[AF] La gripe A/H1N1 y su vacuna

[mmadurga en agemed.es]

Hola Pedro, perdona pero hay cierta inexactitud en tus palabras. Mira las recomendaciones para las vacunas de gripe estacional que salieron en julio de 2009 en la web de la AEMPS, al igual que en otras gencias: siguiendo las recomendaciones de la OMS se citan las 3 cepas de virus gripal que deben contener las vacunas estacionales este año. A estas vacunas solo se les exige cada año aportar datos clínicos en paralelo a su autorización. Así ha sido siempre. Por lo tanto es inexacto que a la vacuna pandémica no se le exijan pruebas como al resto de medicamentos. Habrá que decir: a las vacunas pandémicas se les va a exigir más datos clínicos que al resto de vacunas de gripe (estacional y anuales).
El síndrome de Guillain-Barré se da en España con una incidencia basal de 1,26 casos por 100.000 habitantes, y tienen tratamiento establecido. Lógicamente se vigila la posibilidad de incremento, como se hace en otros países.
 
Estamos tan 'sensibilizados' con esta gripe, que ya no nos deja ver la realidad.
Os invito a entrar e incorporarse a: "Gripe A: ante todo mucha calma" : http://gripeycalma.wordpress.com/
Abrazos
Mariano Madurga
 
Info: 
1-los requerimientos para las vacunas de gripe estacionales, ver la Circular 3/2009, Normas sobre vacunas antigripales (Campaña 2009/2010), de la AEMPS en la web:   http://www.agemed.es/actividad/documentos/docs/circulares/2009/circular_3-2009.pdf <http://www.agemed.es/actividad/documentos/docs/circulares/2009/circular_3-2009.pdf>  
2-las características de las vacunas pandémicas frente al H1N1, en documento de Q&A de la EMEA: http://www.emea.europa.eu/pdfs/human/pandemicinfluenza/PandemicVaccines_Q&A_46147609en.pdf
3-Plan de Farmacovigilancia para Vacunas pandémicas elaborado por el CHMP (comité con representantes de los 30 estados miembros de la UE), en el seno de la EMEA: http://www.emea.europa.eu/pdfs/human/pandemicinfluenza/35938109en.pdf
4-vacunas de virus que pueden inducir síndrome de Guillain-Barré: artículo en Drug Safety 2009; 32 (4): 309-323. Adjunto el resumen:

Abstract:

Guillain-Barré syndrome (GBS) is the leading cause of acute flaccid paralysis in developed countries and is characterized by various degrees of weakness, sensory abnormalities and autonomic dysfunction. Although the underlying aetiology and pathophysiology of GBS are not completely understood, it is broadly believed that immune stimulation plays a role in its pathogenesis. Thus, since vaccines have an effect on the immune system it is biologically plausible that immunizations may be associated with subsequent GBS. 

The objective of this article is to review the current body of evidence that either supports or does not support a causal, rather than just temporal, association between various vaccines and GBS, and to provide an evidence-based review of this issue. The scope of the article includes published reports that, regardless of method of case ascertainment, appeared in peer-reviewed literature between 1950 and 2008. 

Our review indicates that, with rare exceptions, associations between vaccines and GBS have been only temporal. There is little evidence to support a causal association with most vaccines. The evidence for a causal association is strongest for the swine influenza vaccine that was used in 1976-77. Studies of influenza vaccines used in subsequent years, however, have found small or no increased risk of GBS. 

Older formulations of rabies vaccine cultured in mammalian brain tissues have been found to have an increased risk of GBS, but newer formulations of rabies vaccine, derived from chick embryo cells, do not appear to be associated with GBS at a greater than expected rate. 

In an earlier review, the Institute of Medicine concluded that the evidence favoured a causal association between oral polio vaccine and tetanus toxoid-containing vaccines and GBS. However, recent evidence from large epidemiological studies and mass immunization campaigns in different countries found no correlation between oral polio vaccine or tetanus toxoid-containing vaccines and GBS. 

Spontaneous reports to the US Vaccine Adverse Events Reporting System shortly after the introduction of quadrivalent conjugated meningococcal vaccine (MCV4) raised concerns of a possible association with GBS. Comparisons with expected rates of GBS, however, were inconclusive for an increased risk, and lack of controlled epidemiological studies makes it difficult to draw conclusions about a causal association. 

For other vaccines, available data are based on isolated case reports or very small clusters temporally related to immunizations, and no conclusion about causality can be drawn. 

There are certain circumstances in which immunizing individuals, particularly those with a prior history of GBS, may require caution. However, the benefit of vaccines in preventing disease and decreasing morbidity and mortality, particularly for influenza, needs to be weighed against the potential risk of GBS. 



>________________________________
>De: af
>En nombre de Pedro del Río Pérez
>Enviado el: vie 4/9/09 19:09
>Para: AF - Uninet
>Asunto: [AF] La gripe A/H1N1 y su vacuna