GAITHERSBURG, Md., and MADISON, N.J., Sept. 2 /PRNewswire-FirstCall/ --
MedImmune Vaccines, Inc., and Wyeth Vaccines announced today that FluMist(TM)
(Influenza Virus Vaccine Live, Intranasal), the first influenza vaccine
delivered as a nasal mist approved in the United States for healthy people, is
now available in doctors' offices and in some pharmacies nationwide for the
2003-2004 influenza season. FluMist(TM) 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.
(Photo: http://www.newscom.com/cgi-bin/prnh/20030902/DCTU010 )
"FluMist(TM) is the first needle-free option in the U.S. for immunizing
healthy children and adults against influenza," said Robert B. Belshe, M.D.,
Professor of Internal Medicine, Pediatrics, Molecular Microbiology and
Immunology at Saint Louis University, and the lead investigator of key
FluMist(TM) clinical trials. "Healthy people should consider vaccination
against the flu, as the burden of influenza in this population is significant.
With the availability of FluMist(TM), more healthy people could get vaccinated
against influenza this fall."
The flu is a recurrent epidemic infectious disease that significantly
affects and disrupts the lives of healthy children and adults. Each year in
the U.S., an estimated 17 million to 50 million people, many of whom are
otherwise healthy children and adults, are infected with the influenza virus.
Influenza also results in approximately $3 billion to $15 billion annually in
direct and indirect costs, including approximately 70 million missed workdays
and approximately 38 million missed school days.
Because the influenza virus is airborne, it is easily transmitted, placing
nearly everyone at risk for exposure. Areas where people gather, such as
schools, homes, and offices, are likely locations for catching the flu. The
most effective way to prevent influenza is vaccination.
Many health care professionals immunize against the flu between October
and November, although vaccination can be beneficial even beyond December.
Flu season peaks between December and March; however, many health care
professionals vaccinate as soon as vaccine is available.
For more information about FluMist(TM) and where it is available, visit
www.FluMist.com or call 1-877-FluMist.
FluMist(TM) 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(TM) does not protect 100% of individuals vaccinated, or protect
against viral strains not represented in the vaccine. FluMist(TM) is not
indicated for immunization of individuals less than 5 years of age, or 50
years of age and older. FluMist(TM) 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(TM)
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
About MedImmune, Inc., and Wyeth
MedImmune Vaccines, Inc., is a wholly owned subsidiary of MedImmune, Inc.
(Nasdaq: MEDI). MedImmune, Inc., 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 www.medimmune.com.
Wyeth Vaccines is a business unit of Wyeth Pharmaceuticals, a division of
Wyeth (NYSE: WYE). 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.
SOURCE MedImmune, Inc.; Wyeth Vaccines
/CONTACT: Media: Jamie Lacey of MedImmune, Inc., +1-240-632-4035; or
Douglas Petkus of Wyeth Pharmaceuticals, +1-484-865-5140; or Investors: Will
Roberts of MedImmune, Inc., +1-301-527-4358; or Justin Victoria of Wyeth,
/Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20030902/DCTU010
AP Archive: http://photoarchive.ap.org
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/Web site: http://www.medimmune.com
CO: MedImmune, Inc.; Wyeth Vaccines; MedImmune Vaccines, Inc.; Wyeth
ST: Maryland, New Jersey
IN: MTC HEA
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3546 09/02/2003 09:23 EDT http://www.prnewswire.com