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1.
MMWR Morb Mortal Wkly Rep ; 72(19): 529-535, 2023 May 12.
Artigo em Inglês | MEDLINE | ID: mdl-37167204

RESUMO

When the U.S. COVID-19 public health emergency declaration expires on May 11, 2023, national reporting of certain categories of COVID-19 public health surveillance data will be transitioned to other data sources or will be discontinued; COVID-19 hospitalization data will be the only data source available at the county level (1). In anticipation of the transition, national COVID-19 surveillance data sources and indicators were evaluated for purposes of ongoing monitoring. The timeliness and correlations among surveillance indicators were analyzed to assess the usefulness of COVID-19-associated hospital admission rates as a primary indicator for monitoring COVID-19 trends, as well as the suitability of other replacement data sources. During April 2022-March 2023, COVID-19 hospital admission rates from the National Healthcare Safety Network (NHSN)† lagged 1 day behind case rates and 4 days behind percentages of positive test results and COVID-19 emergency department (ED) visits from the National Syndromic Surveillance Program (NSSP). In the same analysis, National Vital Statistics System (NVSS) trends in the percentage of deaths that were COVID-19-associated, which is tracked by date of death rather than by report date, were observable 13 days earlier than those from aggregate death count data, which will be discontinued (1). During October 2020-March 2023, strong correlations were observed between NVSS and aggregate death data (0.78) and between the percentage of positive SARS-CoV-2 test results from the National Respiratory and Enteric Viruses Surveillance System (NREVSS) and COVID-19 electronic laboratory reporting (CELR) (0.79), which will also be discontinued (1). Weekly COVID-19 Community Levels (CCLs) will be replaced with levels of COVID-19 hospital admission rates (low, medium, or high) which demonstrated >99% concordance by county during February 2022-March 2023. COVID-19-associated hospital admission levels are a suitable primary metric for monitoring COVID-19 trends, the percentage of COVID-19 deaths is a timely disease severity indicator, and the percentages of positive SARS-CoV-2 test results from NREVSS and ED visits serve as early indicators for COVID-19 monitoring. Collectively, these surveillance data sources and indicators can support monitoring of the impact of COVID-19 and related prevention and control strategies as ongoing public health priorities.


Assuntos
COVID-19 , Humanos , Estados Unidos/epidemiologia , COVID-19/epidemiologia , Fonte de Informação , SARS-CoV-2 , Vigilância de Evento Sentinela , Hospitalização
2.
MMWR Morb Mortal Wkly Rep ; 72(14): 355-361, 2023 Apr 07.
Artigo em Inglês | MEDLINE | ID: mdl-37022977

RESUMO

In the United States, respiratory syncytial virus (RSV) infections cause an estimated 58,000-80,000 hospitalizations among children aged <5 years (1,2) and 60,000-160,000 hospitalizations among adults aged ≥65 years each year (3-5). U.S. RSV epidemics typically follow seasonal patterns, peaking in December or January (6,7), but the COVID-19 pandemic disrupted RSV seasonality during 2020-2022 (8). To describe U.S. RSV seasonality during prepandemic and pandemic periods, polymerase chain reaction (PCR) test results reported to the National Respiratory and Enteric Virus Surveillance System (NREVSS)* during July 2017-February 2023 were analyzed. Seasonal RSV epidemics were defined as the weeks during which the percentage of PCR test results that were positive for RSV was ≥3% (9). Nationally, prepandemic seasons (2017-2020) began in October, peaked in December, and ended in April. During 2020-21, the typical winter RSV epidemic did not occur. The 2021-22 season began in May, peaked in July, and ended in January. The 2022-23 season started (June) and peaked (November) later than the 2021-22 season, but earlier than prepandemic seasons. In both prepandemic and pandemic periods, epidemics began earlier in Florida and the Southeast and later in regions further north and west. With several RSV prevention products in development,† ongoing monitoring of RSV circulation can guide the timing of RSV immunoprophylaxis and of clinical trials and postlicensure effectiveness studies. Although the timing of the 2022-23 season suggests that seasonal patterns are returning toward those observed in prepandemic years, clinicians should be aware that off-season RSV circulation might continue.


Assuntos
COVID-19 , Infecções por Vírus Respiratório Sincicial , Vírus Sincicial Respiratório Humano , Criança , Adulto , Estados Unidos/epidemiologia , Humanos , Lactente , Pandemias , COVID-19/epidemiologia , Infecções por Vírus Respiratório Sincicial/epidemiologia , Florida/epidemiologia , Estações do Ano
3.
MMWR Morb Mortal Wkly Rep ; 72(5): 125-127, 2023 Feb 03.
Artigo em Inglês | MEDLINE | ID: mdl-36730050

RESUMO

Monitoring emerging SARS-CoV-2 lineages and their epidemiologic characteristics helps to inform public health decisions regarding vaccine policy, the use of therapeutics, and health care capacity. When the SARS-CoV-2 Alpha variant emerged in late 2020, a spike gene (S-gene) deletion (Δ69-70) in the N-terminal region, which might compensate for immune escape mutations that impair infectivity (1), resulted in reduced or failed S-gene target amplification in certain multitarget reverse transcription-polymerase chain reaction (RT-PCR) assays, a pattern referred to as S-gene target failure (SGTF) (2). The predominant U.S. SARS-CoV-2 lineages have generally alternated between SGTF and S-gene target presence (SGTP), which alongside genomic sequencing, has facilitated early monitoring of emerging variants. During a period when Omicron BA.5-related sublineages (which exhibit SGTF) predominated, an XBB.1.5 sublineage with SGTP has rapidly expanded in the northeastern United States and other regions.


Assuntos
COVID-19 , Saúde Pública , Estados Unidos/epidemiologia , Humanos , SARS-CoV-2/genética , COVID-19/epidemiologia , Mutação , Teste para COVID-19
4.
MMWR Morb Mortal Wkly Rep ; 72(5): 119-124, 2023 02 03.
Artigo em Inglês | MEDLINE | ID: mdl-36730051

RESUMO

The SARS-CoV-2 Omicron sublineage XBB was first detected in the United States in August 2022.* XBB together with a sublineage, XBB.1.5, accounted for >50% of sequenced lineages in the Northeast by December 31, 2022, and 52% of sequenced lineages nationwide as of January 21, 2023. COVID-19 vaccine effectiveness (VE) can vary by SARS-CoV-2 variant; reduced VE has been observed against some variants, although this is dependent on the health outcome of interest. The goal of the U.S. COVID-19 vaccination program is to prevent severe disease, including hospitalization and death (1); however, VE against symptomatic infection can provide useful insight into vaccine protection against emerging variants in advance of VE estimates against more severe disease. Data from the Increasing Community Access to Testing (ICATT) national pharmacy program for SARS-CoV-2 testing were analyzed to estimate VE of updated (bivalent) mRNA COVID-19 vaccines against symptomatic infection caused by BA.5-related and XBB/XBB.1.5-related sublineages among immunocompetent adults during December 1, 2022­January 13, 2023. Reduction or failure of spike gene (S-gene) amplification (SGTF) in real-time reverse transcription­polymerase chain reaction (RT-PCR) was used as a proxy indicator of infection with likely BA.5-related sublineages and S-gene target presence (SGTP) of infection with likely XBB/XBB.1.5-related sublineages (2). Among 29,175 nucleic acid amplification tests (NAATs) with SGTF or SGTP results available from adults who had previously received 2­4 monovalent COVID-19 vaccine doses, the relative VE of a bivalent booster dose given 2­3 months earlier compared with no bivalent booster in persons aged 18­49 years was 52% against symptomatic BA.5 infection and 48% against symptomatic XBB/XBB.1.5 infection. As new SARS-CoV-2 variants emerge, continued vaccine effectiveness monitoring is important. Bivalent vaccines appear to provide additional protection against symptomatic BA.5-related sublineage and XBB/XBB.1.5-related sublineage infections in persons who had previously received 2, 3, or 4 monovalent vaccine doses. All persons should stay up to date with recommended COVID-19 vaccines, including receiving a bivalent booster dose when they are eligible.


Assuntos
COVID-19 , Adulto , Estados Unidos/epidemiologia , Humanos , COVID-19/epidemiologia , COVID-19/prevenção & controle , Vacinas contra COVID-19 , SARS-CoV-2/genética , Vacinas Combinadas , Teste para COVID-19 , Eficácia de Vacinas , RNA Mensageiro
5.
MMWR Morb Mortal Wkly Rep ; 72(19): 523-528, 2023 May 12.
Artigo em Inglês | MEDLINE | ID: mdl-37167154

RESUMO

On January 31, 2020, the U.S. Department of Health and Human Services (HHS) declared, under Section 319 of the Public Health Service Act, a U.S. public health emergency because of the emergence of a novel virus, SARS-CoV-2.* After 13 renewals, the public health emergency will expire on May 11, 2023. Authorizations to collect certain public health data will expire on that date as well. Monitoring the impact of COVID-19 and the effectiveness of prevention and control strategies remains a public health priority, and a number of surveillance indicators have been identified to facilitate ongoing monitoring. After expiration of the public health emergency, COVID-19-associated hospital admission levels will be the primary indicator of COVID-19 trends to help guide community and personal decisions related to risk and prevention behaviors; the percentage of COVID-19-associated deaths among all reported deaths, based on provisional death certificate data, will be the primary indicator used to monitor COVID-19 mortality. Emergency department (ED) visits with a COVID-19 diagnosis and the percentage of positive SARS-CoV-2 test results, derived from an established sentinel network, will help detect early changes in trends. National genomic surveillance will continue to be used to estimate SARS-CoV-2 variant proportions; wastewater surveillance and traveler-based genomic surveillance will also continue to be used to monitor SARS-CoV-2 variants. Disease severity and hospitalization-related outcomes are monitored via sentinel surveillance and large health care databases. Monitoring of COVID-19 vaccination coverage, vaccine effectiveness (VE), and vaccine safety will also continue. Integrated strategies for surveillance of COVID-19 and other respiratory viruses can further guide prevention efforts. COVID-19-associated hospitalizations and deaths are largely preventable through receipt of updated vaccines and timely administration of therapeutics (1-4).


Assuntos
COVID-19 , Vigilância de Evento Sentinela , Humanos , COVID-19/epidemiologia , COVID-19/prevenção & controle , Teste para COVID-19 , Vacinas contra COVID-19 , Saúde Pública , SARS-CoV-2 , Estados Unidos/epidemiologia , Vigilância Epidemiológica Baseada em Águas Residuárias
6.
MMWR Morb Mortal Wkly Rep ; 72(24): 651-656, 2023 Jun 16.
Artigo em Inglês | MEDLINE | ID: mdl-37319011

RESUMO

CDC has used national genomic surveillance since December 2020 to monitor SARS-CoV-2 variants that have emerged throughout the COVID-19 pandemic, including the Omicron variant. This report summarizes U.S. trends in variant proportions from national genomic surveillance during January 2022-May 2023. During this period, the Omicron variant remained predominant, with various descendant lineages reaching national predominance (>50% prevalence). During the first half of 2022, BA.1.1 reached predominance by the week ending January 8, 2022, followed by BA.2 (March 26), BA.2.12.1 (May 14), and BA.5 (July 2); the predominance of each variant coincided with surges in COVID-19 cases. The latter half of 2022 was characterized by the circulation of sublineages of BA.2, BA.4, and BA.5 (e.g., BQ.1 and BQ.1.1), some of which independently acquired similar spike protein substitutions associated with immune evasion. By the end of January 2023, XBB.1.5 became predominant. As of May 13, 2023, the most common circulating lineages were XBB.1.5 (61.5%), XBB.1.9.1 (10.0%), and XBB.1.16 (9.4%); XBB.1.16 and XBB.1.16.1 (2.4%), containing the K478R substitution, and XBB.2.3 (3.2%), containing the P521S substitution, had the fastest doubling times at that point. Analytic methods for estimating variant proportions have been updated as the availability of sequencing specimens has declined. The continued evolution of Omicron lineages highlights the importance of genomic surveillance to monitor emerging variants and help guide vaccine development and use of therapeutics.


Assuntos
COVID-19 , SARS-CoV-2 , Humanos , SARS-CoV-2/genética , Pandemias , COVID-19/epidemiologia , Genômica
7.
Eur J Epidemiol ; 38(11): 1125-1128, 2023 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-37093505

RESUMO

While some studies have previously estimated lives saved by COVID-19 vaccination, we estimate how many deaths could have been averted by vaccination in the US but were not because of a failure to vaccinate. We used a simple method based on a nationally representative dataset to estimate the preventable deaths among unvaccinated individuals in the US from May 30, 2021 to September 3, 2022 adjusted for the effects of age and time. We estimated that at least 232,000 deaths could have been prevented among unvaccinated adults during the 15 months had they been vaccinated with at least a primary series. While uncertainties exist regarding the exact number of preventable deaths and more granular data are needed on other factors causing differences in death rates between the vaccinated and unvaccinated groups to inform these estimates, this method is a rapid assessment on vaccine-preventable deaths due to SARS-CoV-2 that has crucial public health implications. The same rapid method can be used for future public health emergencies.


Assuntos
COVID-19 , Adulto , Estados Unidos/epidemiologia , Humanos , COVID-19/prevenção & controle , Vacinas contra COVID-19 , SARS-CoV-2 , Vacinação , Saúde Pública
8.
Rev Panam Salud Publica ; 47: e53, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-36895677

RESUMO

Objective: Systematize the experience and identify challenges and lessons learned in the implementation of an initiative for integrated serosurveillance of communicable diseases using a multiplex bead assay in countries of the Americas. Methods: Documents produced in the initiative were compiled and reviewed. These included concept notes, internal working papers, regional meetings reports, and survey protocols from the three participating countries (Mexico, Paraguay, and Brazil) and two additional countries (Guyana and Guatemala) where serology for several communicable diseases was included in neglected tropical diseases surveys. Information was extracted and summarized to describe the experience and the most relevant challenges and lessons learned. Results: Implementing integrated serosurveys requires interprogrammatic and interdisciplinary work teams for the design of survey protocols to respond to key programmatic questions aligned to the needs of the countries. Valid laboratory results are critical and rely on the standardized installment and roll-out of laboratory techniques. Field teams require adequate training and supervision to properly implement survey procedures. The analysis and interpretation of serosurveys results should be antigen-specific, contextualizing the responses for each disease, and triangulated with programmatic and epidemiological data for making decisions tailored to specific population socioeconomic and ecologic contexts. Conclusions: Integrated serosurveillance as a complementary tool for functional epidemiological surveillance systems is feasible to use and key components should be considered: political engagement, technical engagement, and integrated planning. Aspects such as designing the protocol, selecting target populations and diseases, laboratory capacities, anticipating the capacities to analyze and interpret complex data, and how to use it are key.

9.
Emerg Infect Dis ; 28(13): S203-S207, 2022 12.
Artigo em Inglês | MEDLINE | ID: mdl-36502406

RESUMO

Global emergence of the COVID-19 pandemic in 2020 curtailed vaccine-preventable disease (VPD) surveillance activities, but little is known about which surveillance components were most affected. In May 2021, we surveyed 214 STOP (originally Stop Transmission of Polio) Program consultants to determine how VPD surveillance activities were affected by the COVID-19 pandemic throughout 2020, primarily in low- and middle-income countries, where program consultants are deployed. Our report highlights the responses from 154 (96%) of the 160 consultants deployed to the World Health Organization African Region, which comprises 75% (160/214) of all STOP Program consultants deployed globally in early 2021. Most survey respondents observed that VPD surveillance activities were somewhat or severely affected by the COVID-19 pandemic in 2020. Reprioritization of surveillance staff and changes in health-seeking behaviors were factors commonly perceived to decrease VPD surveillance activities. Our findings suggest the need for strategies to restore VPD surveillance to prepandemic levels.


Assuntos
COVID-19 , Poliomielite , Doenças Preveníveis por Vacina , Humanos , Doenças Preveníveis por Vacina/epidemiologia , Doenças Preveníveis por Vacina/prevenção & controle , Pandemias/prevenção & controle , COVID-19/epidemiologia , COVID-19/prevenção & controle , Poliomielite/epidemiologia , Organização Mundial da Saúde
10.
MMWR Morb Mortal Wkly Rep ; 71(40): 1265-1270, 2022 Oct 07.
Artigo em Inglês | MEDLINE | ID: mdl-36201400

RESUMO

Increases in severe respiratory illness and acute flaccid myelitis (AFM) among children and adolescents resulting from enterovirus D68 (EV-D68) infections occurred biennially in the United States during 2014, 2016, and 2018, primarily in late summer and fall. Although EV-D68 annual trends are not fully understood, EV-D68 levels were lower than expected in 2020, potentially because of implementation of COVID-19 mitigation measures (e.g., wearing face masks, enhanced hand hygiene, and physical distancing) (1). In August 2022, clinicians in several geographic areas notified CDC of an increase in hospitalizations of pediatric patients with severe respiratory illness and positive rhinovirus/enterovirus (RV/EV) test results.* Surveillance data were analyzed from multiple national data sources to characterize reported trends in acute respiratory illness (ARI), asthma/reactive airway disease (RAD) exacerbations, and the percentage of positive RV/EV and EV-D68 test results during 2022 compared with previous years. These data demonstrated an increase in emergency department (ED) visits by children and adolescents with ARI and asthma/RAD in late summer 2022. The percentage of positive RV/EV test results in national laboratory-based surveillance and the percentage of positive EV-D68 test results in pediatric sentinel surveillance also increased during this time. Previous increases in EV-D68 respiratory illness have led to substantial resource demands in some hospitals and have also coincided with increases in cases of AFM (2), a rare but serious neurologic disease affecting the spinal cord. Therefore, clinicians should consider AFM in patients with acute flaccid limb weakness, especially after respiratory illness or fever, and ensure prompt hospitalization and referral to specialty care for such cases. Clinicians should also test for poliovirus infection in patients suspected of having AFM because of the clinical similarity to acute flaccid paralysis caused by poliovirus. Ongoing surveillance for EV-D68 is critical to ensuring preparedness for possible future increases in ARI and AFM.


Assuntos
Asma , COVID-19 , Enterovirus Humano D , Infecções por Enterovirus , Mielite , Infecções Respiratórias , Adolescente , Asma/epidemiologia , Viroses do Sistema Nervoso Central , Criança , Surtos de Doenças , Infecções por Enterovirus/epidemiologia , Humanos , Mielite/epidemiologia , Doenças Neuromusculares , Infecções Respiratórias/epidemiologia , Rhinovirus , Estados Unidos/epidemiologia
11.
MMWR Morb Mortal Wkly Rep ; 71(6): 206-211, 2022 02 11.
Artigo em Inglês | MEDLINE | ID: mdl-35143464

RESUMO

Genomic surveillance is a critical tool for tracking emerging variants of SARS-CoV-2 (the virus that causes COVID-19), which can exhibit characteristics that potentially affect public health and clinical interventions, including increased transmissibility, illness severity, and capacity for immune escape. During June 2021-January 2022, CDC expanded genomic surveillance data sources to incorporate sequence data from public repositories to produce weighted estimates of variant proportions at the jurisdiction level and refined analytic methods to enhance the timeliness and accuracy of national and regional variant proportion estimates. These changes also allowed for more comprehensive variant proportion estimation at the jurisdictional level (i.e., U.S. state, district, territory, and freely associated state). The data in this report are a summary of findings of recent proportions of circulating variants that are updated weekly on CDC's COVID Data Tracker website to enable timely public health action.† The SARS-CoV-2 Delta (B.1.617.2 and AY sublineages) variant rose from 1% to >50% of viral lineages circulating nationally during 8 weeks, from May 1-June 26, 2021. Delta-associated infections remained predominant until being rapidly overtaken by infections associated with the Omicron (B.1.1.529 and BA sublineages) variant in December 2021, when Omicron increased from 1% to >50% of circulating viral lineages during a 2-week period. As of the week ending January 22, 2022, Omicron was estimated to account for 99.2% (95% CI = 99.0%-99.5%) of SARS-CoV-2 infections nationwide, and Delta for 0.7% (95% CI = 0.5%-1.0%). The dynamic landscape of SARS-CoV-2 variants in 2021, including Delta- and Omicron-driven resurgences of SARS-CoV-2 transmission across the United States, underscores the importance of robust genomic surveillance efforts to inform public health planning and practice.


Assuntos
COVID-19/epidemiologia , COVID-19/virologia , SARS-CoV-2/genética , Centers for Disease Control and Prevention, U.S. , Genômica , Humanos , Prevalência , Vigilância em Saúde Pública/métodos , Estados Unidos/epidemiologia
12.
Emerg Infect Dis ; 27(5): 1477-1481, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33900192

RESUMO

We examined disparities in cumulative incidence of severe acute respiratory syndrome coronavirus 2 by race/ethnicity, age, and sex in the United States during January 1-October 1, 2020. Hispanic/Latino and non-Hispanic Black, American Indian/Alaskan Native, and Native Hawaiian/other Pacific Islander persons had a substantially higher incidence of infection than non-Hispanic White persons.


Assuntos
COVID-19 , Etnicidade , Havaí , Disparidades nos Níveis de Saúde , Humanos , Incidência , Grupos Raciais , SARS-CoV-2 , Estados Unidos/epidemiologia
13.
J Clin Microbiol ; 59(6)2021 05 19.
Artigo em Inglês | MEDLINE | ID: mdl-33731416

RESUMO

Serosurveys are important tools for estimating population immunity and providing immunization activity guidance. The measles and rubella multiplex bead assay (MBA) offers multiple advantages over standard serological assays and was validated by comparison with the enzyme-linked immunosorbent assay (ELISA) and the measles plaque reduction neutralization (PRN) assay. Results from a laboratory-produced purified measles virus whole-virus antigen MBA (MeV WVAL) correlated better with ELISA and PRN than results from the baculovirus-expressed measles nucleoprotein (N) MBA. Therefore, a commercially produced whole-virus antigen (MeV WVAC) was evaluated. Serum IgG antibody concentrations correlated significantly with a strong linear relationship between the MeV WVAC and MeV WVAL MBAs (R = 0.962 and R2 = 0.926). IgG concentrations from the MeV WVAC MBA showed strong correlation with PRN titers (R = 0.846), with a linear relationship comparable to values obtained with the MeV WVAL MBA and PRN assay (R2 = 0.716 and R2 = 0.768, respectively). Receiver operating characteristic (ROC) curve analysis of the MeV WVAC using PRN titer as the comparator resulted in a seroprotection cutoff of 153 mIU/ml, similar to the established correlate of protection of 120 mIU/ml, with a sensitivity of 98% and a specificity of 83%. IgG concentrations correlated strongly between the rubella WVA MBA and ELISA (R = 0.959 and R2 = 0.919). ROC analysis of the rubella MBA using ELISA as the comparator yielded a cutoff of 9.36 IU/ml, similar to the accepted cutoff of 10 IU/ml for seroprotection, with a sensitivity of 99% and a specificity of 100%. These results support use of the MBA for multiantigen serosurveys assessing measles and rubella population immunity.


Assuntos
Sarampo , Rubéola (Sarampo Alemão) , Anticorpos Antivirais , Ensaio de Imunoadsorção Enzimática , Humanos , Imunoglobulina G , Sarampo/diagnóstico , Vírus do Sarampo , Rubéola (Sarampo Alemão)/diagnóstico
14.
MMWR Morb Mortal Wkly Rep ; 70(20): 749-752, 2021 May 21.
Artigo em Inglês | MEDLINE | ID: mdl-34014913

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. Vaccination with the Pfizer-BioNTech COVID-19 vaccine consists of 2 intramuscular doses (30 µg, 0.3 mL each) administered 3 weeks apart. On December 11, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for use of the Pfizer-BioNTech COVID-19 vaccine (Pfizer, Inc; Philadelphia, Pennsylvania) in persons aged ≥16 years (1); on December 12, 2020, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation for use of the vaccine in the same age group (2). As of May 12, 2021, approximately 141.6 million doses of the Pfizer-BioNTech COVID-19 vaccine had been administered to persons aged ≥16 years.* On May 10, 2021, FDA expanded the EUA for the Pfizer-BioNTech COVID-19 vaccine to include adolescents aged 12-15 years (1). On May 12, 2021, ACIP issued an interim recommendation† for use of the Pfizer-BioNTech COVID-19 vaccine in adolescents aged 12-15 years for the prevention of COVID-19. To guide its deliberations regarding the vaccine, ACIP used the Evidence to Recommendation (EtR) Framework,§ using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach.¶ The ACIP recommendation for the use of the Pfizer-BioNTech COVID-19 vaccine in persons aged ≥12 years under an EUA is interim and will be updated as additional information becomes available.


Assuntos
Vacinas contra COVID-19/administração & dosagem , COVID-19/prevenção & controle , Imunização/normas , Guias de Prática Clínica como Assunto , Adolescente , Comitês Consultivos , COVID-19/epidemiologia , Criança , Aprovação de Drogas , Humanos , Estados Unidos/epidemiologia
15.
MMWR Morb Mortal Wkly Rep ; 70(17): 651-656, 2021 Apr 30.
Artigo em Inglês | MEDLINE | ID: mdl-33914723

RESUMO

On February 27, 2021, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the Janssen COVID-19 (Ad.26.COV2.S) vaccine (Janssen Biotech, Inc., a Janssen Pharmaceutical company, Johnson & Johnson; New Brunswick, New Jersey), and on February 28, 2021, the Advisory Committee on Immunization Practices (ACIP) issued interim recommendations for its use in persons aged ≥18 years (1,2). On April 13, 2021, CDC and FDA recommended a pause in the use of the Janssen COVID-19 vaccine after reports of six U.S. cases of cerebral venous sinus thrombosis (CVST) with thrombocytopenia, a rare thromboembolic syndrome, among Janssen COVID-19 vaccine recipients (3). Two emergency ACIP meetings were rapidly convened to review reported cases of thrombosis with thrombocytopenia syndrome (TTS) and to consider updated recommendations for use of the Janssen COVID-19 vaccine in the United States. On April 23, 2021, after a discussion of the benefits and risks of resuming vaccination, ACIP reaffirmed its interim recommendation for use of the Janssen COVID-19 vaccine in all persons aged ≥18 years under the FDA's EUA, which now includes a warning that rare clotting events might occur after vaccination, primarily among women aged 18-49 years. Patient and provider education about the risk for TTS with the Janssen COVID-19 vaccine, especially among women aged <50 years, as well as the availability of alternative COVID-19 vaccines, is required to guide vaccine decision-making and ensure early recognition and clinical management of TTS.


Assuntos
Vacinas contra COVID-19/administração & dosagem , Vacinas contra COVID-19/efeitos adversos , Aprovação de Drogas , Guias de Prática Clínica como Assunto , Trombocitopenia/epidemiologia , Trombose/epidemiologia , Adolescente , Adulto , Sistemas de Notificação de Reações Adversas a Medicamentos , Comitês Consultivos , COVID-19/epidemiologia , COVID-19/prevenção & controle , Centers for Disease Control and Prevention, U.S. , Rotulagem de Medicamentos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Medição de Risco , Retirada de Medicamento Baseada em Segurança , Estados Unidos/epidemiologia , United States Food and Drug Administration , Adulto Jovem
16.
MMWR Morb Mortal Wkly Rep ; 70(27): 977-982, 2021 Jul 09.
Artigo em Inglês | MEDLINE | ID: mdl-34237049

RESUMO

In December 2020, the Food and Drug Administration (FDA) issued Emergency Use Authorizations (EUAs) for the Pfizer-BioNTech COVID-19 (BNT162b2) vaccine and the Moderna COVID-19 (mRNA-1273) vaccine,† and the Advisory Committee on Immunization Practices (ACIP) issued interim recommendations for their use in persons aged ≥16 years and ≥18 years, respectively.§ In May 2021, FDA expanded the EUA for the Pfizer-BioNTech COVID-19 vaccine to include adolescents aged 12-15 years; ACIP recommends that all persons aged ≥12 years receive a COVID-19 vaccine. Both Pfizer-BioNTech and Moderna vaccines are mRNA vaccines encoding the stabilized prefusion spike glycoprotein of SARS-CoV-2, the virus that causes COVID-19. Both mRNA vaccines were authorized and recommended as a 2-dose schedule, with second doses administered 21 days (Pfizer-BioNTech) or 28 days (Moderna) after the first dose. After reports of myocarditis and pericarditis in mRNA vaccine recipients,¶ which predominantly occurred in young males after the second dose, an ACIP meeting was rapidly convened to review reported cases of myocarditis and pericarditis and discuss the benefits and risks of mRNA COVID-19 vaccination in the United States. Myocarditis is an inflammation of the heart muscle; if it is accompanied by pericarditis, an inflammation of the thin tissue surrounding the heart (the pericardium), it is referred to as myopericarditis. Hereafter, myocarditis is used to refer to myocarditis, pericarditis, or myopericarditis. On June 23, 2021, after reviewing available evidence including that for risks of myocarditis, ACIP determined that the benefits of using mRNA COVID-19 vaccines under the FDA's EUA clearly outweigh the risks in all populations, including adolescents and young adults. The EUA has been modified to include information on myocarditis after receipt of mRNA COVID-19 vaccines. The EUA fact sheets should be provided before vaccination; in addition, CDC has developed patient and provider education materials about the possibility of myocarditis and symptoms of concern, to ensure prompt recognition and management of myocarditis.


Assuntos
Vacinas contra COVID-19/administração & dosagem , Vacinas contra COVID-19/efeitos adversos , Imunização/normas , Miocardite/epidemiologia , Guias de Prática Clínica como Assunto , Vacinas Sintéticas/administração & dosagem , Vacinas Sintéticas/efeitos adversos , Adolescente , Adulto , Sistemas de Notificação de Reações Adversas a Medicamentos , Comitês Consultivos , COVID-19/epidemiologia , COVID-19/prevenção & controle , Centers for Disease Control and Prevention, U.S. , Criança , Feminino , Humanos , Masculino , Estados Unidos/epidemiologia , Adulto Jovem , Vacinas de mRNA
17.
MMWR Morb Mortal Wkly Rep ; 70(37): 1284-1290, 2021 Sep 17.
Artigo em Inglês | MEDLINE | ID: mdl-34529637

RESUMO

COVID-19 vaccine breakthrough infection surveillance helps monitor trends in disease incidence and severe outcomes in fully vaccinated persons, including the impact of the highly transmissible B.1.617.2 (Delta) variant of SARS-CoV-2, the virus that causes COVID-19. Reported COVID-19 cases, hospitalizations, and deaths occurring among persons aged ≥18 years during April 4-July 17, 2021, were analyzed by vaccination status across 13 U.S. jurisdictions that routinely linked case surveillance and immunization registry data. Averaged weekly, age-standardized incidence rate ratios (IRRs) for cases among persons who were not fully vaccinated compared with those among fully vaccinated persons decreased from 11.1 (95% confidence interval [CI] = 7.8-15.8) to 4.6 (95% CI = 2.5-8.5) between two periods when prevalence of the Delta variant was lower (<50% of sequenced isolates; April 4-June 19) and higher (≥50%; June 20-July 17), and IRRs for hospitalizations and deaths decreased between the same two periods, from 13.3 (95% CI = 11.3-15.6) to 10.4 (95% CI = 8.1-13.3) and from 16.6 (95% CI = 13.5-20.4) to 11.3 (95% CI = 9.1-13.9). Findings were consistent with a potential decline in vaccine protection against confirmed SARS-CoV-2 infection and continued strong protection against COVID-19-associated hospitalization and death. Getting vaccinated protects against severe illness from COVID-19, including the Delta variant, and monitoring COVID-19 incidence by vaccination status might provide early signals of changes in vaccine-related protection that can be confirmed through well-controlled vaccine effectiveness (VE) studies.


Assuntos
Vacinas contra COVID-19/administração & dosagem , COVID-19/epidemiologia , COVID-19/prevenção & controle , Hospitalização/estatística & dados numéricos , Vacinação/estatística & dados numéricos , Adolescente , Adulto , Idoso , COVID-19/mortalidade , COVID-19/terapia , Humanos , Incidência , Pessoa de Meia-Idade , Estados Unidos/epidemiologia , Adulto Jovem
18.
Emerg Infect Dis ; 24(7): 1188-1194, 2018 07.
Artigo em Inglês | MEDLINE | ID: mdl-29912680

RESUMO

Antibodies are unique among biomarkers in their ability to identify persons with protective immunity to vaccine-preventable diseases and to measure past exposure to diverse pathogens. Most infectious disease surveillance maintains a single-disease focus, but broader testing of existing serologic surveys with multiplex antibody assays would create new opportunities for integrated surveillance. In this perspective, we highlight multiple areas for potential synergy where integrated surveillance could add more value to public health efforts than the current trend of independent disease monitoring through vertical programs. We describe innovations in laboratory and data science that should accelerate integration and identify remaining challenges with respect to specimen collection, testing, and analysis. Throughout, we illustrate how information generated through integrated surveillance platforms can create new opportunities to more quickly and precisely identify global health program gaps that range from undervaccination to emerging pathogens to multilayered health disparities that span diverse communicable diseases.


Assuntos
Controle de Doenças Transmissíveis , Doenças Transmissíveis/epidemiologia , Doenças Transmissíveis/transmissão , Vigilância da População , Estudos Soroepidemiológicos , Controle de Doenças Transmissíveis/métodos , Doenças Transmissíveis/imunologia , Interações Hospedeiro-Patógeno/imunologia , Humanos , Vigilância Imunológica , Vigilância da População/métodos , Testes Sorológicos
20.
MMWR Morb Mortal Wkly Rep ; 65(2): 36-7, 2016 Jan 22.
Artigo em Inglês | MEDLINE | ID: mdl-26797167

RESUMO

Voluntary medical male circumcision (VMMC) decreases the risk for female-to-male HIV transmission by approximately 60%, and the President's Emergency Plan for AIDS Relief (PEPFAR) is supporting the scale-up of VMMC for adolescent and adult males in countries with high prevalence of human immunodeficiency virus (HIV) and low coverage of male circumcision. As of September 2015, PEPFAR has supported approximately 8.9 million VMMCs.


Assuntos
Circuncisão Masculina/efeitos adversos , Infecções por HIV/prevenção & controle , Tétano/diagnóstico , Programas Voluntários , Adolescente , Adulto , África Oriental , África Austral , Criança , Humanos , Masculino , Pessoa de Meia-Idade , Adulto Jovem
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