Navigation Links
MedImmune Resolves FDA Observations Regarding Manufacturing Process for FluMist(R)
Date:9/7/2007

FluMist Expected to Be Available Soon for 2007-2008 Season

GAITHERSBURG, Md., Sept. 7 /PRNewswire/ -- MedImmune announced today that it has resolved the observations made by the U.S. Food and Drug Administration (FDA) during an annual inspection of the company's influenza vaccine manufacturing facility in Speke, United Kingdom. The agency's observations led to the issuance of a Warning Letter on May 24, 2007, which has now been resolved. The UK facility is the bulk manufacturing site for FluMist(R) (Influenza Virus Vaccine Live, Intranasal). MedImmune will continue to work with the FDA on the implementation and ongoing execution of all quality and compliance commitments.

MedImmune is currently working with the FDA on the standard annual lot release process so that shipping of FluMist to customers can soon begin for the upcoming influenza season. MedImmune can now also take the necessary regulatory steps to seek the FDA's final approval of the company's supplemental biologics licensing application requesting expansion of the vaccine's indication to include children below 5 years of age.

About FluMist

FluMist is currently 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. As with any vaccine, FluMist does not protect 100 percent of individuals vaccinated and may not protect against viral strains not contained in the vaccine.

Under no circumstances should FluMist be administered as an injection (i.e. parenterally). FluMist is contraindicated in persons with hypersensitivity to any component of the vaccine, including eggs; in children and adolescents receiving aspirin therapy or aspirin-containing therapy; in individuals with a history of Guillain-Barre syndrome; and in individuals with known or suspected immune deficiency. The safety and efficacy of FluMist have not been established in pregnant women or for patients with chronic underlying medical conditions, including asthma or reactive airways disease; the vaccine should not be administered to these patients.

In randomized, placebo-controlled clinical trials of FluMist in its refrigerated and frozen formulations, the most common solicited adverse events in the indicated population (n=11,604) included runny nose/nasal congestion, sore throat, cough, irritability, headache, chills, vomiting, muscle aches, decreased appetite, abdominal pain, and decreased activity/feeling of tiredness/weakness.

On January 5, 2007, the FDA approved MedImmune's sBLA for a refrigerated version of FluMist, which is being manufactured for the 2007-2008 influenza season. Prior seasons' versions required frozen storage. Due to the seasonal nature of influenza vaccine, full prescribing information for the refrigerated version does not yet contain complete details on vaccine strains to be included for this season's vaccine. However, preliminary prescribing information can be found at http://www.fda.gov/cber/label/inflmed010507LB.pdf.

About MedImmune

MedImmune strives to provide better medicines to patients, new medical options for physicians and rewarding careers to employees. 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 approximately 3,000 employees worldwide and headquarters in Maryland, MedImmune is wholly owned by AstraZeneca plc (LSE: AZN.L, NYSE: AZN). For more information, visit MedImmune's website at http://www.medimmune.com.


'/>"/>
SOURCE MedImmune
Copyright©2007 PR Newswire.
All rights reserved

Related medicine news :

1. Kenya Resolves to Fight Tuberculosis
2. IIT Delhi Scientist Finds Climate Models Consistent With Ocean Warming Observations
3. Fresh warnings to doctors regarding abortion pill
4. Researchers Present Data Regarding The Efficiency Of Herbs
5. Will anxiety regarding fertility treatment affect the chances of conception?
6. Changing Trends Regarding Insurance Cover For Weight Reduction Surgery
7. Indian Government warns Gujarat regarding possibility of bird flu
8. Leeches Provide Clues Regarding The Prevention Of Heart Disease
9. AIDS control requires co-coordinated move regarding safe sexual practices
10. Legal Action against Authority Regarding Outbreak of Legionnaires’ Diseas
11. Mixed Opinion Regarding Common Medical And Engineering Entrance Test
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/18/2017)... ... 2017 , ... PrideStaff, a national, franchised staffing organization ... Turner Pizarro, was recently featured on Fox Business Network's Worldwide Business with kathy ... leaders from across the globe, provides viewers an opportunity to find solutions to ...
(Date:1/18/2017)... ... January 18, 2017 , ... Dr. Farhan Qureshi is an esteemed dentist who ... modern dental practice has two convenient office locations in Alexandria and Arlington, Virginia. Recently, ... for the Alexandria area. This award confirms the fact that Dr. Qureshi’s patients ...
(Date:1/18/2017)... ... January 18, 2017 , ... Rollerblade®, ... Brake Technology (ABT), an innovative braking system that allows skaters of all levels ... one of the biggest concerns of beginner and intermediate skaters – learning how ...
(Date:1/17/2017)... ... ... Anesthesia Progress – Everyone wants less pain during dental surgery, but it can ... have several general anesthesia alternatives and finding the right option can result in less ... Tokyo, Japan wanted to find out which anesthetic was the better choice in a ...
(Date:1/17/2017)... ... January 17, 2017 , ... Today, to help those who ... powerfully uplifting interview with medical expert and prolific author, Dr. Bernie Siegel. ... tough times, Dr. Bernie Siegel energizes listeners to live life with intrigue, magic ...
Breaking Medicine News(10 mins):
(Date:1/18/2017)...  Robust competition in the private marketplace is resulting in ... to a new study by the Berkeley ... to examine the share of prescription medicine spending retained ... health plans and other stakeholders in the supply chain. ... show what happens when the list price of a ...
(Date:1/17/2017)... North America Insulin Delivery Market Outlook to ... Insulin Delivery Market Outlook to 2022", provides key market ... report provides value, in millions of US dollars, volume ... - Insulin Pens, Insulin Pumps, Insulin Syringes and Traditional ... shares and distribution shares data for each of these ...
(Date:1/17/2017)... , Jan 17, 2017 Research and ... Healing Materials: 2017 - 2024" report to their offering. ... This new report ... market report that was issued in May of 2015. Self-healing is ... In our previous analysis we projected a market potential of $2.7 ...
Breaking Medicine Technology: