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[PMID]:28465097
[Au] Autor:Cohet C; Rosillon D; Willame C; Haguinet F; Marenne MN; Fontaine S; Buyse H; Bauchau V; Baril L
[Ad] Endereço:GSK Vaccines, Wavre, Belgium. Electronic address: catherine.x.cohet@gsk.com.
[Ti] Título:Challenges in conducting post-authorisation safety studies (PASS): A vaccine manufacturer's view.
[So] Source:Vaccine;35(23):3041-3049, 2017 05 25.
[Is] ISSN:1873-2518
[Cp] País de publicação:Netherlands
[La] Idioma:eng
[Ab] Resumo:Post-authorisation safety studies (PASS) of vaccines assess or quantify the risk of adverse events following immunisation that were not identified or could not be estimated pre-licensure. The aim of this perspective paper is to describe the authors' experience in the design and conduct of twelve PASS that contributed to the evaluation of the benefit-risk of vaccines in real-world settings. We describe challenges and learnings from selected PASS of rotavirus, malaria, influenza, human papillomavirus and measles-mumps-rubella-varicella vaccines that assessed or identified potential or theoretical risks, which may lead to changes to risk management plans and/or to label updates. Study settings include the use of large healthcare databases and de novo data collection. PASS methodology is influenced by the background incidence of the outcome of interest, vaccine uptake, availability and quality of data sources, identification of the at-risk population and of suitable comparators, availability of validated case definitions, and the frequent need for case ascertainment in large databases. Challenges include the requirement for valid exposure and outcome data, identification of, and access to, adequate data sources, and mitigating limitations including bias and confounding. Assessing feasibility is becoming a key step to confirm that study objectives can be met in a timely manner. PASS provide critical information for regulators, public health agencies, vaccine manufacturers and ultimately, individuals. Collaborative approaches and synergistic efforts between vaccine manufacturers and key stakeholders, such as regulatory and public health agencies, are needed to facilitate access to data, and to drive optimal study design and implementation, with the aim of generating robust evidence.
[Mh] Termos MeSH primário: Sistemas de Notificação de Reações Adversas a Medicamentos
Indústria Farmacêutica/legislação & jurisprudência
Tecnologia Farmacêutica/legislação & jurisprudência
Vacinas/efeitos adversos
[Mh] Termos MeSH secundário: Vacina contra Varicela/efeitos adversos
Seres Humanos
Vacinas contra Influenza/efeitos adversos
Vacinas Antimaláricas/efeitos adversos
Vacina contra Sarampo-Caxumba-Rubéola/efeitos adversos
Vacinas contra Papillomavirus/efeitos adversos
Medição de Risco
Vacinas contra Rotavirus/efeitos adversos
Tecnologia Farmacêutica/métodos
Tecnologia Farmacêutica/organização & administração
Vacinação
Vacinas/administração & dosagem
Vacinas Atenuadas
Vacinas Combinadas/efeitos adversos
[Pt] Tipo de publicação:JOURNAL ARTICLE; RESEARCH SUPPORT, NON-U.S. GOV'T
[Nm] Nome de substância:
0 (Chickenpox Vaccine); 0 (Influenza Vaccines); 0 (Malaria Vaccines); 0 (Measles-Mumps-Rubella Vaccine); 0 (Papillomavirus Vaccines); 0 (Rotavirus Vaccines); 0 (Vaccines); 0 (Vaccines, Attenuated); 0 (Vaccines, Combined); 0 (measles, mumps, rubella, varicella vaccine)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180308
[Lr] Data última revisão:
180308
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170504
[St] Status:MEDLINE


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[PMID]:27772619
[Au] Autor:Abad CL; Razonable RR
[Ad] Endereço:Division of Infectious Diseases, Department of Medicine, Mayo Clinic, Rochester, MN.
[Ti] Título:α Herpes Virus Infections Among Renal Transplant Recipients.
[So] Source:Semin Nephrol;36(5):344-350, 2016 09.
[Is] ISSN:1558-4488
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:The α herpes viruses HSV-1, HSV-2, and VZV often reactivate in the setting of immune suppression after solid organ transplantation. Oral or genital mucocutaneous disease is the most common clinical manifestation of HSV disease while VZV manifests as varicella (or chickenpox) or reactivation herpes zoster, characterized by a diffuse rash, or a painful unilateral vesicular eruption in a dermatomal distribution, respectively. The diagnosis of HSV and VZV is primarily based on history and clinical presentation, although diagnostic tests may be necessary for atypical presentations of disease. Treatment usually involves oral or intravenous antiviral therapy, depending on severity of illness.
[Mh] Termos MeSH primário: Varicela/induzido quimicamente
Rejeição de Enxerto/prevenção & controle
Herpes Simples/induzido quimicamente
Herpes Zoster/induzido quimicamente
Imunossupressores/efeitos adversos
Falência Renal Crônica/cirurgia
Transplante de Rim
[Mh] Termos MeSH secundário: Antivirais/uso terapêutico
Varicela/diagnóstico
Varicela/tratamento farmacológico
Varicela/prevenção & controle
Vacina contra Varicela/uso terapêutico
Técnicas de Cultura
Técnica Direta de Fluorescência para Anticorpo
Herpes Simples/diagnóstico
Herpes Simples/tratamento farmacológico
Herpes Zoster/diagnóstico
Herpes Zoster/tratamento farmacológico
Herpes Zoster/prevenção & controle
Herpesvirus Humano 1
Herpesvirus Humano 2
Herpesvirus Humano 3
Seres Humanos
Reação em Cadeia da Polimerase
Testes Sorológicos
Ativação Viral
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Nm] Nome de substância:
0 (Antiviral Agents); 0 (Chickenpox Vaccine); 0 (Immunosuppressive Agents)
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180222
[Lr] Data última revisão:
180222
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:161025
[St] Status:MEDLINE


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[PMID]:29278902
[Au] Autor:Oh HS; Bae JM
[Ad] Endereço:Jeju Heathcare Center of Jeju-si, Jeju, Korea.
[Ti] Título:Vaccination history in elementary school children enrolled in the varicella epidemic investigations held in Jeju-si, Korea in the first half of 2017.
[So] Source:Epidemiol Health;39:e2017053, 2017.
[Is] ISSN:2092-7193
[Cp] País de publicação:Korea (South)
[La] Idioma:eng
[Ab] Resumo:OBJECTIVES: The reported incidence rate of varicella infection in Jeju-do is higher compared with the national average. This study aimed to examine varicella vaccination history and evaluate clinical manifestation of varicella cases in Jeju-do. METHODS: Based on the guideline suggested by the Korea Centers for Disease Control and Prevention (KCDC), two epidemic investigations for varicella infection were conducted in the first half of 2017. The history of varicella vaccination was confirmed using the Integrated Control System for Diseases and Health operated by the KCDC. RESULTS: Out of a total of 60 elementary school children as the study subjects, all had been previously vaccinated against varicella. Twenty cases (33%) showed mild clinical manifestations and no complications. CONCLUSIONS: As the government of Jeju-do has supplied a single-labeled vaccine since 2011, there is a need to evaluate the type of vaccination failure such as primary or secondary.
[Mh] Termos MeSH primário: Vacina contra Varicela/administração & dosagem
Varicela/prevenção & controle
Epidemias/prevenção & controle
Vacinação/estatística & dados numéricos
[Mh] Termos MeSH secundário: Varicela/epidemiologia
Criança
Seres Humanos
Programas de Imunização
República da Coreia/epidemiologia
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Chickenpox Vaccine)
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180213
[Lr] Data última revisão:
180213
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171228
[St] Status:MEDLINE
[do] DOI:10.4178/epih.e2017053


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[PMID]:27771122
[Au] Autor:Bonhomme A; Fréling E; Reigneau M; Poreaux C; Valois A; Truchetet F; Barbaud A; Schmutz JL
[Ad] Endereço:Service de dermatologie, hôpitaux de Brabois, CHU de Nancy, 6, rue du Morvan, 54500 VandÅ“uvre-lès-Nancy, France. Electronic address: axelle_b92@hotmail.com.
[Ti] Título:[Vaccination status in psoriasis patients on immunosuppressant therapy (including biologics)].
[Ti] Título:Couverture vaccinale avant et après instauration d'un traitement immunosuppresseur (y compris biothérapie) pour psoriasis..
[So] Source:Ann Dermatol Venereol;144(2):92-99, 2017 Feb.
[Is] ISSN:0151-9638
[Cp] País de publicação:France
[La] Idioma:fre
[Ab] Resumo:OBJECTIVES: To evaluate the vaccine coverage of psoriasis patients prior to initiating or changing immunosuppressant therapy, and to verify that the prescribed vaccines have been administered. PATIENTS AND METHODS: We conducted a bi-centre, observational, cross-sectional study over 9 months. Psoriasis patients in whom immunosuppressant therapy (comprising cyclosporine, methotrexate, etanercept, infliximab, adalimumab or ustekinumab) was indicated were included. Medical history, previous treatments, vaccination status, viral serology results (for hepatitis B, measles, and chickenpox), and reasons for non-vaccination were assessed via questionnaire. RESULTS: Sixty-eight patients were included. One third brought their immunization records. Overall, 54.4% had already received immunosuppressant therapy; of these, 9 were up to date for influenza and 3 were up to date for pneumococcus. Only one patient was up to date for all of the recommended vaccinations. A total of 61% of patients were seronegative for hepatitis B. The following vaccines were updated: DTP (in 2 patients), DTP-pertussis (12), influenza (22), pneumococcus (45), and hepatitis B (6). None of the three patients with plans to travel to yellow fever-endemic countries had been vaccinated. In all, 53 (78%) stated that they had already had chickenpox and 43 (63.2%) stated that they had had one of the following three diseases: measles, rubella, or mumps. Fifty-two patients were serologically tested for chickenpox, and 98% were immunized. The most common reasons for not updating the immunization schedule were the absence of any notification or proposal by the patient's doctor and oversight. CONCLUSION: This study should help raise awareness among patients and health professionals concerning the new vaccination recommendations for a population particularly at risk of infection.
[Mh] Termos MeSH primário: Produtos Biológicos/efeitos adversos
Produtos Biológicos/uso terapêutico
Imunossupressores/efeitos adversos
Imunossupressores/uso terapêutico
Psoríase/tratamento farmacológico
Psoríase/imunologia
Cobertura Vacinal
[Mh] Termos MeSH secundário: Adolescente
Adulto
Idoso
Idoso de 80 Anos ou mais
Vacina contra Varicela/administração & dosagem
Vacina contra Varicela/imunologia
Estudos Transversais
Vacina contra Difteria, Tétano e Coqueluche/administração & dosagem
Vacina contra Difteria, Tétano e Coqueluche/imunologia
Feminino
França
Vacinas contra Hepatite B/administração & dosagem
Vacinas contra Hepatite B/imunologia
Seres Humanos
Programas de Imunização
Esquemas de Imunização
Vacinas contra Influenza/administração & dosagem
Vacinas contra Influenza/imunologia
Masculino
Meia-Idade
Vacinas Pneumocócicas/administração & dosagem
Vacinas Pneumocócicas/imunologia
Vacina contra Rubéola/administração & dosagem
Vacina contra Rubéola/imunologia
Inquéritos e Questionários
Adulto Jovem
[Pt] Tipo de publicação:JOURNAL ARTICLE; MULTICENTER STUDY; OBSERVATIONAL STUDY
[Nm] Nome de substância:
0 (Biological Products); 0 (Chickenpox Vaccine); 0 (Diphtheria-Tetanus-Pertussis Vaccine); 0 (Hepatitis B Vaccines); 0 (Immunosuppressive Agents); 0 (Influenza Vaccines); 0 (Pneumococcal Vaccines); 0 (Rubella Vaccine)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180212
[Lr] Data última revisão:
180212
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:161025
[St] Status:MEDLINE


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[PMID]:28748773
[Au] Autor:Jin L; Xu S; Maple PAC; Xu W; Brown KE
[Ad] Endereço:Virus Reference Department,National Infections Service,Public Health England,London,UK.
[Ti] Título:Differentiation between wild-type and vaccines strains of varicella zoster virus (VZV) based on four single nucleotide polymorphisms.
[So] Source:Epidemiol Infect;145(12):2618-2625, 2017 09.
[Is] ISSN:1469-4409
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:Varicella-zoster virus (VZV) infection (chickenpox) results in latency and subsequent reactivation manifests as shingles. Effective attenuated vaccines (vOka) are available for prevention of both illnesses. In this study, an amplicon-based sequencing method capable of differentiating between VZV wild-type (wt) strains and vOka vaccine is described. A total of 44 vesicular fluid specimens collected from 43 patients (16 from China and 27 from the UK) with either chickenpox or shingles were investigated, of which 10 had received previous vaccination. Four sets of polymerase chain reactions were set up simultaneously with primers amplifying regions encompassing four single nucleotide polymorphisms (SNPs), '69349-106262-107252-108111'. Nucleotide sequences were generated by Sanger sequencing. All samples except one had a wt SNP profile of 'A-T-T-T'. The sample collected from a patient who received vaccine 7-10 days ago, along with VZV vaccine preparations, Zostavax and Baike-varicella gave a SNP profile 'G-C-C-C'. The results show that this method can distinguish vaccine-derived virus from wt viruses from main four clades, (clades 1-4) and should be of utility worldwide.
[Mh] Termos MeSH primário: Vacina contra Varicela/genética
Herpesvirus Humano 3/genética
Reação em Cadeia da Polimerase
Polimorfismo de Nucleotídeo Único
[Mh] Termos MeSH secundário: Adolescente
Adulto
Idoso
Idoso de 80 Anos ou mais
Varicela/virologia
Vacina contra Varicela/classificação
Criança
Pré-Escolar
China
Inglaterra
Feminino
Herpes Zoster/virologia
Herpesvirus Humano 3/classificação
Seres Humanos
Lactente
Masculino
Meia-Idade
Escócia
Análise de Sequência de DNA
Vacinas Atenuadas/classificação
Vacinas Atenuadas/genética
Adulto Jovem
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Chickenpox Vaccine); 0 (Vaccines, Attenuated)
[Em] Mês de entrada:1708
[Cu] Atualização por classe:171125
[Lr] Data última revisão:
171125
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170728
[St] Status:MEDLINE
[do] DOI:10.1017/S0950268817001509


  6 / 1842 MEDLINE  
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[PMID]:29023430
[Au] Autor:Seither R; Calhoun K; Street EJ; Mellerson J; Knighton CL; Tippins A; Underwood JM
[Ti] Título:Vaccination Coverage for Selected Vaccines, Exemption Rates, and Provisional Enrollment Among Children in Kindergarten - United States, 2016-17 School Year.
[So] Source:MMWR Morb Mortal Wkly Rep;66(40):1073-1080, 2017 Oct 13.
[Is] ISSN:1545-861X
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:State and local school vaccination requirements help protect students and communities against vaccine-preventable diseases (1). CDC reports vaccination coverage and exemption data for children attending kindergarten (kindergartners) collected by federally funded immunization programs in the United States.* The typical age range for kindergartners is 4-6 years. Although vaccination requirements vary by state (the District of Columbia [DC] is counted as a state in this report.), the Advisory Committee on Immunization Practices recommends that children in this age range have received, among other vaccinations, 5 doses of diphtheria, tetanus, and acellular pertussis vaccine (DTaP), 2 doses of measles, mumps, and rubella vaccine (MMR), and 2 doses of varicella vaccine (2). This report summarizes 2016-17 school year MMR, DTaP, and varicella vaccination coverage reported by immunization programs in 49 states, exemptions in 50 states, and kindergartners provisionally enrolled or within a grace period in 27 states. Median vaccination coverage was 94.5% for the state-required number of doses of DTaP; 94.0% for 2 doses of MMR; and 93.8% for 2 doses of varicella vaccine. The median percentage of kindergartners with an exemption from at least one vaccine was 2.0%, similar to 2015-16 (1.9%). Median grace period and provisional enrollment was 2.0%. Vaccination coverage remains consistently high and exemptions low at state and national levels. Local-level vaccination coverage data provide opportunities for immunization programs to identify schools, districts, counties, or regions susceptible to vaccine-preventable diseases and for schools to address undervaccination through implementation of existing state and local vaccination policies (1) to protect communities through increased coverage.
[Mh] Termos MeSH primário: Vacina contra Varicela/administração & dosagem
Vacina contra Difteria, Tétano e Coqueluche/administração & dosagem
Vacina contra Sarampo-Caxumba-Rubéola/administração & dosagem
Vacinação/utilização
[Mh] Termos MeSH secundário: Criança
Pré-Escolar
Seres Humanos
Esquemas de Imunização
Instituições Acadêmicas
Estados Unidos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Chickenpox Vaccine); 0 (Diphtheria-Tetanus-Pertussis Vaccine); 0 (Measles-Mumps-Rubella Vaccine)
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171018
[Lr] Data última revisão:
171018
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171013
[St] Status:MEDLINE
[do] DOI:10.15585/mmwr.mm6640a3


  7 / 1842 MEDLINE  
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[PMID]:28837546
[Au] Autor:Walker TY; Elam-Evans LD; Singleton JA; Yankey D; Markowitz LE; Fredua B; Williams CL; Meyer SA; Stokley S
[Ti] Título:National, Regional, State, and Selected Local Area Vaccination Coverage Among Adolescents Aged 13-17 Years - United States, 2016.
[So] Source:MMWR Morb Mortal Wkly Rep;66(33):874-882, 2017 Aug 25.
[Is] ISSN:1545-861X
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:The Advisory Committee on Immunization Practices (ACIP) recommends that adolescents routinely receive tetanus, diphtheria, and acellular pertussis vaccine (Tdap), meningococcal conjugate vaccine (MenACWY), and human papillomavirus (HPV) vaccine (1) at age 11-12 years. ACIP also recommends catch-up vaccination with hepatitis B vaccine, measles, mumps, and rubella (MMR) vaccine, and varicella vaccine for adolescents who are not up to date with childhood vaccinations. ACIP recommends a booster dose of MenACWY at age 16 years (1). In December 2016, ACIP updated HPV vaccine recommendations to include a 2-dose schedule for immunocompetent adolescents initiating the vaccination series before their 15th birthday (2). To estimate adolescent vaccination coverage in the United States, CDC analyzed data from the 2016 National Immunization Survey-Teen (NIS-Teen) for 20,475 adolescents aged 13-17 years.* During 2015-2016, coverage increased for ≥1 dose of Tdap (from 86.4% to 88.0%) and for each HPV vaccine dose (from 56.1% to 60.4% for ≥1 dose). Among adolescents aged 17 years, coverage with ≥2 doses of MenACWY increased from 33.3% to 39.1%. In 2016, 43.4% of adolescents (49.5% of females; 37.5% of males) were up to date with the HPV vaccination series, applying the updated HPV vaccine recommendations retrospectively. Coverage with ≥1 HPV vaccine dose varied by metropolitan statistical area (MSA) status and was lowest (50.4%) among adolescents living in non-MSA areas and highest (65.9%) among those living in MSA central cities. Adolescent vaccination coverage continues to improve overall; however, substantial opportunities exist to further increase HPV-associated cancer prevention.
[Mh] Termos MeSH primário: Vacinação/utilização
Vacinas/administração & dosagem
[Mh] Termos MeSH secundário: Adolescente
Comitês Consultivos
Vacina contra Varicela/administração & dosagem
Vacinas contra Difteria, Tétano e Coqueluche Acelular/administração & dosagem
Feminino
Vacinas contra Hepatite B/administração & dosagem
Seres Humanos
Esquemas de Imunização
Masculino
Vacina contra Sarampo-Caxumba-Rubéola/administração & dosagem
Vacinas Meningocócicas/administração & dosagem
Programas Nacionais de Saúde
Vacinas contra Papillomavirus/administração & dosagem
Guias de Prática Clínica como Assunto
Estados Unidos
Vacinas Conjugadas/administração & dosagem
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Chickenpox Vaccine); 0 (Diphtheria-Tetanus-acellular Pertussis Vaccines); 0 (Hepatitis B Vaccines); 0 (Measles-Mumps-Rubella Vaccine); 0 (MenACWY); 0 (Meningococcal Vaccines); 0 (Papillomavirus Vaccines); 0 (Vaccines); 0 (Vaccines, Conjugate)
[Em] Mês de entrada:1708
[Cu] Atualização por classe:170828
[Lr] Data última revisão:
170828
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170825
[St] Status:MEDLINE
[do] DOI:10.15585/mmwr.mm6633a2


  8 / 1842 MEDLINE  
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[PMID]:28837183
[Au] Autor:Grillo AP; Fraunfelder FW
[Ad] Endereço:Department of Ophthalmology, Mason Eye Institute, University of Missouri School of Medicine, Columbia, Missouri, USA.
[Ti] Título:Keratitis in association with herpes zoster and varicella vaccines.
[So] Source:Drugs Today (Barc);53(7):393-397, 2017 Jul.
[Is] ISSN:1699-3993
[Cp] País de publicação:Spain
[La] Idioma:eng
[Ab] Resumo:The objective of this review was to collect reports of keratitis in association with herpes zoster virus (HZV) or varicella zoster virus (VZV) vaccines. HZV vaccination is intended for at-risk adult populations and VZV vaccination is intended for all pediatric patients. We reviewed the literature and reports of keratitis in association with herpes zoster or varicella vaccine from the National Registry of Drug-Induced Ocular Side Effects and the World Health Organization. Twenty-four cases of unilateral keratitis in association with VZV vaccines were collected from the adverse reaction databases and literature. In most cases, the onset of keratitis occurred within days of vaccination and resolved with topical steroid eye drops and oral acyclovir. Data suggest that keratitis in association with herpes zoster or varicella vaccine is rare, is usually self-limited or resolves with treatment. The mechanism may be the persistence of viral antigens in the cornea after VZV vaccination or herpes zoster ophthalmicus. This reaction is probable, given the plausible biological mechanism, the temporal relationship between vaccination and keratitis, and overall patterns of presentation after vaccination.
[Mh] Termos MeSH primário: Vacina contra Varicela/efeitos adversos
Herpesvirus Humano 3/patogenicidade
Ceratite/imunologia
Ceratite/virologia
Vacinação/efeitos adversos
[Mh] Termos MeSH secundário: Adolescente
Antivirais/uso terapêutico
Vacina contra Varicela/imunologia
Criança
Pré-Escolar
Feminino
Herpes Zoster Oftálmico/complicações
Herpes Zoster Oftálmico/tratamento farmacológico
Herpes Zoster Oftálmico/virologia
Herpesvirus Humano 3/efeitos dos fármacos
Seres Humanos
Ceratite/tratamento farmacológico
Ceratite/etiologia
Masculino
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Antiviral Agents); 0 (Chickenpox Vaccine)
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171004
[Lr] Data última revisão:
171004
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170825
[St] Status:MEDLINE
[do] DOI:10.1358/dot.2017.53.7.2667582


  9 / 1842 MEDLINE  
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[PMID]:28806450
[Au] Autor:Macartney K; Gidding HF; Trinh L; Wang H; Dey A; Hull B; Orr K; McRae J; Richmond P; Gold M; Crawford N; Kynaston JA; McIntyre P; Wood N; Paediatric Active Enhanced Disease Surveillance Network
[Ad] Endereço:National Centre for Immunisation Research and Surveillance, Sydney, Australia.
[Ti] Título:Evaluation of Combination Measles-Mumps-Rubella-Varicella Vaccine Introduction in Australia.
[So] Source:JAMA Pediatr;171(10):992-998, 2017 Oct 01.
[Is] ISSN:2168-6211
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Importance: Incorporating combination vaccines, such as the measles-mumps-rubella-varicella (MMRV) vaccine, into immunization schedules should be evaluated from a benefit-risk perspective. Use of MMRV vaccine poses challenges due to a recognized increased risk of febrile seizures (FSs) when used as the first dose in the second year of life. Conversely, completion by age 2 years of measles, mumps, rubella, and varicella immunization may offer improved disease control. Objective: To evaluate the effect on safety and coverage of earlier (age 18 months) scheduling of MMRV vaccine as the second dose of measles-containing vaccine (MCV) in Australia. Design, Setting, and Participants: Prospective active sentinel safety surveillance comparing the relative incidence (RI) of FSs in toddlers given MMRV and measles-mumps-rubella (MMR) and a national cohort study of vaccine coverage rates and timeliness before and after MMRV vaccine introduction were conducted. All Australian children aged 11 to 72 months were included in the coverage analysis, and 1471 Australian children aged 11 to 59 months were included in the FS analysis, with a focus on those aged 11 to 23 months. Main Outcomes and Measures: MMRV vaccine safety, specifically, the RI of FSs after MMRV vaccine at age 18 months, compared with risk following MMR vaccine and vaccine uptake for 2-dose MCV and single-dose varicella vaccine, focusing on timeliness. Results: Of the 1471 children, the median age at first FS was 21 months (interquartile range [IQR], 14-31 months). Three hundred ninety-one children were aged 11 to 23 months and had at least 1 FS included in the analysis; of these, 207 (52.9%) were male. A total of 278 children (71.1%) had received MMR followed by MMRV vaccine, 97 (24.8%) had received MMR vaccine only, and 16 (4.1%) had received neither vaccine. There was no increased risk of FSs (RI, 1.08; 95% CI, 0.55-2.13) in the 5 to 12 days following MMRV vaccine given as the second MCV to toddlers. Febrile seizures occurred after dose 1 of MMR vaccine at a known low increased risk (RI, 2.71; 95% CI, 1.71- 4.29). Following program implementation, 2-dose MCV coverage at age 36 months exceeded that obtained at age 60 months in historical cohorts recommended to receive MMR vaccine before school entry, and on-time vaccination increased by 13.5% (from 58.9% to 72.4%). Despite no change in the scheduled age of varicella vaccine, use of MMRV vaccine was associated with a 4.0% increase in 1-dose varicella vaccine coverage. Conclusions and Relevance: To our knowledge, this is the first study to provide evidence of the absence of an association between use of MMRV vaccine as the second dose of MCV in toddlers and an increased risk of FSs. Incorporation of MMRV vaccine has facilitated improvements in vaccine coverage that will potentially improve disease control.
[Mh] Termos MeSH primário: Vacina contra Varicela/administração & dosagem
Vacina contra Sarampo-Caxumba-Rubéola/administração & dosagem
Convulsões Febris/etiologia
[Mh] Termos MeSH secundário: Austrália
Vacina contra Varicela/efeitos adversos
Criança
Pré-Escolar
Feminino
Seres Humanos
Esquemas de Imunização
Incidência
Lactente
Masculino
Vacina contra Sarampo-Caxumba-Rubéola/efeitos adversos
Estudos Prospectivos
Convulsões Febris/epidemiologia
Vacinas Combinadas/administração & dosagem
Vacinas Combinadas/efeitos adversos
[Pt] Tipo de publicação:EVALUATION STUDIES; JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Chickenpox Vaccine); 0 (Measles-Mumps-Rubella Vaccine); 0 (Vaccines, Combined); 0 (measles, mumps, rubella, varicella vaccine)
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171006
[Lr] Data última revisão:
171006
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:170815
[St] Status:MEDLINE
[do] DOI:10.1001/jamapediatrics.2017.1965


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[PMID]:28705150
[Au] Autor:Meszner Z; Molnar Z; Rampakakis E; Yang HK; Kuter BJ; Wolfson LJ
[Ad] Endereço:St. László Hospital for Infectious Diseases, National Institute of Child Health, Budapest, Hungary.
[Ti] Título:Economic burden of varicella in children 1-12 Years of age in Hungary, 2011-2015.
[So] Source:BMC Infect Dis;17(1):495, 2017 Jul 14.
[Is] ISSN:1471-2334
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Although live-attenuated varicella-zoster virus (VZV) vaccines have been proven to be safe and effective in preventing varicella and real-word evidence shows routine childhood immunization programs are effective in dramatically reducing varicella associated morbidity and mortality, varicella vaccine is not included in the National Immunization Program (NIP) in Hungary. The purpose of this study was to evaluate the clinical and economic burden associated with varicella in Hungary. METHODS: This was a multicenter, retrospective, chart review study of patients aged 1-12 years with a primary varicella diagnosis between 2011 and 2015. Healthcare resource utilization (HCRU) associated with varicella, unit costs, and work loss were used to estimate direct and indirect costs. All costs are presented in 2015 HUF / Euros (€). RESULTS: 156 children with varicella were included (75 outpatients, 81 inpatients), with a mean age of 4.4 (SD: 2.0) and 3.7 (SD: 2.1) years, respectively. One or more complications were reported by 12.0% of outpatients and 92.6% of inpatients, the most common being dehydration, skin and soft tissue infections, pneumonia, keratoconjunctivitis, and cerebellitis. HCRU estimates included use of over-the-counter (OTC) medications (96.0% outpatients, 53.1% inpatients), prescription medications (9.3% outpatients, 70.4% inpatients), tests/procedures (4.0% outpatients, 97.5% inpatients), and consultation with allied health professionals (2.7% outpatients, 30.9% inpatients). The average duration of hospital stay (inpatients) was 3.6 (95% CI: 3.2, 4.1) days. The total combined direct and indirect cost per varicella case was 228,146.7 Hungarian Forint (HUF)/€ 736.0 for inpatients and 49,790.6 HUF/€ 106.6 for outpatients. The overall annual cost of varicella in Hungary for children aged <15 years in 2015 was estimated at 1,903,332,524.3 HUF/ € 6,139,980.4. CONCLUSION: Varicella is associated with substantial clinical burden in Hungary, resulting in the utilization of a significant amount of healthcare resources. These results support the need for routine vaccination of all healthy children to reduce the varicella-associated disease burden.
[Mh] Termos MeSH primário: Varicela/economia
Varicela/epidemiologia
[Mh] Termos MeSH secundário: Varicela/prevenção & controle
Varicela/terapia
Vacina contra Varicela/economia
Vacina contra Varicela/uso terapêutico
Criança
Pré-Escolar
Custos e Análise de Custo
Feminino
Seres Humanos
Hungria/epidemiologia
Programas de Imunização/economia
Lactente
Pacientes Internados
Tempo de Internação
Masculino
Morbidade
Pacientes Ambulatoriais
Estudos Retrospectivos
[Pt] Tipo de publicação:JOURNAL ARTICLE; MULTICENTER STUDY; OBSERVATIONAL STUDY
[Nm] Nome de substância:
0 (Chickenpox Vaccine)
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171010
[Lr] Data última revisão:
171010
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170715
[St] Status:MEDLINE
[do] DOI:10.1186/s12879-017-2575-6



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