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Objetivo. La inmunización es una de las intervenciones más importantes para prevenir la morbimortalidad en la población mundial. No obstante, aún persisten brechas para alcanzar coberturas ideales de vacunación. Además, las múltiples dosis y vacunas dificultan alcanzar las metas mínimas establecidas. Por ello, se desarrollan vacunas combinadas y fraccionadas para reducir el número de inyecciones, errores programáticos, reactogenicidad y mejorar la adherencia. En tres días distintos, durante 9 horas, se reunieron 6 médicos pediatras expertos en vacunas en el Perú siguiendo el método RAND/UCLA, con el objeto de elaborar un consenso de opinión y actualización de la vacuna combinada hexavalente [DTaP+Haemophilus influenzae tipo b (Hib)+Hepatitis B (HVB)+antipolio inactivada (IPV)] y su eventual uso en el Programa ampliado de inmunizaciones (PAI). Las recomendaciones del consenso son: reemplazar las vacunas, antipolio oral (OPV) por IPV, pertussis de células enteras por vacunas acelulares y DTP de los 4 años por dTap entre los 4 y 6 años; usar la vacuna hexavalente para la serie primaria (2, 4 y 6 meses); usar 4 dosis de vacuna contra Hib (2, 4, 6 y 18 meses); incorporar la vacuna hexavalente en el PAI; no usar la IPV fraccionada (fIPV) y administrar solo 4 dosis de IPV.
Objetive. Immunization is one of the most important interventions to prevent morbidity and mortality in the world population. However, gaps persist to achieve ideal vaccination coverage. In addition, the multiple vaccines and necessary doses make it difficult to reach the minimum established goals. On this scenario, combined and fractionated vaccines are being developed with the aim of reducing the injections number, programmatic errors, reactogenicity and improving adherence. On three different days, for 9 hours, 6 pediatricians experts in vaccines in Peru met following the RAND/UCLA method in order to develop a consensus opinion and update of the combined hexavalent vaccine [DTaP+Haemophilus influenzae type b (Hib)+Hepatitis B (HVB)+Inactivated Polio Vaccine (IPV)] and its eventual use in the Extended Immunization Program (EPI). The consensus recommendation are: replace the vaccines, Oral Polio Vaccine (OPV) by IPV, pertussis of whole cells by acellular vaccines and DTP of 4 years old by dTap between 4 and 6 years old; use the hexavalent vaccine for the primary series (2, 4 and 6 months); use 4 doses of Hib vaccine (2, 4, 6 and 18 months); incorporate the hexavalent vaccine in the EPI; do not use fractionated IPV (fIPV) and only administer 4 doses of IPV.
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Objective@#To compare the safety and immunogenicity of two different sequential schedules of inactivated poliomyelitis vaccine made from Sabin strain (sIPV) followed by typeⅠ+Ⅲ bivalent oral poliovirus vaccine (bOPV) in Drug Candy (DC) form or liquid dosage form).@*Methods@#This randomized, blinded, single center, parallel-group controlled trial was done from September 2015 to June 2016 in Liuzhou, Guangxi province. Healthy infants aged ≥2 months were eligible for enrollment and divided into 1sIPV+2bOPV or 2sIPV+1bOPV sequential schedules. According to the bOPV dosage form each sequential schedules, the subjects again were divided into drug candy(DC) form or liquid dosage form group, being 1sIPV+bOPV (DC)/1sIPV+2bOPV(liquid)/2sIPV+1bOPV(DC)/2sIPV+1bOPV(liquid). According to 0, 28, 56 d immunization schedule, Each group were given 3 doses. We recorded adverse events during the clinical trial (399 participants who receive at least one dose). 28 days post-Dose 3, we receive a total of 350 blood samples (excluding the quitters or subjects against trial plan), using cell culture trace against polio virus neutralization test Ⅰ, Ⅱ, Ⅲ neutralizing antibody (GMT), calculating the antibody positive rate.PolioⅠ,Ⅱand Ⅲ antibody titers were assessed by virus-neutralizing antibody assay and the seroconversion (4-fold increase in titer) from pre-Dose 1 to 28 days post-Dose 3 was calculated (total 350 samples) .@*Results@#During the vaccination, the incidence of AEs in 1sIPV+2bOPV(DC), 1sIPV+2bOPV (liquid), 2sIPV+1bOPV(DC), 2sIPV+1bOPV (liquid) group were 79%, 76%, 80% and 74% (χ2=1.23, P=0.747) , respectively. The severe AEs in groups were 6%, 5%, 6% and 4% (χ2=0.57, P=0.903) , respectively, and none was considered to be vaccination related. 28 days after 3rd vaccination, the seroconversion rates in 1sIPV+2bOPV (DC), 1sIPV+2bOPV (liquid), 2sIPV+1bOPV (DC), 2sIPV+1bOPV (liquid) group, were 99%, 100%, 99% and 99% (χ2=0.94, P=0.815) , respectively, for type Ⅰ poliovirus; and 47%, 57%, 80%, 79% (χ2=31.56, P<0.001) , respectively, for type Ⅱ; and were 100%, 99%, 100%, 99% (χ2=2.02, P=0.568) , respectively, for type Ⅲ. In each group, the GMT of antibody against poliovirus typeⅠ were 4 539.68, 6 243.43, 6 819.53 and 7 916.29 (F=25.87, P<0.001) , respectively; Type Ⅱ were 12.98, 10.54, 63.75 and 84.21 (F=8.68, P=0.034) , respectively; Type Ⅲ were 1 172.55, 1 416.03, 2 648.89 and 3 250.75 (F=14.50, P=0.002) , respectively.@*Conclusion@#On the same sequential schedules, there was no significant difference between the dosage forms, all of them showed good safety and immunogenicity. In the same dosage forms with different sequential schedules, the seroconversion rate was higher in 2 dose sIPV group than the 1 dose sIPV group, especially at the neutralizing antibody GMT level against polio type Ⅱ and Ⅲ after vaccination.
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OBJECTIVE To analyze the costs of vaccination regimens for introducing inactivated polio vaccine in routine immunization in Brazil. METHODS A cost analysis was conducted for vaccines in five vaccination regimens, including inactivated polio vaccine, compared with the oral polio vaccine-only regimen. The costs of the vaccines were estimated for routine use and for the “National Immunization Days”, during when the oral polio vaccine is administered to children aged less than five years, independent of their vaccine status, and the strategic stock of inactivated polio vaccine. The presented estimated costs are of 2011. RESULTS The annual costs of the oral vaccine-only program (routine and two National Immunization Days) were estimated at US$19,873,170. The incremental costs of inclusion of the inactivated vaccine depended on the number of vaccine doses, presentation of the vaccine (bottles with single dose or ten doses), and number of “National Immunization Days” carried out. The cost of the regimen adopted with two doses of inactivated vaccine followed by three doses of oral vaccine and one “National Immunization Day” was estimated at US$29,653,539. The concomitant replacement of the DTPw/Hib and HepB vaccines with the pentavalent vaccine enabled the introduction of the inactivated polio without increasing the number of injections or number of visits needed to complete the vaccination. CONCLUSIONS The introduction of the inactivated vaccine increased the annual costs of the polio vaccines by 49.2% compared with the oral vaccine-only regimen. This increase represented 1.13% of the expenditure of the National Immunization Program on the purchase of vaccines in 2011. .
OBJETIVO Analisar os custos de esquemas de vacinação para a introdução da vacina inativada de pólio na imunização de rotina no Brasil. MÉTODOS Foi realizada análise de custos das vacinas de cinco esquemas de vacinação, incluindo vacina pólio inativada, comparados ao esquema apenas-vacina oral de pólio. Foram estimados custos das vacinas para rotina, para os “Dias Nacionais de Imunização”, quando a vacina de pólio oral é administrada para menores de cinco anos, independentemente da situação vacinal, e do estoque estratégico de vacina pólio inativada. Os custos estimados foram os de 2011. RESULTADOS Os custos anuais do programa apenas-vacina de pólio oral (de rotina e de dois Dias Nacionais de Imunização) foram estimados em US$19.873.170. Os custos incrementais da inclusão da vacina pólio inativada dependeram: do número de doses da vacina, da apresentação da vacina (frascos com dose única ou dez doses) e do número de “Dias Nacionais de Imunização” realizados. O esquema adotado, com duas doses de VIP seguidas de três doses de VOP e um “Dia Nacional de Imunização”, foi estimado em US$29.653.539. A concomitante substituição das vacinas DTPw/Hib e HepB pela vacina pentavalente permitiu a introdução da vacina pólio inativada sem aumento do número de injeções ou visitas necessárias para completar a vacinação. CONCLUSÕES A introdução da vacina pólio inativada aumentou os custos anuais das vacinas de pólio em 49,2%, comparado ao esquema apenas-vacina de pólio oral. Esse aumento representou 1,13% dos gastos do Programa Nacional de Imunização com a compra de vacinas em 2011. .
Subject(s)
Adolescent , Female , Humans , Male , Accidents, Traffic/statistics & numerical data , Adolescent Behavior , Attention , Automobile Driving/statistics & numerical data , Wounds and Injuries/epidemiology , Peer Group , Safety , Social BehaviorABSTRACT
OBJETIVO: Analisar as estratégias propostas pela Organização Mundial da Saúde (OMS) para controle da poliomielite. FONTES DE DADOS: Levantamento das publicações sobre poliomielite indexadas no Medline, Lilacs e sites da OMS e Ministério da Saúde de janeiro de 2000 a dezembro de 2006. SÍNTESEDOS DADOS: O reconhecimento da paralisia associada aos vírus vacinais e por vírus circulantes derivados da vacina oral não deixa dúvidas de que, em breve, será necessário interromper o uso da vacina oral para poliomielite. Após os vírus selvagens serem erradicados, a vacina oral para poliomielite deverá ser interrompida, de preferência de forma sincronizada em todos os países. Após a interrupção da vacinação, as populações voltarão a ser suscetíveis à poliomielite, podendo ocorrer surtos da doença por vírus selvagens (escape dos laboratórios de forma acidental ou por bioterrorismo). Nos países que já utilizam a vacina para poliomielite com vírus inativado é pouco provável que haja interrupção da vacinação. Países que atualmente utilizam exclusivamente a vacina oral ficarão na dependência da vigilância epidemiológica e dos estoques de vacina oral para controlar eventuais surtos de pólio. Se a vacina oral para poliomielite for reintroduzida nessas populações, haverá novamente o risco de paralisia associada aos vírus vacinais e por vírus circulantes derivados da vacina oral, que podem se disseminar rapidamente para outras regiões e países vizinhos. CONCLUSÕES: É necessário planejar a introdução da vacina para poliomielite com vírus inativado no calendário de rotina brasileiro, assim como adquirir tecnologia para sua produção, que atualmente é insuficiente para as necessidades globais.
OBJECTIVE: Review the World Health Organization (WHO) strategies for poliomyelitis control. DATA SOURCES: Retrieval of publications on poliomyelitis indexed in Medline, Lilacs and in the WHO and Health Ministry sites, from January 2000 to December 2006. DATA SYNTHESIS: Acknowledgement of vaccine-associated paralysis and oral vaccine-derived circulating viruses' paralysis shall certainly require discontinuation of oral vaccination for poliomyelitis use in a short time. After eradication of the wild viruses, oral vaccination for poliomyelitis should be discontinued, preferably in a synchronized manner in all the countries. After termination of vaccination programs, people will become susceptible again to poliomyelitis virus and disease outbreaks caused by wild viruses may occur (accidental escape from laboratories or bioterrorism). In countries already using inactivated poliovirus vaccine, it is unlikely that vaccination will be interrupted. Countries that currently use exclusively oral poliovirus vaccine will have to rely on epidemiological surveillance and on oral vaccine inventories to control potential polio outbreaks. If the oral poliovirus vaccine is reintroduced in those populations, there will be again a risk for vaccine-associated paralysis and oral vaccine-derived circulating viruses' that may spread rapidly to other regions and to nearby countries. CONCLUSIONS: Inactivated poliovirus vaccine introduction in the routine Brazilian vaccination calendar should be programmed as well as acquisition of technology for inactivated poliovirus vaccine production since the latter is currently insufficient to cover global demand.