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H1N1 Vaccine Trials: NIH & WHO Can't Declare 'Safe and Effective' 'til September

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posted on Aug, 23 2009 @ 10:35 AM
According to the WHO, various virus strains are being turned into H1N1 vaccines, but early results of trials won't be available until sometime in September.

Given that serious complications may not be immediately apparent, are you ready to be 'first in line?'

The WHO says vaccine manufacturers are on track to develop a vaccine for the H1N1 virus. It says more than 400 shipments of different viruses have been made to manufacturers and some of the experimental vaccines are now being used in clinical trials in China, Australia, the United Kingdom, Germany and the U.S.

"For the clinical trials started already, we should have early results during September," Kieny said. "So, we will know after these clinical trials whether the formulation that the vaccine manufacturers are using will give protection against the H1N1 virus."

The National Institues of Health is moving forward with an expedited approval process, but won't reach any conclusions before then, either.

NIAID Set to Launch Clinical Trials to Test 2009 H1N1 Influenza Vaccine Candidates

Scientists across the US are to begin clinical trials to gather critical data about candidate H1N1 flu vaccines. The research will be under the direction of the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

"With the emergence of the H1N1 virus, we have undertaken vaccine development that is proceeding in stepwise fashion," says NIAID Director Anthony S. Fauci, M.D.

The U. S. Centers for Disease Control and Prevention generated and distributed a 2009 H1N1 seed virus to vaccine manufacturers for testing in clinical trials.

"NIAID will use vaccine clinical trials infrastructure — the Vaccine and Treatment Evaluation Units — to quickly evaluate whether the vaccines are safe and to assess their ability to induce protective immune responses," says Dr. Fauci.

The trials are being conducted in a compressed timeframe.

Close collaboration among NIAID, the U.S. Food and Drug Administration (FDA) and the Biomedical Advanced Research and Development Authority (a component of the Department of Health and Human Services) was key to launching the trials quickly.

I'd certainly like to see WHO and FDA results of these "clinical trials," especially since various manufacturers are working independently with different 'seed' virus strains.


[edit on 23-8-2009 by jdub297]

posted on Aug, 26 2009 @ 08:19 PM
Even so, the CDC intends to go forward with vaccinations.


posted on Sep, 6 2009 @ 01:19 PM
New reports indicate that shipments have already been arranged.

Care givers will be first, but some schools will also get attention.


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