The U.S. Food and Drug Administration has asked for additional information, but no additional clinical trials, as it considers approval of FluMist, an influenza vaccine delivered as a nasal spray.
FluMist was invented by Hunein "John" Maassab after more than four decades of research at the University of Michigan School of Public Health. Gaithersburg, Md.-based MedImmune has licensed the rights to FluMist from U-M, and has a marketing agreement with pharmaceutical giant Wyeth.
"I am pleased that the FDA does not believe that additional clinical trials are necessary. The efficacy of FluMist is clearly established. I expect that MedImmune will be able to respond to any FDA questions. I am happy to see this progress," Maassab said today (JULY 11). Maassab is on medical leave from U-M and is unavailable for media interviews. Rosemary Rochford, assistant professor of epidemiology, is the U-M spokesperson on FluMist.
MedImmune plans a webcast at 5:30 p.m. today (JULY 11) to discuss the FDAs response to its biologics license application for FluMist. The site is http://www.medimmune.com. A replay of the webcast will be available via MedImmunes website until midnight July 18. A MedImmune press release on the FDAs response is available at http://investor.medimmune.com/news/20020711-84556.cfm?ReleaseID=84556
Maassab finished his doctoral dissertation on influenza in 1956, inspired by his mentor, Dr. Thomas Francis Jr., who had overseen the U.S. Armys flu vaccine program during World War II. Francis was founder of U-Ms epidemiology department and a mentor to Jonas Salk; he oversaw the polio vaccine clinical trials conducted at U-M.
Maassab maintained his interest in flu, building on one finding after another before ultimately coming to the approach used in FluMist, a cold-adapted, live-attenuated, trivalent influenza virus vaccine.
Unlike traditional flu shots, which are made from killed viruses, FluMist is designed with weakened live viruses that are modified to grow in the cooler nasal passages but not in the warmer lungs, where flu develops. It helps the recipient develop immunity at the site where the flu virus typically enters the body, the nose. Trivalent means it would include three strains of the flu virus because multiple strains of influenza virus circulate in the population every year. The immune response is different to each of these strains so an effective vaccine gives protection against each.
According to the Centers for Disease Control and Prevention, millions of Americans get the flu each year. An average of about 20,000 people in the United States die from the flu annually, and 114,000 per year are admitted to the hospital because of flu. For more information: http://www.cdc.gov/ncidod/diseases/flu/fluinfo.htm
For background on Maassabs work on influenza at Michigan, including a timeline of his research and biographical information: www.sph.umich.edu/news_events/flumist/ This site also includes information on U-Ms Technology Transfer Office, past media coverage, a list of related web sites, and photos of Maassab.
In January, MedImmune acquired Aviron, which previously held the license for FluMist. For more on that merger, visit the MedImmune web site news section: investor.medimmune.com/news/20011203-66085.cfm
Editors: Rosemary Rochford, assistant professor of epidemiology, is a close friend of Maassab and runs his labs at the School of Public Health. She is available for interviews through July 12 to explain how FluMist works and to talk about Maassabs dedication to this project.
Producers: U-M has professional studios and uplink capabilities. B-roll footage of U-Ms campus and the School of Public Health are available. Visit www.sph.umich.edu/news_events/flumist/ and view a short John Maassab tribute video, which includes an interview with Rosemary Rochford.
The University of Michigan
Ann Arbor, MI 48109-1399
Colleen Newvine | EurekAlert
Hot cars can hit deadly temperatures in as little as one hour
24.05.2018 | Arizona State University
3D images of cancer cells in the body: Medical physicists from Halle present new method
16.05.2018 | Martin-Luther-Universität Halle-Wittenberg
The more electronics steer, accelerate and brake cars, the more important it is to protect them against cyber-attacks. That is why 15 partners from industry and academia will work together over the next three years on new approaches to IT security in self-driving cars. The joint project goes by the name Security For Connected, Autonomous Cars (SecForCARs) and has funding of €7.2 million from the German Federal Ministry of Education and Research. Infineon is leading the project.
Vehicles already offer diverse communication interfaces and more and more automated functions, such as distance and lane-keeping assist systems. At the same...
A research team led by physicists at the Technical University of Munich (TUM) has developed molecular nanoswitches that can be toggled between two structurally different states using an applied voltage. They can serve as the basis for a pioneering class of devices that could replace silicon-based components with organic molecules.
The development of new electronic technologies drives the incessant reduction of functional component sizes. In the context of an international collaborative...
At the LASYS 2018, from June 5th to 7th, the Laser Zentrum Hannover e.V. (LZH) will be showcasing processes for the laser material processing of tomorrow in hall 4 at stand 4E75. With blown bomb shells the LZH will present first results of a research project on civil security.
At this year's LASYS, the LZH will exhibit light-based processes such as cutting, welding, ablation and structuring as well as additive manufacturing for...
There are videos on the internet that can make one marvel at technology. For example, a smartphone is casually bent around the arm or a thin-film display is rolled in all directions and with almost every diameter. From the user's point of view, this looks fantastic. From a professional point of view, however, the question arises: Is that already possible?
At Display Week 2018, scientists from the Fraunhofer Institute for Applied Polymer Research IAP will be demonstrating today’s technological possibilities and...
So-called quantum many-body scars allow quantum systems to stay out of equilibrium much longer, explaining experiment | Study published in Nature Physics
Recently, researchers from Harvard and MIT succeeded in trapping a record 53 atoms and individually controlling their quantum state, realizing what is called a...
25.05.2018 | Event News
02.05.2018 | Event News
13.04.2018 | Event News
25.05.2018 | Event News
25.05.2018 | Machine Engineering
25.05.2018 | Life Sciences