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An Honest Vaccine Discussion with the Public

Re: An Honest Vaccine Discussion with the Public

Bloomberg Reporting on this subject area has always been top notch, and another reason I love them....they stole my line.:rolleyes:


Swine Flu Shots May Be Too Little, Too Late to Halt Outbreaks
http://www.bloomberg.com/apps/news?pid=20601103&sid=aoKnGT96tLng
Aug. 19 (Bloomberg) -- Swine flu vaccines under development by drugmakers may not provide immunity until the last week of November, too late to hold off outbreaks triggered by infected students returning to schools in the U.S. and Europe.
Just 45 million of 195 million doses ordered for the U.S. will be delivered by mid-October, said health officials who lowered their estimates yesterday. The vaccine will probably require two shots given three weeks apart, and the body won’t produce antibodies for two additional weeks, according to an Aug. 7 report by the Department of Health and Human Services.
U.S. students go back to school this week after more than 80 outbreaks of swine flu, also known as H1N1, were reported in summer camps, government health officials said. U.K. classes begin Sept. 1, a week before results from the first test of the new vaccine are set to be released by CSL Ltd., the Australian drugmaker that makes 20 percent of the U.S. supply.
“This has been a virus that’s been smoldering, particularly among children at the many summer camp outbreaks,” said William Schaffner, of the Vanderbilt University School of Medicine. “There’s no doubt it’s coming, and we could see it as early as September. Every pediatrician, internist and public health official is cross-eyed” with worry, he said.
Swine flu infection won’t protect patients from seasonal influenza, so the coming season may be “double-barreled,” marked by successive rounds of illness, Schaffner, chairman of the Nashville, Tennessee school’s department of preventive medicine, said in an interview.
170 Countries
H1N1 has reached more than 170 countries and territories in the four months since being identified, the Geneva-based World Health Organization said. Swine flu causes similar symptoms as seasonal strains. It has so far resulted in “slightly worse” than normal flu seasons, with increased hospitalizations and cases of severe illness, the WHO said in an Aug. 12 release.
The median age of those with the pandemic virus has been 12 to 17 years, the WHO said on July 24, citing data from Canada, Chile, Japan, U.K. and the U.S.
Patients who have already had swine flu will be immune to it in the fall, Schaffner said. Recovered patients shouldn’t count on having immunity unless their illness was confirmed by laboratory tests. If they weren’t tested, they should get the vaccine to ensure they’re protected, he said.
Sanofi-Aventis SA, based in Paris, began vaccine trials on August 6 and needs “two to three months” to complete them, said Donna Cary, a company spokeswoman, in an e-mail yesterday. London-based GlaxoSmithKline Plc and AstraZeneca Plc both have said they began testing in the last two weeks.
Required for Licensing
The company tests are required for licensing and are separate from U.S.-funded studies to determine dose and timing of the vaccine, said Bill Hall, a spokesman for the U.S. Department of Health and Human Services.
The U.S. will receive 45 million vaccine doses by mid- October, and get an additional 20 million each week until its full order of 195 million doses from five companies has been received, Hall said.
CSL, based in Melbourne, is delaying its shipment to the U.S. to speed up shots to people in the company’s home country, Hall said in a telephone interview yesterday. All U.S. shots are provided by companies based outside the U.S.
“I can confirm that CSL’s first commitment is to Australia,” said Sheila Burke, a spokeswoman for CSL, in an e- mail yesterday.
Rapid Outbreaks
Australia and nations in South America had rapid outbreaks early in their winter season, and rates in those countries have begun to recede this month, the WHO said. South Africa was the biggest exception in the hemisphere, being struck first by seasonal flu strains that peaked in June, and only recently experiencing a second wave dominated by H1N1, the WHO said.
Companies haven’t been able to grow enough antigen, a key ingredient needed for production, to fill vaccine orders, said Rachel David, a spokeswomen from CSL, and Kim White, a spokeswoman for Baxter International Inc. in telephone interviews last week.
“It’s apparent that the vaccine availability is going to be delayed, and that the number of doses available is going to be less,” said Gregory A. Poland, head of the vaccine research group at the Mayo Clinic in Rochester, Minnesota, in an Aug. 14 telephone interview. “Right now they are getting yields of about 50 percent roughly of what they expected.”
Information about the required dose of vaccine and number of shots needed probably won’t be complete until late September, said Marie-Paule Kieny, director of the WHO’s initiative on vaccine research, in a telephone interview from Washington yesterday.
Protection Priorities
Authorities want to ensure adequate supplies to protect health-care workers, pregnant women, people at risk of developing severe complications from flu and children, whose close contact in tightly packed schoolrooms and in other social settings makes them the biggest spreaders of the virus.
Part of the U.S. plan to vaccinate children is to encourage state and local health departments to set up school-based vaccine clinics. In the U.K., most shots will be given by family doctors and nurses who provide routine health care including seasonal flu shots, according to the Department of Health.
Schools that arrange in-house immunizations will face logistical hurdles, said Mel Riddile, the National Association of Secondary School Principals’ associate director for high school services in the U.S. Riddile, a former principal at a Fairfax County, Virginia, high school, said it typically took a month just for all 2,500 students to turn in their emergency medical information forms at the beginning of the school year.
Immunization Permissions
“It’s going to be difficult getting immunization permissions, particularly with some of the misconceptions about the effectiveness and the dangers around flu shots,” Riddile said in an interview Aug. 7. “It certainly can be done, but it’s going to be challenging for principals to pull that off.”
Charles Saylors, president of the National Parent Teachers Association, the non-profit organization that helps organize parents and teachers in local PTA groups, said that even though he has never before received a shot for seasonal flu, he’ll get one for H1N1 when it becomes available.
“I would like to see our communities, our families take this more seriously than they normally would a regular seasonal vaccine,” Saylors said.
During the initial U.S. outbreak, hospitals saw a surge of patients that were either seriously ill or concerned about the virus. The federal government is now working with communities to encourage that only the sickest go to hospitals, with the rest making appointments with doctors or clinics, the HHS’s Kevin Yeskey said.
“What we saw in the springtime was a lot of people who were referred directly to an emergency department rather than being seen in clinics,” said Yeskey, director of the Office of Preparedness and Emergency Operations. “That kind of overwhelmed” the hospitals, he said.
To contact the reporters on this story: Tom Randall in New York at trandall6@bloomberg.net
 
Re: An Honest Vaccine Discussion with the Public

The vaccine will probably require two shots given three weeks apart, and the body won?t produce antibodies for two additional weeks, according to an Aug. 7 report by the Department of Health and Human Services.

So here is what the timeline looks like:

October 15th: 1st shot recieved.
November 5th: 2nd shot recieved.
November 19th: Sufficient Immune Response to protect against H1N1.

In 1918, by November 23rd...the second wave was over.

Conclusion: Vaccination starting October 15th is worthless for second wave
 
Re: An Honest Vaccine Discussion with the Public

Most Americans are either "not too" or "not at all" worried about the swine flu hitting home and broad majorities have confidence the government and local health providers will be able to effectively deal with an outbreak, according to a new Washington Post-ABC News poll.

In general, nearly three-quarters have confidence the government can respond effectively to a swine flu outbreak in this country; more than eight in 10 say so about their local health agencies.

Full article posted here - http://www.flutrackers.com/forum/showthread.php?t=121971

I think most people think the government will save them. They also are getting pounded with the "fact" that this flu is no more lethal than the seasonal flu. Are they even going to be ABLE to run a flu clinic now because of the decreased number of available shots? Oh, and LOL at Jeremy about the Crystal Pepsi, HAHA.
 
Re: An Honest Vaccine Discussion with the Public

Full article posted here - http://www.flutrackers.com/forum/showthread.php?t=121971

I think most people think the government will save them. They also are getting pounded with the "fact" that this flu is no more lethal than the seasonal flu. Are they even going to be ABLE to run a flu clinic now because of the decreased number of available shots? Oh, and LOL at Jeremy about the Crystal Pepsi, HAHA.


It is dishearting to say the least that most people "don't get it".

Which is why I believe an open honest discussion with the general public is the best way to go. Furthermore, it is really the responsibility of those who have the loudest microphones to put this issue into the public forum for discussion and debate...just like Bloomberg did today with their report.

However, we need more reporting on this issue...

In regards to the number of available shots....you could have 600 million shots available on October 15th for every American (both doses) and it would still be worthless for 95% of those given the shot because the second wave will hit and pass before people have a sufficient immune response. If you don't believe that, then just look at the school reports already starting to trickle in...it is already starting.
 
Re: An Honest Vaccine Discussion with the Public

You know what I realized, it may be due to politics as well that people will not to believe.

"In September or October there will be a hyped up outbreak of the swine flu which they’ll say is as bad as the bubonic plague to scare the bed-wetters to vote for healthcare reform,” said Mr Armey. “That is the only way they can push something on to the American people that the American people don’t want.”

http://www.ft.com/cms/s/0/a6a34fa8-8a85-11de-ad08-00144feabdc0.html

Saying stuff like that doesn't exactly help things, though I'm sure both parties would probably try to use the flu to further their own agendas.
 
Re: An Honest Vaccine Discussion with the Public

You know what I realized, it may be due to politics as well that people will not to believe.



http://www.ft.com/cms/s/0/a6a34fa8-8a85-11de-ad08-00144feabdc0.html

Saying stuff like that doesn't exactly help things, though I'm sure both parties would probably try to use the flu to further their own agendas.

Form my experience, there are many reasons people will choose to believe or disbelieve something, from religion, politics, science, facts, beliefs, word of mouth, a favorite celebrity, etc.....

Unfortuantly, for most, educating themselves on the facts is more of a challenge than picking up what another person says as truth....
 
Re: An Honest Vaccine Discussion with the Public

Form my experience, there are many reasons people will choose to believe or disbelieve something, from religion, politics, science, facts, beliefs, word of mouth, a favorite celebrity, etc.....

Unfortuantly, for most, educating themselves on the facts is more of a challenge than picking up what another person says as truth....

What is really scarey is the number of people who refuse to search for the truth. They would rather believe whatever some person (who shares some of their personal biased beliefs) tells them. That large population is so easily manipulated. :rolleyes:

.
 
Re: An Honest Vaccine Discussion with the Public

At the June pandemic workshop, it was agreed
It’s best not to have the President out there as a spokesperson for vaccine policy

I don't know what to make of that.
 
Re: An Honest Vaccine Discussion with the Public

I am highlighting this story because Austrailia is about to begin their vaccination campaign in a couple of weeks. Which, if they were peaking in Mid-October would be perfect timing to help their citizens.

Since the U.S. doesn't create the necessary amount of vaccine in the country it is reliant on other countries to provide it's vaccine. Those vaccine companies have regulations that say they must give to their host country first. Therefore the U.S. is second in line behind host country (in this case Austrialia).

It is not that the United States couldn't have had the vaccine in a timely manner....it is that we outsourced our vaccine production and now it is biting us in the keester.

This is of course, if the vaccine is proven to be safe.

http://news.smh.com.au/breaking-news-national/mass-h1n1-vaccinations-within-weeks-20090820-eqsu.html

Mass H1N1 vaccinations 'within weeks'</HEADLINE><!-- Class 'push-0' just right-aligns the element so that the main content comes first. -->
<!-- cT-storyDetails --><CITE>August 20, 2009 - 5:49AM</CITE>

<BOD>Pregnant women, health workers and the chronically ill will be given the first of millions of swine flu vaccinations to be available within weeks.
The federal government is about to take delivery of two million doses of swine flu vaccine by the end of the week, News Limited newspapers reported on Thursday.

More than 450,000 doses had been earmarked for Victoria.
Special immunisation clinics were likely to be set up in major hospitals, while GPs would also administer the vaccine.

If Australia's chief medical officer, Jim Bishop, approves of the mass vaccination, doses of the vaccine will be available from September 7, News Limited said.

Federal health authorities were still awaiting safety data from vaccine manufacturer CSL before approving the vaccination program.

The federal government has ordered 21 million doses of CSL's vaccine in all, should it be proven to work.

CSL spokeswoman Rachel David said trials had revealed no unexpected side effects, and the company would supply the vaccine in batches to the government until January.
 
Re: An Honest Vaccine Discussion with the Public

#23:

"Patients who have already had swine flu will be immune to it in the fall, Schaffner said.

Recovered patients shouldn?t count on having immunity unless their illness was confirmed by laboratory tests.


If they weren?t tested, they should get the vaccine to ensure they?re protected, he said."
 
Re: An Honest Vaccine Discussion with the Public

Originally Posted by Jeremy
Form my experience, there are many reasons people will choose to believe or disbelieve something, from religion, politics, science, facts, beliefs, word of mouth, a favorite celebrity, etc.....

Unfortuantly, for most, educating themselves on the facts is more of a challenge than picking up what another person says as truth....
What is really scarey is the number of people who refuse to search for the truth. They would rather believe whatever some person (who shares some of their personal biased beliefs) tells them. That large population is so easily manipulated. :rolleyes:
.
this is why they're called sheep.
 
Last edited:
Re: An Honest Vaccine Discussion with the Public

Form my experience, there are many reasons people will choose to believe or disbelieve something, from religion, politics, science, facts, beliefs, word of mouth, a favorite celebrity, etc.....

Unfortuantly, for most, educating themselves on the facts is more of a challenge than picking up what another person says as truth....

What is really scarey is the number of people who refuse to search for the truth. They would rather believe whatever some person (who shares some of their personal biased beliefs) tells them. That large population is so easily manipulated. :rolleyes:

.

Equally scary is the inability of many Americans to even seek out the truth....

<table class="Style1c" align="center" border="0" cellpadding="2" cellspacing="1" width="100%"><tbody> <tr valign="top"> <td width="78%">The Health Literacy of America’s Adults is the first release of the National Assessment of Adult Literacy (NAAL) health literacy results. The results are based on assessment tasks designed specifically to measure the health literacy of adults living in the United States. Health literacy was reported using four performance levels: Below Basic, Basic, Intermediate, and Proficient. The majority of adults (53 percent) had Intermediate health literacy. About 22 percent had Basic and 14 percent had Below Basic health literacy. Relationships between health literacy and background variables (such as educational attainment, age, race/ethnicity, where adults get information about health issues, and health insurance coverage) were also examined and reported. For example, adults with Below Basic or Basic health literacy were less likely than adults with higher health literacy to get information about health issues from written sources (newspapers, magazines, books, brochures, or the Internet) and more likely than adults with higher health literacy to get a lot of information about health issues from radio and television.</td></tr></tbody></table>
snipped from http://nces.ed.gov/pubsearch/pubsinfo.asp?pubid=2006483

I was just told by a teacher at my child's school that a survey of households in our district showed that approx 40% of people did not have access to the internet at home!
 
Re: An Honest Vaccine Discussion with the Public

this is why they're called sheep.

And how many shepherds even TRY to "convince" their sheep.

When I had a wether goat, "convincing" him entailed a short 2X4. :D

Perhaps the human version of a 2X4 is......when local hospital beds are filled with severely ill flu patients you know that if any of your family gets ill - there is no room for them.

.
 
Re: An Honest Vaccine Discussion with the Public

I was just told by a teacher at my child's school that a survey of households in our district showed that approx 40% of people did not have access to the internet at home!

That's one of the reasons why the main awareness must be trumpeted by TV.
 
Re: An Honest Vaccine Discussion with the Public

Perhaps the human version of a 2X4 is......when local hospital beds are filled with severely ill flu patients you know that if any of your family gets ill - there is no room for them.

And the sheeple nor the shepherds couldn't induct any augmentation of the hospital beds worldwide, in a bright new 21century.
 
Re: An Honest Vaccine Discussion with the Public

We are all part of somebody's herd. This social engineering study was done on college kids, so peer pressure may play a bigger part with that age group, but I bet it is a factor at any age if you are socially networked.

They mention personal experience as an overriding factor in decision making if I remember correctly. I feel like personal history with either disease or vaccinations would trump all else, unless you were in a really unique situation. (Like 1918?)

Federal Reserve Bank of Boston
November 6, 2007 Working Paper

http://www.bos.frb.org/economic/wp/wp2007/wp0712.pdf
Social Networks and Vaccination Decisions
 
Re: An Honest Vaccine Discussion with the Public

Issues with government policy single payer system for vaccines impedes the market. I interviewed him once for Court TV. He's an interesting man.

Over-Regulation by FDA Blocks Vaccine Advances
Health Care News > March 2006
Health Care
Health Care > FDA Reform

Email a Friend
Written By: Dr. Henry I. Miller
Published In: Health Care News > March 2006
Publication date: 03/01/2006
Publisher: The Heartland Institute

--------------------------------------------------------------------------------

Vaccination to prevent viral and bacterial diseases is modern medicine's most cost-effective intervention. Were a vaccine to be available quickly after the onset of the widely predicted pandemic from an H5N1 strain of avian influenza, for example, it might save scores of millions of lives worldwide--but that's not now feasible.

Congress and the federal government's executive branch have ensured low returns on investment and high exposure to legal liability for producers of vaccines. The predictable result: U.S. vaccine research, development, and production have been decimated.


Underpriced, Over-Regulated

The Vaccines for Children Program, a do-gooder innovation of the Clinton administration, disrupted market forces and dealt a blow to vaccine producers. Established in 1994, it created a single-buyer system for children's vaccines, making the government by far the largest purchaser of childhood vaccines--at a mandated discount of 50 percent.

Arbitrary and excessive regulation is another obstacle. The highly risk-averse U.S. Food and Drug Administration (FDA) has been especially tough on vaccines. The agency has rejected evidence of safety and efficacy from European and Canadian vaccine approvals; prematurely withdrawn life-saving products from the market because of mere perceptions of risk; and set the bar for the testing of new vaccines almost impossibly high.

As a result of our disastrous public policy, innovation has suffered and vaccine producers have abandoned the field in droves, leaving only four major American manufacturers and a few dozen products. As of the last flu season, there were only two producers of injectable flu vaccine for the U.S. market, and both were using antiquated technology.


Preparedness Doubtful

That brings us to the recent issue of the hour: a pandemic of H5N1 avian flu. We are woefully short of capacity to manufacture a vaccine against the pandemic strain, which cannot actually begin until we have it in hand and have "reverse engineered" the virus to prevent it from killing the chicken embryos in which it is grown.

An optimistic estimate is that there is sufficient flu vaccine capacity worldwide for approximately 450 million people--but that calculation assumes two inoculations of 15 micrograms each would confer protection, whereas in a recent trial of a vaccine against the current H5N1 strain, two doses of 90 micrograms were required. Other things being equal, this suggests the true capacity might be closer to being sufficient for only 75 million people. The world's population is more than six billion.

Another worry is that when a pandemic strain of H5N1 avian flu appears, virtually all of the world's flu-vaccine-development and production capacity will shift to producing a vaccine against it, which will leave us vulnerable to the non-pandemic strains that cause the usual annual or seasonal flu. The annual flu bug kills, on average, 30,000 to 40,000 Americans each year even when we have an effective, widely used vaccine. As Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases, has observed, "The biggest challenge unequivocally is vaccine production capacity."


Alternatives to Consider

Remedying that shortfall of production capacity won't be easy: Currently, it requires five to six years, and a massive investment, to build and validate a new manufacturing plant to the satisfaction of regulators. In the meantime, there are other possible approaches to making the vaccine we can produce go further.

A proven technique is the addition to vaccines of chemical ingredients known as adjuvants, which increase their effectiveness and make it possible to use lower doses of the vaccine antigens themselves.

Another complementary approach to conserving vaccine antigen was suggested by the work of researchers at the University of British Columbia, who used genetic engineering techniques to incorporate into vaccines two proteins that help cells of the immune system process foreign antigens. They found these proteins act as a potent booster, inducing the immunized recipient to produce more immunologically active cells against foreign antigens contained in the vaccines.

In their animal model, in which a challenge of a potentially lethal dose of virus was administered after vaccination, one of their engineered vaccines "provided protection against a lethal challenge ... at doses 100-fold lower" than controls that did not have the modification. (Their experiments involved several viruses, but not influenza.)

Another research group has taken a conceptually similar approach by genetically engineering an adenovirus, a virus that infects the membranes of the respiratory tract, eyes, intestines, or urinary tract, to produce the influenza H5 hemagglutinin, a capsid protein of the H5N1 virus. In testing on mice, they found their vaccine protected the animals from death and weight loss when challenged with H5N1 viruses, and that the protection was due, at least in part, to the induction of specific "killer T cells" that neutralized the virus.

The National Institute of Allergy and Infectious Diseases is funding yet another approach to optimize a limited vaccine supply: intradermal (under the skin) administration of the H5N1 vaccine, in order to ascertain whether a smaller intradermal dose is as effective as a larger dose administered intramuscularly (into the muscle, the usual route of immunization).


Federal Officials Created Problem

Which strategy should we adopt? My answer is all of the above and more.

Vaccines are widely acknowledged to have high "social value," but compared to therapeutic drugs their "economic value" to pharmaceutical companies is low. Because government miscues have caused rampant market failures in vaccine R&D, government actions must be an integral part of the solution to rewarding the creation, testing, and production of vaccines.

We need a variety of incentives to revitalize the portion of the private sector that has been battered by policymakers and regulators both to push forward good scientific ideas and to pull big drug makers into the field. Public policy must reward inputs on vaccine R&D (via grants and tax credits) and outputs of products (with guaranteed purchases, milestone payments when regulatory approval of new vaccines are granted, indemnification from liability claims, waiver of FDA user fees for vaccine reviews, and reciprocity between U.S. regulatory approvals and those in certain foreign countries).

Part of this effort should be aggressive funding of "proof of concept" R&D on various new technologies and approaches to making flu vaccine, to boosting the immune response, and to creating greater reserve capacity for the commercial production of vaccines. Finally, instead of being a major cause of the problem, regulators must become part of the solution.

Federal officials and lawmakers are largely responsible for the current lack of societal resilience needed to combat a flu pandemic. Now they must do more than fiddle while the flu fulminates.


--------------------------------------------------------------------------------

Henry I. Miller (miller@hoover.standford.edu), a physician and fellow at the Hoover Institution and Competitive Enterprise Institute, headed the FDA's Office of Biotechnology from 1989 to 1994. Barron's selected his most recent book, The Frankenfood Myth, as one of the 25 Best Books of 2004. This article is adapted from an essay published on Tech Central Station on February 1. Used with permission. To read the entire essay, go to http://www.tcsdaily.com/article.aspx?id=020106D.






http://www.heartland.org/publicatio...egulation_by_FDA_Blocks_Vaccine_Advances.html
 
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