New Data Show 98 Percent Protection Against Flu-Related Otitis Media (Ear
Infections)
MOUNTAIN VIEW, Calif., May 13 /PRNewswire/ -- A study published in the
May 14 issue of the "New England Journal of Medicine" (NEJM), and announced by
the National Institute of Allergy and Infectious Diseases (NIAID) of the
National Institutes of Health (NIH), found Aviron's (pronounced AV-uh-ron)
(Nasdaq: AVIR) FluMist(TM), intranasal influenza virus vaccine, provided
93 percent protection against culture-confirmed influenza and also provided
98 percent protection against influenza-associated otitis media (ear
infections). Throughout the entire cough, cold and flu season, children
vaccinated with FluMist(TM) experienced 30 percent fewer ear infections with
fever and a 35 percent reduction in related antibiotic use for ear infections
with fever compared to the placebo group.
In the randomized, placebo-controlled study, a team of Aviron- and
NIAID-supported researchers reported that only 1 percent of vaccinated
children experienced culture-confirmed influenza compared to 18 percent of
those receiving the placebo. Of the 1,070 children who received FluMist(TM),
only one child developed influenza-associated ear infection, versus 20 of the
532 placebo recipients. The study team was led by Robert Belshe, M.D.,
Professor of Internal Medicine, Director of the Division of Infectious
Diseases and Immunology, and Director of the Center for Vaccine Development at
Saint Louis University.
This trial was conducted under a Collaborative Research and Development
Agreement (CRADA) between Aviron and NIAID. It involved ten sites nationwide,
including six Vaccine and Treatment Evaluation Units (VTEUs) supported by
NIAID and four sites supported by Aviron.(1)
"This novel product is the result of a successful partnership between the
government and private industry," said J. Leighton Read, M.D., Chairman and
CEO of Aviron.
"To supplement this efficacy data from children and the data we have
already collected in adults, Aviron has a large study underway to evaluate the
benefits of FluMist(TM) on reducing work loss and health care utilization in
healthy working adults, and is planning a study of the value of
co-administration of FluMist(TM) with the flu shot in a high-risk elderly
population," said Read.
"FluMist(TM) has been tested in over 5,500 individuals in Aviron -- and
NIAID -- supported trials and it has been well tolerated. The most common
complaint was a runny nose, typically lasting for one day," said C. Jo White,
M.D., Senior Vice President of Medical Affairs at Aviron.
The data published today will be part of a Product License Application
(PLA) Aviron plans to file with the U.S. Food and Drug Administration (FDA)
this summer. Subject to licensure by the FDA, FluMist(TM) could be available
for influenza vaccination campaigns beginning in 1999.
The Cost of Otitis Media
Acute otitis media -- an infection of the middle ear and a common cause of
earache -- is the most common bacterial infection in young children. Each
year, this condition is responsible for more than 31 million visits to doctors
(approximately one-third of all pediatric office visits) and $3-$4 billion in
treatment costs. Overuse of antibiotics to treat the condition can lead to
the development of more dangerous drug-resistant bacteria. In addition to
medical costs, work hours lost by parents contribute to the high cost of
otitis media and make treating the illness expensive.
Additional Safety Data in High Risk Elderly, Children with Asthma and
Healthy Adults
Today, Aviron also announced safety data from three Aviron-sponsored
Phase 3 trials which show FluMist(TM) was found to be generally safe and
well-tolerated in children with moderate to severe asthma, high-risk elderly,
and healthy working adults.
The safety trial in children with asthma was a randomized, double-blind,
placebo-controlled trial in 48 children from 9-17 years of age who had
moderate to severe asthma, as defined by the 1997 criteria of the National
Heart, Blood and Lung Institute.
The study, conducted by Garrison H. Ayars, M.D., Allergy and Asthma
Associates, Kirkland, WA, George Wm. Bensch, M.D., George Bensch, Inc.,
Stockton, CA and Frank S. Virant, M.D., Northwest Allergy and Asthma Center,
Seattle, WA, showed no significant decrease in a lung function test called
Forced Expiratory Volume. There were no significant differences between
vaccine and placebo recipients in the occurrence of upper respiratory symptoms
during the ten days following vaccination, nor in the occurrence of other
asthma stability measures.
The trial in high-risk elderly was a randomized, double-blind,
placebo-controlled trial in 200 participants who were at least 65 years of age
and had at least one additional health factor which put them at high risk for
complications of influenza. All participants received a commercially
available flu shot plus FluMist(TM) or placebo. There were no significant
differences between vaccine and placebo recipients in the occurrence of fever,
cough, runny nose, headache, chills, muscle aches, or tiredness. Sore throat
was reported by 15 percent of participants who received FluMist(TM), compared
to 2 percent of participants who received placebo. In most cases, the
duration of sore throat was only one or two days. This study was performed by
Lisa Jackson, M.D., Center for Health Studies, Group Health Cooperative,
Seattle, WA.
The randomized, double-blind, placebo-controlled study of 4,561 healthy
working adults showed no serious adverse events associated with vaccine.
FluMist(TM) (or placebo) was self-administered by 71 percent of study
participants under the supervision of study personnel at their work site or
nearby clinics. The rate of transient upper respiratory symptoms above
placebo was consistent with previous large-scale studies of the intranasal
influenza virus vaccine sponsored by NIH. Runny nose was reported by
44 percent of vaccine recipients compared with 27 percent of placebo
recipients. Sore throat was reported by 27 percent of vaccine recipients
compared with 16 percent of placebo recipients. Vaccine recipients reported
slightly higher (2-4 percent) rates of cough, chills, and tiredness than
placebo recipients. The most common duration of such symptoms was one day or
less. The clinical investigators who participated in the healthy adult study
were: Jeffrey Adelglass, M.D., Research Across America, Dallas, TX; Stan
Block, M.D., Kentucky Pediatric/Adult Research, Bardstown, KY; Geoffrey Gorse,
M.D., Saint Louis University Health Sciences Center, St. Louis, MO; Lisa
Jackson, M.D., Center for Health Studies, Group Heath Cooperative, Seattle,
WA; Harry Keyserling, M.D., Emory University School of Medicine, Atlanta, GA;
William Lang, M.D., ViRx, Inc., San Francisco, CA; James McCarty, M.D., Hill
Top Research, Inc., Fresno, CA; Kristin Nichol, M.D., VA Medical Center,
Minneapolis, MN; Keith S. Reisinger, M.D., Primary Physician's
Research/Pittsburgh Pediatric Research, Pittsburgh, PA; Gilbert M. Schiff,
M.D., Children's Hospital Medical Center, Cincinnati, OH; Innovative Medical
Research, Baltimore, MD; Karl V. Sitz, M.D., University of Arkansas for
Medical Sciences, Little Rock, AK; and Mark Snell, M.D. Golden Valley Memorial
Hospital, Clinton, MO.
FluMist(TM) is based on master seed strains for a cold-adapted influenza
vaccine first developed by Dr. H.F. Maassab at the University of Michigan in
1967. Early preclinical and clinical research on cold-adapted influenza
vaccines made from these strains was conducted by NIAID scientists and outside
collaborators. Prior to 1995, when Aviron entered into a license agreement
with the University of Michigan and NIH, components of the vaccine had been
tested in more than 9,000 individuals aged two months to 103 years.
The National Institute of Allergy and Infectious Disease (NIAID), a
division of the National Institutes of Health (NIH), conducts and supports
research to prevent, diagnose, and treat infectious and immunologic diseases.
NIAID has a major responsibility within the federal government for developing
vaccines to control and prevent infectious and immunologic diseases. NIH is
an agency of the U.S. Department of Health and Human Services.
Aviron has a commercial supply agreement with its contract manufacturer,
Evans Medical Ltd., a subsidiary of Medeva PLC in the UK, who manufactured the
vaccine used in this trial.
Aviron is an emerging biopharmaceutical company based in Mountain View,
California whose strategy is to focus on the prevention of disease. The
Company's goal is to develop vaccines to prevent a wide range of viral
infections that affect the general population, providing a cost-effective
means of addressing a number of major diseases.
The majority of the Company's products under development are live vaccines
against viral infections, including influenza, parainfluenza (PIV-3),
cytomegalovirus (CMV), genital herpes (HSV-2) and respiratory syncytial virus
(RSV). Aviron is also developing -- in collaboration with SmithKline Beecham
Biologicals -- a subunit vaccine against Epstein-Barr Virus (EBV) infection, a
major cause of infectious mononucleosis.
This press release contains forward-looking statements. Actual results
may differ materially from those suggested here. Additional information
concerning factors that could cause such a difference is contained in Aviron's
Annual Report on Form 10-K for the year ended December 31, 1997.
(1) For a complete list of investigators, refer to Belshe, Robert B. MD,
et al. "Efficacy of Trivalent Live Attenuated Intranasal Influenza Vaccine in
Children." New England Journal of Medicine. 1998; 338, 20.
SOURCE Aviron
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CONTACT:
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