First Innovation in Flu Vaccine Delivery in Over 50 Years
GAITHERSBURG, Md., and MADISON, N.J., June 17 /PRNewswire-FirstCall/ --
The U.S. Food and Drug Administration (FDA) today approved FluMist(TM)
(Influenza Virus Vaccine Live, Intranasal), the first influenza vaccine
delivered as a nasal mist available in the United States for healthy people.
FluMist(TM) will be available in physicians' offices and some pharmacies
beginning in late summer to early fall, in time for this flu season.
FluMist(TM), indicated for active immunization for the prevention of
disease caused by influenza A and B viruses in healthy children and
adolescents, 5-17 years of age, and healthy adults, 18-49 years of age, is
manufactured and marketed by MedImmune Vaccines, Inc., a wholly owned
subsidiary of MedImmune, Inc. (Nasdaq: MEDI), and is co-marketed by Wyeth
Vaccines, a business unit of Wyeth Pharmaceuticals, a division of Wyeth
"The innovative delivery of FluMist(TM) is changing the way we think about
flu prevention and could increase the number of healthy people who receive a
yearly influenza vaccination," said Robert B. Belshe, MD, professor of
Internal Medicine, Pediatrics, Molecular Microbiology and Immunology at Saint
Louis University, and the lead investigator of key FluMist(TM) clinical
trials. "There is a strong need for healthy people to get vaccinated against
influenza. For example, healthy school-aged children are often the first to
be infected by influenza and can infect others in the community."
Each year in the U.S., influenza infects an estimated 17 million to 50
million people, many of whom are otherwise healthy children and adults.
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.
"MedImmune is proud to bring FluMist(TM) to market as a new, needle-free
option to help reduce the occurrence and impact of the flu," said David Mott,
Chief Executive Officer of MedImmune, Inc.
"The FDA approval of FluMist(TM) brings the public an innovative vaccine
delivery system aimed at protecting the health of school-aged children and
adults," said Geno Germano, Executive Vice President and General Manager of
Wyeth Global Vaccines. "FluMist(TM) is cutting-edge technology in influenza
vaccine delivery in the U.S."
In a clinical trial with adults aged 18 years to 41 years (N=60), the
ability of FluMist(TM) to protect adults from influenza illness was 85 percent
(95 percent confidence interval [CI]: 28, 100) in those who were intentionally
exposed to wild-type virus. In a two-year pediatric field trial, the efficacy
of FluMist(TM) in preventing influenza was 87 percent (P less than or equal to
0.05) among healthy children aged 60 months to 84 months (N=544). 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. In placebo-
controlled clinical trials, the most common adverse events in healthy adults
(n=2,548) included runny nose, headache, sore throat, tiredness/weakness,
muscle aches, cough, and chills. In clinical trials, in the indicated
population, these events were transient.
FluMist(TM) is indicated for active immunization for the prevention of
disease caused by influenza A and B viruses in healthy children and
adolescents, 5-17 years of age, and healthy adults, 18-49 years of age.
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 is not
indicated for children less than 5 years or for adults 50 years 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 airway 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, Inc., is a leading biotechnology company focused on
researching, developing, and commercializing products to prevent or treat
infectious disease, autoimmune disease, and cancer. MedImmune currently
markets four products, Synagis(R) (palivizumab), Ethyol(R) (amifostine),
CytoGam(R) (cytomegalovirus immune globulin intravenous [human]), and
FluMist(TM) (influenza virus vaccine live, intranasal), and has several
products in clinical testing. MedImmune employs over 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.
SOURCE MedImmune, Inc.
/CONTACT: Media: Jamie Lacey of MedImmune, Inc., +1-240-632-4035, or
Natalie de Vane of Wyeth Pharmaceuticals, +1-484-865-5139; Investors: William
Roberts of MedImmune, Inc., +1-301-527-4358, or Justin Victoria of Wyeth,
/Web site: http://www.medimmune.com/
CO: MedImmune, Inc.; Wyeth Pharmaceuticals; Wyeth Vaccines; U.S. Food and
Drug Administration; FDA
ST: Maryland, New Jersey
IN: HEA MTC
SU: CHI PDT SVY
-- DCTU057 --
9071 06/17/2003 16:42 EDT http://www.prnewswire.com