- Submission Marks Milestone in Company's Goal to Launch Improved Formulation
of Intranasal Influenza Vaccine with a Broader Pediatric Label in 2007 -
GAITHERSBURG, Md., July 31 /PRNewswire-FirstCall/ -- MedImmune, Inc.
(Nasdaq: MEDI) announced today it has submitted to the U.S. Food and Drug
Administration (FDA) a supplemental Biologics License Application (sBLA) for
use of CAIV-T (cold adapted influenza vaccine, trivalent) in children 12
months to 59 months of age who do not have a history of wheezing or asthma.
CAIV-T is the refrigerator-stable formulation of FluMist (Influenza Virus
Vaccine Live, Intranasal), a frozen vaccine approved in the U.S. to prevent
influenza in individuals 5 to 49 years of age.
"This is a very satisfying moment for MedImmune as it represents the
culmination of multi-year clinical, manufacturing and regulatory efforts to
improve the profile of our influenza vaccine," said Edward M. Connor, Jr.,
M.D., executive vice president and chief medical officer. "Pending FDA review
and approval, we believe that our live, attenuated influenza vaccine will be
an important new vaccine for many children currently recommended for annual
influenza vaccination by the U.S. Centers for Disease Control and Prevention's
Advisory Committee on Immunization Practices (ACIP)."
The sBLA consists of data from more than 30,000 subjects in 15 clinical
studies, including MedImmune's pivotal Phase 3 trial involving approximately
8,500 children between 6 months and 59 months of age. In this trial, efficacy
of the vaccine was established across all age groups of children.
Specifically, children vaccinated with CAIV-T had 55-percent fewer overall
confirmed cases of influenza compared to the injectable vaccine. The study
also showed that CAIV-T vaccination resulted in 89-percent fewer cases of
matched H1N1 strains and 79-percent fewer cases of circulating mismatched H3N2
strains as compared to the flu shot. MedImmune's risk-benefit analysis of age
subgroups of children within this trial indicated that CAIV-T is appropriate
for use in children older than 12 months of age who do not have a history of
wheezing or asthma.
Influenza's Impact On The Community
The case for immunizing young children against influenza is well
documented and continues to grow. During the 2003-2004 influenza season, 153
children died of influenza-related causes. Approximately 23 percent of those
children were 2 to 4 years of age and nearly 50 percent of the deaths occurred
among previously healthy children. Data from a study published in the New
England Journal of Medicine in July 2006 indicated that influenza infections
were missed in four out of five preschool-aged children who were treated for
flu symptoms at a doctor's office or emergency room and in about three-
quarters of those who were hospitalized.(1) The authors suggest that under-
reporting/missed diagnoses of influenza may indicate that children can become
infected with influenza at much higher rates than previously believed.(2)
These statistics underscore the need to immunize children below the age of 5
to help reduce the burden of influenza disease.
"It is particularly important to vaccinate young children against
influenza to help reduce hospitalizations and morbidity associated with
influenza disease," said Kathryn Edwards, M.D., professor, pediatrics and vice
chair, clinic research at Vanderbilt University Medical Center. "Recognizing
the need to help reduce the influenza disease burden in children, the ACIP
recently recommended influenza immunization for children 6 months to 59 months
Experts have also long proposed that vaccinating school-aged children
would considerably reduce influenza in the general population and help keep it
from reaching epidemic levels. According to the CDC, influenza causes seasonal
epidemics of disease resulting in approximately 36,000 deaths each year in the
FluMist Now Available for 2006-2007 Influenza Season
Last week, MedImmune announced that it was shipping commercial FluMist for
the 2006-2007 influenza season. This early shipment enables physicians to
immunize healthy individuals 5 to 49 years of age as soon as they receive
doses of the vaccine. This year physicians have the opportunity to leverage
the busy back-to-school season to accomplish immunization before influenza
season begins. This should ease the burden in physicians' offices associated
with fall and late-season immunization. The CDC's July 28 Morbidity and
Mortality Weekly Report stated: "Administration of live, attenuated influenza
vaccine is encouraged as soon as it is available and throughout the
FluMist 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 studies of people
between the ages of 5 and 49 years, runny nose was the most commonly reported
side effect. Other common side effects included various cold-like symptoms,
such as headache, cough, sore throat, tiredness/weakness, irritability, and
FluMist should not be used, under any circumstances, in anyone with an
allergy to any part of the vaccine, including eggs; in children and
adolescents receiving aspirin therapy; in people who have a history of
Guillain-Barre syndrome; and in people with known or suspected immune system
problems. Pregnant women and people with certain medical conditions, asthma,
or reactive airways disease should not get FluMist.
Please see the Prescribing Information at
http://www.flumist.com/pdf/prescribinginfo.pdf, visit http://www.flumist.com,
or call 1-877-633-4411 for additional information.
CAIV-T is an investigational intranasal, cold-adapted trivalent influenza
vaccine. It is the refrigerator-stable formulation of FluMist, which is a
frozen, live attenuated cold-adapted trivalent influenza vaccine. To date, the
safety, tolerability and efficacy of CAIV-T has been studied in both healthy
and at-risk populations between the ages of 6 weeks and 98 years.
On May 1, 2006 at the Pediatric Academic Societies' annual meeting,
MedImmune presented its pivotal Phase 3 study for CAIV-T, entitled,
"Comparison of the Efficacy and Safety of Cold-Adapted Influenza Vaccine,
Trivalent With Trivalent Inactivated Influenza Vaccine in Young Children 6 to
59 Months of Age." The study included 8,475 children at 249 sites in 16
countries in North America, Europe, the Middle East and Asia. Study
participants were randomized one-to-one to receive either CAIV-T or the flu
shot during the 2004-2005 influenza season. Each participant also received a
placebo nasal spray or placebo injection to preserve the double-blind design
of the study. Participants were followed through the influenza season and
evaluated to identify illnesses caused by influenza virus. The trial included
more than 6,300 previously unvaccinated children and nearly 50 percent of the
children enrolled were less than 2 years of age.
The results of this trial showed that CAIV-T was 55 percent more effective
than the trivalent injectable inactivated influenza vaccine (TIV) in reducing
influenza illness caused by any influenza strain in children 6 months to 59
months of age, including both matched and mismatched strains. The influenza
attack rate was 8.6 percent for study participants receiving the flu shot
compared to 3.9 percent for those who received CAIV-T (P <0.001). Against
matched strains alone, CAIV-T was 45 percent more effective than the flu shot
(attack rates: TIV = 2.4 percent, CAIV-T = 1.4 percent; P<0.001). In this
study, CAIV-T also appeared to be 89 percent more effective than the flu shot
in reducing influenza illness caused by the matched H1N1 A strain (attack
rates: TIV = 0.7 percent, CAIV-T = 0.1 percent; P<0.001) and 79 percent more
effective than the flu shot against the circulating mismatched H3N2 A strain
(attack rates: TIV = 4.5 percent, CAIV-T = 0.9 percent; P<0.001). There were
no cultures of mismatched H1N1 strains or matched H3N2 strains detected in the
trial. While there were 16-percent fewer children with illnesses associated
with B strains in the CAIV-T group compared to TIV (attack rates: TIV= 3.5
percent, CAIV-T = 2.9 percent), this difference was not statistically
In the study, the overall incidence of adverse events and serious adverse
events was similar in both groups except for a higher incidence of runny nose
and nasal congestion in CAIV-T recipients (4.4 ~ 11.1 percent increase) and a
higher incidence of injection site reactions in those receiving the flu shot
(3.6 ~ 7.6 percent increase). A statistically significant increase in the
incidence of medically significant wheezing was seen in CAIV-T recipients 6
months to 23 months of age within 42 days following vaccination. Post-hoc
analyses showed higher all-cause hospitalizations occurring through 180 days
after vaccination in CAIV-T recipients 6 months to 11 months of age. Risk-
benefit analyses showed a favorable profile for CAIV-T as compared to TIV in
children 12 months to 59 months of age without a prior history of wheezing or
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 2,300 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" relating to 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.
(1) Poehling KA, et al. (for the CDC's "New Vaccine Surveillance
Network"): The underrecognized burden of influenza in young children.
New England Journal of Medicine. 2006/July 6; 355:37-40.
(2) Poehling KA, et al. (for the CDC's "New Vaccine Surveillance
Network"): The underrecognized burden of influenza in young children.
New England Journal of Medicine. 2006/July 6; 355:38-40.
(3) Smith, NM. Prevention and Control of Influenza: Recommendations of the
Advisory Committee on Immunization Practices (ACIP). Morbidity and
Mortality Weekly Report. 2006/July 28; 55: RR-10.
SOURCE MedImmune, Inc.
CONTACT: Media: Clarencia Stephen, +1-301-398-4073, or Jamie Lacey,
+1-301-398-4035, Investors: Pete Vozzo, +1-301-398-4358, all of MedImmune,