GAITHERSBURG, Md., July 25 /PRNewswire-FirstCall/ -- MedImmune, Inc.
(Nasdaq: MEDI) announced today that it is now shipping FluMist (Influenza
Virus Vaccine Live, Intranasal) to customers for the 2006-2007 influenza
season. FluMist is MedImmune's live, attenuated influenza vaccine (LAIV)
approved for use in healthy individuals between 5 and 49 years of age.
Yesterday, the U.S. Food and Drug Administration (FDA) released MedImmune's
first lots of FluMist, allowing distribution to begin. MedImmune expects to
have all lots of FluMist approved and released for commercial sale by mid-
September.
(Photo: http://www.newscom.com/cgi-bin/prnh/20060725/DCTU044 )
"With FluMist doses available in time for back-to-school check-ups,
physicians can now embrace the U.S. Centers for Disease Control & Prevention's
(CDC) recent recommendations to begin immunizing against influenza as soon as
vaccine is available," said Frank J. Malinoski, M.D., Ph.D., vice president,
infectious disease, medical affairs. "Additionally, the CDC encourages
administration of LAIV throughout the season since the CDC does not limit the
timing or prioritization of administering LAIV given the vaccine's approved
use in healthy persons aged 5-49 years."
Influenza Vaccine Recommendations from CDC's Advisory Committee on
Immunization Practices (ACIP)
The CDC's ACIP recently expanded its original routine influenza
vaccination guidelines to include household contacts of high-risk individuals.
Despite this recommendation, vaccination rates of household contacts remain at
12 percent.(1) Immunizing household contacts helps stop the spread of
influenza to persons considered at high-risk of the disease and its
complications. High-risk persons include individuals under the age of five
years, over the age of 50 years, and those with chronic health issues.
School-aged children are especially important to immunize since more than 30
percent are household contacts of high-risk individuals.(2) These children
often spread influenza disease to the elderly. Further, data from a study
published in the July 2006 issue of the New England Journal of Medicine
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.(3)
The authors suggest that under-reporting/missed diagnoses of influenza may
indicate that children can become infected with influenza at much higher rates
than the previously estimated 30 percent attack rate.(4) Experts have long
suggested that vaccinating school-aged children would considerably reduce
influenza in the general population and help keep it from reaching epidemic
levels.(5) The ACIP has expanded its guidelines to annually vaccinate
children up to 5 years of age and have considered additional expansion of
influenza immunization recommendations to include all school-aged children.
FluMist is a comprehensive immunization option because the vaccine has
been shown to provide protection against drifted strains of influenza.(6)
Each year, three strains for the seasonal influenza vaccine are chosen in
advance of the influenza season. "Vaccine mismatch" occurs when the
predominant circulating strains do not match those in the vaccine.
Significant vaccine mismatch has occurred in four of the last eight influenza
seasons. Studies of FluMist have indicated that the vaccine protected against
matched and mismatched strains.
Each year in the U.S., approximately 36,000 people die from influenza.
Additionally, in the 2003-2004 influenza season, when 153 children died of
influenza-related causes, approximately 23 percent of those children were 2 to
4 years of age.
About FluMist
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
muscle aches.
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.
FluMist can be ordered by calling (877) FLU-MIST.
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" regarding the regulatory approval and release of
commercial lots of FluMist and expectations related to FluMist in the
marketplace. 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 spite
of regulatory approval, there can be no assurance that 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.
(1) Centers for Disease Control and Prevention. Interim estimates of
populations targeted for influenza vaccination from 2003 National Institutes
of Health Interview Survey Data. Available at:
http://www.cdc.gov/flu/professionals/vaccination/pdf/targetpopchart.pdf.
Accessed June 14, 2006
(2) Centers for Disease Control and Prevention. Interim estimates of
populations targeted for influenza vaccination from 2003 National Institutes
of Health Interview Survey Data. Available at:
http://www.cdc.gov/flu/professionals/vaccination/pdf/targetpopchart.pdf.
Accessed June 14, 2006
(3) 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.
(4) 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.
(5) 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.
(6) Belshe RB, Gruber WC, Mendelman PM, et al. Efficacy of vaccination
with live attenuated, cold-adapted, trivalent, intranasal influenza virus
vaccine against a variant (A/Sydney) not contained in the vaccine. J
Pediatrics. 2000b;136: 168-175.
SOURCE MedImmune, Inc.
CONTACT: Media: Clarencia Stephen, +1-301-398-4073, or Investors: Pete
Vozzo, +1-301-398-4358, both of MedImmune, Inc.