Friday, February 08, 2008

Beijing Boost for Japanese Encephalitis Vaccine

China has been preparing feverishly for the Beijing Olympics for years to showcase its new world position and economic power.

China's cool new National Swim Center

At the same time, there’s an interesting product development race in the vaccine field that relates directly to the safety of increased travel to Asia from the West. After a long ten-year effort, the race to develop a new Japanese encephalitis virus vaccine is into its final stretch.

Vienna, Austria-based Intercell AG has a BLA (biologics) application pending at FDA for a new inactivated JEV vaccine. Intercell filed its application with FDA at the end of December,
within weeks after filing for a similar marketing authorization application in Europe.

The vaccine, developed over a decade in conjunction with the Walter Reed Army Institute of Research, will be marketed and distributed for Intercell in the US by Novartis. Intercell will manufacture the tissue culture based product in Scotland. The vaccine (IC51) is the Intercell’s leading product candidate.

A preliminary discussion of the vaccine will take place at the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) meeting on Feb. 27-28.

The chairman of the ACIP committee, Dale Morse, MD, Director of the Office of Science and Public Health at the New York State Department of Health, said that the discussion of the JEV vaccine will be one of the interesting topics for the upcoming meeting. Morse told the Feb. 6 meeting of the National Vaccine Advisory Committee that “the current vaccine is in limited supply” and “there may be increased demand around the Olympics for that vaccine.” The US Army has noted the shortage of the current vaccine from Biken due to a halt in production.

Intercell acknowledges that it would take an unusually rapid review of the product by the FDA to have it available for the Olympics in late summer. A spokesperson for Intercell, Lucia Malfent, says: “We do expect licensure for our product in 2008 but most likely the full process of market authorization will not be completed before the Olympics. Therefore, the vaccine will not be available in time for travelers to the summer Olympics in Beijing.” JE vaccinations are not routinely recommended for travelers to Chinese urban areas; the mosquito borne disease is more prevlaent in rural areas.

Intercell IC51 is not on the agenda for FDA’s next Vaccines and Related Biological Products Advisory Committee Meeting (Feb. 20-21). There is one tentative date for VRBPAC in late may before the summer Olympics. The product review for the February VRBPAC meeting is GlaxoSmithKline’s Rotarix (rotavirus vaccine).

Acambis is also working on a JE vaccine, ChimeriVax-JE. The company reported results from Phase III safety and efficacy trials in the first quarter of 2007. Acambis has not reported filing an application for marketing yet.

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