The scandalous promotion for H1N1 vaccines is dying naturally, so...

The scandalous promotion for H1N1 vaccines is dying naturally, so...

By Maggie Fox, Health and Science Editor

GAITHERSBURG, Md., July 23 - The U.S. Food and Drug Administration wants to help rush through approval of new vaccine to fight the pandemic H1N1 virus, promising to watch more closely than ever bad effects from the immunization, officials said on Thursday.
The FDA said it would help companies design ways to quickly test experimental versions of the vaccine, which experts say is likely to be given to people alongside the seasonal flu vaccine.

Getting a vaccine approved as soon as possible is important, the FDA's Dr. Wellington Sun told a committee of experts who advise the FDA on vaccine policy.
"Time is really not on our side," Sun said. "We have to prepare for the worst."
He noted that the companies making H1N1 swine flu vaccine had a proven track record of safety and had been making seasonal flu vaccines for the U.S. market for years.
But FDA's Dr. Hector Izurieta said the agency would watch carefully for what are called adverse events from vaccination.

"If something happens after vaccination, the vaccine will be accused," Izurieta told the meeting. "There will be many, many reports of things that could be, or not, associated with vaccination."

Five companies making H1N1 vaccine laid out their plans for testing various formulas for the U.S. market.
AstraZeneca's MedImmune unit,
Australia's CSL Ltd ,
GlaxoSmithKline Plc ,
Novartis AG and
Sanofi-Aventis SA all are making H1N1 vaccines.

LOWER YIELD
The U.S. Health and Human Services Department said it had bought 195 million doses of H1N1 swine flu vaccine for a possible autumn vaccination campaign, and the National Institutes of Health outlined its plan, announced on Wednesday, to start testing swine flu vaccines in people.

Dr. Robin Robinson of HHS predicted 160 million doses of vaccine could be ready for the U.S. public in October.

Most of the vaccine makers are struggling to make the swine flu vaccine because they get a yield of 30 percent from H1N1 compared to seasonal flu vaccine strains, Dr. Jerry Weir, the FDA's director of the division of viral products told the meeting.

This means makers may end up with fewer doses than expected to fight the pandemic strain. But MedImmune's Dr. Raburn Mallory said his company was getting a better vaccine yield than other companies -- and could make more vaccine than it could put into spray bottles to deliver.

MedImmune's FluMist uses a live, weakened virus that is sprayed into the nose.

MedImmune's Ben Machielse told Reuters the company could make 200 million doses of bulk vaccine but only had 40 million sprayers.

GlaxoSmithKline's Dr. Bruce Innes told the meeting his company would test a vaccine with and without adjuvant -- a compound that stimulates the body's response to the vaccine -- while Dr. Theodore Tsai of Novartis said tests on 3,000 young children showed no bad side-effects from its seasonal flu vaccine with adjuvant.

H1N1 flu, first identified in March, spread globally in a matter of weeks to cause the first pandemic of the 21st century. It is still causing illness globally, including in the Southern Hemisphere, which is in its winter influenza season.

While it is about as bad as a moderate seasonal flu, it is attacking younger people than seasonal flu usually does. Seasonal influenza kills between 250,000 and 500,000 people globally in an average year.

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Forewarned is forearmed:premature death under the hands of 'sick'care systems in the country. Unlike many of its predecessors, "Hippocraic Oaths": Medicine and its Discontents, on the ills of present medicine is not so much a polemic as a balanced and highly personal search for the reasons why a profession that has achieved so much for the benefits of patients during my lifetime is now at such a low ebb.

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I concentrate much of my attention on the rise of consumerism and with it the inexorable rise of political interference and control in matters which i see as best belonging to the profession.

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This blogger knows his subject intimately, writes beautifully and is very very angry.

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As a doctor, it is not often that I read as clear and thoughtful an analysis of the medical profession and the National Health Service as that given in this blog . . . a brilliant analysis of modern medicine.

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