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
New approach for targeted cancer immunotherapy
30.07.2020 | Universität Basel
A new way to target cancers using 'synthetic lethality'
28.07.2020 | University of California - San Diego
Traditional single-cell sequencing methods help to reveal insights about cellular differences and functions - but they do this with static snapshots only...
“Core-shell” clusters pave the way for new efficient nanomaterials that make catalysts, magnetic and laser sensors or measuring devices for detecting electromagnetic radiation more efficient.
Whether in innovative high-tech materials, more powerful computer chips, pharmaceuticals or in the field of renewable energies, nanoparticles – smallest...
An international research team with Prof. Cornelia Denz from the Institute of Applied Physics at the University of Münster develop for the first time light fields using caustics that do not change during propagation. With the new method, the physicists cleverly exploit light structures that can be seen in rainbows or when light is transmitted through drinking glasses.
Modern applications as high resolution microsopy or micro- or nanoscale material processing require customized laser beams that do not change during...
Although no life has been detected on the Martian surface, a new study from astrophysicist and research scientist at the Center for Space Science at NYU Abu...
New approach creates synthetic layered magnets with unprecedented level of control over their magnetic properties
The magnetic properties of a chromium halide can be tuned by manipulating the non-magnetic atoms in the material, a team, led by Boston College researchers,...
23.07.2020 | Event News
21.07.2020 | Event News
07.07.2020 | Event News
04.08.2020 | Life Sciences
04.08.2020 | Medical Engineering
04.08.2020 | Ecology, The Environment and Conservation