The U.S. Food and Drug Administration, this week, approved a vaccine for the 2009 H1N1 flu, for four pharmaceutical manufacturers, the FDA announced Tuesday.
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Gordon Potter, right, receives a shot from nurse Wendy Nesheim
during the first of several clinical trials of a new H1N1 flu vaccine
conducted by Emory University, in Atlanta, on August 10, 2009.
(AP Photo/John Amis)
Calling the inoculation an "important tool to fight [the] pandemic," the FDA's announcement means that CSL Limited, MedImmune LLC, Novartis Vaccines and Diagnostics Limited, and Sanofi Pasteur Inc., who all manufacture vaccines for the seasonal flu, are expected to have the first lots of H1N1 vaccine available for distribution within four weeks.
Contrary to earlier reports saying that it may take two doses of the vaccine to provide the proper immunity to the virus, the FDA confirmed - in its press release - that clinical trials indicate "the 2009 H1N1 vaccines induce a robust immune response in most healthy adults eight to 10 days after a single dose." They go on to say that the response time is typical of even seasonal flu vaccines.
The drug manufacturer Novartis claimed on September, 3, that "the study showed a strong, potentially protective, immune response in 80% of subjects after one dose." MedImmune also claims that its intranasal spray vaccine "prompts the body to begin mounting an immune response after the first dose."
Clinical trials for properly dosing children are still underway, and the results are expected shortly, the FDA said.
- The New England Journal of Medicine just published a report on the response to H1N1 vaccine after a single dose.
- Follow the latest on the swine flu on Examiner.com
Comments
Is there no worry about the speed at which this vaccine was tested and approved?
Has it been tested on children under 10?
Has it been tested on pregnant women?
Why is it that ONLY last week, AFTER it was approved, did word come out about whether one or two doses was required?
I do not trust it. ESPECIALLY for my children.
30,000 people die of the flu or associated ailments every year and we don't worry about that.
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