Due to the extraordinary efforts of the FDA and HHS, we believe we can increase our expected delivery of FluMist to a total of 3 million doses this flu season, said David M. Mott, president and chief executive officer. To succeed in these efforts, we will need to work closely with the FDA to produce and release 400,000 doses of FluMist per week for five consecutive weeks beginning in early November.
The October 8, 2004 Morbidity and Mortality Weekly Report distributed by the U.S. Centers for Disease Control and Prevention (CDC) stated that FluMist, if available, should be encouraged for healthy persons who are aged five to 49 years and are not pregnant, including health-care workers (except those who care for severely immunocompromised patients in special care units) and persons caring for children aged less than six months.
MedImmune also discussed with HHS and FDA its production plans for 2005 and beyond. In these discussions the company described what actions would be needed before the end of this year to enable the company to increase its production plan for 2005 from two to three million doses to eight to 10 million doses. The company currently has the capacity to produce up to 20 million doses of FluMist, and expects to be able to double that capacity to 40 million doses by 2007.
We remain committed to continuing to work with Secretary Thompson and public heath officials in doing everything that is reasonable and feasible to increase our production, continued Mott. We are also committed to developing our next-generation, refrigerator-stable FluMist formulation, known as CAIV-T, to demonstrate that it is the product of choice, particularly for children. Toward this goal, we have already completed 42 clinical trials involving more than 64,000 subjects for both FluMist and CAIV-T. We also have eight more clinical trials currently underway involving an additional 70,000 subjects for these vaccines.
The company did not change its financial guidance issued earlier in the day as a result of the late-breaking collaborative discussions with health authorities as it is too early to know how many, if any, of the additional doses produced will actually be sold. MedImmunes financial guidance released earlier today assumed that one to two million doses of FluMist would be sold during the 2004 influenza season.
In a typical year, influenza is responsible for an average of 36,000 deaths (primarily in the elderly) and 200,000 hospitalizations in the
FluMist was approved by the FDA in June 2003. It is the first live, attenuated influenza vaccine indicated for active immunization for the prevention of disease caused by influenza A and B viruses in healthy children and adolescents, five to 17 years of age, and healthy adults, 18 to 49 years of age.
There are risks associated with all vaccines, including FluMist. FluMist does not protect 100-percent of individuals vaccinated, or may not protect against viral strains not represented in the vaccine. FluMist is contraindicated in persons with hypersensitivity to any component of the vaccine, including eggs; in children and adolescents receiving aspirin therapy or aspirin-containing therapy; in individuals with a history of Guillain-Barri syndrome; and in individuals with known or suspected immune deficiency. The safety and efficacy of FluMist have not been established in pregnant women or for patients with chronic underlying medical conditions, including asthma or reactive airways disease; the vaccine should not be administered to these patients. See prescribing information for indications and usage, dosage and administration and safety information.
Source: MedImmune, Inc.