MedImmune Resolves FDA Observations Regarding Manufacturing Process for FluMist(R)
FluMist Expected to Be Available Soon for 2007-2008 Season
GAITHERSBURG, Md., Sept. 7 -- MedImmune announced today that it has resolved the observations made by the U.S. Food and Drug Administration (FDA) during an annual inspection of the company's influenza vaccine manufacturing facility in Speke, United Kingdom. The agency's observations led to the issuance of a Warning Letter on May 24, 2007, which has now been resolved. The UK facility is the bulk manufacturing site for FluMist(R) (Influenza Virus Vaccine Live, Intranasal). MedImmune will continue to work with the FDA on the implementation and ongoing execution of all quality and compliance commitments.
MedImmune is currently working with the FDA on the standard annual lot release process so that shipping of FluMist to customers can soon begin for the upcoming influenza season. MedImmune can now also take the necessary regulatory steps to seek the FDA's final approval of the company's supplemental biologics licensing application requesting expansion of the vaccine's indication to include children below 5 years of age.
FluMist is currently indicated for active immunization for the prevention of disease caused by influenza A and B viruses in healthy children and adolescents, 5 to 17 years of age, and healthy adults, 18 to 49 years of age. There are risks associated with all vaccines, including FluMist. As with any vaccine, FluMist does not protect 100 percent of individuals vaccinated and may not protect against viral strains not contained in the vaccine.
Under no circumstances should FluMist be administered as an injection (i.e. parenterally). 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-Barre 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.
In randomized, placebo-controlled clinical trials of FluMist in its refrigerated and frozen formulations, the most common solicited adverse events in the indicated population (n=11,604) included runny nose/nasal congestion, sore throat, cough, irritability, headache, chills, vomiting, muscle aches, decreased appetite, abdominal pain, and decreased activity/feeling of tiredness/weakness.
On January 5, 2007, the FDA approved MedImmune's sBLA for a refrigerated version of FluMist, which is being manufactured for the 2007-2008 influenza season. Prior seasons' versions required frozen storage. Due to the seasonal nature of influenza vaccine, full prescribing information for the refrigerated version does not yet contain complete details on vaccine strains to be included for this season's vaccine. However, preliminary prescribing information can be found at http://www.fda.gov/cber/label/inflmed010507LB.pdf.
MedImmune strives to provide better medicines to patients, new medical options for physicians and rewarding careers to employees. Dedicated to advancing science and medicine to help people live better lives, the company is focused on the areas of infectious diseases, cancer and inflammatory diseases. With approximately 3,000 employees worldwide and headquarters in Maryland, MedImmune is wholly owned by AstraZeneca plc (LSE: AZN.L, NYSE: AZN). For more information, visit MedImmune's website at http://www.medimmune.com.