- Results Presented at Pediatric Academic Societies Annual Meeting -
WASHINGTON, May 14, 2005 /PRNewswire-FirstCall via COMTEX/ -- MedImmune, Inc.
(Nasdaq: MEDI) announced today data from several studies that provide evidence
that its live, attenuated intranasal influenza vaccines may provide broad
protection against influenza. Results from clinical trials of the currently
marketed FluMist(R) (Influenza Vaccine Live, Intranasal) and the
investigational, next-generation refrigerator stable CAIV-T (cold adapted
influenza vaccine, trivalent) are being presented at the annual meeting of the
Pediatric Academic Societies (PAS) in Washington, DC, beginning on May 14,
"These presentations add to the growing body of data regarding the
potential advantages of live, attenuated intranasal influenza vaccine
technology," said Francois Lebel, M.D., vice president, medical affairs. "The
studies support previous clinical observations that this vaccine technology
appears to provide benefit during years in which the circulating strains of
influenza were mismatched to the influenza vaccines administered in the
Each year, strains for the annual influenza vaccines are chosen in advance
of the flu season. In some seasons, the predominantly circulating strains do
not match those within the vaccines. When this "vaccine mismatch" occurs, it
is more difficult for influenza vaccines to provide comprehensive protection.
Significant vaccine mismatch has occurred in four of the last eight influenza
seasons, including both the 2003-2004 and 2004-2005 seasons. Data from three
studies and a retrospective review support the conclusion that FluMist helps
provide protection in both matched and mismatched influenza seasons.
- "Live Attenuated Influenza Vaccine (LAIV) Administration in
Schoolchildren Coincident With the 2003-2004 Outbreak Provided Herd
Immunity Against a Drifted Influenza Variant A/Fujian/411/2002 (H3N2)."
Results from this herd immunity study indicated that immunizing school-
aged children helped protect both the children and the extended
community from influenza during a mismatched season.
- "Protection of Live Attenuated Intranasal Influenza Vaccine-Trivalent
(FluMist(R)) Against Pneumonia and Influenza (P-I) in School-Aged
Children in the 2003-2004 Influenza Type A (H3N2) Outbreak." Data from
this pilot, National Institutes of Health-sponsored, community-based
intervention trial suggest that FluMist may be efficacious when
administered during an influenza outbreak when the predominant
circulating strains were mismatched to the vaccine.
- "Cross-Protection Against Antigenic Variants by Live-Attenuated
Influenza Vaccine in Children." This is a retrospective review of
mismatch efficacy of live attenuated intranasal vaccine in children 6
months to 18 years of age from 1996 to 2002. Efficacy against the
mismatched strain A/H3N2 was 86 percent to 89 percent, and efficacy
against the mismatched type B strains was 50 percent to 66 percent.
- "A Pilot Study of the Effectiveness of a School-Based Influenza
Vaccination Program Using the Nasally Administered Vaccine FluMist." In
this pilot intervention study, children who were immunized with FluMist
in their schools experienced a reduction in medical visits and missed
school days in the mismatched 2003-2004 influenza season. Overall
school absenteeism was not statistically different among the
intervention and control schools.
Two Phase 3 placebo-controlled studies presented at the PAS meeting
provide evidence for the safety and efficacy of CAIV-T in young children,
- "Efficacy of a Cold-Adapted, Live Attenuated, Influenza Vaccine in
Children Aged 6 to <36 Months Attending Day Care Centers in Europe and
Israel Against Culture-Confirmed Influenza"
- "Efficacy and Safety of a Live Attenuated, Trivalent Influenza Vaccine
(CAIV-T) in Children Living in South East Asia Against Community
Acquired Culture-Confirmed Influenza"
These studies add to the body of data presented at last year's PAS annual
meeting, which included two international Phase 3 studies in children with a
history of respiratory illness. Results from the studies presented in 2004
demonstrated a 35 percent to 53 percent relative decrease in influenza with
CAIV-T as compared to the traditional injectable vaccine.
FluMist was approved by the FDA in June 2003. It is the first live,
attenuated influenza vaccine in the U.S. that is 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. Like any vaccine, FluMist does not protect 100 percent of
individuals vaccinated. In placebo-controlled clinical trials, the most
common solicited adverse events in the indicated population of 2,762 included
runny nose/nasal congestion, headache, cough, sore throat, tiredness/weakness,
irritability, decreased activity and muscle aches. For full prescribing
information for FluMist, see the company's website at
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 approximately 2,000 employees
worldwide, MedImmune is headquartered in Maryland. For more information, visit
the company's website at http://www.medimmune.com.
This announcement contains, in addition to historical information, certain
"forward-looking statements" regarding the results of clinical trials for
FluMist and CAIV-T. 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 development
efforts for CAIV-T will succeed, that CAIV-T will receive required regulatory
approval or that, even if regulatory approval is received, CAIV-T 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.
SOURCE MedImmune, Inc.
Clarencia Stephen, +1-301-398-4073
John Filler, +1-301-398-4086
all of MedImmune, Inc.