OT: Data Show FluMist(R) May Reduce Seasonal Influenza Burden Among Children In

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Data Show FluMist® May Reduce Seasonal Influenza Burden Among

Children In School, Daycare Settings

Main Category: Immune System / Vaccines News

Article Date: 09 May 2007 - 0:00 PDT

Article Also Appears In

Pediatrics / Children's HealthClinical Trials / Drug TrialsFlu /

Cold / SARS

MedImmune, Inc. (Nasdaq: MEDI) announced today research results

showing that use of FluMist® (Influenza Virus Vaccine Live,

Intranasal) in daycare and school settings may help reduce the burden

of seasonal influenza. Economic analyses applied to outcomes observed

in previously completed clinical studies suggest that influenza

vaccination may provide a beneficial cost savings to the community at

large. The results were presented at the annual meeting of the

Pediatric Academic Societies (PAS) taking place this week in Toronto,

Canada. Additional data were presented from a study showing that

increased vaccination rates may help prevent late-season influenza B

outbreaks, as well as from a post-licensure safety analysis of

FluMist that showed that the vaccine was well-tolerated.

" The results of the various FluMist-associated clinical and

pharmacoeconomic studies presented at the PAS meeting are encouraging

both individually and collectively, " said , M.D., vice

president, clinical development. " These data show us that innovative

influenza vaccination approaches may have benefits that extend beyond

just protection of the vaccinated individual. Immunizing children at

places where they gather such as schools and daycare is logical,

since children are often the main source of the spread of influenza

in a community. "

Cost-Effectiveness of Preventing Influenza in Young Children

Attending Daycare Centers

Results from a previously completed and published placebo-controlled,

two- season trial involving children aged 6 months to 36 months

attending daycare centers showed that those children receiving

FluMist experienced significantly fewer cases of influenza-like

illness (ILI) (Vesikari, T, et.al., Pediatrics, 2006). New data

presented at the PAS meeting estimate the economic impact of these

clinical outcomes and find a potential societal cost savings

associated with immunizing children against influenza. In the first

year of the study, vaccination provided savings of approximately

$5.47 per child, while in the second year of the study, the projected

savings increased to almost $144 per child. The economic analysis

also indicated that the significantly higher savings projected in the

second year of the study were due in part to the substantially higher

rate of influenza infection among the study population.

" From the societal perspective, influenza immunization of young

children at daycare or school settings seems to make economic sense.

By reducing influenza attack rates, there is less burden on the

healthcare system and fewer days missed from school and work, which

drive the societal cost savings, " said Parthiv Mahadevia, M.D., MPH,

senior director of health outcomes and pharmacoeconomics.

Reduction of Disease Burden and Increased Savings in School-based

Vaccination Program

Data from a community-based study involving 15,000 children in 28

schools across four states (land, Texas, Minnesota and

Washington) showed that households of the 11 schools where children

received FluMist reported statistically significant reductions in

ILI, child doctors' office visits, medications and work/school

absenteeism in the peak flu week as compared to the households of the

17 control schools where no influenza vaccinations were provided. The

study, conducted by researchers at the University of land Medical

Center, was designed to determine the impact of school-based

vaccination on children and households. All school households were

asked to complete a survey on ILI symptoms, healthcare use (such as

spending on over- the-counter medicines and healthcare provider

appointments), and absenteeism from school and work (for direct

illness or to care for a sick child) during the predicted peak week

for influenza epidemics.

An analysis comparing control school households to target school

households showed that the target school homes reported statistically

significant reductions in ILI, child office visits, medications and

work and school absenteeism in the peak flu week. In a per-household

economic analysis of the data, it was projected that costs related to

immunizing children were largely recouped through reduced healthcare

use and fewer work absences compared to those in the control schools.

Lower Absenteeism for School-Aged FluMist Recipients in Vaccination

Program

After the conclusion of the 2005-2006 flu season, researchers in a

land county examined the impact on school absenteeism rates of

immunizing eligible students against influenza. In the study, more

than 5,300 (44 percent) of the county's elementary school children at

21 public schools received FluMist. While absenteeism rates increased

during the school-based vaccination program, researchers found that

the rates rose less during the season among the FluMist intervention

group. In elementary schools, the increase in absenteeism was three

times greater in the control group than the intervention group (1.78

vs. 0.61 percent increase, p = 0.032). In addition, even though only

elementary school children received vaccinations, researchers found

an impact on absenteeism rates in middle and high schools as well. In

middle schools, the rise in absenteeism in the control group was

nearly three times that of intervention-group schools (1.84 vs. 0.61

percent increase, p = 0.12). In high schools, the increase in

absenteeism was five times higher in control schools (1.80 vs. 0.32

percent increase, p = 0.003). This study was conducted as part of a

public health initiative by the Carroll County Health Department and

Public School System in Carroll County, land.

Increasing Vaccination Rates in Children May Help Prevent Late-Season

Influenza B Outbreaks

At the PAS meeting, researchers in central Texas reported that

immunizing less than one-third of children participating in influenza

intervention programs appears to have reduced Medically Attended

Acute Respiratory Illness (MAARI) caused by influenza type B when

compared to age-specific expected rates.

In the study, nearly 29 percent of children 5 to 19 years of age were

vaccinated (73 percent with FluMist; 27 percent with the flu shot) in

the 2005-2006 season, in which influenza outbreaks occurred in two

waves, with type A predominating early in the season, and type B in

the later wave. Despite the higher pre-epidemic relative rate of

MAARI in all age groups (particularly in children 5 to 17 years of

age), there was a statistically reduced relative rate of MAARI in the

B wave of the epidemic in two of the age groups and a suggestion of

reduction in the others. There was no reduction of type A disease.

Phase 4 Study of 45,000 Reveals FluMist Well-Tolerated

Interim data were also presented at the PAS meeting from an ongoing

post- marketing safety evaluation that has thus far revealed no

unanticipated safety concerns in the approximately 45,000 FluMist

recipients assessed to date. Neither asthma/reactive airway disease

nor wheezing/shortness of breath occurred at rates that were

statistically significant in any age group in the risk period

compared to the control period. In the study, interim results were

analyzed for the 2003-2004 and 2004-2005 seasons. Analyses were

conducted for all ages combined and for three separate age subgroups:

5 to 8 years; 9 to 17 years; and 18 to 49 years. Researchers analyzed

rates of adverse events leading to visits to healthcare providers,

emergency room use, or hospitalizations through a review of medical

utilization data on the vaccine recipients. The rates of events

within the risk period (0 to 3 or 0 to 21 days after vaccination,

depending on the event) were then compared to a corresponding

reference control time period.

Abstracts for each of the studies above are available on the

Pediatric Academic Societies' web site at http://www.pas-

meeting.org/2007Toronto/default.htm.

About FluMist

FluMist is currently indicated for active immunization for the

prevention of disease caused by influenza A and B viruses in healthy

children and adolescents, 5 to 17 years of age, and healthy adults,

18 to 49 years of age. There are risks associated with all vaccines,

including FluMist. As with any vaccine, FluMist does not protect 100

percent of individuals vaccinated and may not protect against viral

strains not contained in the vaccine.

Under no circumstances should FluMist be administered as an injection

(i.e., parenterally). FluMist is contraindicated in persons with

hypersensitivity to any component of the vaccine, including eggs; in

children and adolescents receiving aspirin therapy or aspirin-

containing therapy; in individuals with a history of Guillain-Barre

syndrome; and in individuals with known or suspected immune

deficiency. The safety and efficacy of FluMist have not been

established in pregnant women or for patients with chronic underlying

medical conditions, including asthma or reactive airways disease; the

vaccine should not be administered to these patients.

In randomized, placebo-controlled clinical trials of FluMist in its

refrigerated and frozen formulations, the most common solicited

adverse events in the indicated population (n=11,604) included runny

nose/nasal congestion, sore throat, cough, irritability, headache,

chills, vomiting, muscle aches, decreased appetite, abdominal pain,

and decreased activity/feeling of tiredness/weakness.

On January 5, 2007, the FDA approved MedImmune's supplemental

Biologics Licensing Application (sBLA) for a refrigerated version of

FluMist, which will be manufactured for the 2007-2008 influenza

season. Prior versions required frozen storage. Due to the seasonal

nature of influenza vaccine, full prescribing information for the

refrigerated version does not yet contain complete details on vaccine

strains to be included for next season's vaccine.

About MedImmune, Inc.

MedImmune strives to provide better medicines to patients, new

medical options for physicians, rewarding careers to employees, and

increased value to shareholders. Dedicated to advancing science and

medicine to help people live better lives, the company is focused on

the areas of infectious diseases, cancer and inflammatory diseases.

With more than 2,500 employees worldwide, MedImmune is headquartered

in land. For more information, visit the company's website at

http://www.medimmune.com.

Forward Looking Statements

This announcement contains, in addition to historical information,

certain " forward-looking statements " regarding the potential

prospects of and the results of clinical trials for FluMist. Such

forward-looking statements are based on current expectations and

involve inherent risks and uncertainties, including factors that

could delay, divert or change current expectations and could cause

actual outcomes and results to differ materially from current

expectations. In addition to risks and uncertainties discussed in

MedImmune's filings with the U.S. Securities and Exchange Commission,

no assurance exists that FluMist will receive required regulatory

approval for children 12 months to 59 months of age or that, even if

regulatory approval is received, FluMist will be commercially

successful. MedImmune undertakes no obligation to update any forward-

looking statement, whether as a result of new information, future

events or otherwise except as may be required by applicable law or

regulation.