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Additional Studies Report on FluMist Efficacy in Children; Indicate How Pediatricians Might Increase Influenza Vaccination Rates

GAITHERSBURG, MD, May 5, 2009 — Data presented suggest that FluMist® (Influenza Vaccine Live, Intranasal) has an acceptable safety profile among mild to moderately immunocompromised children with cancer.   The immune systems of children with cancer can be weakened due to cancer treatments, making them vulnerable to influenza or other infections.   The small multi-center, randomized, double-blind pilot study compared FluMist to placebo in 20 children, five to 17 years of age.   The results, along with data from 10 other MedImmune-sponsored, influenza-related studies, were presented at the 2009 Pediatric Academic Societies (PAS) annual meeting in Baltimore, MD.

In our pilot study, immunocompromised children with cancer who received FluMist had no related serious adverse events, explained Pat Flynn M.D., director, clinical research, infectious diseases, St. Jude Children’s Research Hospital. We believe these data are promising and add to the extensive body of evidence supporting the overall safety of FluMist in the population for whom it is approved.   A larger study will help us confirm the safe use of FluMist in immunocomprised patients.     The value of this type of research is even more apparent today as we all consider how best to protect all of our patients against the threat of emerging, new influenza viruses.

FluMist, a live attenuated influenza vaccine (LAIV), is the only nasal spray influenza vaccine approved in the United States to help prevent influenza in eligible individuals ages two to 49 years of age.   (Please see About FluMist for important safety and eligibility information later in this release).

Additional studies presented at PAS explored various aspects of FluMist, including its efficacy as a function of age from six months to 17 years of age*, results with only a single dose in previously unvaccinated children, and data regarding influenza-related ear infections.   Research also evaluated the effect of FluMist against opposite-lineage influenza B strains.  Other research focused on influenza vaccination practices of U.S. pediatricians during the 2007 — 2009 flu seasons and the impact of respiratory illness in children on parent work absenteeism and productivity.  

In a time when influenza prevention is receiving so much attention, MedImmune is pleased to share a number of new studies and analyses with the medical community as we work together to help protect our children and families from influenza, said Chris Ambrose, M.D., senior director, medical affairs, MedImmune.

Brief summaries of the ten (10) MedImmune-sponsored abstracts presented at PAS are provided below.

LAIV Use in Children

• In an abstract that reviewed data from multiple randomized, controlled studies among children six months to 17 years of age, LAIV efficacy against culture-confirmed influenza did not vary with age.   Compared to placebo, LAIV had high efficacy and this efficacy did not vary among children 15 to 84 months of age.     LAIV had higher efficacy in children six months to 17 years of age compared to the traditional injectable vaccine.* (Belshe R, #5529.501)    
• In an analysis of three randomized, double-blind studies, a single dose of LAIV in previously unvaccinated children two to six years of age provided significant protection against culture-confirmed influenza compared to placebo.   These findings are significant because most children who are recommended to receive two doses of influenza vaccine only receive one dose. The efficacy of one LAIV dose was approximately 90 percent of the efficacy of two doses.   Efficacy after revaccination in year two with a single dose was comparable whether the child received one or two doses in the previous year.   (Block, #5529.505)
• Across eight randomized, controlled studies, LAIV reduced influenza-associated acute otitis media (AOM) — commonly referred to as an ear infection — caused by influenza strains matched to the vaccine by 73 percent to 98 percent.   These data suggest that FluMist has the potential to reduce the burden of AOM in young children with influenza.   (Block S, #5529.504)
• An analysis of LAIV efficacy against opposite-lineage influenza B strains, against which efficacy of all influenza vaccines has been believed to be low or zero, was conducted with data from six randomized, double-blind studies.   In young children, LAIV may provide some efficacy against opposite-lineage influenza B strains, but this efficacy is lower than efficacy against influenza B strains of the same lineage as the vaccine.     Based on these findings, study authors suggest that quadrivalent vaccines containing influenza B strains of both lineages should be considered.   (Belshe R, #4357.473)
• In an analysis of a previously conducted study that compared LAIV and injectable influenza vaccine in children six to 59 months of age* and found 51 percent  fewer cases of influenza illness among LAIV recipients compared to injectable vaccine recipients, the amount of viral RNA recovered from subjects with breakthrough influenza illness was analyzed.   No statistically significant differences were seen, and analysis of infectious virus by cell culture will gather additional data.(Belshe R, 5529.502)

      *LAIV is not approved for use in children under two years of age.  

Influenza Vaccination Practices of U.S. Pediatricians

• Four additional MedImmune-sponsored studies evaluated influenza vaccination practices among U.S. pediatricians, based on a prospective, observational study of pediatric offices during the 2007-2009 flu seasons.   The principal conclusions of the studies included the following:
• Pediatric influenza vaccination rates in pediatric offices may have increased in 2008-09 compared to the previous year, and LAIV represented approximately one-third of the vaccinations given to children two to 18 years of age during the 2008-2009 season (Bhatt P, #5529.499)
• Pediatricians may be able to vaccinate more children by offering flu vaccine to their patients before October and after December (Bhatt P, #5529.500)
• Pediatricians are supportive of vaccinating parents in their offices (Toback S, # 5529.498)
• Generally, pediatric offices have little influenza vaccine left-over at the end of the influenza season (Block S, #5529.503)

Increased Employee Absenteeism Seen Among Adults from Homes Where Kids Had Influenza-like-Illness

• A final MedImmune-sponsored study presented at PAS prospectively followed 2,298 households during the 2007-2008 influenza season. (Rousculp M, #3866.255)  
• The research found that employed adults had increased work absenteeism in homes where children had influenza-like illnesses, as well as other acute respiratory illnesses.
• The study’s authors conclude that employers should evaluate opportunities to reduce influenza-like illnesses and other acute respiratory illnesses in both the employee and employee’s children in order to maximize employee productivity.

About FluMist

FluMist® (Influenza Virus Vaccine Live, Intranasal) is a 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/prescribing-information.aspx for additional information.

About MedImmune

MedImmune, the worldwide biologics business for AstraZeneca PLC (LSE: AZN.L, NYSE: AZN), has approximately 3,100 employees worldwide and is headquartered in Gaithersburg, Maryland. With an advancing pipeline of promising candidates, we aim to be the next revolutionary force in biotechnology by delivering life-changing products, industry-leading performance, and a tireless commitment to improving patient health. For more information, visit MedImmune’s website at www.medimmune.com.