Intercell AG announced that the US Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) voted to update its previous recommendations and include Ixiaro, a new Japanese Encephalitis (JE) vaccine for travellers to countries in Asia where the disease is endemic, as well as Americans living in such high-risk areas.
ACIP made significant changes to their previous Japanese Encephalitis recommendations, last updated in 1993, noting that many more travellers are now visiting areas where the disease is endemic. In addition to recognizing the recent licensure of Ixiaro, the committee's expanded recommendations urged clinicians to consider vaccinating travellers visiting endemic areas during the transmission season, even those on short-term visits, if they plan to spend a substantial amount of time outdoors. The panel also concluded that Ixiaro, which is derived from a well-established cell line and does not contain stabilizers or preservatives, has a lower risk of vaccine-associated adverse events than older Japanese Encephalitis vaccines.
Ixiaro received marketing approval from the US Food and Drug Administration on March 30, 2009 on the basis of studies that showed the vaccine is highly immunogenic after only two doses. Ixiaro has been shown to stimulate a long-lasting immune response and to be well tolerated. It is the only currently manufactured Japanese Encephalitis vaccine available in the United States. Ixiaro was developed by Intercell AG; the rights to market and distribute the vaccine to the private sector in the United States are held by Novartis Vaccines.
"The consequences of contracting this disease can be devastating due to the high morbidity and mortality associated with the disease, making Ixiaro a crucial preventive tool for those spending time in endemic areas. It is gratifying that the ACIP committee of the CDC has chosen to broaden its recommendations and to recognize the benefits of Ixiaro," said Gerd Zettlmeissl, chief executive officer of Intercell. "This underscores our commitment to serving the needs of the travellers' and of the military market and developing vaccines to address unmet needs."
The ACIP consists of 15 experts in fields associated with immunization who have been selected by the Secretary of the US Department of Health and Human Services to provide advice and guidance on the control of vaccine-preventable diseases. ACIP develops written recommendations for the routine administration of vaccines to children and adults in the civilian population. The ACIP is the only entity in the federal government that makes such recommendations.