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PostPosted: Tue Jan 12, 2010 11:55 am 
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http://www.cdc.gov/h1n1flu/open_letter_h1n1_vaccine.htm
Quote:
January 11, 2010 3:00 PM ET

Open Letter to the American People:

Since the 2009 H1N1 flu virus hit our shores, scientists, manufacturers, health providers, and federal, state, and local health officials have worked together to protect the health of the American people. Over 110 million doses of the H1N1 vaccine are now available, with more coming every day. Now is the time to protect yourself and those around you by getting vaccinated against the H1N1 flu.

The traditional flu season is just beginning and typically lasts until May. History tells us to prepare for another serious wave of illness. With H1N1 flu declining in many areas, we have a window of opportunity to help prevent the flu from spreading further and causing even more illness, hospitalization, and death.

The H1N1 flu vaccine is safe, effective, and the best way to protect yourself and your family from the H1N1 flu.

The H1N1 vaccine is made the same way seasonal flu vaccines are made every year. Extensive testing and monitoring have shown that the vaccine is not only safe, but also an excellent match for the H1N1 flu virus. And remember that when you get vaccinated, you don’t just help yourself; you help your community by preventing the spread of the flu virus.

We especially encourage people with underlying health conditions, pregnant women, children, young adults, caretakers of infants, and health care workers to get vaccinated against H1N1. Unlike the seasonal flu, H1N1 has hit children, young people, and adults under age 65 exceptionally hard. That is why we encourage you to get the H1N1 vaccine as soon as possible.

Fighting the flu is a shared responsibility. We ask you to join us in this fight to protect yourself and your community by getting the H1N1 flu vaccine.

Sincerely,


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PostPosted: Tue Jan 12, 2010 6:22 pm 
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Joined: Wed Nov 11, 2009 12:20 pm
Posts: 117
CDC Open Letter wrote:
...
The H1N1 flu vaccine is safe, effective, and the best way to protect yourself and your family from the H1N1 flu.
...

The jury is still out on the part that says "the H1N1 flu vaccine is the best way to protect yourself and your family from the H1N1 flu." With anecdotal evidence from members of this board, there are cases of reinfection even after both prior infection and vaccination. This is still an on-going experiment and everyone is a test subject, willingly or not.

CDC Open Letter wrote:
...
Extensive testing and monitoring have shown that the vaccine is not only safe, but also an excellent match for the H1N1 flu virus.
...

Unfortunately, there is evidence that the virus is evolving away from the target that the vaccine is such "an excellent match".

Shhhhh..,let's keep it quiet. We still need to push another 140 million doses of vaccine in the next few weeks.


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PostPosted: Tue Jan 12, 2010 6:46 pm 
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Joined: Fri Nov 06, 2009 5:20 pm
Posts: 374
saraseer wrote:
http://www.cdc.gov/h1n1flu/open_letter_h1n1_vaccine.htm
Quote:
January 11, 2010 3:00 PM ET

Open Letter to the American People:

Since the 2009 H1N1 flu virus hit our shores, scientists, manufacturers, health providers, and federal, state, and local health officials have worked together to protect the health of the American people. Over 110 million doses of the H1N1 vaccine are now available, with more coming every day. Now is the time to protect yourself and those around you by getting vaccinated against the H1N1 flu.

The traditional flu season is just beginning and typically lasts until May. History tells us to prepare for another serious wave of illness. With H1N1 flu declining in many areas, we have a window of opportunity to help prevent the flu from spreading further and causing even more illness, hospitalization, and death.

The H1N1 flu vaccine is safe, effective, and the best way to protect yourself and your family from the H1N1 flu.

The H1N1 vaccine is made the same way seasonal flu vaccines are made every year. Extensive testing and monitoring have shown that the vaccine is not only safe, but also an excellent match for the H1N1 flu virus. And remember that when you get vaccinated, you don’t just help yourself; you help your community by preventing the spread of the flu virus.

We especially encourage people with underlying health conditions, pregnant women, children, young adults, caretakers of infants, and health care workers to get vaccinated against H1N1. Unlike the seasonal flu, H1N1 has hit children, young people, and adults under age 65 exceptionally hard. That is why we encourage you to get the H1N1 vaccine as soon as possible.

Fighting the flu is a shared responsibility. We ask you to join us in this fight to protect yourself and your community by getting the H1N1 flu vaccine.

Sincerely,


I think it's certainly true that vaccination is the best medical means by which you can prevent an H1N1 infection. Loccking yourself up in an underground bunker with years of food supplies may also be effective but not very practical.

Of course, will the vaccine be 100% effective for all people? Obviously not.

Some people may have needed a larger than recommended dose to achieve the proper level of anti-H1N1 antibodies.

Some people may get exposed to a viral strain not anticipated in the creation of the vaccine.

The people giving the vaccine may have injected a less than recommended dose OR may not have properly refrigerated the live vaccine OR the vaccine batch itself was less potent than it should have been.

Etc., etc., etc.

So...there will no doubt be instances where someone may get an infection after getting vaccinated, even after sufficient time has elapsed so that full protection should have developed. But over the course of 100s of millions of vaccinations, the vast majority will have substantial protection and, even if they encounter an unanticipated viral strain, resulting infections will likely be milder as the vaccine successfully fights off off those aspects of the strain for which it IS prepared.

It's not just the BEST way to prevent an infection, it may for all practical purposes be the ONLY way.


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PostPosted: Tue Jan 12, 2010 10:52 pm 
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The only situation in which vaccination would be the BEST method to prevent infection is if the virus stays stable and doesn't mutate.

Unfortunately, it has already mutated (and they haven't even finished delivering the first vaccine).

I would entirely agree with you, but only IF they could produce AND DISTRIBUTE a vaccine quickly enough and safely enough to a large enough population of the world to kick the virus down within one season.

Thus far, it is clear we aren't anywhere near those capabilities yet. And current evidence indicating that a significant portion of the worlds population won't take the vaccine even when it is in plentiful supply implies that we might never gain those capabilities.

Perhaps it's time to rethink the entire strategy.


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PostPosted: Wed Jan 13, 2010 1:00 am 
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Joined: Mon Sep 28, 2009 10:19 pm
Posts: 4059
Quote:
Some people may have needed a larger than recommended dose to achieve the proper level of anti-H1N1 antibodies.

Some people may get exposed to a viral strain not anticipated in the creation of the vaccine.

The people giving the vaccine may have injected a less than recommended dose OR may not have properly refrigerated the live vaccine OR the vaccine batch itself was less potent than it should have been.

Etc., etc., etc.

Boy, that sure is a lot variables, isn't it? Which may amount to a lot of vaccinated people thinking they're protected when, for any number of reasons (a few of which you allude to above, andre10056), they actually may not be protected at all.


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PostPosted: Wed Jan 13, 2010 9:43 am 
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Joined: Fri Nov 06, 2009 5:20 pm
Posts: 374
Pandora wrote:
The only situation in which vaccination would be the BEST method to prevent infection is if the virus stays stable and doesn't mutate.

Unfortunately, it has already mutated (and they haven't even finished delivering the first vaccine).

I would entirely agree with you, but only IF they could produce AND DISTRIBUTE a vaccine quickly enough and safely enough to a large enough population of the world to kick the virus down within one season.

Thus far, it is clear we aren't anywhere near those capabilities yet. And current evidence indicating that a significant portion of the worlds population won't take the vaccine even when it is in plentiful supply implies that we might never gain those capabilities.

Perhaps it's time to rethink the entire strategy.


I think your definition of "best" is "perfect". Vaccination is not a perfect strategy but the best among whatever other strategies might be possible. Unless you have another idea that I haven't heard as yet.

If so, let's have it.


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PostPosted: Wed Jan 13, 2010 10:17 am 
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Posts: 374
But if, Pandora, you're saying that vaccination can be made better, I agree with you 100%. Here's one article from October that details some of the problems with the existing, "time honored" (i.e., antiquated) US vaccination strategy:

http://online.wsj.com/article/SB1000142 ... 41690.html

Why You Can't Get the Swine Flu Vaccine

U.S. regulations are too cautious. Europe has adopted a more sensible approach.

By SCOTT GOTTLIEB

Though the swine flu is widespread in 46 states many Americans are still waiting to get their vaccines. The Obama administration blames the shortage on manufacturing delays at the five firms making these products. But production issues only explain part of the shortfall. Also to blame are a series of policy decisions that reflect our extreme caution when it comes to these products.

From a regulatory standpoint, vaccines are unique in many ways. Since we distribute them widely to otherwise healthy people, they deserve careful oversight. But right now we are shunning new, superior vaccine science by being overly cautious.

On Saturday, when President Obama declared the outbreak a national emergency, he enabled the suspension of federal rules in order to speed the distribution of treatments. Yet less than half the projected vaccine has been actually shipped. Supply is far below the government's estimate of 40 million ready vaccines by November.

The first fateful policy decision, made last spring, was to forgo vaccine additives—called adjuvants—that activate the immune system and make shots more potent. Adjuvants allow a smaller supply of vaccine stock to be stretched across more doses. These adjuvants are included in H1N1 vaccines world-wide, but not in the U.S.

Why do adjuvants matter? An adjuvanted H1N1 vaccine being used in Europe contains 3.75 micrograms of vaccine stock. The same vaccine in the U.S., without the adjuvant, requires 15 micrograms of vaccine for equal potency. If we used adjuvants, we could have had four times the number of shots with the same raw material.

The second cautious decision was to require that the H1N1 vaccine be a single shot. The government demanded single-dose syringes because they contain smaller amounts of thimerosal than multi-dose vials. This mercury-containing vaccine preservative continues to stir concern it can trigger childhood autism, even though this has been firmly disproven.

The third policy decision was to stick for too long with a proven, but slow process for making flu shots that uses chicken eggs to grow the raw vaccine material. Shots can be made much faster using mammalian cells to grow vaccine, and this process is already being used in Europe. The cell-based vaccines are unlikely to be approved in the U.S. Our precaution when it comes to vaccines means we don't easily embrace novel technologies, even if the Europeans would part with some of their limited supply.

How can we improve our regulatory process to prevent such shortages? First, the Food and Drug Administration (FDA) needs to create a review pathway for adjuvants that can become components of multiple vaccines. One, called monophosphoryl lipid A, was recently the first modern adjuvant to be approved in the U.S.—in this case as part of a vaccine for cervical cancer. We've been slow to integrate vaccine additives, bowing to imprudent activism and litigation. The European strategy of having adjuvants preapproved, as part of mock up pandemic vaccines, was smart. We should adopt it.

Second, the FDA requires vaccines to sit for weeks after they come off the manufacturing line to make sure they haven't grown bacterial impurities. This is why most of the H1N1 vaccine supply is released in waves and won't be ready until later this winter. The FDA can work with manufacturers to develop better standardized tools, called assays, to quickly assess new vaccine.

Finally, we need to invest in more modern facilities for manufacturing flu vaccine, particularly cell-based facilities. These plants can be scaled more quickly, enabling rapid production. A certain amount of these facilities should be built here at home. In a full-blown pandemic, with a very deadly strain of flu, it's hard to imagine that foreign nations would allow limited supplies of vaccine to be shipped outside their borders.

The Obama team deserves credit for ordering vaccines early last spring when H1N1 first emerged. They contracted properly for the shots and negotiated a fair price. But passing all the blame for our current vaccine shortage onto manufacturers is unfair. The administration needs to take responsibility for improving our current system.

Dr. Gottlieb, a practicing physician and resident fellow at the American Enterprise Institute, was deputy commissioner of the FDA from 2005-2007. He is partner to a firm that invests in health-care companies.


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PostPosted: Wed Jan 13, 2010 10:48 am 
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Here's one technology, growing vaccine in caterpillar cells, that would allow vaccine to come into being in about two months (!!!). It was delayed by the FDA in November because one of the trial participants had her face swell up an hour after getting the vaccine. Apparently, it was a pre-existing condition, and many of the advisory panel members urged the FDA to approve the methodology, but the FDA decided to require the company to carry out a bigger trial. Bad news for the company since such a bigger trial will cost them mega megabucks, particularly since it looks like their biggest problem was inadvertently allowing a person with pre-existing conditions to be part of the study:

http://www.reuters.com/article/idUSTRE5AI53E20091119

A follow-up article entitled "Caterpillar Vaccine Delayed" from the MIT Technology Review:

http://www.technologyreview.com/biomedi ... 031/page1/


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