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MedImmune Prepared To Support Implementation Of Expanded ACIP Recommendations For Influenza Vaccinations
MedImmune, the manufacturer
of FluMist(R) (Influenza Virus Vaccine Live, Intranasal), 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," added Malinoski.
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 people.
"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.
About FluMist
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.
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.
About MedImmune
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 http://www.medimmune.com.
References
(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.
MedImmune
http://www.medimmune.com
View drug information on FluMist.
MedImmune pregãtit pentru a sprijini punerea în aplicare a extins ACIP recomandãri pentru virusul gripal de vaccinari - MedImmune Prepared To Support Implementation Of Expanded ACIP Recommendations For Influenza Vaccinations - articole medicale engleza - startsanatate