisystem inflammatory syndrome in children associated with SARS-CoV-2 led to serious and life-threatening illness in previously healthy children and adolescents. (Funded by the Centers for Disease Control and Prevention.).


Assuntos
Infecções por Coronavirus/complicações , Pneumonia Viral/complicações , Síndrome de Resposta Inflamatória Sistêmica/epidemiologia , Síndrome de Resposta Inflamatória Sistêmica/virologia , Adolescente , Betacoronavirus , COVID-19 , Centers for Disease Control and Prevention, U.S. , Criança , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/terapia , Cuidados Críticos , Feminino , Glucocorticoides/uso terapêutico , Humanos , Imunoglobulinas Intravenosas/uso terapêutico , Imunomodulação , Inflamação , Tempo de Internação , Masculino , Síndrome de Linfonodos Mucocutâneos/epidemiologia , Síndrome de Linfonodos Mucocutâneos/terapia , Síndrome de Linfonodos Mucocutâneos/virologia , Pandemias , Pneumonia Viral/epidemiologia , Pneumonia Viral/terapia , Estudos Prospectivos , Respiração Artificial , Estudos Retrospectivos , SARS-CoV-2 , Síndrome de Resposta Inflamatória Sistêmica/terapia , Estados Unidos
7.
Open Forum Infect Dis ; 7(4): ofaa113, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-32341933

RESUMO

In 2017, state health departments notified the Centers for Disease Control and Prevention about 4 patients with shigellosis who experienced persistent illness after treatment with oral third-generation cephalosporins. Given increasing antibiotic resistance among Shigella, these cases highlight the need to evaluate the efficacy of oral cephalosporins for shigellosis.

8.
Clin Infect Dis ; 70(10): 2121-2130, 2020 05 06.
Artigo em Inglês | MEDLINE | ID: mdl-31298691

RESUMO

BACKGROUND: Hospitalized immunocompromised (IC) adults with influenza may have worse outcomes than hospitalized non-IC adults. METHODS: We identified adults hospitalized with laboratory-confirmed influenza during 2011-2015 seasons through CDC's Influenza Hospitalization Surveillance Network. IC patients had human immunodefiency virus (HIV)/AIDS, cancer, stem cell or organ transplantation, nonsteroid immunosuppressive therapy, immunoglobulin deficiency, asplenia, and/or other rare conditions. We compared demographic and clinical characteristics of IC and non-IC adults using descriptive statistics. Multivariable logistic regression and Cox proportional hazards models controlled for confounding by patient demographic characteristics, pre-existing medical conditions, influenza vaccination, and other factors. RESULTS: Among 35 348 adults, 3633 (10%) were IC; cancer (44%), nonsteroid immunosuppressive therapy (44%), and HIV (18%) were most common. IC patients were more likely than non-IC patients to have received influenza vaccination (53% vs 46%; P < .001), and ~85% of both groups received antivirals. In multivariable analysis, IC adults had higher mortality (adjusted odds ratio [aOR], 1.46; 95% confidence interval [CI], 1.20-1.76). Intensive care was more likely among IC patients 65-79 years (aOR, 1.25; 95% CI, 1.06-1.48) and those >80 years (aOR, 1.35; 95% CI, 1.06-1.73) compared with non-IC patients in those age groups. IC patients were hospitalized longer (adjusted hazard ratio of discharge, 0.86; 95% CI, .83-.88) and more likely to require mechanical ventilation (aOR, 1.19; 95% CI, 1.05-1.36). CONCLUSIONS: Substantial morbidity and mortality occurred among IC adults hospitalized with influenza. Influenza vaccination and antiviral administration could be increased in both IC and non-IC adults.


Assuntos
Influenza Humana , Adulto , Hospitalização , Humanos , Hospedeiro Imunocomprometido , Influenza Humana/epidemiologia , Laboratórios , Estados Unidos/epidemiologia , Vacinação
9.
J Pediatric Infect Dis Soc ; 8(6): 539-549, 2019 Dec 27.
Artigo em Inglês | MEDLINE | ID: mdl-30358877

RESUMO

BACKGROUND: Existing data on the clinical features and outcomes of immunocompromised children with influenza are limited. METHODS: Data from the 2011-2012 through 2014-2015 influenza seasons were collected as part of the Centers for Disease Control and Prevention (CDC) Influenza Hospitalization Surveillance Network (FluSurv-NET). We compared clinical features and outcomes between immunocompromised and nonimmunocompromised children (<18 years old) hospitalized with laboratory-confirmed community-acquired influenza. Immunocompromised children were defined as those for whom ≥1 of the following applies: human immunodeficiency virus/acquired immunodeficiency syndrome, cancer, stem cell or solid organ transplantation, nonsteroidal immunosuppressive therapy, immunoglobulin deficiency, complement deficiency, asplenia, and/or another rare condition. The primary outcomes were intensive care admission, duration of hospitalization, and in-hospital death. RESULTS: Among 5262 hospitalized children, 242 (4.6%) were immunocompromised; receipt of nonsteroidal immunosuppressive therapy (60%), cancer (39%), and solid organ transplantation (14%) were most common. Immunocompromised children were older than the nonimmunocompromised children (median, 8.8 vs 2.8 years, respectively; P < .001), more likely to have another comorbidity (58% vs 49%, respectively; P = .007), and more likely to have received an influenza vaccination (58% vs 39%, respectively; P < .001) and early antiviral treatment (35% vs 27%, respectively; P = .013). In multivariable analyses, immunocompromised children were less likely to receive intensive care (adjusted odds ratio [95% confidence interval], 0.31 [0.20-0.49]) and had a slightly longer duration of hospitalization (adjusted hazard ratio of hospital discharge [95% confidence interval], 0.89 [0.80-0.99]). Death was uncommon in both groups. CONCLUSIONS: Immunocompromised children hospitalized with influenza received intensive care less frequently but had a longer hospitalization duration than nonimmunocompromised children. Vaccination and early antiviral use could be improved substantially. Data are needed to determine whether immunocompromised children are more commonly admitted with milder influenza severity than are nonimmunocompromised children.


Assuntos
Criança Hospitalizada , Hospedeiro Imunocomprometido , Vacinas contra Influenza , Influenza Humana/imunologia , Influenza Humana/prevenção & controle , Adolescente , Antivirais/uso terapêutico , Criança , Pré-Escolar , Comorbidade , Estudos Transversais , Feminino , Hospitalização , Humanos , Imunossupressores , Lactente , Influenza Humana/terapia , Masculino , Neoplasias , Razão de Chances , Transplante de Órgãos , Estados Unidos , Vacinação
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