- School-Based Vaccination Programs Using FluMist(R) May Serve as Model to
Help Vaccinate Large Numbers of Eligible Children -
GAITHERSBURG, Md, Feb. 27 /PRNewswire/ -- 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," 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.
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 information.
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 http://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.
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