- Studies Involved Infants, Young Children, and Elderly,
In Addition to Healthy Adults -
GAITHERSBURG, Md., and MADISON, N.J., Oct. 13 /PRNewswire-FirstCall/ --
Data from five large studies with an investigational intranasal, cold-adapted
trivalent influenza vaccine (CAIV-T) were presented at the Fifth International
Options for the Control of Influenza Conference in Okinawa, Japan. The
studies involved nearly 5,500 individuals from a wide range of populations,
including infants as young as six weeks of age, young children in day care
settings, adults aged 60 years or older, and healthy adult males from 24 to 45
years of age.
"These data are very encouraging and will be important additions to our
ongoing development plans for our next generation intranasal flu vaccine
program," says Dr. Peter Paradiso, Vice President, New Business and Scientific
Affairs for Wyeth.
James F. Young, PhD, MedImmune's President, Research and Development,
says, "The cold-adapted flu technology used to manufacture CAIV-T -- a liquid,
refrigerator-stable formulation -- is the same technology used to make the
current frozen version of FluMist(TM) (Influenza Virus Vaccine Live,
Intranasal), which is the first needle-free flu vaccine approved in the United
States. FluMist(TM) is currently indicated for healthy people 5-49 years of
age. The data presented at the Options conference shows that the body of
clinical data for the use of live, attenuated, intranasal flu vaccines is
expanding rapidly."
The studies presented in Okinawa, listed below, collected data relating to
the safety, tolerability, efficacy and transmissibility of CAIV-T in the
populations tested.
* Safety and Tolerability of a Live, Attenuated, Influenza Vaccine in
Infants and Young Children Aged 6 to <24 Weeks
* A Randomized, Double-Blind, Placebo-Controlled Trial of the Safety,
Transmissibility and Phenotypic Stability of a Live, Attenuated,
Influenza Virus Vaccine in Children Attending Day Care
* Efficacy of a Live, Attenuated, Influenza Vaccine in South African
Adults Aged 60 Years or Older Against Community-Acquired Culture
Confirmed Influenza
* Safety and Tolerability of a Live, Attenuated, Influenza Vaccine in
Healthy Japanese Male Adults Aged 20 to 45 Years
* Efficacy of Live, Attenuated Influenza Vaccine in Children Aged 6 to <36
Months Attending Day Care Centers in Europe and Israel Against
Community-Acquired Culture Confirmed Influenza
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. The most effective way to
help 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, health care
professionals may vaccinate as soon as vaccine is available, usually in
September.
About the Options for the Control of Influenza Conference
The international conference, Options for the Control of Influenza, traces
back to 1985 when Options I was organized under the scientific direction of
the influenza program staff at the U.S. Centers for Disease Control.
The intention of the conference was to stimulate discussion and interest
in the variety of possible approaches to annual prevention of influenza,
primarily in European and North American industrialized countries, where
traditional approaches to influenza prevention remained dominant. Since 1985,
each Options conference has built on its predecessor (Options II was held in
France in 1992; Options III in Australia in 1996; and Options IV in Greece in
2000), focusing participant attention on the extent of progress in basic
virology, immunology, clinical research and public health experience, with the
intent of stimulating increased public and private sector efforts. For
Options V, the current conference, scientific guidance of the agenda has been
broadened, and new issues have been added, including ecology of influenza, and
preparing for pandemics.
For additional information about FluMist(TM) (Influenza Virus Vaccine
Live, Intranasal), please see prescribing information.
About MedImmune, Inc. and Wyeth
MedImmune, Inc. (Nasdaq: MEDI) 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 and its products,
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.
SOURCE MedImmune, Inc.; Wyeth
-0- 10/13/2003
/CONTACT: Media: Douglas Petkus of Wyeth Pharmaceuticals,
+1-484-865-5140; or Jamie Lacey of MedImmune, Inc., +1-240-632-4035; or
Investors: Will Roberts of MedImmune, Inc., +1-301-527-4358; or Justin
Victoria of Wyeth, +1-973-660-5340/
/Web site: http://www.medimmune.com/
(MEDI WYE)
CO: MedImmune, Inc.; Wyeth; Wyeth Vaccines
ST: Maryland, New Jersey, Japan
IN: HEA MTC
SU: SVY TDS CHI
MB-JA
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3037 10/13/2003 09:35 EDT http://www.prnewswire.com