Fast Facts

• Crucell is involved in a number of different programs to address the pandemic threat of avian influenza.
• New vaccines that can be easily and quickly produced for all flu virus strains are urgently required. 

Description

Crucell has chosen to focus on the generic process for producing pandemic flu vaccines. We believe this will allow a fast and flexible approach in the event of a pandemic outbreak. We are currently involved in two different pandemic flu programs as outlined below:

Development Rationale

There is a growing fear within the medical community concerning the potential re-occurrence of a pandemic influenza outbreak, similar to the 1918 “Spanish flu” pandemic. To protect against a future potential influenza pandemic, new vaccines that can be easily and quickly produced for all flu virus strains are urgently needed.

Development Status

“Pandemic Core Dossier”:

In May 2006, we announced the commencement of a large Phase I clinical trial to test a vaccine against avian influenza in humans, in collaboration with the University Hospitals of Leicester. Three types of vaccine will be tested for safety and immunogenicity, all based on the H9N2 virus: a non-adjuvanted whole virion vaccine, an alum-adjuvanted whole virion vaccine and a virosomal subunit vaccine. Trials with subtypes of influenza A with pandemic potential, such as H9N2, can be used in support of a “pandemic core dossier”, which forms the basis for rapid approval by the regulatory authority of a vaccine against an actual pandemic threat once it emerges. The study will allow Crucell to investigate several options to lower the amounts of antigen per dose by exploring different adjuvants and routes of immunization. It will also guide us in determining how to make an effective vaccine against any avian flu strain, including H5N1. 

Phase I and II studies have been completed and the results are currently being analyzed. No serious adverse side effects were reported to date. Findings are expected to be released first half of 2008.

FLUPAN:

In Europe, Crucell and sanofi pasteur combined as the only manufacturer for the FLUPAN program. FLUPAN intends to enhance EU preparedness for an influenza pandemic by improving on existing vaccine production techniques through the development of novel cell-based vaccines. Phase I clinical trials for the pandemic flu vaccine have started in September 2006. The study is completed and the vaccine was found to be sound, safe and well tolerated as presented during the "Options for the Control of Influenza VI Conference" held in Toronto, Canada, June 2007.

US Government Initiative:

In April 2005, sanofi pasteur, with Crucell as a subcontractor, received a US$ 97 million contract by the US Department of Health and Human Services (HHS) for clinical development of PER.C6^®-based influenza vaccine and other related activities. (See the sanofi pasteur website.) The objective of the contract is to accelerate the licensure in the U.S. of a PER.C6^®-based cell-culture influenza vaccine and vaccine manufacturing facility. The project is part of the U.S. government's effort to increase influenza vaccine manufacturing capacity in the event of a pandemic or other influenza health emergency.

About Avian and Pandemic Influenza

Avian influenza is an infection caused by avian, or bird, influenza viruses that occur naturally among wild birds. It is usually very contagious among birds and can make some domestic poultry (chickens, ducks or turkeys) very sick and potentially kill them. Although uncommon, infections with these viruses can occur in humans. Since 1997, more than 230 confirmed cases of human infection with avian influenza strains, principally the influenza A virus H5N1, have been reported resulting in death in more than 50% of those infected. Most cases have occured from close contact with infected poultry or with secretions or excretions from infected birds. The spread of avian influenza viruses from person to person has been reported very rarely.

Pandemic flu is a virulent human flu that causes a global outbreak, or pandemic, of serious illness. During the 20^th century there were three influenza pandemics, with the 1918 “Spanish” flu causing up to 50 million deaths worldwide. Genetic studies have confirmed that the H5N1 virus mutates rapidly. Should it adapt to allow easy human-to-human transmission, a pandemic could ensue. Because there is little natural immunity, the disease can spread easily from person to person. At this time, it is uncertain whether the currently circulating H5N1 virus will lead to a pandemic in humans.

Further Information

For Press Releases and Scientific Papers that relate specifically to our Influenza program, please refer to the Influenza Media Kit.