SAN FRANCISCO, May 1, 2006 /PRNewswire via COMTEX News Network/ -- MedImmune, Inc. (Nasdaq: MEDI)
announced today new data from studies involving FluMist (Influenza Virus
Vaccine Live, Intranasal), the company's currently marketed live, attenuated,
needle-free influenza vaccine. These studies provide additional data regarding
the direct and indirect effects of administering FluMist in the school
setting, as well as the safety and immunogenicity of concurrent administration
of FluMist with measles-mumps-rubella and varicella vaccines. The data are
being presented at the annual meeting of the Pediatric Academic Societies
(PAS) in San Francisco, April 29 - May 2, 2006.
"As the first innovation in influenza vaccine technology in more than 50
years, FluMist has been shown to be a well-tolerated and effective needle-free
option for immunizing healthy children and adults aged 5 to 49 years," said
Edward M. Connor, Jr., M.D., executive vice president and chief medical
Influenza disease is the leading cause of vaccine-preventable death
throughout the U.S. population. Increasing influenza vaccination rates,
particularly among children, can help reduce the incidence of disease in
vaccinated individuals and may have indirect effects in the community at
Results from a study titled "Impact of School-Based Influenza Vaccination
Intervention on Influenza-Related Outcomes Within Households," suggest that
vaccinating school-aged children with FluMist resulted in fewer doctor or
clinic visits for influenza-like illnesses, less prescription and non-
prescription drug use, lower school absentee rates and fewer missed work days
for adults in the household. This study included 28 schools that were divided
into 11 clusters, each with one target school and one-to-two control schools.
A total of 2,717 target school students received FluMist during the study.
Data on influenza-like illness were collected from questionnaires completed by
parents for both target and control schools.
In the study entitled "Safety and Immunogenicity of Concurrent LAIV
(FluMist(R)) with Measles-Mumps-Rubella (MMR(R) II) and Varicella (VARIVAX(R))
Vaccines in Infants 12 to 15 Months of Age," the safety and immunogenicity of
concurrently administering FluMist with the measles-mumps-rubella (MMR) and
varicella vaccines was evaluated. The results suggest that concurrent
administration of the vaccines was well tolerated in infants 12 to 15 months
of age. Immune responses to the antigens in each vaccine were similar when the
vaccines were administered concurrently or separately. The study randomized
1,245 children (1:1:1) to receive: the MMR and varicella vaccines with
placebo, MMR and varicella with FluMist, or FluMist alone. No clinically
important differences in adverse events were observed between groups.
In addition to the studies listed above, a post-marketing medical review
entitled "Post Marketing Evaluation of Safety of Live Attenuated Influenza
Vaccine FluMist," was presented at the PAS meeting. Medical data for
approximately 17,000 FluMist recipients were reviewed as part of a post-
marketing evaluation to assess the long-term safety of FluMist in healthy
people 5 to 49 years of age. Safety data from this post-marketing experience
were consistent with what was seen in pre-licensure clinical trials of
FluMist. No new safety issues were identified.
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 www.flumist.com, or call
1-877-633-4411 for additional information.
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 2,200 employees worldwide,
MedImmune is headquartered in Maryland. For more information, visit the
company's website at 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, Investors: Pete Vozzo, +1-301-398-4358