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1.
MMWR Morb Mortal Wkly Rep ; 73(15): 345-350, 2024 Apr 18.
Artigo em Inglês | MEDLINE | ID: mdl-38635488

RESUMO

Meningococcal disease is a life-threatening invasive infection caused by Neisseria meningitidis. Two quadrivalent (serogroups A, C, W, and Y) meningococcal conjugate vaccines (MenACWY) (MenACWY-CRM [Menveo, GSK] and MenACWY-TT [MenQuadfi, Sanofi Pasteur]) and two serogroup B meningococcal vaccines (MenB) (MenB-4C [Bexsero, GSK] and MenB-FHbp [Trumenba, Pfizer Inc.]), are licensed and available in the United States and have been recommended by CDC's Advisory Committee on Immunization Practices (ACIP). On October 20, 2023, the Food and Drug Administration approved the use of a pentavalent meningococcal vaccine (MenACWY-TT/MenB-FHbp [Penbraya, Pfizer Inc.]) for prevention of invasive disease caused by N. meningitidis serogroups A, B, C, W, and Y among persons aged 10-25 years. On October 25, 2023, ACIP recommended that MenACWY-TT/MenB-FHbp may be used when both MenACWY and MenB are indicated at the same visit for the following groups: 1) healthy persons aged 16-23 years (routine schedule) when shared clinical decision-making favors administration of MenB vaccine, and 2) persons aged ≥10 years who are at increased risk for meningococcal disease (e.g., because of persistent complement deficiencies, complement inhibitor use, or functional or anatomic asplenia). Different manufacturers' serogroup B-containing vaccines are not interchangeable; therefore, when MenACWY-TT/MenB-FHbp is used, subsequent doses of MenB should be from the same manufacturer (Pfizer Inc.). This report summarizes evidence considered for these recommendations and provides clinical guidance for the use of MenACWY-TT/MenB-FHbp.


Assuntos
Infecções Meningocócicas , Vacinas Meningocócicas , Neisseria meningitidis Sorogrupo B , Neisseria meningitidis , Humanos , Estados Unidos/epidemiologia , Comitês Consultivos , Vacinas Combinadas , Imunização , Infecções Meningocócicas/prevenção & controle
2.
ACS ES T Water ; 3(4): 1126-1133, 2023 Mar 15.
Artigo em Inglês | MEDLINE | ID: mdl-37213412

RESUMO

Naegleria fowleri is a thermophilic ameba found in freshwater that causes primary amebic meningoencephalitis (PAM) when it enters the nose and migrates to the brain. In September 2018, a 29-year-old man died of PAM after traveling to Texas. We conducted an epidemiologic and environmental investigation to identify the water exposure associated with this PAM case. The patient's most probable water exposure occurred while surfing in an artificial surf venue. The surf venue water was not filtered or recirculated; water disinfection and water quality testing were not documented. N. fowleri and thermophilic amebae were detected in recreational water and sediment samples throughout the facility. Codes and standards for treated recreational water venues open to the public could be developed to address these novel venues. Clinicians and public health officials should also consider novel recreational water venues as a potential exposure for this rare amebic infection.

3.
PLoS One ; 17(12): e0278624, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36473010

RESUMO

In December 2020, an interim recommendation for the use of Pfizer-BioNTech COVID-19 vaccine in persons aged ≥16 years was made under Food and Drug Administration's Emergency Use Authorization. In preparation for Biologics License Application approval, we conducted a systematic review and meta-analysis to inform the U.S. Centers for Disease Control and Prevention's Advisory Committee for Immunization Practice's (ACIP) decision-making for a standard recommendation. We conducted a rapid systematic review and meta-analysis of Pfizer-BioNTech vaccine effectiveness (VE) against symptomatic COVID-19, hospitalization due to COVID-19, death due to COVID-19, and asymptomatic SARS-CoV-2 infection. We identified studies through August 20, 2021 from an ongoing systematic review conducted by the International Vaccine Access Center and the World Health Organization. We evaluated each study for risk of bias using the Newcastle-Ottawa Scale. Pooled estimates were calculated using meta-analysis. The body of evidence for each outcome was assessed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. We identified 80 articles, selected 35 for full-text review, and included 26. The pooled VE of Pfizer-BioNTech COVID-19 vaccine was 92.4% (95% CI: 87.5%-95.3%) against symptomatic COVID-19 with moderate evidence certainty (eight studies), 94.3% (95% CI: 87.9%-97.3%) against hospitalization due to COVID-19 with moderate certainty (eight studies), 96.1% (95% CI: 91.5%-98.2%) against death due to COVID-19 with moderate certainty (four studies), and 89.3% (88.4%-90.1%) against asymptomatic SARS-CoV-2 infection with very low certainty (two studies). The Pfizer-BioNTech COVID-19 vaccine demonstrated high effectiveness in all pre-specified outcomes and extended knowledge of the vaccine's benefits to outcomes and populations not informed by the RCTs. Use of an existing systematic review facilitated a rapid meta-analysis to inform an ACIP policy decision. This approach can be utilized as additional COVID-19 vaccines are considered for standard recommendations by ACIP.


Assuntos
Vacinas contra COVID-19 , COVID-19 , Estados Unidos , Humanos , Vacina BNT162 , COVID-19/epidemiologia , COVID-19/prevenção & controle , SARS-CoV-2 , Políticas
4.
MMWR recomm. rep ; 70(45): 1579-1583, Nov. 12, 2022. tab
Artigo em Inglês | BIGG - guias GRADE | ID: biblio-1397007

RESUMO

The Pfizer-BioNTech COVID-19 (BNT162b2) vaccine is a lipid nanoparticle­formulated, 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 12­15 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 5­11 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 5­11 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 5­11 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 5­11 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
Humanos , Pré-Escolar , Criança , Programas de Imunização/normas , COVID-19/prevenção & controle , Vacina BNT162/uso terapêutico , Vacina BNT162/imunologia
5.
MMWR Morb Mortal Wkly Rep ; 71(40): 1260-1264, 2022 Oct 07.
Artigo em Inglês | MEDLINE | ID: mdl-36201372

RESUMO

To evaluate progress toward prevention of enteric infections in the United States, the Foodborne Diseases Active Surveillance Network (FoodNet) conducts active population-based surveillance for laboratory-diagnosed infections caused by Campylobacter, Cyclospora, Listeria, Salmonella, Shiga toxin-producing Escherichia coli (STEC), Shigella, Vibrio, and Yersinia at 10 U.S. sites. This report summarizes preliminary 2021 data and describes changes in annual incidence compared with the average annual incidence for 2016-2018, the reference period for the U.S. Department of Health and Human Services' (HHS) Healthy People 2030 goals for some pathogens (1). During 2021, the incidence of infections caused by Salmonella decreased, incidence of infections caused by Cyclospora, Yersinia, and Vibrio increased, and incidence of infections caused by other pathogens did not change. As in 2020, behavioral modifications and public health interventions implemented to control the COVID-19 pandemic might have decreased transmission of enteric infections (2). Other factors (e.g., increased use of telemedicine and continued increase in use of culture-independent diagnostic tests [CIDTs]) might have altered their detection or reporting (2). Much work remains to achieve HHS Healthy People 2030 goals, particularly for Salmonella infections, which are frequently attributed to poultry products and produce, and Campylobacter infections, which are frequently attributed to chicken products (3).


Assuntos
COVID-19 , Doenças Transmitidas por Alimentos , Vibrio , Doenças Transmitidas por Alimentos/epidemiologia , Humanos , Incidência , Pandemias , Vigilância da População , Salmonella , Estados Unidos/epidemiologia , Conduta Expectante
6.
MMWR Recomm Rep ; 71(2): 1-8, 2022 09 30.
Artigo em Inglês | MEDLINE | ID: mdl-36173766

RESUMO

THIS REPORT SUMMARIZES ALL RECOMMENDATIONS FROM CDC'S ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES (ACIP) FOR THE USE OF LYOPHILIZED CVD 103-HGR VACCINE (CVD 103-HGR) (VAXCHORA, EMERGENT BIOSOLUTIONS, GAITHERSBURG, MD) IN THE UNITED STATES. THE LIVE ATTENUATED ORAL CHOLERA VACCINE IS DERIVED FROM: Vibrio cholerae O1 and is administered in a single dose. Cholera is a toxin-mediated bacterial gastrointestinal illness caused by toxigenic V. cholerae serogroup O1 or, uncommonly, O139. Up to 10% of infections manifest as severe cholera (i.e., cholera gravis), profuse watery diarrhea that can cause severe dehydration and death within hours. Fluid replacement therapy can reduce the fatality rate to <1%. Risk factors for cholera gravis include high dose exposure, blood group O, increased gastric pH (e.g., from antacid therapy), and partial gastrectomy. Cholera is rare in the United States, but cases occur among travelers to countries where cholera is endemic or epidemic and associated with unsafe water and inadequate sanitation. Travelers might be at increased risk for poor outcomes from cholera if they cannot readily access medical services or if they have a medical condition that would be worsened by dehydration, such as cardiovascular or kidney disease. This report describes previously published ACIP recommendations about use of CVD 103-HgR for adults aged 18-64 years and introduces a new recommendation for use in children and adolescents aged 2-17 years. ACIP recommends CVD 103-HgR, the only cholera vaccine licensed for use in the United States, for prevention of cholera among travelers aged 2-64 years to an area with active cholera transmission. Health care providers can use these guidelines to develop the pretravel consultation for persons traveling to areas with active cholera transmission.


Assuntos
Vacinas contra Cólera , Cólera , Adolescente , Adulto , Comitês Consultivos , Antiácidos , Antígenos de Grupos Sanguíneos , Criança , Pré-Escolar , Cólera/epidemiologia , Cólera/prevenção & controle , Vacinas contra Cólera/administração & dosagem , Desidratação , Humanos , Pessoa de Meia-Idade , Estados Unidos/epidemiologia , Vacinação , Vacinas Atenuadas , Vibrio cholerae O1 , Água , Adulto Jovem
7.
Infect Control Hosp Epidemiol ; 43(12): 1880-1889, 2022 12.
Artigo em Inglês | MEDLINE | ID: mdl-36017721

RESUMO

OBJECTIVE: To describe national antibiotic prescribing for acute gastroenteritis (AGE). SETTING: Ambulatory care. METHODS: We included visits with diagnoses for bacterial and viral gastrointestinal infections from the National Ambulatory Medical Care Survey and National Hospital Ambulatory Medical Care Survey (NAMCS/NHAMCS; 2006-2015) and the IBM Watson 2014 MarketScan Commercial Claims and Encounters Database. For NAMCS/NHAMCS, we calculated annual percentage estimates and 99% confidence intervals (CIs) of visits with antibiotics prescribed; sample sizes were too small to calculate estimates by pathogen. For MarketScan, we used Poisson regression to calculate the percentage of visits with antibiotics prescribed and 95% CIs, including by pathogen. RESULTS: We included 10,210 NAMCS/NHAMCS AGE visits; an estimated 13.3% (99% CI, 11.2%-15.4%) resulted in antibiotic prescriptions, most frequently fluoroquinolones (28.7%; 99% CI, 21.1%-36.3%), nitroimidazoles (20.2%; 99% CI, 14.0%-26.4%), and penicillins (18.9%; 99% CI, 11.6%-26.2%). In NAMCS/NHAMCS, antibiotic prescribing was least frequent in emergency departments (10.8%; 99% CI, 9.5%-12.1%). Among 1,868,465 MarketScan AGE visits, antibiotics were prescribed for 13.8% (95% CI, 13.7%-13.8%), most commonly for Yersinia (46.7%; 95% CI, 21.4%-71.9%), Campylobacter (44.8%; 95% CI, 41.5%-48.1%), Shigella (39.7%; 95% CI, 35.9%-43.6%), typhoid or paratyphoid fever (32.7%; (95% CI, 27.2%-38.3%), and nontyphoidal Salmonella (31.7%; 95% CI, 29.5%-33.9%). Antibiotics were prescribed for 12.3% (95% CI, 11.7%-13.0%) of visits for viral gastroenteritis. CONCLUSIONS: Overall, ∼13% of AGE visits resulted in antibiotic prescriptions. Antibiotics were unnecessarily prescribed for viral gastroenteritis and some bacterial infections for which antibiotics are not recommended. Antibiotic stewardship assessments and interventions for AGE are needed in ambulatory settings.


Assuntos
Antibacterianos , Gastroenterite , Estados Unidos/epidemiologia , Humanos , Antibacterianos/uso terapêutico , Assistência Ambulatorial , Pesquisas sobre Atenção à Saúde , Serviço Hospitalar de Emergência , Gastroenterite/tratamento farmacológico , Gastroenterite/epidemiologia , Padrões de Prática Médica
8.
Clin Infect Dis ; 74(3): 455-460, 2022 02 11.
Artigo em Inglês | MEDLINE | ID: mdl-33993224

RESUMO

BACKGROUND: In 2018, the Centers for Disease Control and Prevention 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, 4 were treated with azithromycin; all had clinical treatment failure and 2 also had microbiologic treatment failure. Isolates were susceptible to ciprofloxacin but contained a gyrA mutation; 2 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.


Assuntos
Disenteria Bacilar , Shigella , Antibacterianos/farmacologia , Antibacterianos/uso terapêutico , Azitromicina/farmacologia , Azitromicina/uso terapêutico , Ciprofloxacina/farmacologia , Ciprofloxacina/uso terapêutico , Surtos de Doenças , Farmacorresistência Bacteriana/genética , Disenteria Bacilar/tratamento farmacológico , Disenteria Bacilar/epidemiologia , Humanos , Macrolídeos/uso terapêutico , Testes de Sensibilidade Microbiana , Aposentadoria , Shigella sonnei/genética , Resultado do Tratamento , Vermont
9.
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
10.
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 , Vacina BNT162 , 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
11.
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
12.
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 , Vacinas de mRNA
13.
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
14.
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.

15.
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
16.
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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