GAITHERSBURG, Md., July 25 /PRNewswire-FirstCall/ -- MedImmune, Inc. 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.
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“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.
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CONTACT: Media: Clarencia Stephen, +1-301-398-4073, or Investors: PeteVozzo, +1-301-398-4358, both of MedImmune, Inc.
