Huntsville-developed H1N1 test receives FDA authorization
Posted: Oct 15, 2009 5:14 PM EDT
Updated: Oct 15, 2009 5:47 PM EDT
HUNTSVILLE, AL (WAFF) - The FDA gave its approval to a faster test for identifying the H1N1 virus developed in Huntsville. The virus was developed in Huntsville?
Dr. Jian Han of the HudsonAlpha Institute developed the test.
The FDA has given it Emergency Use Authorization.
Basically what that means is that the FDA has vouched for the validity of the test and has approved it for use during this declared pandemic.
This is significant because approving a new test or drug can take years.
Tucked behind the walls of the HudsonAlpha Institute in Huntsville lies a little company called Diatherix, a little company doing big things.
Dennis Grimaud is chairman and CEO of Diatherix, the lab that produces the H1N1-09 Influenza test developed by Dr. Jian Han.
The test is known for its quick results and was given Emergency Use Authorization by the FDA on Friday.
“For us, what that really does is validates our testing through the FDA,” Grimaud said.
Samples come into this lab from across the United States and once they’re here, doctors usually get those results back that very same day.
“In our hands, from the sample receipt to actual results, is somewhere between four and five hours,” Grimaud said.
It also tests for 26 other viruses and infections along with H1N1 flu, with just one test, giving doctors valuable information and saving patients’ time and money.
“Turning the test around quickly is very important for a patient to be stabilized and for a physician to be able to properly treat them,” Grimaud said.
The workload at the lab has been so overwhelming that the company has tripled its workforce in the past month.
The FDA has given this test authorization through April 2010. If we are still in a declared pandemic at that time, then the authorization will be renewed.
http://www.waff.com/Global/story.asp?S=11322620
Our View: Do the math, and get vaccinated
By: Abel Gustafson, Budgeteer News
After six long months of H1N1 (swine flu) pandemonium, we finally have a vaccine (for the flu, not the pandemonium). Ironically, now that the vaccine is finally here, many are afraid to use it because — get this — they fear it might make you sick.
To be fair, there are understandably a couple reasons why some might be reluctant: One being the side effects of the vaccine during the 1976 swine flu scare; and the other being the chemical contents of a preservative it contains. However, when examined a little more closely, we find that neither of these concerns should deter you from vaccination.
In 1976, the first discovered swine flu case was an Army recruit at Fort Dix in New Jersey. Of the 218 million American citizens living then, 240 contracted swine flu, 13 were hospitalized and exactly one person died (that first soldier). All 240 cases were at Fort Dix. Nevertheless, we promptly overreacted.
Of the 43 million Americans subsequently vaccinated, there were 500 cases in which the vaccine was linked to Guillain-Barré syndrome (GBS), a neuromuscular disorder that can induce temporary paralysis. Twenty-five people died from complications. It is ironic to note that by raw numbers (not percentage), the vaccine killed more people than the disease did.
This year’s vaccine is not the same vaccine as the one given in 1976. In fact, it’s a different virus, hence the name occasionally used by the Minnesota Department of Health: H1N1 novel influenza. This year’s H1N1 vaccine has not been shown to have any causal relationship to GBS. (The Centers for Disease Control and Prevention and its partners have several systems in place to monitor vaccine safety/adverse reactions.)
What is more, we are not dealing with 240 cases of the flu. As of Oct. 4, 2009, the World Health Organization reported 375,000 lab-confirmed cases of H1N1 across the world, low because many countries have stopped counting. The reported death total is 4,500 worldwide. Do the math and you’ll find you have infinitely greater chances of suffering health problems should you not get vaccinated than of experiencing side effects from the vaccine.
One of the most publicized vaccination fears is that thimerosal, a preservative in some of the vaccines, contains a mercury compound. Although true, the Food and Drug Administration has specifically stated that this minute amount of mercury in vaccines — less than a hundredth of 1 percent — is not harmful.
Even if you think the FDA is wrong, thimerosal remains a non-issue. The CDC announced that manufacturers expect to produce at least 50 million doses of various thimerosal-free versions of the H1N1 vaccine, available either in nasal spray or standard injection.
So there really are only two reasons left for anyone to not get vaccinated. The first is if you are simply unequivocally opposed to vaccinations, whether seasonal or swine. The second is if you have an egg allergy. Strange as it may sound, flu vaccines are grown in fertilized chicken eggs.
The H1N1 vaccine should be viewed no differently than the annual seasonal flu vaccine. It is tested, it is safe and it can protect you and your loved ones from the H1N1 flu. Hopefully, they have someone working on a vaccine for the pandemonium too.
http://www.duluthnewstribune.com/event/article/id/149200/group/Opinion/