Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

Nasal spray flu vaccine developed at U-M needs no additional clinical trials, says FDA

12.07.2002


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 FDA’s response to its biologics license application for FluMist. The site is http://www.medimmune.com. A replay of the webcast will be available via MedImmune’s website until midnight July 18. A MedImmune press release on the FDA’s 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. Army’s flu vaccine program during World War II. Francis was founder of U-M’s 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 Maassab’s 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-M’s 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 Maassab’s dedication to this project.

Producers: U-M has professional studios and uplink capabilities. B-roll footage of U-M’s 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
News Service
412 Maynard
Ann Arbor, MI 48109-1399
Web: www.umich.edu/~newsinfo

Colleen Newvine | EurekAlert

More articles from Health and Medicine:

nachricht The FiTS app now offering cooking videos as it expands its concept for long-term behavior modification
18.09.2018 | vitaliberty GmbH

nachricht The microbiota in the intestines fuels tumour growth
18.09.2018 | Technische Universität München

All articles from Health and Medicine >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: Patented nanostructure for solar cells: Rough optics, smooth surface

Thin-film solar cells made of crystalline silicon are inexpensive and achieve efficiencies of a good 14 percent. However, they could do even better if their shiny surfaces reflected less light. A team led by Prof. Christiane Becker from the Helmholtz-Zentrum Berlin (HZB) has now patented a sophisticated new solution to this problem.

"It is not enough simply to bring more light into the cell," says Christiane Becker. Such surface structures can even ultimately reduce the efficiency by...

Im Focus: New soft coral species discovered in Panama

A study in the journal Bulletin of Marine Science describes a new, blood-red species of octocoral found in Panama. The species in the genus Thesea was discovered in the threatened low-light reef environment on Hannibal Bank, 60 kilometers off mainland Pacific Panama, by researchers at the Smithsonian Tropical Research Institute in Panama (STRI) and the Centro de Investigación en Ciencias del Mar y Limnología (CIMAR) at the University of Costa Rica.

Scientists established the new species, Thesea dalioi, by comparing its physical traits, such as branch thickness and the bright red colony color, with the...

Im Focus: New devices based on rust could reduce excess heat in computers

Physicists explore long-distance information transmission in antiferromagnetic iron oxide

Scientists have succeeded in observing the first long-distance transfer of information in a magnetic group of materials known as antiferromagnets.

Im Focus: Finding Nemo's genes

An international team of researchers has mapped Nemo's genome

An international team of researchers has mapped Nemo's genome, providing the research community with an invaluable resource to decode the response of fish to...

Im Focus: Graphene enables clock rates in the terahertz range

Graphene is considered a promising candidate for the nanoelectronics of the future. In theory, it should allow clock rates up to a thousand times faster than today’s silicon-based electronics. Scientists from the Helmholtz Zentrum Dresden-Rossendorf (HZDR) and the University of Duisburg-Essen (UDE), in cooperation with the Max Planck Institute for Polymer Research (MPI-P), have now shown for the first time that graphene can actually convert electronic signals with frequencies in the gigahertz range – which correspond to today’s clock rates – extremely efficiently into signals with several times higher frequency. The researchers present their results in the scientific journal “Nature”.

Graphene – an ultrathin material consisting of a single layer of interlinked carbon atoms – is considered a promising candidate for the nanoelectronics of the...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

VideoLinks
Industry & Economy
Event News

One of the world’s most prominent strategic forums for global health held in Berlin in October 2018

03.09.2018 | Event News

4th Intelligent Materials - European Symposium on Intelligent Materials

27.08.2018 | Event News

LaserForum 2018 deals with 3D production of components

17.08.2018 | Event News

 
Latest News

Making better use of enzymes: a new research project at Jacobs University

19.09.2018 | Life Sciences

Light provides spin

19.09.2018 | Physics and Astronomy

Enjoying virtual-reality-entertainment without headache or motion sickness

19.09.2018 | Information Technology

VideoLinks
Science & Research
Overview of more VideoLinks >>>