Nasal vaccine developed for swine flu
Published: July 31, 2009
Maryland-based Medimmune pharmaceuticals expects to produce nearly five times the amount of H1N1 vaccine originally anticipated, its executives said.
Medimmune, a subsidiary of AstraZeneca, expects to make 200 million doses by March, so many doses it will run out of nasal spray devices and may have to use nose droppers, Bernardus N.M. Machielse, Medimmune's executive vice president for operations told The New York Times.
Medimmune is of the five companies under contract to the U.S. government to produce H1N1 flu vaccine. Medimmune also makes the nasal spray vaccine FluMist for seasonal flu viruses.
An H1N1 nasal spray vaccine could be a strong weapon against swine flu because makers of conventional flu shots have reported problems producing their vaccines, the Times reported.
So far, the U.S. government has ordered 12.8 million doses of H1N1 vaccine from Medimmune for $151 million and could order millions more doses, federal officials told the Times.
© 2009 United Press International, Inc. All Rights Reserved.
Beware! Flu Shot Propaganda Now on Fast Track - 9/30/08
Merck's Grand Plan for ALL Children - 10/28/07
ORIGINALLY POSTED 9/20/07
I don't know who may be crazier on the FluMist issue, the CDC or the people who believe the propaganda and line up for the shots or the sniff.
I am not at all in favor of flu shots because I have seen that health problems skyrocket in communities where most everyone goes for this gusto. To confirm this all you have to do is search the net for related news stories.
And in response to this latest insanity of giving this to 2-5 year old children, and last year's push to vaccinate pregnant women and infants, I'm adding some facts about FluMist I've had for a few years that you might not know about.
The Risks of FluMist
There's more information here on how to stay well or get well naturally.
And if you need help recovering from a vaccine reaction contact us for some recommendations.
Published on The Money Times (http://www.themoneytimes.com)
FDA approves FluMist influenza vaccine for young kids
The US Food and Drug Administration (FDA) has approved on Wednesday a nasal spray influenza vaccine FluMist for the treatment of children between 2 and 5 years of age, saying it can be effective in protecting young children against this highly contagious disease.
Manufactured by MedImmune, FluMist spray vaccine that contains a weakened form of the live virus was previously approved for healthy children and adults age 5 to 49.
The approval by federal health agency came seven months after a major study conducted by researchers from medical schools in St. Louis, Tennessee, California and Finland, found the FluMist influenza vaccine effective in young children.
In February, the study which involved 8,475 children, 6 months to 59 months of age, at 249 sites across the United States, Europe, Asia and the Middle East discovered that children from 6 months to 5 years old had 55 percent fewer cases of flu when they were protected by the nasal spray vaccine FluMist, rather than traditional shots.
FluMist spray vaccine, which does not need to be kept frozen, only refrigerated, was not yet licensed by the FDA for children under 5, but after examining the trial results the agency gave its node to FluMist for children 2 to 5 years old.
"The goal of preventing influenza is now more attainable with the availability of FluMist for younger children," said Dr. Jesse Goodman, director of the FDA's Center for Biologics Evaluation and Research. "This approval also offers parents and health professionals a needle-free option for squeamish toddlers who may be reluctant to get a traditional influenza shot."
However, FDA is not allowing use of FluMist for children under 2 due to an increased risk of hospitalization and wheezing being reported in clinical trials.
The U.S. Centers for Disease Control recommends flu vaccination for those aged 6 months to 5 years to prevent the spread of the virus. Before the approval of FluMist, there were only two vaccines licensed in the U.S. for children under the age of 5, Fluzone, manufactured by Sanofi Pasteur and indicated for children over 6 months of age, and Fluvirin, available for use in children age 4 and older, manufactured by Novartis.
Winning approval for FluMist marks a major victory for Gaithersburg, Maryland-based MedImmune, which was looking forward to get federal regulators’ approval for younger children.
"As a company dedicated to innovative advancements in pediatric medicine, MedImmune is delighted to be able to offer FluMist as an option for children as young as two years old to help protect them from influenza," said James F. Young, Ph.D., President, Research and Development. "With the new, refrigerated formulation approved in January, the results from our head-to- head study published in the February issue of The New England Journal of Medicine, and the expanded age indication now within the label, it is an exciting time for FluMist."
The approval to market the inhalable influenza vaccine to young children could provide a major revenue boost for the company. In 2006, FluMist sales totaled more than $36.4 million, lagging behind MedImmune's top-selling respiratory virus drug Synagis, which posted sales of $1.1 billion. FluMist competes with injectable flu vaccines made by GlaxoSmithKline Plc, Sanofi-Aventis' Sanofi Pasteur unit, and Chiron, which was recently acquired by Novartis AG.
MedImmune, which recently has bought by London-based AstraZeneca Plc for US$15.6 billion in cash, is a biopharmaceutical company that develops and markets products to combat infectious disease and cancer, among other things.
Its flagship product, Synagis, prevents respiratory syncytial virus (RSV), a major cause of pneumonia and other respiratory disease in infants and children. Besides FluMist, its nasal spray flu vaccine, also on the market are Ethyol, which treats side effects of chemotherapy and radiation; and Neutrexin, a treatment for a kind of pneumonia that often afflicts AIDS patients.
Influenza (commonly known as "the flu") is an acute respiratory illness caused by one of the family of influenza viruses. In infants, persons over the age of 65 years, and those with chronic medical conditions, the flu can lead to pneumonia, hospitalization, and even death. Each winter, influenza engulfs 36,000 lives in America, most of them elderly and children.