ROTAVIRUS - JANOes - Sanidad mantiene la restriccion para la vacuna frente al rotavirus - JANO.es - ELSEVIER

VACUNAS
Sanidad mantiene la restricción para la vacuna frente al rotavirus
JANO.es · 26 Julio 2010 09:13

La EMA ha determinado que no existen problemas de seguridad con su uso, pero España no liberará los lotes “como medida de precaución”.



Imagen del Rotavirus
La Agencia Española del Medicamento y Productos Sanitarios (AEMPS) sigue sin autorizar la liberación de nuevos lotes de la vacuna frente a la gastroenteritis por rotavirus Rotarix, comercializada por GlaxoSmithKline (GSK), después de que el pasado marzo se detectasen muestras de ADN de un circovirus porcino (PCV-1) y pese a haber confirmado que "no supone un riesgo para la salud".

En los últimos meses, las autoridades españolas han frenado la entrada de nuevos lotes de las dos vacunas frente al rotavirus que hay en España, la citada Rotarix y Rotateq, de Sanofi Pasteur MSD, tras haber detectado muestras de estos virus en varios lotes, lo que llevó también a desaconsejar su uso salvo en casos especiales.

El Comité de Medicamentos Humanos (CHMP) de la Agencia Europea del Medicamento (EMA) ha evaluado todos los datos disponibles hasta el momento en relación a este problema, determinando que el PCV-1 "no causa enfermedad alguna en humanos" ni existe un problema de seguridad ni de eficacia con su uso.

“Medida de precaución”
Sin embargo, según una nota remitida por la AEMPS a los profesionales sanitarios, el hallazgo de estos virus supone "un defecto de calidad importante" en esta vacuna, de ahí que se sigan sin liberar los lotes que hay en España "como medida de precaución" y "hasta que no se solucione el problema".

La EMA determina que "no existen motivos para un uso restringido" a nivel europeo o mundial aunque deja la administración de Rotarix a criterio de las recomendaciones oficiales de cada Estado miembro "en función de las circunstancias epidemiológicas locales".
Las investigaciones apuntan a que estos virus pueden haber estado presentes en la vacuna desde el principio, ya que se han encontrado también en el material de partida con el que se fabrica la vacuna.

No obstante, "este virus no debería hallarse en la vacuna", insisten las autoridades españolas, de ahí que el fabricante esté adoptando medidas para producir una vacuna "libre de virus".


AEMPS
http://www.aemps.es/

EMA
http://www.ema.europa.eu/ema/index.jsp?curl=/pages/home/Home_Page.jsp&jsenabled=true


Actualidad Ultimas noticias - JANOes - Sanidad mantiene la restriccion para la vacuna frente al rotavirus - JANO.es - ELSEVIER

European Medicines Agency confirms positive benefit-risk balance of Rotarix
Porcine circovirus type 1 in the oral vaccine poses no risk to public health
Following a review of the oral vaccine Rotarix, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has concluded that the vaccine continues to have a positive benefit-risk balance and that the presence of a very small amount of viral particles does not present a risk to public health.
Results from a very large clinical study database, together with safety data from millions of children who have already received the vaccine, show no safety concern with the vaccine.
Rotarix is a vaccine given by mouth to children of 6 weeks and older, to protect against gastroenteritis (diarrhoea and vomiting) due to rotavirus infection.
The review of Rotarix was initiated after the unexpected detection of DNA of Porcine circovirus type 1 (PCV-1) in the vaccine. PCV-1 is commonly found in certain meat and other food products, and is not known to cause any disease in either humans or animals.
Data from tests carried out by the manufacturer, GlaxoSmithKline Biologicals S.A., showed that the vaccine contained only very small amounts of live PCV-1. The viral particles may have always been present in the vaccine, and have been found in the raw material used to make the vaccine. Their presence was detected only now because of the emergence of new technology.
The Committee concluded that the detection of PCV-1 did not change the benefit-risk balance of Rotarix, and noted that the vaccine is effective in preventing rotavirus infections which are responsible for half a million deaths each year, mostly in developing countries.
However, since PCV-1 should not be present in the Rotarix vaccine, the manufacturer has proposed measures to manufacture the vaccine free of the virus.
The CHMP’s recommendation has been forwarded to the European Commission for the adoption of a binding decision.
Notes:
1.Rotarix contains a live attenuated (‘weakened’) virus. It is prepared from live human rotavirus strains that are manipulated to make them unable to cause the disease, while keeping their ability to trigger an immune response.
2.Rotarix was approved in the European Union (EU) in February 2006. It is not usually part of Member States’ childhood vaccination schedules, but is approved in all EU Member States. As for many vaccines, Rotarix is given according to official recommendations in line with vaccination programmes in the different Member States.
3.The vaccine is widely used outside of the European Union and is part of the World Health Organization (WHO) prequalification programme for vaccines. Some 51,000 children received the vaccine in clinical trials (out of a total of 91,000 children) and about 68 million doses have been distributed worldwide to date.
4.The review of Rotarix was conducted in the context of a formal review, initiated by the European Commission under Article 20 of Regulation (EC) No 726/2004/EC.