SWINDLE FLU: Doctors laugh at consumers wanting shots

JR8805

TravisTheSky wrote:

JR8805 wrote:

If it's not scarce, why can't any of my family get the shot at any price--even my high-risk group daughter?

Here's one possible scenario: The reports of more deaths in Canada, and that mysterious 'plague' in Ukraine are going to make people demand the vac. The government/drug companies will swoop down to save us by saying, "We don't have enough doses to go around. So we're going to thin out the supply by adding Squalene. Trust us. We love you, and would never do anything to harm you."

Squalene is an adjuvant- an ingredient that massively overstimulates the immune system. Natural squalene is a fatty acid found in all animals. The manmade version of it is so similar that, when injected, it is likely to cause the human immune system to attack itself. Just as vaccines try to get the body to produce antibodies against a particular virus, antibodies can be made against squalene. Squalene is highly suspected of causing Gulf War Illness in soldiers given experimental Anthrax vaccines. Squalene was so deadly that the post-9/11 Smallox vaccine campaign was stopped.

Here's an article that summarises much of what is questionable and dangerous about the vaccine:
EDIT- Oops! Sorry, an annoying dialogue box pops up asking the reader to register. The article is so long, that copying and pasting it would take up way too much space here. http://articles.mercola.com/sites/articles/archive/2009/11/03/What-We-Have-Learned-About-the-Great-Swine-Flu-Pandemic.aspx Be sure to click on the blue 'References' under the article to see all of the sources. A few highlights of the article: Children under 3 have no antibody response from the shot. Only 35% of 3-9 year olds do. Taking the seasonal flu shot makes a person twice as likely to develop Swine Flu. (Cause and effect?) Flu deaths in small children multiplied when mass vaccination began, and have remained high. The CDC stopped testing patients for various strains of flu virus on August 30. Now any flu-like illness can be attributed to H1N1. "Far fewer people have died [from 2009 H1N1] than any seasonal flu in the past."

Go to http://www.fda.gov to read the package insert for the vaccine. It states, "May not protect all recipients." "Clinical studies are ongoing to determine the optimal dosage, number of doses, and schedule." "Specific levels of antibody titer post-vaccination have not been correlated with protection from influenza." The shots for people over 2 contain mercury, polyethylene glycol, gelatin (often bovine,) and cells from the host animal, a chicken embryo.

Like most vaccines, this one is Pregnancy Category C. It is not recommended for pregnant women. Flu shots have not even been tested on pregnant lab animals! "It is not known whether these vaccines can cause fetal harm or can affect reproductive capacity." Seasonal and Swine flu shots have NOT been, "Evaluated for carcinogenic or mutagenic potential, or for impairment of fertility."

"Immunologic response may be diminished" in anyone with a compromised immune system. (The old, the very young, people with asthma, allergies, diabetes, obesity, etc.) It is these already-ill people who are succumbing to this year's flu. Trying to prevent the thousands of viruses we may catch by having thousands of vaccinations is not healthy. We need to restore our immune systems naturally, with vitamins D3 and C. (Read up on how deficiencies in those 2 cause the deadly lung infections that kill people with influenza and pneumonia.) Probiotics, Omega-3s, sleep, fresh air, and exercise are consistently better disease-fighters than shots of heavy metal mixed with genetic material.

My favourite randomly-found internet quote of the week: "Were humans created to be this sick, or are we just programmed to believe this is normal?"

I'm a relatively terrible person in some ways. When someone starts to say things that aren't even a bit true, I just stop reading. Squalene is not even in any H1N1 vaccines being distributed to Americans. Squalene has been used in Europe since the 90s with no ill effects. Squalene is fish oil that is purified and then extremely diluted into the vaccine. I take fish oil capsules everyday...about 200 times more fish oil than there is in the vaccine. I'm not dead yet even though I have undoubtedly been popping squalene for years...in fact, my heart is more protected. Furthermore, squalene is found occurring naturally in humans. Yeah, your liver makes it, then it travels around in your bloodstream. You can find it in many kinds of foods you regularly eat, in cosmetics, in OTC drugs millions of people take every day, and in supplements (like my fish oil). "A few people have tried to link the health problems of Gulf War veterans to the possible presence of squalene in the vaccines these soldiers received. One published report suggested that some veterans who received anthrax vaccines developed anti-squalene antibodies and these antibodies caused disabilities. It is now known that squalene was not added to the vaccines administered to these veterans, and technical deficiencies in the report suggesting an association have been published." So, squalene could not have caused these people disabilities if it wanted to. So, all these odd stories floating around are just that--odd stories. Kinda like the "men can lick hands, too" stories...you're supposed to get a good scare until you realize...hey...it WAS just a scary story. Come on. If every one of our livers makes squalene which then travels around our bodies, just how scary can squalene be? Unless you are afraid of yourself and your liver, not very scary.

TravisTheSky

JR8805 wrote:

Squalene is not even in any H1N1 vaccines being distributed to Americans. Squalene has been used in Europe since the 90s with no ill effects. Squalene is fish oil that is purified and then extremely diluted into the vaccine. I take fish oil capsules everyday...about 200 times more fish oil than there is in the vaccine.

I wasn't talking about eating squalene. Injecting it so that it bypasses all of our first defenses, like the digestive tract, is very different. No, squalene is NOT in the American H1N1 shots yet. It's in "Pandremix," the British version. I've heard a lot of predictions that in order to increase supply, the government is going to allow squalene to be added. It hasn't happened so far.

TravisTheSky

scb wrote:

TravisTheSky wrote:

Like most vaccines, this one is Pregnancy Category C. It is not recommended for pregnant women.

Huh?? :?

Preganant women are in Group 1 - first on the list of people for whom the H1N1 flu shot IS recommended. Are you talking about the nasal spray vaccine or something?

On a brighter note... I'm happy to report that I just got my H1N1 shot! (And I haven't even died yet or developed autism or anything.)

As a nurse scb, PLEASE read the package inserts! I was quoting directly from Sanofi Pasteur's "Fluzone and Influenza A (H1N1) 2009 Monovalent." You can find it at http://www.fda.gov. I have not looked at the insert for the nasal vac, but the 4 or 5 different brands of injectable flu shots that are available this year are all Pregnancy Category C. They all have never been tested on the pregnant or the unborn. They have not been studied long-term to see if they cause cancer or infertility. It's the U.S. government stating this, not me! Much of what I type can be argued from 500 different viewpoints. But not this paragraph! Please print out the inserts and share them with your colleagues.

I was horrified to learn about the 'Vaccine Information Statements' that are given to people about to take the vaccine. They say that a person should not get the vaccine if he is allergic to any of the ingredients...but does not disclose what any of the ingredients are!!!
They also say, "Experts are confident that the pandemic H1N1 influenza vaccine will be safe and effective." Oh, great scientific method there!
"Vaccines that contain thimerosal are safe, including for pregnant women, their fetus [sic], and children 2-18 years of age." Hello! The package insert clearly states that the risk for pregnant women and the unborn is a giant unknown.

I'm pleased that you don't have any vaccine injuries. My baby niece developed pneumonia after the useless "seasonal" flu shot last month.

Jeanwah

TravisTheSky wrote:

scb wrote:

TravisTheSky wrote:

Like most vaccines, this one is Pregnancy Category C. It is not recommended for pregnant women.

Huh?? :?

Preganant women are in Group 1 - first on the list of people for whom the H1N1 flu shot IS recommended. Are you talking about the nasal spray vaccine or something?

On a brighter note... I'm happy to report that I just got my H1N1 shot! (And I haven't even died yet or developed autism or anything.)

As a nurse scb, PLEASE read the package inserts! I was quoting directly from Sanofi Pasteur's "Fluzone and Influenza A (H1N1) 2009 Monovalent." You can find it at http://www.fda.gov. I have not looked at the insert for the nasal vac, but the 4 or 5 different brands of injectable flu shots that are available this year are all Pregnancy Category C. They all have never been tested on the pregnant or the unborn. They have not been studied long-term to see if they cause cancer or infertility. It's the U.S. government stating this, not me! Much of what I type can be argued from 500 different viewpoints. But not this paragraph! Please print out the inserts and share them with your colleagues.

I was horrified to learn about the 'Vaccine Information Statements' that are given to people about to take the vaccine. They say that a person should not get the vaccine if he is allergic to any of the ingredients...but does not disclose what any of the ingredients are!!!
They also say, "Experts are confident that the pandemic H1N1 influenza vaccine will be safe and effective." Oh, great scientific method there!
"Vaccines that contain thimerosal are safe, including for pregnant women, their fetus [sic], and children 2-18 years of age." Hello! The package insert clearly states that the risk for pregnant women and the unborn is a giant unknown.

I'm pleased that you don't have any vaccine injuries. My baby niece developed pneumonia after the useless "seasonal" flu shot last month.

I don't know anything about pregnancy catogories, but wanted to add this:

There have been not enough (if any) testing on breast milk, or much of anything else stemming from a pregnant woman getting the H1N1 shot. It's well known that when you're pregnant, anything that goes into your system, goes into the baby's. So whatever side-effects or long-term effects of this "not-tested for safety enough" vaccine can do unknowing things to that baby. I would never take that risk for my baby, never.

polaris_x

latest stat i hear is 1 in 100,000 will have a severe reaction to the h1n1 shot ... i am not sure but i hear the adjuvanted vaccines is the primary one causing the reactions ... this ratio is better than the normal flu shot ...

JR8805

TravisTheSky wrote:

JR8805 wrote:

Squalene is not even in any H1N1 vaccines being distributed to Americans. Squalene has been used in Europe since the 90s with no ill effects. Squalene is fish oil that is purified and then extremely diluted into the vaccine. I take fish oil capsules everyday...about 200 times more fish oil than there is in the vaccine.

I wasn't talking about eating squalene. Injecting it so that it bypasses all of our first defenses, like the digestive tract, is very different. No, squalene is NOT in the American H1N1 shots yet. It's in "Pandremix," the British version. I've heard a lot of predictions that in order to increase supply, the government is going to allow squalene to be added. It hasn't happened so far.

There's no data showing it's bad for you if injected. In fact, the data points pretty much in the opposite direction of doing us no harm. Speaking of the UK and Europe, they've been adding squalene since the 90s. "Since 1997, tens of millions of doses of Fluad, the European vaccine that contains squalene, have been administered safely to patients in Germany and Italy." (Wired) Okay. So tens of millions of people have gotten squalene in vaccine form. There have been tens of millions dead or horribly crippled in Germany and Italy, too. Ha! They're not in any more trouble than us, but they have the potential to give many more people the vaccine than we do because we're easily scared, in some respects. We do believe the oddest stories. We're the kind of people that go nuts when a vaccine contains fish oil, but are the same kind of people that will take illegal drugs that might very well have come out of someone's ass...literally.

JR8805

TravisTheSky wrote:

scb wrote:

TravisTheSky wrote:

Like most vaccines, this one is Pregnancy Category C. It is not recommended for pregnant women.

Huh?? :?

Preganant women are in Group 1 - first on the list of people for whom the H1N1 flu shot IS recommended. Are you talking about the nasal spray vaccine or something?

On a brighter note... I'm happy to report that I just got my H1N1 shot! (And I haven't even died yet or developed autism or anything.)

As a nurse scb, PLEASE read the package inserts! I was quoting directly from Sanofi Pasteur's "Fluzone and Influenza A (H1N1) 2009 Monovalent." You can find it at http://www.fda.gov. I have not looked at the insert for the nasal vac, but the 4 or 5 different brands of injectable flu shots that are available this year are all Pregnancy Category C. They all have never been tested on the pregnant or the unborn. They have not been studied long-term to see if they cause cancer or infertility. It's the U.S. government stating this, not me! Much of what I type can be argued from 500 different viewpoints. But not this paragraph! Please print out the inserts and share them with your colleagues.

I was horrified to learn about the 'Vaccine Information Statements' that are given to people about to take the vaccine. They say that a person should not get the vaccine if he is allergic to any of the ingredients...but does not disclose what any of the ingredients are!!!
They also say, "Experts are confident that the pandemic H1N1 influenza vaccine will be safe and effective." Oh, great scientific method there!
"Vaccines that contain thimerosal are safe, including for pregnant women, their fetus [sic], and children 2-18 years of age." Hello! The package insert clearly states that the risk for pregnant women and the unborn is a giant unknown.

I'm pleased that you don't have any vaccine injuries. My baby niece developed pneumonia after the useless "seasonal" flu shot last month.

The seasonal flu shot might have been useless for your niece, but it didn't cause the pneumonia. I believe that youngsters under the age of 10 are supposed to get two flu shots, anyway, about a month apart before fuller immunity occurs. I once got the flu a little more than a week after getting a flu shot, but the shot didn't cause it. I didn't have immunity yet and came across the flu, which was rather abundant at my job. And I got it. All the other flu shots I've gotten have protected me all the way (even the failure was a big help in making it the best, shortest flu ever), and now I understand that having gotten last year's seasonal may be of some help to you in protecting you against the H1N1 this year. http://www.usatoday.com/news/health/200 ... tion_N.htm My understanding from another article I recently read but can't quote right offhand here is that repeated seasonal vaccines also appear to be shielding us somewhat.

_

TravisTheSky wrote:

As a nurse scb,

For the record, I'm not a nurse.

TravisTheSky

scb wrote:

TravisTheSky wrote:

As a nurse scb,

For the record, I'm not a nurse.

I'm sorry, I thought you were. I must be combining you with other posters.

warmbreath

polaris_x wrote:

latest stat i hear is 1 in 100,000 will have a severe reaction to the h1n1 shot ... i am not sure but i hear the adjuvanted vaccines is the primary one causing the reactions ... this ratio is better than the normal flu shot ...

The problem is what is used as an adjuvant, water is used in more modern vaccines, and thats not a problem. The older ones have the harmful additive. Strangley Americans in general dont even know there is an adjuvant issue or even that vaccines have them or that its a real issue in other countries. There are people here who object to the preservative Thimerisol, with its mercury, but again most just stick their arm out, or on the other end wont go at all because they have vaguely heard of some additive problems, but they dont look into it, just wont have the vaccine. We had a clinic in my county this week where 3000 doses were held back for kids with known risk factors, and personal invites were sent to their homes, but only 345 kids showed. The invites were sent pretty late, and the parent has to be there so that meant the parents had to be there, and now the County health Dept is getting the clus that people in this area dont have fancy jobs and cant just take off work, you are likely to get fired, 100 people are lined up for your $10 hr jobs. As for vaccine supply in America we have only one company left that makes vaccines in America, so we are in line behind the countries who manufactur them. If American business doesnt come back on shore our goose is cooked in countless ways. We have have just given then country away with treaties and tax breaks on both ends. And then they import illegals for the farming, construction, even electrician and many other jobs, our goose is cooked, but not for Thanksgiving. Ed said in 91, "there aint gonna be any middle anymore" and boy was he right. Sandy

_

TravisTheSky wrote:

scb wrote:

TravisTheSky wrote:

Like most vaccines, this one is Pregnancy Category C. It is not recommended for pregnant women.

Huh?? :?

Preganant women are in Group 1 - first on the list of people for whom the H1N1 flu shot IS recommended. Are you talking about the nasal spray vaccine or something?

On a brighter note... I'm happy to report that I just got my H1N1 shot! (And I haven't even died yet or developed autism or anything.)

As a nurse scb, PLEASE read the package inserts! I was quoting directly from Sanofi Pasteur's "Fluzone and Influenza A (H1N1) 2009 Monovalent." You can find it at http://www.fda.gov. I have not looked at the insert for the nasal vac, but the 4 or 5 different brands of injectable flu shots that are available this year are all Pregnancy Category C. They all have never been tested on the pregnant or the unborn. They have not been studied long-term to see if they cause cancer or infertility. It's the U.S. government stating this, not me! Much of what I type can be argued from 500 different viewpoints. But not this paragraph! Please print out the inserts and share them with your colleagues.

I was horrified to learn about the 'Vaccine Information Statements' that are given to people about to take the vaccine. They say that a person should not get the vaccine if he is allergic to any of the ingredients...but does not disclose what any of the ingredients are!!!
They also say, "Experts are confident that the pandemic H1N1 influenza vaccine will be safe and effective." Oh, great scientific method there!
"Vaccines that contain thimerosal are safe, including for pregnant women, their fetus [sic], and children 2-18 years of age." Hello! The package insert clearly states that the risk for pregnant women and the unborn is a giant unknown.

I'm pleased that you don't have any vaccine injuries. My baby niece developed pneumonia after the useless "seasonal" flu shot last month.

You conveniently left out the other information provided by the FDA regarding pregnant women:

Use of Influenza A (H1N1) 2009 Monovalent Influenza Vaccine in Pregnant Women
http://www.fda.gov/BiologicsBloodVaccines/Vaccines/QuestionsaboutVaccines/ucm188099.htm

• Pregnant women, compared to the general population, are at increased risk for severe disease and serious complications, including death, from influenza. Pregnant women who are otherwise healthy have been severely impacted by the pandemic 2009 H1N1 influenza virus (formerly called “novel H1N1 flu” or “swine flu”). In comparison to the general population, a greater proportion of pregnant women infected with the pandemic 2009 H1N1 influenza virus have been hospitalized and died. This is why pregnant women are among the highest priority groups for immunization.

• The CDC and its ACIP recommend that pregnant women receive both the inactivated Influenza A H1N1 (2009) monovalent vaccine and the inactivated seasonal influenza vaccine during any stage of pregnancy. These recommendations are based on the increased risks of influenza and its complications for pregnant women, the protection that the influenza vaccines can provide for both pregnant women and their newborns, and the track record of safety of the licensed inactivated seasonal influenza vaccines.

• Influenza vaccines, both seasonal and the recently licensed Influenza A (H1N1) 2009 monovalent vaccines, are not contraindicated for use in pregnancy. As with many other vaccine products, the manufacturers did not conduct clinical studies specifically to evaluate the influenza vaccines in pregnant women prior to approval of these vaccines. Therefore, the pregnancy section of the prescribing information for the licensed influenza vaccines carry either a Category B or C. This allows influenza vaccines to be given to pregnant women if there is a determination that the vaccine is clearly needed, as recommended by the ACIP.

• FDA supports the recommendation of CDC and the ACIP that pregnant women receive vaccinations to help protect them against both the pandemic 2009 H1N1 influenza virus and seasonal influenza.

• Studies of several thousand pregnant women in the scientific literature have shown that inactivated seasonal influenza vaccines are safe during pregnancy. They have shown no evidence for harm to pregnant women, the pregnancy or to newborns of vaccinated women. In addition, FDA and CDC’s routine monitoring of adverse events has not raised safety concerns.

• The FDA-approved Influenza A (H1N1) 2009 monovalent vaccines are made in the same licensed facilities and with the same manufacturing processes used to safely produce hundreds of millions of doses of seasonal influenza vaccine every year.

• In addition, before they can be used, all Influenza A (H1N1) 2009 monovalent vaccines must undergo the same rigorous FDA manufacturing oversight, product quality testing and lot release procedures that apply to seasonal influenza vaccines.

• Because of the scientific information in the literature, the fact that FDA-licensed manufacturers are producing the Influenza A (H1N1) 2009 monovalent vaccine following the same processes as for their seasonal influenza vaccines, and FDA-oversight of manufacturing, product quality testing and lot release procedures, FDA has a high degree of assurance of the safety of both seasonal and Influenza A (H1N1) 2009 monovalent vaccines for pregnant women.

_

As a person who supposedly represents medical opinion to people on the internet, TravisTheSky, PLEASE read and represent the whole story.

The package insert to which you refer states that "Animal reproduction studies have not been conducted with Influenza A (H1N1) 2009 Monovalent Vaccine or Fluzone vaccine" from that manufacturer - and they say this to cover their own asses.

While no one is saying here that we possess ALL possible knowledge about this vaccine (or any other medical issue), the FDA has judged - based on the knowledge they have about the safety of other flu vaccines produced in the exact same way, as well as lack of any information to the contrary - that the H1N1 vaccine is safe for pregnant women. And - based on all the knowledge we have about how H1N1 is having a disproportionately adverse effect on pregnant women - the FDA, CDC, & ACIP all agree that it is more beneficial than risky for pregnant women to get this shot.

Translation: We have no reason to believe that the H1N1 vaccine is harmful to pregnant women and every reason to believe that the H1N1 flu is especially harmful to pregnant women. We also know that the H1N1 vaccine is protective against the H1N1flu. So, according to the very best of our knowledge, pregnant women should get vaccinated.

Analogy: Saying pregnant women shouldn't get the H1N1 vaccination because there haven't been reproduction studies done in animals for this specific version of the flu vaccine is like saying pregnant women shouldn't eat broccoli - despite all its known benefits - because we haven't specifically tested the effects of broccoli on pregnancy. Or like saying blondes shoudln't wear seat belts because we haven't specifically tested the effects of seat belts on blonde people. (Okay, that last one is a little bit of a stretch. But only a little, and hopefully it gets the point across.)

Pepe Silvia

scb wrote:

As a person who supposedly represents medical opinion to people on the internet, TravisTheSky, PLEASE read and represent the whole story.

The package insert to which you refer states that "Animal reproduction studies have not been conducted with Influenza A (H1N1) 2009 Monovalent Vaccine or Fluzone vaccine" from that manufacturer - and they say this to cover their own asses.

While no one is saying here that we possess ALL possible knowledge about this vaccine (or any other medical issue), the FDA has judged - based on the knowledge they have about the safety of other flu vaccines produced in the exact same way, as well as lack of any information to the contrary - that the H1N1 vaccine is safe for pregnant women. And - based on all the knowledge we have about how H1N1 is having a disproportionately adverse effect on pregnant women - the FDA, CDC, & ACIP all agree that it is more beneficial than risky for pregnant women to get this shot.

Translation: We have no reason to believe that the H1N1 vaccine is harmful to pregnant women and every reason to believe that the H1N1 flu is especially harmful to pregnant women. We also know that the H1N1 vaccine is protective against the H1N1flu. So, according to the very best of our knowledge, pregnant women should get vaccinated.

Analogy: Saying pregnant women shouldn't get the H1N1 vaccination because there haven't been reproduction studies done in animals for this specific version of the flu vaccine is like saying pregnant women shouldn't eat broccoli - despite all its known benefits - because we haven't specifically tested the effects of broccoli on pregnancy. Or like saying blondes shoudln't wear seat belts because we haven't specifically tested the effects of seat belts on blonde people. (Okay, that last one is a little bit of a stretch. But only a little, and hopefully it gets the point across.)

correct me if i'm wrong but i thought the FDA didn't actually do any research themselves, they simply accept what's given to them by the company pushing their product....

TravisTheSky

scb wrote:

You conveniently left out the other information..."

As a person who supposedly represents medical opinion to people on the internet, TravisTheSky, PLEASE read and represent the whole story.

The package insert to which you refer states that "Animal reproduction studies have not been conducted with Influenza A (H1N1) 2009 Monovalent Vaccine or Fluzone vaccine" from that manufacturer - and they say this to cover their own asses.

We also know that the H1N1 vaccine is protective against the H1N1flu.

I have conveniently omitted the millions of articles that I have not read. That is a true fact!

The 'whole story?!' I could include thousands of anti-vaccine articles. You could add thousands of pro-vaccine ones. We would not come close to covering the whole story.

"Cover their asses" from what? Lawsuits of victims?

The package insert does not state that it protects against flu.

_

TravisTheSky wrote:

scb wrote:

You conveniently left out the other information..."

As a person who supposedly represents medical opinion to people on the internet, TravisTheSky, PLEASE read and represent the whole story.

The package insert to which you refer states that "Animal reproduction studies have not been conducted with Influenza A (H1N1) 2009 Monovalent Vaccine or Fluzone vaccine" from that manufacturer - and they say this to cover their own asses.

We also know that the H1N1 vaccine is protective against the H1N1flu.

I have conveniently omitted the millions of articles that I have not read. That is a true fact!

The 'whole story?!' I could include thousands of anti-vaccine articles. You could add thousands of pro-vaccine ones. We would not come close to covering the whole story.

"Cover their asses" from what? Lawsuits of victims?

The package insert does not state that it protects against flu.

Okay, to recap...
You said about the H1N1 vaccine: “It is not recommended for pregnant women.”
To which I said: “Huh?? It IS recommended for pregnant women.”
To which you replied: “They all have never been tested on the pregnant or the unborn. They have not been studied long-term to see if they cause cancer or infertility. It's the U.S. government stating this, not me!”

I think the implication of your statements is that the government is saying the shot isn’t safe for pregnant women. I’m simply pointing out that that’s the exact opposite of the truth. Just because a package insert from a pharmaceutical company that can be accessed through a government website states that not every test known to man has been done regarding this particular variation of the flu shot and pregnant women DOES NOT mean that the government (or any reputable healthcare related organization, including the pharm company itself) is saying that pregnant women shouldn’t get the shot. Your implication is completely misleading.

_

Pepe Silvia wrote:

scb wrote:

As a person who supposedly represents medical opinion to people on the internet, TravisTheSky, PLEASE read and represent the whole story.

The package insert to which you refer states that "Animal reproduction studies have not been conducted with Influenza A (H1N1) 2009 Monovalent Vaccine or Fluzone vaccine" from that manufacturer - and they say this to cover their own asses.

While no one is saying here that we possess ALL possible knowledge about this vaccine (or any other medical issue), the FDA has judged - based on the knowledge they have about the safety of other flu vaccines produced in the exact same way, as well as lack of any information to the contrary - that the H1N1 vaccine is safe for pregnant women. And - based on all the knowledge we have about how H1N1 is having a disproportionately adverse effect on pregnant women - the FDA, CDC, & ACIP all agree that it is more beneficial than risky for pregnant women to get this shot.

Translation: We have no reason to believe that the H1N1 vaccine is harmful to pregnant women and every reason to believe that the H1N1 flu is especially harmful to pregnant women. We also know that the H1N1 vaccine is protective against the H1N1flu. So, according to the very best of our knowledge, pregnant women should get vaccinated.

Analogy: Saying pregnant women shouldn't get the H1N1 vaccination because there haven't been reproduction studies done in animals for this specific version of the flu vaccine is like saying pregnant women shouldn't eat broccoli - despite all its known benefits - because we haven't specifically tested the effects of broccoli on pregnancy. Or like saying blondes shoudln't wear seat belts because we haven't specifically tested the effects of seat belts on blonde people. (Okay, that last one is a little bit of a stretch. But only a little, and hopefully it gets the point across.)

correct me if i'm wrong but i thought the FDA didn't actually do any research themselves, they simply accept what's given to them by the company pushing their product....

I’m not sure I understand your point or what you mean by “do” the research, but it sounds below like the research is done through / overseen by the FDA:

http://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/BiologicsLicenseApplicationsBLAProcess/ucm133096.htm

Vaccine Product Approval Process

FDA's Center for Biologics Evaluation and Research (CBER) is responsible for regulating vaccines in the United States. Current authority for the regulation of vaccines resides primarily in Section 351 of the Public Health Service Act and specific sections of the Federal Food, Drug and Cosmetic Act.

Vaccine clinical development follows the same general pathway as for drugs and other biologics. A sponsor who wishes to begin clinical trials with a vaccine must submit an Investigational New Drug application (IND) to FDA. The IND describes the vaccine, its method of manufacture, and quality control tests for release. Also included are information about the vaccine's safety and ability to elicit a protective immune response (immunogenicity) in animal testing, as well as the proposed clinical protocol for studies in humans.

Pre-marketing (pre-licensure) vaccine clinical trials are typically done in three phases, as is the case for any drug or biologic. Initial human studies, referred to as Phase 1, are safety and immunogenicity studies performed in a small number of closely monitored subjects. Phase 2 studies are dose-ranging studies and may enroll hundreds of subjects. Finally, Phase 3 trials typically enroll thousands of individuals and provide the critical documentation of effectiveness and important additional safety data required for licensing. At any stage of the clinical or animal studies, if data raise significant concerns about either safety or effectiveness, FDA may request additional information or studies, or may halt ongoing clinical studies.

If successful, the completion of all three phases of clinical development can be followed by the submission of a Biologics License Application (BLA). To be considered, the license application must provide the multidisciplinary FDA reviewer team (medical officers, microbiologists, chemists, biostatisticians, etc.) with the efficacy and safety information necessary to make a risk/benefit assessment and to recommend or oppose the approval of a vaccine. Also during this stage, the proposed manufacturing facility undergoes a pre-approval inspection during which production of the vaccine as it is in progress is examined in detail.

Following FDA's review of a license application for a new indication, the sponsor and the FDA may present their findings to FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC). This non-FDA expert committee (scientists, physicians, biostatisticians, and a consumer representative) provides advice to the Agency regarding the safety and efficacy of the vaccine for the proposed indication.

Vaccine approval also requires the provision of adequate product labeling to allow health care providers to understand the vaccine's proper use, including its potential benefits and risks, to communicate with patients and parents, and to safely deliver the vaccine to the public.

The FDA continues to oversee the production of vaccines after the vaccine and the manufacturing processes are approved, in order to ensure continuing safety. After licensure, monitoring of the product and of production activities, including periodic facility inspections, must continue as long as the manufacturer holds a license for the product. If requested by the FDA, manufacturers are required to submit to the FDA the results of their own tests for potency, safety, and purity for each vaccine lot. They may also required to submit samples of each vaccine lot to the FDA for testing. However, if the sponsor describes an alternative procedure which provides continued assurance of safety, purity and potency, CBER may determine that routine submission of lot release protocols (showing results of applicable tests) and samples is not necessary.

Until a vaccine is given to the general population, all potential adverse events cannot be anticipated. Thus, many vaccines undergo Phase 4 studies-formal studies on a vaccine once it is on the market. Also, the government relies on the Vaccine Adverse Event Reporting System (VAERS) to identify problems after marketing begins. The VAERS system and how it works is discussed further on this website.

References
• National Vaccine Advisory Committee. "United States Vaccine Research: A Delicate Fabric of Public and Private Collaboration." Pediatrics, Vol 100(6), Dec.1997, pp. 1015-1020.
• Parkman PD, Hardegree MC. "Regulation and Testing of Vaccines." In Plotkin SA, Orenstein WA, [eds.]. Vaccines, 3d ed. Philadelphia: Saunders; 1999, pp.1131-1143.
• Stehlin, Isadora. "How FDA Works to Ensure Vaccine Safety." FDA Consumer Magazine, March 1996.

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TravisTheSky wrote:

scb wrote:

You conveniently left out the other information..."

As a person who supposedly represents medical opinion to people on the internet, TravisTheSky, PLEASE read and represent the whole story.

The package insert to which you refer states that "Animal reproduction studies have not been conducted with Influenza A (H1N1) 2009 Monovalent Vaccine or Fluzone vaccine" from that manufacturer - and they say this to cover their own asses.

We also know that the H1N1 vaccine is protective against the H1N1flu.

I have conveniently omitted the millions of articles that I have not read. That is a true fact!

The 'whole story?!' I could include thousands of anti-vaccine articles. You could add thousands of pro-vaccine ones. We would not come close to covering the whole story.

Perhaps "bottom line" would have been a more appropriate phrase than "whole story". You quoted something on the FDA website as if that's was the whole story, but conveniently left out the bottom line, the upshot, the end result of what the FDA has to say about it.

TravisTheSky wrote:

"Cover their asses" from what? Lawsuits of victims?

Sure, if you want to put it that way. Anything's possible. Maybe some random pregnant woman out of the millions of pregnant women who get this vaccine could have an adverse event that is perceived (accurately or not) to be a result of the vaccine. In this modern American world of lawsuits, it makes sense for the vaccine manufacturers to want to cover their asses by saying "WE never said it was safe for pregnant women." But you'll note that they also haven't said it's NOT safe for pregnant women.

TravisTheSky wrote:

The package insert does not state that it protects against flu.

Uh, I never said the package states that it protects against the flu.

haffajappa

My mom tried to bribe me to take the shot.
:roll:

haffajappa

lukin2006 wrote:

Here in Canada we have already spent 1.5 billion vaccinating the high priority people, it is expected to go well over 2 billion (flu shot here is free). I work for a school board and they have taken custodians off their regular jobs to go around and wipe all door knobs, sink fixtures and other surfaces touched regularly twice a day, what a waste of time and money. I would be interested to know how much this will cost the government and business's at the end of the day.

everything is kind of getting ridiculous.
BC Soccer Association forwarded an email 2 weeks ago we're not allowed to shake hands after the games anymore. We have to stand across the field and wave "good game" like idiots.

Commy

haffajappa wrote:

lukin2006 wrote:

Here in Canada we have already spent 1.5 billion vaccinating the high priority people, it is expected to go well over 2 billion (flu shot here is free). I work for a school board and they have taken custodians off their regular jobs to go around and wipe all door knobs, sink fixtures and other surfaces touched regularly twice a day, what a waste of time and money. I would be interested to know how much this will cost the government and business's at the end of the day.

everything is kind of getting ridiculous.
BC Soccer Association forwarded an email 2 weeks ago we're not allowed to shake hands after the games anymore. We have to stand across the field and wave "good game" like idiots.

you have to be joking.