Advertisement
MedImmune is currently working with the FDA on the standard annual lotrelease process so that shipping of FluMist to customers can soon begin forthe upcoming influenza season. MedImmune can now also take the necessaryregulatory steps to seek the FDA's final approval of the company'ssupplemental biologics licensing application requesting expansion of thevaccine's indication to include children below 5 years of age.
Advertisement
About FluMist
FluMist is currently indicated for active immunization for the preventionof disease caused by influenza A and B viruses in healthy children andadolescents, 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 anyvaccine, FluMist does not protect 100 percent of individuals vaccinated andmay 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 withhypersensitivity to any component of the vaccine, including eggs; in childrenand adolescents receiving aspirin therapy or aspirin-containing therapy; inindividuals with a history of Guillain-Barre syndrome; and in individuals withknown or suspected immune deficiency. The safety and efficacy of FluMist havenot been established in pregnant women or for patients with chronic underlyingmedical conditions, including asthma or reactive airways disease; the vaccineshould not be administered to these patients.
In randomized, placebo-controlled clinical trials of FluMist in itsrefrigerated and frozen formulations, the most common solicited adverse eventsin 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 oftiredness/weakness.
On January 5, 2007, the FDA approved MedImmune's sBLA for a refrigeratedversion of FluMist, which is being manufactured for the 2007-2008 influenzaseason. Prior seasons' versions required frozen storage. Due to the seasonalnature of influenza vaccine, full prescribing information for the refrigeratedversion does not yet contain complete details on vaccine strains to beincluded for this season's vaccine. However, preliminary prescribinginformation can be found at http://www.fda.gov/cber/label/inflmed010507LB.pdf.
About MedImmune
MedImmune strives to provide better medicines to patients, new medicaloptions for physicians and rewarding careers to employees. Dedicated toadvancing science and medicine to help people live better lives, the companyis focused on the areas of infectious diseases, cancer and inflammatorydiseases. With approximately 3,000 employees worldwide and headquarters inMaryland, MedImmune is wholly owned by AstraZeneca plc(LSE: AZN.L, NYSE: AZN). For more information, visit MedImmune's website athttp://www.medimmune.com.
SOURCE MedImmune
