GAITHERSBURG, Md., and MADISON, N.J., Nov. 7 /PRNewswire-FirstCall/ -- MedImmune Vaccines, Inc., and Wyeth Vaccines announced today that Popular Science magazine has awarded FluMist(TM), Influenza Virus Vaccine Live, Intranasal, as a "Best of What's New" winner in the personal health category. Each year Popular Science editors select 100 new products or technological advances among thousands of innovations. FluMist earned one of 10 awards given in the personal health category.
FluMist is the first and only influenza vaccine available in the United States that is delivered as a nasal mist. It is the first innovation in flu vaccine delivery technology in more than 50 years. FluMist was approved earlier this year by the U.S. Food and Drug Administration and is 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.
"This award is a tribute to the hard work, pioneering research, and cooperative spirit of numerous employees at MedImmune and Wyeth who played a crucial role in the development of this vaccine technology and in bringing it to market," said David M. Mott, Chief Executive Officer of MedImmune, Inc. "Our hope is that FluMist will increase vaccination rates among healthy individuals and contribute to improving public health and reducing the impact of influenza on the entire population."
Delivered as a fine nasal mist, FluMist(TM) helps prevent influenza where the virus usually enters the body -- the nose. FluMist is now available in doctors' offices and in some pharmacies for the 2003-2004 influenza season. Consumers can find a health care provider or pharmacy that is stocking FluMist by utilizing the FluMist(TM) Finder available on http://www.flumist.com/. This tool provides a list of doctors' offices and pharmacies offering the vaccine, which can be searched by ZIP code, city, and state.
FluMist is manufactured by MedImmune Vaccines, Inc., and copromoted with Wyeth Vaccines. For more information about FluMist, visit http://www.flumist.com/ or call 1-877-FluMist.
FluMist is 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.
In placebo-controlled clinical trials, the most common solicited adverse events in healthy children (n=214) included runny nose/nasal congestion, cough, irritability, headache, decreased activity, sore throat, fever (oral temperature > 100 degrees F), muscle aches, chills, and vomiting. The most common adverse events in healthy adults (n=2,548) included runny nose, headache, sore throat, tiredness/weakness, muscle aches, cough, and chills.
There are risks associated with all vaccines, including FluMist(TM). FluMist does not protect 100% of individuals vaccinated, or protect against viral strains not represented in the vaccine. FluMist is not indicated for immunization of individuals less than 5 years of age, or 50 years of age and older.
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. See Prescribing Information for indications and usage, dosage and administration, and safety information.
About MedImmune, Inc., and Wyeth
MedImmune Vaccines, Inc., is a wholly owned subsidiary of MedImmune, Inc. . MedImmune is a leading biotechnology company focused on researching, developing, and commercializing products to prevent or treat infectious disease, autoimmune disease, and cancer. MedImmune actively markets four products, Synagis(R) (palivizumab), FluMist(TM), Influenza Virus Vaccine Live, Intranasal, Ethyol(R) (amifostine), and CytoGam(R) (cytomegalovirus immune globulin intravenous [human]), and has additional products in clinical testing. MedImmune employs approximately 1,700 people, is headquartered in Gaithersburg, Maryland, and has additional operations in Frederick, Maryland, as well as Pennsylvania, California, the United Kingdom, and the Netherlands. For more information on MedImmune, visit the company's Web site at http://www.medimmune.com/.
Wyeth Vaccines is a business unit of Wyeth Pharmaceuticals, a division of Wyeth . Wyeth Pharmaceuticals has leading products in the areas of women's health care, cardiovascular disease, central nervous system, inflammation, hemophilia, oncology, and vaccines. Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing, and marketing of pharmaceuticals, vaccines, biotechnology products, and non-prescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare, and Fort Dodge Animal Health.
The statements in this press release that are not historical facts are forward-looking statements based on current expectations of future events that involve risks and uncertainties including, without limitation, risks associated with the inherent uncertainty of pharmaceutical research, product development, manufacturing and commercialization, economic conditions, including interest and currency exchange rate fluctuations, the impact of competitive or generic products, product liability and other types of lawsuits, the impact of legislative and regulatory compliance and obtaining approvals, and patent, and other risks and uncertainties, including those detailed from time to time in Wyeth's and MedImmune's periodic reports, including quarterly reports on Form 10-Q and annual reports on Form 10-K, filed with the Securities and Exchange Commission. Actual results may vary materially from the forward-looking statements. The Companies assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future events, or otherwise.
MedImmune, Inc.; Wyeth