In response to the U.S. shortage of the injectable influenza vaccine, MedImmune considered the feasibility of completing production of additional doses at its Philadelphia facility from its bulk vaccine material.

Recommended for Lower-Risk Groups

In discussions with Tommy Thompson, Secretary of Health and Human Services (HHS), and Dr. Lester Crawford, Acting Commissioner of the U.S. Food & Drug Administration (FDA), MedImmune described the actions required to allow the expeditious delivery of FluMist to U.S. citizens in its attempt to help alleviate the current vaccine shortage.

"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) states that FluMist, if available, should be encouraged for healthy persons who are aged 5-49 years and are not pregnant, including healthcare workers (except those who care for severely immunocompromised patients in special care units) and persons caring for children less than 6 months old.

MedImmune also discussed with HHS and FDA its production plans for 2005 and beyond, outlining the actions necessary 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," Mott said.

"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," Mott continued. "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 Thursday 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. MedImmune's financial guidance assumes that one to two million doses of FluMist will be sold during the 2004 influenza season, the company says.