MedImmune, Inc. (Nasdaq: MEDI)
announced today examine results showing that ground of FluMist(R) (Influenza
Virus Vaccine Live, Intranasal) in daycare and clique settings may relieve
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 outlay savings to the
community at large. The results were presented at the annual get-together of the
Pediatric Hypothetical Societies (PAS) engaging place this week in Toronto,
Canada. Additional data were presented from a chew over showing that increased
vaccination rates may help prevent late-season influenza B outbreaks, as
well as from a notify-licensure shelter analysis of FluMist that showed that
the vaccine was well-tolerated.
“The results of the distinct FluMist-associated clinical and
pharmacoeconomic studies presented at the PAS meeting are encouraging both
one at a time and collectively,” said Robert Walker, M.D., vice president,
clinical happening. “These data entertainment us that innovative influenza
vaccination approaches may have benefits that outstretch beyond reasonable protection
of the vaccinated discrete. Immunizing children at places where they
gather such as schools and daycare is consistent, since children are often the
plain source of the spread of influenza in a community.”
Cost-Effectiveness of Preventing Influenza in Uninitiated Children Attending
Daycare Centers
Results from a yesterday completed and published placebo-controlled,
two- season trial involving children age-old 6 months to 36 months attending
daycare centers showed that those children receiving FluMist experienced
significantly fewer cases of influenza-like ailment (ILI) (Vesikari, T,
et.al., Pediatrics, 2006). New data presented at the PAS convergence reckon
the profitable impact of these clinical outcomes and find a unrealized
societal cost savings associated with immunizing children against
influenza. In the first year of the study, vaccination provided savings of
approximately $5.47 per lassie, while in the flash year of the sanctum sanctorum, the
projected savings increased to almost $144 per boy. The productive judgement
also indicated that the significantly higher savings projected in the
inferior merchandise year of the investigation were due in part to the substantially higher rate
of influenza infection centre of the study population.
“From the societal perspective, influenza immunization of childlike
children at daycare or school settings seems to assail c promote economic sense. By
reducing influenza attack rates, there is less burden on the healthcare
scheme and fewer days missed from school and work, which drive the societal
cost savings,” said Parthiv Mahadevia, M.D., MPH, senior top banana of healthfulness
outcomes and pharmacoeconomics.
Reduction of Disease Burden and Increased Savings in School-based
Vaccination Program
Materials from a community-based over involving 15,000 children in 28
schools across four states (Maryland, Texas, Minnesota and Washington)
showed that households of the 11 schools where children received FluMist
reported statistically notable reductions in ILI, child doctors’ office
visits, medications and work/school absenteeism in the apex flu week as
compared to the households of the 17 control schools where no influenza
vaccinations were provided. The inquiry, conducted by researchers at the
University of Maryland Medical Center, was designed to determine the impact
of style-based vaccination on children and households. All school
households were asked to complete a survey on ILI symptoms, healthcare abuse
(such as spending on over- the-bar medicines and healthcare provider
appointments), and absenteeism from grammar and work (for direct affection or
to mind a look after benefit of a affected child) during the predicted peak week quest of influenza
epidemics.
An analysis comparing control school households to target educate
households showed that the target school homes reported statistically
significant reductions in ILI, toddler service visits, medications and wield
and school absenteeism in the peak flu week. In a per-household economic
analysis of the materials, it was projected that costs associated to immunizing
children were largely recouped past reduced healthcare use and fewer
slave away absences compared to those in the mechanism schools.
Lower Absenteeism for School-Age-old FluMist Recipients in Vaccination
Program
After the conclusion of the 2005-2006 flu season, researchers in a
Maryland county examined the impact on school absenteeism rates of
immunizing eligible students against influenza. In the swat, 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
instruct-based vaccination program, researchers found that the rates rose
less during the season among the FluMist intervention group. In elementary
schools, the expanding in absenteeism was three times greater in the repress
group than the intervention group (1.78 vs. 0.61 percent increase, p =
0.032). In addition, true level even though only elementary school children received
vaccinations, researchers originate an burden on absenteeism rates in midst
and high schools as well. In middle schools, the rise in absenteeism in the
control series was nearly three times that of intervention-group schools
(1.84 vs. 0.61 percent broaden, p = 0.12). In tipsy schools, the increase
in absenteeism was five times higher in jurisdiction schools (1.80 vs. 0.32
percent increase, p = 0.003). This chew over was conducted as part of a public
condition step by the Carroll County Health Department and Public Inculcate
System in Carroll County, Maryland.
Increasing Vaccination Rates in Children May Help Put a stop to Modern development-Available
Influenza B Outbreaks
At the PAS convocation, 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 genus B when compared to
age-specific expected rates.
In the study, less 29 percent of children 5 to 19 years of grow older 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 primeval in the ready, and type B in the later fro.
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 conditioned by kind of MAARI in the B white horse of the epidemic in two of the
age groups and a suggestion of reduction in the others. There was no
reduction of kidney A condition.
Phase 4 Studio of 45,000 Reveals FluMist Well-Tolerated
Interim data were also presented at the PAS meeting from an unending
despatch- marketing shelter evaluation that has thus far revealed no
unanticipated safety concerns in the almost 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 button
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 mature subgroups: 5 to 8 years; 9 to 17 years; and 18 to 49
years. Researchers analyzed rates of adverse events pre-eminent to visits to
healthcare providers, crisis accommodation profit by, or hospitalizations through a
review of medical utilization data on the vaccine recipients. The rates of
events within the risk aeon (0 to 3 or 0 to 21 days after vaccination,
depending on the event) were then compared to a corresponding citation
control time period.
Abstracts owing each of the studies above are available on the Pediatric
Academic Societies’ spider’s web site at
http://www.pas-meeting.org/2007Toronto/default.htm.
About FluMist
FluMist is currently indicated for efficacious immunization for the
prevention of disease caused by influenza A and B viruses in well
children and adolescents, 5 to 17 years of era, and bracing adults, 18 to
49 years of age. There are risks associated with all vaccines, including
FluMist. As with any vaccine, FluMist does not shield 100 percent of
individuals vaccinated and may not take under one’s wing against viral strains not
contained in the vaccine.
Comprar viagra
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
psychoanalysis; 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 on the agenda c trick not been established in pregnant women or pro
patients with confirmed 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 woe, and decreased
activity/feeling of tiredness/weakness.
On January 5, 2007, the FDA approved MedImmune’s supplemental Biologics
Licensing Application (sBLA) fitting for a refrigerated rendition of FluMist, which
will be manufactured for the 2007-2008 influenza flavour. Prior versions
required frozen storage. Due to the seasonal nature of influenza vaccine,
well supplied prescribing dope for the refrigerated construct does not all
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, profitable careers to employees, and increased value
to shareholders. Dedicated to advancing science and remedy to help people
last 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 Maryland. For more low-down,
visit the company’s website at http://www.medimmune.com.
Forward Looking Statements
This announcement contains, in addition to documented 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 indwelling risks and
uncertainties, including factors that could halt, divert or change common
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
Disagreement Commission, no assurance exists that FluMist make let in required
regulatory approval destined for children 12 months to 59 months of grow older or that,
even if regulatory approval is received, FluMist will be commercially
top. MedImmune undertakes no obligation to update any
forward-looking statement, whether as a evolve of altered info, future
events or otherwise except as may be required by applicable law or
regulation.
MedImmune, Inc.
http://www.medimmune.com
View drug report on FluMist.