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
Satellites, airport visibility readings shed light on troops' exposure to air pollution
09.12.2016 | Veterans Affairs Research Communications
Oxygen can wake up dormant bacteria for antibiotic attacks
08.12.2016 | Penn State
Physicists of the University of Würzburg have made an astonishing discovery in a specific type of topological insulators. The effect is due to the structure of the materials used. The researchers have now published their work in the journal Science.
Topological insulators are currently the hot topic in physics according to the newspaper Neue Zürcher Zeitung. Only a few weeks ago, their importance was...
In recent years, lasers with ultrashort pulses (USP) down to the femtosecond range have become established on an industrial scale. They could advance some applications with the much-lauded “cold ablation” – if that meant they would then achieve more throughput. A new generation of process engineering that will address this issue in particular will be discussed at the “4th UKP Workshop – Ultrafast Laser Technology” in April 2017.
Even back in the 1990s, scientists were comparing materials processing with nanosecond, picosecond and femtosesecond pulses. The result was surprising:...
Have you ever wondered how you see the world? Vision is about photons of light, which are packets of energy, interacting with the atoms or molecules in what...
A multi-institutional research collaboration has created a novel approach for fabricating three-dimensional micro-optics through the shape-defined formation of porous silicon (PSi), with broad impacts in integrated optoelectronics, imaging, and photovoltaics.
Working with colleagues at Stanford and The Dow Chemical Company, researchers at the University of Illinois at Urbana-Champaign fabricated 3-D birefringent...
In experiments with magnetic atoms conducted at extremely low temperatures, scientists have demonstrated a unique phase of matter: The atoms form a new type of quantum liquid or quantum droplet state. These so called quantum droplets may preserve their form in absence of external confinement because of quantum effects. The joint team of experimental physicists from Innsbruck and theoretical physicists from Hannover report on their findings in the journal Physical Review X.
“Our Quantum droplets are in the gas phase but they still drop like a rock,” explains experimental physicist Francesca Ferlaino when talking about the...
16.11.2016 | Event News
01.11.2016 | Event News
14.10.2016 | Event News
09.12.2016 | Life Sciences
09.12.2016 | Ecology, The Environment and Conservation
09.12.2016 | Health and Medicine