Healthcare Industry News: influenza vaccine
News Release - May 1, 2006
MedImmune Presents New Data From Pediatric Studies With FluMist(R) At Pediatric Academic Societies Annual MeetingSAN FRANCISCO, May 1 (HSMN NewsFeed) -- 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 officer.
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 large.
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®) with Measles-Mumps-Rubella (MMR® II) and Varicella (VARIVAX®) 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 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 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.
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