- School-Based Vaccination Programs Using FluMist(R) May Serve as Model to
Help Vaccinate Large Numbers of Eligible Children -
GAITHERSBURG, MD, February 27, 2008 -- MedImmune, the manufacturer of
FluMist(R) (Influenza Virus Vaccine Live, Intranasal), today lauded the U.S.
Centers for Disease Control and Prevention's (CDC) Advisory Committee on
Immunization Practices (ACIP) for its unanimous vote to expand recommendations
for routine seasonal influenza vaccination to include all school-age children
up to the age of 18 years as soon as feasible but no later than the 2009-2010
influenza season. To support this move by the ACIP, MedImmune is preparing to
manufacture a record number of FluMist doses -- about 12 million -- for the
upcoming flu season, with the intention of continuing to substantially
increase production in subsequent seasons.
"MedImmune applauds the ACIP for expanding its recommendations and stands
ready to support this move by nearly tripling its production of FluMist doses
for the 2008-2009 flu season," said Frank J. Malinoski, M.D., Ph.D., senior
vice president of medical and scientific affairs.
"We also believe that positive experiences using FluMist in school-based
programs point to the importance -- and opportunity -- of using non-
traditional venues, in addition to traditional venues, to help achieve the
goal of vaccinating a larger number of school-age children against the flu,"
Research has shown statistically significant reductions in influenza like
illness (ILI), child doctors' office visits, medication use and work/school
absenteeism among households whose children attended schools/daycares with
influenza vaccination programs, compared to those whose children attended
schools/daycares without these programs(1)(2).
Since introduction of the nasal spray vaccine to the U.S. market in 2003,
FluMist has been increasingly utilized in schools, public health centers, and
other community-based programs to efficiently vaccinate a large number of
"Our experience has been that children are generally quite accepting of a
vaccine that does not involve a needle," Malinoski said. "Additionally,
parents and health care providers may appreciate that FluMist works
differently than the flu shot in that it uses live, attenuated -- or weakened
-- vaccine viruses within the vaccine to help stimulate an immune response
that closely resembles the body's natural protective response to an influenza
infection. This may also explain why we have observed some protection against
mismatched strains in past seasons."
While past clinical trial results are not indicative of future results, in
multiple studies across several seasons FluMist demonstrated that it could
help offer protection against mismatched influenza A strains(3).
-- In a two-year, multicenter, randomized, double-blind placebo-controlled
trial (conducted between 1996-1998) in children 24 months-71 months of
age, FluMist provided comparable protection in a year with matched
strains (95 percent protection -- year two) and a year with mismatched
strains (87 percent protection -- year two). The mismatched strain
that circulated during the studied season was A/Sydney (H3N2).
-- In a head-to-head study conducted during the 2004-2005 influenza season
that included over 4,000 children between two and five years of age,
when looking specifically at strains that were mismatched, there were
54.2 percent fewer cases of flu in children who received FluMist versus
those that received the flu shot (Attack rate 3.2 percent vs 7.1
percent, respectively). The mismatched strains that circulated during
the studied season were A/California-like (H3N2), B/Florida and
B/Victoria lineage strains.
MedImmune strongly supports the CDC's efforts to encourage vaccination
against influenza throughout the season even if there is evidence that some
circulating strains are not well-matched to the vaccine. According to the
CDC, an influenza vaccination can provide enough protection to help prevent or
lessen illness severity and help prevent flu-related complications.
FluMist is a live attenuated influenza virus vaccine indicated for active
immunization of individuals two to 49 years of age against influenza disease
caused by influenza virus subtypes A and type B contained in the vaccine.
FluMist is contraindicated in individuals with history of hypersensitivity
to eggs, egg proteins, gentamicin, gelatin or arginine or with life-
threatening reactions to previous influenza vaccinations, and in children and
adolescents receiving concomitant aspirin or aspirin-containing therapy.
Do not administer FluMist to children less than two years of age due to an
increased risk of hospitalization and wheezing that was observed in clinical
trials. FluMist should not be administered to any individual with asthma and
to children less than five years of age with recurrent wheezing unless the
potential benefit outweighs the potential risk. Do not administer FluMist to
individuals with severe asthma or active wheezing.
If Guillain-Barre syndrome has occurred with prior influenza vaccination
or if an individual is immunocompromised, the decision to give FluMist should
be based on careful consideration of the potential benefits and risks.
FluMist should not be administered to individuals with underlying medical
conditions predisposing them to wild-type influenza infection complications
unless the potential benefit outweighs the potential risk. FluMist should be
given to a pregnant woman only if clearly needed.
Most common adverse reactions (occurring in 10 percent or more of
individuals receiving FluMist and at a rate at least five percent higher than
in those receiving placebo) are runny nose or nasal congestion in recipients
of all ages, fever more than 100 degrees F in children two to six years of
age, and sore throat in adults.
FluMist may not protect all individuals receiving the vaccine. FluMist is
for intranasal administration only.
Please see complete Prescribing Information for FluMist, call 1-877-
FLUMIST (1-877-358-6478) or visit http://www.flumist.com for additional
Pricing and Insurance Coverage
FluMist is priced per-dose to be competitive with the flu shot. In
addition, 94 percent of health insurance plans with immunization benefits
provide coverage for FluMist, which is also available to eligible children at
no cost through the federal Vaccines for Children (VFC) program.
MedImmune strives to provide better medicines to patients, new medical
options for physicians and rewarding careers to employees. Dedicated to
advancing science and medicine to help people live better lives, the company
is focused on cardiovascular/gastrointestinal disease, neuroscience, oncology,
infection, respiratory disease and inflammation. With approximately 3,000
employees worldwide and headquarters in Maryland, MedImmune is wholly owned by
AstraZeneca plc (LSE: AZN.L, NYSE: AZN). For more information, visit
MedImmune's website at www.medimmune.com.
(1) King JC, et al. N Engl J Med. 2006;355:2523-2532.
(2) Hurwitz ES, et al. JAMA. 2000;284:1677-1682.
(3) In past studies, FluMist has not provided protection against
different-lineage, mismatched B strains.
Note to Editors: When reporting on the CDC advisory committee's
recommendation today, please recognize that the term "flu shot" is not the
most accurate way to report or describe influenza vaccine options. Please
consider the more accurate term "flu vaccine" to cover both FDA-approved
vaccination options available to people ages 2-49; the nasal spray live
attenuated vaccine and the traditional flu shot. This is particularly
important today given the CDC's focus on influenza vaccination of children.
Please communicate this new information to copy and headline editors.
Media: Karen Lancaster, 301-398-5864
Investors: Peter Vozzo, 301-398-4358
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/PRNewswire - Feb. 27/
/Web site: http://www.medimmune.com
CO: MedImmune; U.S. Centers for Disease Control and Prevention; CDC; ACIP
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2420 02/27/2008 12:34 EST http://www.prnewswire.com