India’s Last Battle in the War Against Polio.

Type 2 vaccine virus is the predominant cause of Vaccine-derived poliovirus and Vaccine-associated paralytic poliomyelitis. Therefore, World Health Organization recommends global synchronized switching from trivalent to bivalent Oral polio vaccine. To prevent the risk of type 2 poliovirus re-emergence, atleast one dose of Inactivated polio vaccine is recommended at 14 weeks of age in routine immunization, before the switch. To protect immunocompromised children and those under 14 weeks of age, an additional dose must be given at 6 weeks of age. Mass campaigns of Injectable polio vaccine in states with poor Routine immunization coverage, before the trivalent to bivalent Oral polio vaccine switch, will reduce risk of Vaccine-derived poliovirus by covering all under-immunized pockets. The additional costs are justified as it is our ethical obligation to eliminate any iatrogenic risk.

Safety and Reactogenicity of the Inactivated Poliomyelitis Vaccine (Poliorix(TM)) in Korea (2006-2012) / 소아감염

OBJECTIVE: As per the requirement of Korean Food and Drug Administration, this post-marketing surveillance was conducted in Korea to evaluate the safety and reactogenicity of Poliorix(TM) following its introduction in 2006. METHODS: In this open, multicenter study, the vaccine was administered as per the current practice of Korean doctors and in reference to the guidebook by the Korean Pediatric Society and as indicated in the Korean label which was as follows - for primary vaccination three doses were given to infants at ages 2, 4 and 6 months whereas, for the booster dose a single dose was given to children aged 4-6 years. Safety data during this six year surveillance was collected using diary cards which were distributed to the parents to record adverse events. RESULTS: A total of 639 subjects were enrolled into the study. Of these, 617 subjects and 22 subjects received the vaccine as a primary and booster dose, respectively. At least one unsolicited symptom was reported in 11.4% (73/639) of the subjects during the 7-day follow-up period; upper respiratory tract infection (2.5%;16/639) was the most frequently reported unsolicited symptom. One subject reported at least one unsolicited symptom (gastroenteritis) of grade 3 intensity within the 31-day post-vaccination period. Approximately 1.7% (11/639) of subjects reported 13 serious adverse events (SAEs). All SAEs were resolved by the end of the study. CONCLUSION: In Korea, primary and booster vaccination with Poliorix(TM) was well-tolerated in healthy subjects when administered according to the prescribing information as part of routine clinical practice.

Polio / Polio

Polio continúa endémica en: Nigeria, Afganistán Pakistán e India. La iniciativa global de erradicación de polio de la OMS estableció que para 2013 no debe haber ningún niño paralítico en el mundo por el virus salvaje o por el virus derivado de la vacuna. En esta revisión se describen ambas vacunas contra el polio, la oral y la inactivada, su inmunogenicidad, seguridad y las condiciones a cumplir por un paíspara que cambie su esquema de vacunación de polio oral a inactivada. La vacuna polio oral ha permitido la erradicación de la enfermedaden varios continentes incluyendo América; sin embargo conlleva riesgos, tales como polio paralítica asociada a vacuna (VAP-siglas en inglés-) y parálisis producida por polio virus derivado de la vacuna (VDP-siglas en inglés-). La Vacuna Polio Inactivada (VPI) es segura e inmunogénica, puede ser administrada en combinaciones vacunales. Para que un país cambie a VPI debe tener cobertura y esquemaóptimo de esta vacuna, 90% de, cobertura de DTP3, vigilancia adecuada de parálisis flácida, no estar próximo en la actualidad o recientemente a un país con polio endémico. Altas coberturas vacunales son esenciales par asegurar una inmunidad adecuada de lapoblación

Polio remains endemic in Nigeria, Afghanistan, Pakistan, India. Strategic plan of Global Poliomyelitis Eradication Initiative (GPEI) of the WHO is that by 2013 no child will be paralyzed by a wild or vaccine derived poliovirus. This paper describes both oral and inactivated vaccine, safety concerns with the use of OPV, immunogenicity of IPV and the conditions to be full filled in order for a country to deliverIPV as a regular vaccine schedule. Oral polio vaccine has successfully contributed to global polio eradication in several continents including America. However, it carries risks, such as Vaccine Derived Poliovirus (VDP) and Vaccine Associated Paralytic Polio (VAPP). Inactivated Poliovirus Vaccine (IPV) is safe and immunogenic; it may be administered as monovalent or in a combined shot. Countries opting to switch from OPV to IPV should have: optimal IPV coverage and schedule, 90% of DTP 3 coverage, good surveillance of flaccid paralysis cases, and should not be near a country with endemic polio recently or at the present time. Are neither currently or were notrecently polio endemic nor has close contacts with such areas. High immunization coverage is essential to ensure adequate populationimmunity

Reactogenicidad asociada a la administración intradérmica de la vacuna de polio inactivada con un inyector sin aguja / Reactogenicity associated to the intradermally administered inactivated poliovirus vaccine with a needle-free injector

INTRODUCCIÓN: en la medida en que la meta de la erradicación de la poliomielitis llega a su concreción, la necesidad de contar con una vacuna de polio inactivada asequible y apropiada para el uso en países en vías de desarrollo se ha convertido en una meta para la Organización Mundial de la Salud. OBJETIVO: la evaluación de la reactogenicidad de la vacuna de polio inactivada. MÉTODOS: se realizó un estudio multicéntrico con diseño experimental, correspondiente a Fase I-II de un ensayo clínico controlado, aleatorio y a simple ciegas, en 471 lactantes sanos de ambos sexos nacidos entre los meses de julio y agosto de 2006 en Camagüey, cuyos padres brindaron su consentimiento por escrito y que cumplieron con los criterios de inclusión establecidos. Los niños recibieron a las 6, 10 y 14 semanas del nacimiento, tres dosis de vacuna de polio inactivada del Instituto de Sueros de Dinamarca, autorizada para su uso en esta investigación por las autoridades regulatorias nacionales. Al grupo de estudio A, se le administró por la vía intradérmica la dosis reducida de 0,1 mL de vacuna de polio inactivada en la cara anterolateral del muslo izquierdo utilizando el inyector sin aguja Biojector® 2000. El grupo control B recibió la dosis usual de 0,5 mL por la vía intramuscular profunda, administrada en el mismo sitio descrito antes con una jeringuilla prellenada. Se observaron los eventos adversos durante la primera hora, 24, 48, y 72 h subsiguientes, así como a los 7 y 30 d de administrada la vacuna. La reactogenicidad se evaluó inicialmente por el pediatra del área y luego por el médico de familia mediante la observación de los eventos adversos. RESULTADOS: 79,6 por ciento del total de niños asignados al grupo A y 75 por ciento del grupo B finalizaron el protocolo de investigación. No se detectaron eventos adversos moderados o serios. Predominaron las reacciones adversas locales menores, sobre todo induración, dolor y enrojecimiento en el sitio de la inyección. CONCLUSIÓN: el ensayo demostró la seguridad de la vacuna de polio inactivada para su uso por vía intramuscular y reconoció la seguridad del uso de la vía intradérmica y del inyector sin agujas.

INTRODUCTION: as the goal of poliomyelitis eradication is about to be accomplished, the need for an affordable and appropriate inactivated poliovirus vaccine (IPV) for use in developing countries has become a target for WHO. OBJECTIVE: to evaluate the reactogenicity of the inactivated poliovirus vaccine. METHOD: an experimental-type multicenter study was conducted, as part of a Phase I-II controlled clinical randomized and blinded assay, in 471 healthy infants of both sexes born in July and August 2006 in Camagüey province. The parents of the children who met the inclusion criteria gave their consent in writing. The children received three doses of the inactivated poliovirus vaccine at 6, 10 and 14 weeks after birth. This vaccine came form the Institute of Sera in Denmark and had been approved for use in this assay by the Cuban regularoty authorities, Low 0.1 ml inactivated poliovirus vaccine dose was intradermally administered to the study group A in the anterolateral side of the left thigh using the needle-free injector called Biojector ® 2000. The usual 0.5 mL dose was intramuscularly administered on the same site using a pre-filled syringe. The adverse events were observed during the first hour, 24, 48, and 72 hours after the immunization, as well as 7 and 30 days afterwards. The pediatrician in charge of the health area evaluated the reactogenicity at first and then the family physician was in charge of observing the adverse events in the remaining period. RESULTS: the 79.6 percent of children in group A and 75 percent in group B completed the research protocol. Mild local adverse reactions prevailed, mainly induration, pain and redness at the injection site. CONCLUSION: the clinical trial proved the safety of the inactivated poliovirus vaccine for intramuscular administration, and also showed the safety of the intradermal route of administration and of the needle-free injector.