While waiting for a friend at my local health center, I was reading a poster hanging on the wall listing who they recommend get the H1N1 vaccine. Among those they considered “at risk” and candidates for getting the vaccine were pregnant women. This didn’t sound right. I had already read about the numerous risks associated with the vaccine and knew from my previous pregnancies that several vaccines are counter indicated for pregnant women as stated by the Center for Disease Control (CDC).

Not only was my local clinic advising pregnant women to get the H1N1 vaccine, but so was the CDC and the FDA, despite the fact that it was not rigorously tested for safety and the fact that some of the ingredients have not been proven to be safe, such as themerosal. In fact, my state lifted the ban on mercury-containing vaccines to pregnant women and children under 3 despite the fact that in July 1999, the Public Health Service agencies, the American Academy of Pediatrics and vaccine manufacturers agreed that thimerosal should be reduced or eliminated in vaccines.  In another contradictory statement the FDA says that “depending on the vaccine formulations used and the weight of the infant, some infants could have been exposed to cumulative levels of mercury during the first six months of life that exceeded EPA recommended guidelines for safe intake of methylmercury”.  Additional exposure in utero to mercury in vaccines the mother received add to this load.

Furthermore, in New ACIP Guidelines: Guidance for Vaccine Recommendations in Pregnant and Breastfeeding Women, the CDC states that:

1. “If a live-virus vaccine is inadvertently given to a pregnant woman, or if a woman becomes pregnant within 4 weeks after vaccination, she should be counseled about the potential effects on the fetus.”

Some advise I learned from a doctor friend of mine was to always take the vaccine inserts and keep them in a safe place, in case you have an adverse reaction and need to report it to the Vaccine Adverse Event Reporting System. However, he didn’t advise me to read the insert before the vaccine is injected. Most of us assume that if our doctor gives us a shot, it should be safe. Well, if they were 100% safe, there would be no need for the VAERS.

Whose responsibility is it to educate us about  unsafe ingredients such as themerosal and adjuvants such as squalene or possible adverse reactions? If you educate yourself and read the insert for Influenza A (H1N1) 2009 Monovalent vaccine you would learn that:

Safety and effectiveness of Influenza A (H1N1) 2009 Monovalent Vaccine have not been established in pregnant women or nursing mothers and in the pediatric population below 6 months of age.

It is also not known whether these vaccines can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Influenza A (H1N1) 2009 Monovalent Vaccine should be given to a pregnant woman only if clearly needed.

Because many drugs are excreted in human milk, caution should be exercised when Influenza A (H1N1) 2009 Monovalent Vaccine is administered to a nursing woman.

This last statement is contradicted by the CDC in it’s “Questions and Answers for Patients” page where it clearly states that “both seasonal and 2009 H1N1 flu vaccines should be given to breastfeeding mothers and breastfeeding women can receive either the shot or the nasal spray form of the vaccine.” There is nothing in this statement that advises breastfeeding mothers to be cautious.

I wonder if the FDA, CDC or the OBGYN’s  at my clinic have read these inserts.

For more on this conflicting information:

Medical Doctor Retracts H1N1 Vaccine Advice After Reading Insert!

The ‘big lie’: H1N1 coincidences, contradictions and conspiring

This is going to be a public relations, trust your government and your health officials campaign.

More H1N1 and vaccine truth serum for ya. I was impressed with Dr. Larry Palevsky, who Dr. Mercola interviewed in Nov. 2009. This audio show is very rational and full of documentation and facts. Palevsky goes to great lengths to avoid making unsubstantiated claims. Very enlightening!

(This was compiled from a multi-part YouTube video series.)

YouTube Playlist (play segments continuously)

Mercola Website Article on the Palevsky Vaccine Interview

Mercola & Polevsky – Vaccine & Swine Flu Interview

Video page updated…added videos on vaccines, aspartame, fluoride, true origins of AIDS and other biological weapons
Health
click here

The Centers for Disease Control and Prevention (CDC) and the National Institute of Allergy and Infectious Diseases (NIAID) offer these flu facts to help the American people understand the safety and effectiveness of the H1N1 flu vaccine.

1.The 2009 H1N1 flu vaccine is safe and well tested.

Clinical trials conducted by the National Institutes of Health and the vaccine manufacturers have shown that the new H1N1 vaccine is both safe and effective. The FDA has licensed it. There have been no safety shortcuts.

It is produced exactly the same way the seasonal flu vaccine is produced every year. It is simply a new virus strain. In fact, had H1N1 struck this country earlier than this spring, the H1N1 strain probably would have been included as part of this year’s seasonal flu shot.

Millions of Americans get the seasonal flu vaccine each year without any problems. Still, since some Americans have concerns about “new” vaccines, the NIH and the vaccine manufacturers have conducted more thorough tests on the H1N1 vaccine than they do on other flu vaccines. There have been no red flags from these clinical trials.

The risk of the flu, especially for pregnant women, children, and people with underlying health conditions, is higher than any risk that might come from the H1N1 vaccine.

2. Pregnant women should definitely get the 2009 H1N1 flu vaccine.

Changes to a pregnant woman’s immune system can make her more sensitive to the flu and result in serious complications if she is infected with H1N1. If you are pregnant, you should get vaccinated against H1N1 as soon as possible. Your vaccination can potentially protect your unborn child from infection.

3. You need only one dose of the H1N1 vaccine.

Good news from our clinical trials being run by the National Institutes of Health and the flu vaccine manufacturers: The H1N1 vaccine is a really good match with the H1N1 virus currently circulating across the country. Healthy adults and children 10 and older will need only one dose of vaccine.

It’s also fine to get the seasonal flu shot and the H1N1 shot at the same time. But if you get the nasal spray form of the vaccine, you need to wait three to four weeks before getting another nasal spray vaccine.

4. Flu shots are vaccines from dead or inactivated forms of the flu virus.

Both the seasonal and 2009 H1N1 flu shots are vaccines that contain killed/inactivated influenza virus. The nasal spray H1N1 vaccine contains a live, but weakened, form of the virus that does not cause flu illness.

5. Healthy people are in danger from the new 2009 H1N1 virus, and they should get vaccinated.

Both healthy people and people with underlying health conditions, such as asthma and diabetes and other chronic diseases, are at risk from the 2009 H1N1 flu. In CDC studies, about 70 percent of people who have been hospitalized with this 2009 H1N1 virus have had one or more medical conditions that place them at “high risk” of serious seasonal flu-related complications. Thirty percent of those hospitalized were previously healthy.

The 2009 H1N1 flu has especially affected young people ages 5 to 24. A recent study in the New England Journal of Medicine of 272 hospitalized H1N1 patients showed that 60 percent of the children who were hospitalized had an underlying condition. The remaining 40 percent had no underlying condition.

Read More “Avoiding the Flu” Articles

Avoiding the Flu / What You Can Do to Stop the Flu

T cells are key players in the immune response to HIV, which are able to delete infected cells. This capacity is used for vaccine development against HIV. “To date however, success of this strategy remains elusive. Our understanding of T cell efficacy is still limited, and we need to identify precise T cell correlates of protection that could guide rationale vaccine design”, says Victor Appay, Group leader HIV Pathogenesis and Immunosenescence, Hopital Pitie-Salpetriere, Paris, at the 2nd European Congress of Immunology ECI 2009 in Berlin.

Can you please explain in layman’s terms the role of T-cells, in particular the  differences between CD4+ and CD8+ cells?

T cells represent one important arm of our defenses against foreign pathogens, also known as the immune system. Together with B cells, T cells permit the establishment of immunological memory: that is to say the capacity of our immune system to remember pathogens and to mount swifter and more vigorous immune responses during the second encounter with a given pathogen. This is the founding principle of vaccinology.

While the role of B cells is to produce antibodies which neutralize foreign pathogens, the role of the T cells is more complex. T cells are divided into two main groups: CD4+ and CD8+ T cells. The principal function of the CD4+ T cells is to coordinate the immune response and they are referred to as helper T cells. They direct, boost but also suppress the immune response (e.g. influencing directly the function of B cells or CD8+ T cells) so that it adapts to the circumstances (like the type of pathogen, the stage of the infection). In contrast, CD8+ T cells present direct effector functions against pathogens. They recognize and kill virus infected cells, in order to limit viral replication, and are often referred to as cytotoxic T cells. CD4+ and CD8+ T cells are thus major players of our immune response against viruses, including HIV.

How are those cells affected during HIV infection?

CD4+ T cells are the main targets of HIV, in which the virus enters and replicates. The infection of CD4+ T cells represent the most fundamental event in HIV infection. The resulting depletion of these key cells by the virus leads to a progressive decline of our immune system competence, and eventually the onset of immunodeficiency.

Although they are not infected, CD8+ T cells can also be affected during HIV infection. The failure of our immune system to eliminate HIV, and the ability of the virus to establish persisting infection in its host imply that CD8+ T cells are continuously mobilized in order to kill virus infected cells and limit viral spread. This can result in the exhaustion of these cells, and thus weaken their capacity to control the virus.

What is T-cell efficacy and why is the scientific community’s understanding of it limited?

T-cell efficacy refers to the ability of T cells to control HIV replication effectively. Based on the evidence of the role of T cells, in particular the CD8+ ones, against HIV, scientists have focused much efforts on the development of vaccines able to induce anti-HIV CD8+ T cells, with the premise that this would be sufficient to control the virus. Two years ago, the results of a large clinical trial were revealed and showed that despite the induction of anti-HIV CD8+ T cells in HIV non infected vaccinees, this had no effect on preventing HIV infection or on decreasing viral replication in vaccinees who got infected. This highlighted that our understanding of T-cell efficacy is still limited. In their fight against HIV, not all T cells are equally effective at controlling the virus.

Can you describe your research, how you came to work on it, and what you hoped to find?

Our research focuses on defining T-cell correlates of efficacy, that is to say specific attributes of T cells which are associated with a better control of HIV replication in infected donors. In contrast to initial belief, the T-cell compartment is actually very heterogeneous, and consists in a variety of T cell subpopulations with different functional capacities and ability to control pathogens like HIV.

Since the early days, my work has concentrated on the characterization of T cells, to understand their function and the role of distinct T cell subpopulations in the immune response. Applying this knowledge to HIV research is a natural move. Identifying the subsets of T-cells that are able to suppress viral replication in HIV infected patients (e.g. those who do not progress towards AIDS) and decipher the T-cell attributes and mechanisms which permit this control are important for vaccine development. This will indeed guide the design of candidate vaccines, in order that these vaccines can induce T-cells with such advantageous attributes in men.

What separates your approach towards vaccine development from other methods currently being explored?

Our approach focuses on the importance of the T-cell sensitivity for the antigen, that is to say the avidity of the T cell for its target, in this case, the HIV infected cell. High avidity T cells can recognize more quickly and eliminate more efficiently target cells, compared to low avidity counterparts. These concepts have been particularly studied in the context of cancer research, where scientists aim at improving the sensitivity of the T cells for the cancer cell targets and thus T-cell efficacy against tumors in patients.

In HIV research, this approach is only emerging. However, recent works, including ours, indicates that T cells with high sensitivity for HIV antigens are indeed associated with a superior control of HIV replication. Importantly, fundamental studies in animal models suggest that it is possible to influence the T-cell sensitivity or avidity using adjuvants which could be developed for use in human vaccines.

Finally, what is your honest assessment of the state of HIV-vaccine development? Also, with regards to the recent Thai trial, which side do you fall on? Do you feel the researchers and the assessment of their data were overly optimistic (even skewed) or were they stating honest assessments?

Over the past quarter century, colossal progress in our understanding of HIV pathogenesis has been achieved. Yet, we have no solution to the pandemic; the search for an HIV vaccine remains among the highest public health priorities. The HIV community may be realizing that true rational vaccine design is only starting now, and that before was just a warm-up exercise. A highly complex task lies ahead of us, but we have encouraging directions and hope that success is in our reach.

In my opinion, the results of the recent Thai trial are good news. Assessment of the data is fair. Obviously, the beneficial effect of the vaccine just passes statistical significance and this result eventually relies on one or two infected volunteers more in the control arm (74 infections) versus the vaccines arm (51 infections). It is very hard to predict if the statistical significance would hold with a longer follow up of the vaccinated volunteers (about 16000 in total). Surely, it is not the end of HIV. Much improvement on vaccine efficacy is obviously necessary before a product can reach large scale development. But this is an encouraging sign, what the field needs most at the moment and what should be kept in mind from this trial.

This week, Erik and I discuss the poisoned world in which we all live. Also, we share our thoughts on the climategate scandal that has reopened the debate about global warming, or climate change, or whatever media buzzword the elites are using these days.

Why the media ignores Climategate

Hot Times:

Penn State investigating climategate

What happened to Global Warming: BBC

Watts up with that?

http://blogs.telegraph.co.uk/news/jamesdelingpole/100017393/climategate-the-final-nail-in-the-coffin-of-anthropogenic-global-warming/

http://pajamasmedia.com/blog/viscount-monckton-on-global-warminggate-they-are-criminals-pjm-exclusive/

http://www.infowars.com/articles/science/vaccines_ingredients_mercury_aspartame_etc.htm

http://www.washingtonpost.com/wp-dyn/content/article/2009/01/26/AR2009012601831.html

http://www.sweetpoison.com/aspartame-side-effects.html

http://www.infowars.com/articles/science/flouride_neurotoxicity_of_flouride_in_water.htm

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Age of Autism, as respectful as always

Sorry to apply this television media term to a serious scientific matter but I’m mainly using it to mock J.B. Handley, who recently used it in his immature attack on Dr. David Gorski. But the phrase isn’t completely out of place here as Age of Autism stepped into a bit of controversy today with an incredibly juvenile attack on their most outspoken critics, you know, actual medical, vaccine, and autism experts.

This entry of theirs is among the more overt examples of their bias, the cult-like influence they have over their readers, and their commitment to focusing on despicable ad hominem attacks over actual scientific arguments and academic rigor.

Now as always, the comment section is full of irrational, nonsensical, vitriolic, fundamentalist tirades (and yes, I’m aware that this sentence includes character attacks but I will attempt to rise above ad hominem by backing up my character attacks with rational argument). But just don’t trust me though; by all means go to the site and judge for yourself. What is unusual for Age of Autism though is that they’re suddenly accepting negative comments, even less than civil ones, whereas  I don’t recall a single comment I’ve ever made on their site ever getting published no matter how civil I made it. This could mean that they’re deliberately trying to collect some of the harsher comments as something to point to in order to make their critics look nuts. But whatever the case, several comments come from alleged fans of the site who expressed their disgust over this latest stunt along with a statement that they would not return to Age of Autism. Of course, there’s no way of knowing whether these were the true feelings of actual former fans of the site but they may very well be.

What’s also strange is that such outrage came about as a result of a stunt that’s really no lower than anything else Age of Autism has done. All they do on Age of Autism is ad hominem attacks against their critics and praising media exposure of their ideology. I sure as hell can’t find anything on the site that makes a coherent scientific argument. And here are just a few examples of me giving point-by-point criticisms of Age of Autism articles that seem particularly light on science and substance but far heavier than this particular instance on ad hominem attack and dishonest reporting here, here, here, here (also from Adriana Gamondes who’s responsible for the latest offending article), here, here (the second item in the list), here, and here. Again, that’s just to name a few examples. For the truly masochistic, use them to play the Age of Autism Drinking Game where you drink every time an article hurls baseless insults at those that don’t agree with them.

Though there may be an explanation for some of the particular outrage over this particular article beyond just its overall offensiveness, a new site called Countering Age of Autism. The site’s latest entry encourages readers to go after Age of Autism’s inclusion in the Google News Feed given that Age of Autism is not a news source but, by their own admission, just an “edgy” blog. Of course, this is just editor Mark Blaxill’s attempt to disown any responsibility for the harm he causes. It’s like Oprah claiming that she’s just putting out information to her audience and expects them to do all the research to determine the validity of any scientific claims presented on her show themselves. But as Uncle Ben taught us, with great power comes great responsibity. And if you have an audience that listens to you and trusts you, you are accountable for what you say, regardless of how you might try to spin your more repulsive tactics as light-hearted satire.

To be honest, I’m not really offended by Age of Autism’s latest stunt. I’ve seen far worse from them and had no expectations that they were better than this. And I’m surely guilty of equally offensive images on this blog from time to time. Though of course I tend to back up my position with substantive facts more often than not. Sure, I’m guilty of Godwin’s Law from time to time. I’ve compared the Catholic Church to Nazis and actually intend to write a particularly long piece either here or elsewhere soon that further attacks the Catholic Church. But it will be very long because I plan to illustrate my points with lots and lots of legitimate examples to prove my points. Bottom line is that I too am not above controversy and offending people. I actually tend to enjoy offending certain types of people (Go fuck yourself, Handley, you despicable douchebag). But what’s important to me is that this particular Age of Autism blog seemed to penetrate that veneer of righteousness that Age of Autism’s PR people have been so successful building and caused some to question that facade. Of course only time will tell if this marks the decline of the anti-vaccine propagandists the way we’ve seen a sharp decline in 9/11 denialism.

But to think, this wasn’t even the only straight hit piece the site put up today. Having learned that Denial author Michael Specter would be featured on the Daily Show this week, thehthe site urged its readers to express their outrage to Comedy Central. I on the other hand intend to write the network to express the opposite view and I encourage my few readers to do the same.

Last time I addressed the topic of vaccines it was to make sure we were all clear that vaccinations are not a matter of salvation.  If you missed that post, please read it here.

But I also gave my main reason for continuing a discussion about it, namely because we should be seekers of the truth.  Scripture tells us to “test everything; hold fast to what is good.  Abstain from every form of evil.” (1 Thessalonians 5:21)

To this end, I have a few more pieces of news to share specifically with my precious, pregnant friends.  With the fear-mongering going on in the government and media, and with so many pregnant friends who are still trying to determine what they should do, I feel obligated to share this information. Especially in light of the recently reported miscarriages.

So, here’s some critical information for your consideration.  If nothing else, please view the six minute video below to hear dozens of medical professionals voice their concerns about the vaccine.

Our media and government are targeting pregnant women.

We are being inundating with stories of the danger this virus poses to pregnant women. We are told daily that young, healthy people are dying.  The truth is that 73% of hospitalized H1N1 patients have underlying health conditions, such as heart disease, diabetes, cancer and other immune suppressive diseases.

Dr. Russell Blaylock, a board certified neurosurgeon, author and lecturer says, “The Minister of Fear (the CDC) was working overtime peddling doom and gloom, knowing that frightened people do not make rational decisions — nothing sells vaccines like panic.”

Which is worse: H1N1 or the Vaccine?

This is the big question. Is the risk from this virus significant enough to justify mass vaccinations with a vaccine that is essentially experimental, poorly tested, and of questionable benefit?

The H1N1 virus is quite mild even for pregnant women.

According to Dr. Michael Bronze, chair of Internal Medicine at University of Oklahoma Health Science Center, 0.32 per 100,000 pregnant women (or about 1 in 300,000 pregnant women) were hospitalized because of the H1N1 flu or something that presented like H1N1. It’s important to note that even these small numbers aren’t limited to confirmed H1N1 cases.  It includes confirmed and “probable” H1N1 cases.

The vast majority of people who get H1N1 have a brief and mild illness. Based on the Australian/New Zealand experience (at the peak of their flu season, which has already passed) and the American data somewhere in the middle of our flu season, pregnant women have about a 99.97% chance they will not become so sick as to require hospital care at any level.

Zero studies to prove safety

There have been no studies to prove safety of the H1N1 vaccines in pregnant women. Even the vaccine inserts themselves say so.  Simply follow the links and do a search for the word “pregnant” to find these statements yourself.

MedImmune (intranasal spray)
Novartis
Sanofi-Pasteur
CSL Biotherapies, Inc.

All of them say either word-for-word or very closely word-for-word:

• “Safety and effectiveness of [this] vaccine have not been studied in pregnant women or nursing mothers.”
• “Animal reproduction studies have not been conducted with [this] vaccine. It is not known whether [this] vaccine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.”
• “[This] vaccine should be given to a pregnant woman only if clearly needed.”
• “It is not known whether [this] vaccine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when [this] vaccine is administered to a nursing woman.”

The studies that have been done show serious risks.

Perhaps even more concerning than the admission that no one has studied the safety and effectiveness of these vaccines in humans, is that studies that have been done on pregnant animals with non-H1N1 vaccines show that a single vaccine produces damage in the offspring’s brain exactly like autism and schizophrenia.

In this article, Dr. Blaylock refers to compelling research that shows that stimulating a pregnant mom’s immune system during mid-term and later term pregnancy:

• Significantly increases the risk that her baby will develop autism during childhood and schizophrenia sometime during the teenage years and afterward.
• Increases the baby’s risk of having a seizure both as a baby and as an adult
• Can trigger preclampsia in the mother
• Can trigger hypertension when the baby becomes an adult.

(See also Dr. Blaylock’s article entitled, Vaccines, Neurodevelopment and Autism Sectrum Disorders or listen to the interview linked at the very bottom of this article.)

Vaccinating pregnant women has gone seriously wrong in the recent past.

Gardasil vaccine was recommended to pregnant women, but was immediately pulled once women began losing their babies or delivering malformed babies.  Now they are careful to say, “the vaccine is not recommended for use in women known to be pregnant.”  But it’s a little late for all those women who lost their healthy babies.

1% vs 100% chance

Yes, a serious flu infection during pregnancy can cause damage to the baby because of the immune system stimulation it would cause in you. But Dr. Blaylock warns that getting the vaccination will guarantee immune system stimulation.

So, we’re talking less than 1% chance that you’d get a serious case of H1N1 and have serious immune system stimulation vs 100% chance that you will have serious immune system stimulation because of the vaccine.

Vaccine manufacturers have legal immunity

If you or your baby are injured by a vaccine, you have no access to the legal system.  According to the Public Readiness and Emergency Act (the PREP act), unless you can provide evidence of willful misconduct AND you get permission from the DHHS Secretary, you can’t sue to receive compensation or justice.  The manufacturers are completely shielded from liability.  This also means that they have no incentive to test their vaccines for safety.  After all, if they test and find that something is dangerous, they have to start all over again.  So, you take the vaccines completely at your own risk.

Reported Miscarriages

To me, this is the most compelling reason to avoid the H1N1 vaccine if you’re pregnant.  Here are just a couple of the first-hand reports from a June 2010 birth club.

EBWashington:

I am so upset. I was so excited to be pregnant after trying for a year. As soon as I found out I was pregnant, I joined this birth club and I was due June 25th. We have two healthy boys with no history of miscarriage. Everything was going great. Last Monday, I got the H1N1 vaccine thimerosal reduced (mercury reduced for pregnant women). On Tuesday morning, I started cramping and on Wednesday I started bleeding heavily. My hcg was 50 on Wednesday and I was almost 6 weeks along so it was low. They still thought that I might be pregnant but on Friday my hcg was down to 22. I am an emotional wreck. I feel like I had a healthy baby and I caused this by getting the H1N1 vaccine. My doctors pushed it. I researched online and there have been many miscarriages after the H1N1 vaccine but they haven’t been reported since it is hard to say what caused the miscarriages. I hope that I did not cause this. I wish everyone the best.

Tayla08:

I don’t have an answer for you, but a friend of a friend just had a miscarriage 2-3 days after getting the shot. She was 7weeks. She had no previous history of m/c… No one can answer if they’re related…it hasn’t been out long enough and there haven’t been any studies done on pregnant women. I will tell you, that it has made up my mind on getting it…I won’t and I’m not going to get it for my DD either. My daughter and I both had H1N1 last week, and although it truly sucks…I think I’ll take my chances. One doctor will tell you to get it and the next will tell you not too…you have to do what’s in your heart.

90707:

my heart goes out to you as i recently miscarried as well and was due in june. i had a healthy heart beat at 6wks. then at 7.5 wks my son got the h1n1 mist vaccine which has live vaccine in it. the nurse said to be careful b/c it could technically spread if he rubbed his nose and touched a surface etc. the next night i miscarried and 5 days later was diagnosed with h1n1. i work from home, kids are home, hadnt been anywhere during that time. so the chances that it is all related are very high. the flu mist vaccine warns for immunocompromised patients (which includes prego) to stay away from recipients of the flu mist for 21 days.

You can read the full story along with many, many more first-hand reports of miscarriages here.

What Experts Are Saying

Suspicion about the H1N1 vaccines isn’t coming only from moms who have recently lost their babies and a single neurosurgeon who has dedicated his retirement years to studying these things more in-depth.  Here is what some other well-respected professionals are also saying.

Dr. Bob Sears, a board-certified pediatrician trained at Georgetown University School of medicine and co-author in the Sears Parenting Library, says:

As a doctor, we swear an oath to “First, do no harm.” So I have a hard time recommending a treatment that doesn’t show it causes no harm. It’s not just the H1N1 vaccine that’s not been tested. The regular flu vaccine has not been tested in pregnant women, either, to show that it’s safe in babies. That kind of boggles my mind, because the regular flu vaccine has been around for years, and there have been plenty of opportunities for the companies to do some safety testing on them so pregnant women can feel more comfortable about them.

Dr. Larry Palevsky, a board-certified pediatrician trained at the New York School of Medicine says:

When I went through medical school, I was taught that vaccines were completely safe and completely effective, and I had no reason to believe otherwise. All the information that I was taught was pretty standard in all the medical schools and the teachings and scientific literature throughout the country. I had no reason to disbelieve it.

Over the years, I kept practicing medicine and using vaccines and thinking that my approach to vaccines was completely onboard with everything else I was taught.

But more and more, I kept seeing that my experience of the world, my experience in using and reading about vaccines, and hearing what parents were saying about vaccines were very different from what I was taught in medical school and my residency training.

… It didn’t appear that the scientific studies that we were given were actually appropriately designed to prove and test the safety and efficacy. It also came to my attention that there were ingredients in there that were not properly tested, that the comparison groups were not appropriately set up, and that conclusions made about vaccine safety and efficacy just did not fit the scientific standards that I was trained to uphold in my medical school training.

Dr. Joseph Mercola, an osteopathic physician, board-certified in family medicine and NY Times best-selling author, says:

I’ve said it before, but I’ll say it again: I’m not anti-vaccines, but rather pro vaccine-safety. That means, I strongly believe that we should only inject substances into our bodies, and especially into the bodies of infants and the unborn, that have been rigorously studied and proven safe both short-term and long-term.

As it stands now, we’ve spent decades injecting materials into the bodies of young and old alike, without sufficient amounts of safety testing of the ingredients, and our society is showing the signs of this neglect.

Neurological dysfunction and disorders such as autism and Alzheimer’s have been growing steadily and show no signs of slowing down.

More resources about vaccines and pregnancy

• 9 Minute Audio: Mercola’s interview with Dr. Russell Blaylock
• Audio and Article:  Expert Pediatrician Exposes Vaccine Myths
• Article: Concerns over Swine Flu Vaccine During Pregnancy
• Article: Safety of First Trimester Flu Vaccines
• Article: Updates on Flu Vaccine Safety Research
• Article: Dealing with Unexplained Miscarriage
• And for a whole page of articles, visit organichealthadviser.com

My hopes

(This comes straight from my Cross-Centered Discussion of Vaccines? post I mentioned at the start of this post.  I thought it would be good to re-print after sharing all of this information.)

I hope that my communication on this topic informs you.

If you’re a wife, I hope you bring everything to your husband and ultimately rest in his leadership.

I hope that those of you who disagree with me never feel condemned or judged by me.

I hope that you will engage with me in this topic.  If you disagree, I’d love to hear why.  I am SO grateful for those willing to engage in debate, not just on this issue but on any!  There are certainly things I haven’t thought of, studies that I am not aware of, and sources I don’t know about that would be beneficial for consideration.  I am not seeking to be right.  I am seeking the truth.

AS03-Adjuvanted H1N1 Pandemic Influenza Vaccine
Emulsion for Injection
ATC Code J07BB02
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
Date of Preparation:
21 October 2009
© 2009 GlaxoSmithKline Inc. All Rights Reserved
™AREPANRIX H1N1 used under license by GlaxoSmithKline Inc.
CAPA01/PIL 1.0 – 1 -
AREPANRIX™ H1N1 GlaxoSmithKline
PRODUCT INFORMATION LEAFLET
Arepanrix™ H1N1
AS03-Adjuvanted H1N1 Pandemic Influenza Vaccine
Version 1 approved October 21, 2009
Health Canada has authorized the sale of Arepanrix™ H1N1 based on limited clinical testing in humans under the provision of an Interim Order (IO) issued on October 13, 2009. The authorization is based on the Health Canada review of the available data on quality, safety and immunogenicity, and given the current pandemic threat and its risk to human health, Health Canada considers that the benefit/risk profile of the Arepanrix™ H1N1 vaccine is favourable for active immunization against the H1N1 2009 influenza strain in an officially declared pandemic situation.
As part of the authorization for sale for Arepanrix™ H1N1, Health Canada has requested the sponsor agree to post-market commitments. Adherence to these commitments, as well as updates to information on quality, non-clinical, and clinical data will be continuously monitored by Health Canada and the Public Health Agency of Canada.
THIS LEAFLET WILL BE UPDATED ACCORDINGLY.
PLEASE CONSULT THE HEALTH CANADA WEBSITE FOR THE MOST UP-TO-DATE INFORMATION FOR THIS PRODUCT:
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/legislation/interimorders-arretesurgence/index-eng.php
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/legislation/interimorders-arretesurgence/index-fra.php
RECOMMENDATIONS MADE BY THE PUBLIC H EALTH AGENCY OF CANADA SHOULD ALSO BE TAKEN INTO CONSIDERATION.
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-=-TABLE OF CONTENTS-=-

PAGE
1.0 PHARMACEUTICAL FORM……………………………………………………………………………4
2.0 QUALITATIVE AND QUANTITATIVE COMPOSITION……………………………………….4
3.0 CLINICAL PARTICULARS………………………………………………………………………………5
Indications……………………………………………………………………………………………………5
Dosage and Administration…………………………………………………………………………….5
Contraindications………………………………………………………………………………………….6
Warnings and Precautions……………………………………………………………………………..6
Interactions………………………………………………………………………………………………….7
Effects on Ability to Drive and Use Machines……………………………………………………8
Adverse Reactions………………………………………………………………………………………..8
Clinical trials………………………………………………………………………………………9
Overdose…………………………………………………………………………………………………..14
4.0 PHARMACOLOGICAL PROPERTIES…………………………………………………………….15
Pharmacodynamics……………………………………………………………………………………..15
Pharmacokinetics………………………………………………………………………………………..18
Pre-clinical Safety Data………………………………………………………………………………..18
5.0 PHARMACEUTICAL PARTICULARS……………………………………………………………..19
List of Excipients…………………………………………………………………………………………19
Incompatibilities…………………………………………………………………………………………..19
Shelf Life……………………………………………………………………………………………………19
Special Precautions for Storage…………………………………………………………………….19
Nature and Contents of Container…………………………………………………………………19
Instructions for Use/Handling………………………………………………………………………..20
CONSUMER INFORMATION……………………………………………………………………………..22
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1.0 PHARMACEUTICAL FORM
Arepanrix™ H1N1 (AS03-adjuvanted H1N1 pandemic influenza vaccine) is a two-component vaccine consisting of an H1N1 immunizing antigen (as a suspension), and an AS03 adjuvant (as an oil-in-water emulsion).
The H1N1 antigen is a sterile, colorless to slightly opalescent suspension that may sediment slightly in a 10mL vial. The antigen is prepared from virus grown in the allantoic cavity of embryonated hen’s eggs. The virus is inactivated with ultraviolet light treatment followed by formaldehyde treatment, purified by centrifugation and disrupted with sodium deoxycholate.
The AS03 adjuvant system is a sterile, homogenized, whitish emulsion composed of DL-α-tocopherol, squalene and polysorbate 80 in a 3mL vial.
Immediately prior to use, the full contents of the AS03 vial is withdrawn and added to the antigen vial (mix ratio 1:1). The mixed final product for administration is an emulsion, containing enough product for 10 doses.
2.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
After combining and mixing the two components, 0.5mL of the resultant emulsion is withdrawn into a syringe for intramuscular injection. The final composition of each vaccine component per 0.5mL dose is as follows:
Antigen:
Split influenza virus, inactivated, containing antigen* equivalent to:
A/California/7/2009 (H1N1)v-like strain (X-179A) 3.75μg HA** per 0.5mL dose
* isolated from virus propagated in eggs
** HA = haemagglutinin
Preservative content is 5μg Thimerosal USP per 0.5mL dose or 2.5 micrograms organic mercury (Hg) per 0.5mL dose
Adjuvant: DL-α-tocopherol 11.86 milligrams/0.5mL dose Squalene 10.69 milligrams/0.5mL dose, Polysorbate 80 4.86 milligrams/0.5mL dose
The suspension and emulsion vials, once mixed, form a multidose vaccine in a vial. See section Nature and Contents of Container for the number of doses per vial.
For a full list of excipients, see section List of Excipients under 5.0.
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3.0 CLINICAL PARTICULARS
Indications
Arepanrix™ H1N1 Vaccine is indicated for active immunization against H1N1 influenza strain in an officially declared pandemic situation.
(see section 2.0 Qualitative and Quantitative Composition).
Dosage and Administration
There is currently limited clinical experience with Arepanrix™ H1N1, and limited clinical experience with an investigational formulation of another AS03-adjuvanted vaccine containing the same or a slightly higher amount of antigen derived from A/California/7/2009 (H1N1) (see section Pharmacodynamics) in healthy adults aged 18-60 years and no clinical experience yet in the elderly, in children or in adolescents. The decision to use Arepanrix™ H1N1 in each age group defined below should take into account the extent of the clinical data available with a version of the vaccine containing H5N1 antigen and the disease characteristics of the current influenza pandemic.
The dose recommendations are based on:
• safety and immunogenicity data available on the administration of AS03-adjuvanted vaccine containing 3.75 μg HA derived from A/Indonesia/5/2005 (H5N1) (Arepanrix™ H5N1) at 0 and 21 days to adults, including the elderly
• safety and immunogenicity data available on the administration of the adult dose and half of the adult dose to children aged from 3-9 years with anotherAS03-adjuvanted vaccine containing 3.75 μg HA derived from A/Vietnam/1194/2004 (H5N1) at 0 and 21 days
• limited immunogenicity data from 2 studies obtained three weeks after administration of a single dose of an investigational formulation of another AS03-adjuvanted H1N1 vaccine containing either 5.25 μg or 3.75 μg HA derived from A/California/7/2009 (H1N1) (Pandemrix™) to healthy adults aged 18-60 years. See section Pharmacodynamics.
Adults aged 18-60 years: One dose of 0.5mL at an elected date. The need for a second dose is currently unknown. However, preliminary immunogenicity data obtained at three weeks after administration of an investigational formulation of another AS03-adjuvanted H1N1 vaccine containing either 5.25 μg or 3.75 μg HA derived from A/California/7/2009 (H1N1) (Pandemrix™) to a limited number of healthy adults aged 18-60 years suggest that a single dose may be sufficient in this age group. See section Pharmacodynamics.
If a second dose is needed, it should be given after an interval of at least three weeks.
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Elderly (>60 years): No clinical data are available for Arepanrix™ H1N1 in this age group. One dose of 0.5mL at an elected date may be considered.
The need for a second dose of vaccine is unknown. If a second dose is needed, it should be given after an interval of at least three weeks. See section Pharmacodynamics.
Children and adolescents aged 10-17 years: No clinical data are available for any influenza vaccines with AS03 in this age group. Consideration may be given to dosing in accordance with recommendations for adults.
Children aged 3-9 years: Based on limited clinical data available for AS03-adjuvanted H5N1 vaccine containing 3.75 μg HA derived from A/Vietnam/1194/2004 in this age group, 0.25mL of vaccine (i.e. half of the adult dose) at an elected date and a second dose administered at least three weeks later may be considered sufficient. See section Pharmacodynamics.
Children aged from 6-35 months: No clinical data are available for influenza vaccines with AS03 in this age group. Consideration may be given to dosing in accordance with the recommendation in children aged 3-9 years.
Children aged less than 6 months: Vaccination is not currently recommended in this age group.
For further information, see section Pharmacodynamics.
Method of administration:
Immunization should be carried out by intramuscular injection preferably into the deltoid muscle or anterolateral thigh (depending on muscle mass).
Contraindications
History of an anaphylactic reaction (i.e. life-threatening) to any of the constituents or trace residues of this vaccine.
See also section Warnings and Precautions.
Warnings and Precautions
Caution is needed when administering this vaccine to persons with a known hypersensitivity (other than anaphylactic reaction) to the active substance, to any of the excipients and to residues.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
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If the pandemic situation allows, immunization shall be postponed in patients with severe febrile illness or acute infection.
Arepanrix™ H1N1 should under no circumstances be administered intravascularly or intradermally.
Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.
A protective immune response may not be elicited in all vaccinees (see section Pharmacodynamics).
Pediatric: There is very limited experience with AS03-adjuvanted H5N1 vaccine in children between 3 and 9 years of age, and no experience in children less than 3 years of age or in children and adolescents between 10 and 17 years of age. See sections Dosage and Administration, Adverse Reactions and Pharmacodynamics.
Pregnancy and Lactation
No data have been generated in pregnant women with Arepanrix™ H1N1 nor with the prototype AS03 adjuvanted H5N1 vaccine. Data from vaccinations with seasonal trivalent influenza vaccines in pregnant women do not indicate that adverse foetal and maternal outcomes were attributable to the vaccine.
CONSIDERATION SHOULD BE TAKEN OF ANY RECOMMENDATIONS MADE BY THE PUBLIC H EALTH AGENCY OF CANADA.
Animal studies have not demonstrated harmful effects with respect to fertility, pregnancy, embryonal/foetal development, parturition or post-natal development (see also the section Non-clinical information).
No data have been generated in breast-feeding women.
Interactions
No data are available on the concomitant administration of Arepanrix™ H1N1 with other vaccines, including seasonal trivalent influenza vaccines. Such data are in development, and this document will be amended to include them as soon as available. However, if co-administration with another vaccine is indicated, immunization should be carried out on separate limbs. It should be noted that the adverse reactions may be intensified.
The immunological response may be diminished if the patient is undergoing immunosuppressant treatment.
Following influenza vaccination, false positive serology test results may be obtained by the ELISA method for antibodies to HIV-1, Hepatitis C, and especially HTLV-1. These transient false-positive results may be due to cross-reactive IgM elicited by the vaccine. For this reason, a definitive diagnosis of HIV-1, Hepatitis C, or HTLV-1 infection
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AREPANRIX™ H1N1 GlaxoSmithKline
requires a positive result from a virus-specific confirmatory test (e.g,Western Blot or immunoblot).
Effects on Ability to Drive and Use Machines
No studies on the effects on the ability to drive and use machines have been performed.
Adverse Reactions
H1N1 Studies:
Preliminary reactogenicity (solicited local and general adverse events reported within 7 days of vaccination) are provided for 2 studies which evaluated the safety of another AS03-adjuvanted vaccine containing HA derived from A/California/7/2009 (H1N1)v-like (Pandemrix™) in healthy subjects aged 18-60 years. In one study, the vaccine contained a higher amount of antigen (5.25 μg HA). In both studies, a group of subjects received the vaccine without the AS03 adjuvant. Solicited local and general symptoms were generally reported more frequently in the H1N1+AS03 group compared to the H1N1 group. Pain at the injection site was the most frequently reported solicited adverse events (AE). The frequency of ‘’related’ Grade 3 symptoms was low and did not exceed 1.6%.
D-Pan H1N1-021 (Day 0 to Day 6 solicited adverse events following a single dose of 5.25μg HA + AS03 H1N1 vaccine [Pandemrix™] versus a single dose of 21 μg HA unadjuvanted H1N1 vaccine) – Adverse Events with a causal relationship
Adverse reactions
H1N1/AS03
N=63
H1N1
N=66
Pain
88.9%
59.1%
Redness
31.7%
4.5%
Swelling
30.2%
1.5%
Fatigue
15.9%
10.6%
Headache
14.3%
7.6%
Arthralgia
14.3%
3.0%
Myalgia
15.9%
4.5%
Shivering
3.2%
4.5%
Sweating
6.3%
4.5%
Fever
0.0%
0.0%
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AREPANRIX™ H1N1 GlaxoSmithKline
D-Pan H1N1-007 (Day 0 to Day 6 solicited adverse events following a single dose of 3.75 μg HA + AS03 vaccine [Pandemrix™] versus a single dose of 15 μg HA unadjuvanted H1N1 vaccine) – Adverse Events with a causal relationship
Adverse reactions
H1N1/AS03
N=62
H1N1
N=62
Pain
90.3%
37.1%
Redness
1.6%
0.0%
Swelling
6.5%
0.0%
Fatigue
32.3%
25.8%
Headache
14.3%
7.6%
Arthralgia
11.3%
4.8%
Myalgia
33.9%
8.1%
Shivering
8.1%
3.2%
Sweating
9.7%
8.1%
Fever
0.0%
0.0%
A total of four serious adverse events (SAEs) have been reported with the H1N1 studies. Three of them were considered by the investigators to be unrelated to the study vaccine. One reported case of hypersensitivity was considered by the investigator to be related to vaccination.
H5N1 Studies:
Clinical trials
Adverse reactions from clinical trials conducted using the mock-up vaccine are listed below.
Adults: Clinical studies have evaluated the incidence of adverse reactions listed below in approximately 3,500 subjects 18 years old and above who received Influenza Virus Vaccine containing A/Indonesia/05/2005 (Arepanrix™ H5N1) with at least 3.75 μg HA/AS03.
The reactogenicity of vaccination was solicited by collecting adverse events using standardized forms for 7 consecutive days following vaccination with Arepanrix™ H5N1 or placebo (i.e., Day 0 to Day 6). The average frequencies of solicited local and general adverse events reported within 7 days after each vaccination dose are presented below:
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Percentage of Doses Followed by Solicited Local or General Adverse Events Within 7 Days of Any Vaccination With Arepanrix™ H5N1 (Total Vaccinated Cohort*)
AREPANRIX™ H5N1
Placebo
Local
N=6647 doses
N=2209 doses
Pain
73.1
12.0
Swelling
6.7
0.4
Redness
5.25
0.4
General
N=6639 doses
N=2210 doses
Muscle Aches
33.3
11.8
Headache
23.4
17.6
Fatigue
23.3
14.1
Joint Pain
16.4
7.4
Shivering
9.8
6.0
Sweating
6.3
4.4
Fever, ≥38.0 °C
2.4
1.9
* Total Vaccinated Cohort = all subjects who received at least one dose of vaccine and for whom any safety data were available.
Pain at the injection site was the most commonly reported solicited local symptom in both Arepanrix™ H5N1 and placebo groups and was reported at a 6-fold higher frequency (i.e. following 73% of doses) in the Arepanrix™ H5N1 group. Despite the high incidence of injection site pain, the incidence of severe pain was low, with reports occurring after 2.7% of Arepanrix™ H5N1 doses and 0.4% of placebo doses. Overall, severe solicited or unsolicited adverse events of any type occurred in the 7 days after 6.4 to 7.0% of Arepanrix™ H5N1 doses and 3.6% of placebo doses. The most common severe solicited adverse event was local injection site pain; all severe general solicited adverse events occurred after <2% of doses.
Other/Additional adverse reactions reported are listed according to the following frequency classification:
Very common (≥1/10)
Common (≥1/100 to <1/10)
Uncommon (≥1/1,000 to <1/100)
Rare (≥1/10,000 to <1/1,000)
Very rare (<1/10,000)
Not known (cannot be estimated from the available data)
Blood and lymphatic system disorders
Common: lymphadenopathy
Psychiatric disorders
Uncommon: insomnia
Nervous system disorders
Uncommon: dizziness, paraesthesia
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Ear and labyrinth disorders
Uncommon: vertigo
Respiratory, thoracic and mediastinal disorders
Uncommon: dyspnoea
Gastrointestinal disorders
Common: nausea, diarrhoea
Uncommon: abdominal pain, vomiting, dyspepsia, stomach discomfort
Skin and subcutaneous tissue disorders
Common: pruritus
Uncommon: rash
Musculoskeletal and connective tissue disorders
Uncommon: back pain, musculoskeletal stiffness, neck pain, muscle spasms, pain in extremity
General disorders and administration site conditions
Common: injection site reactions (such as bruising, pruritus, warmth)
Uncommon: asthenia, chest pain, malaise
Serious Adverse Events in Adults An integrated summary of safety was developed based on the first 9,873 adults to receive Arepanrix™ H5N1 or a closely similar product, Pandemrix™ H5N1, containing influenza antigen made in Germany combined with the AS03 adjuvant system. These trials enrolled adults 18 year of age or older, and included elderly subjects with pre-existing chronic medical conditions. In the primary analysis, which compared six months of safety follow-up in 7,224 recipients of Arepanrix™ H5N1 or Pandemrix™ H5N1 to a similar follow-up in 2,408 recipients of seasonal influenza vaccine or placebo, serious adverse events occurred in 1.6% of Arepanrix™ H5N1 or Pandemrix™ H5N1 recipients (95% Confidence interval 1.3 to 1.9%) versus 1.3% of seasonal influenza vaccine recipients (95% Confidence interval 0.7 to 2.0%) and 1.8% of placebo recipients (95% Confidence interval 1.1 to 2.8%). None of the serious adverse events was considered related to the study drugs by the investigators. Among Arepanrix™ H5N1 or Pandemix™ H5N1 recipients, five (<0.1%) had fatal serious adverse events, including two instances of ovarian carcinoma, a metastatic malignancy of unspecified type, a myocardial infarction, and exacerbation of diabetes mellitus and hepatic cirrhosis. Among placebo recipients, three (0.1%) sustained fatal serious adverse events one instance of brain neoplasm, one instance of cardiomegaly secondary to chronic obstructive pulmonary disease, and one instance of bilateral pneumonia. During six months of follow-up for the entire group of 9,873 Arepanrix™ or Pandemrix™ H5N1 recipients, 7 (<0.1%) reported an Adverse Event of Special Interest as defined by EMEA. Four subjects reported facial palsy (Bell’s palsy) at intervals ranging from hours to 135 days after vaccine exposure; all of these resolved spontaneously and completely. A 45 year old male had an anaphylactic reaction to food six (6) days after first exposure to H5N/AS03 vaccine, and a 25 year old white female had a single episode of convulsions
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35 days after the second dose. None of these Adverse Events of Special Interest was assessed as treatment-related by the investigators. One 48 year old female had “neuritis” with onset almost immediately after injection. Symptoms were localized entirely to the injected arm and compatible with a perineural injection injury; the problem resolved spontaneously. Eleven of 9,873 (0.1%) Arepanrix™ or Pandemrix™ H5N1 recipients were reported to have potential immune-mediated diseases. Diagnoses included two instances of psoriasis, four instances of polymyalgia rheumatica (all in 59 to 84 year-old women, three of whom had symptoms antedating vaccine), and one instance each of Grave’s disease, uveitis, scleroderma, isolated IVth nerve palsy, and erythema nodosum. None of these was assessed as a serious adverse event or as related to the investigational vaccine by the investigators.
Children aged 3-9 years: A clinical study evaluated the reactogenicity in children 3 to 5 and 6 to 9 years of age who received either a full or a half dose of AS03-adjuvanted vaccine containing 3.75 μg HA derived from A/Vietnam/1194/2004 (H5N1).
The per-dose frequency of adverse reactions observed in the groups of children who received a full dose of AS03-adjuvanted vaccine containing 3.75 μg HA derived from A/Vietnam/1194/2004 (H5N1) was higher than that observed in the groups of children who received half of the dose, except for redness in the 6-9 years of age group. The per-dose frequency of specifically-solicited adverse events in the 7 days after each dose is illustrated in the following table. Grade 3 (severe) events of all types, solicited or unsolicited, in the 7 days after each dose, occurred following 9.3% of Arepanrix™ H5N1 doses and 2.8% of Fluarix™ control doses.
ANRIX™ H1N1 GlaxoSmithKline
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Reactogenicity in children 3 to 5 and 6 to 9 years of age (full or a half dose of AS03-adjuvanted vaccine containing 3.75 μg HA derived from A/Vietnam/1194/2004 (H5N1) versus Fluarix™) – Adverse Events with a causal relationship
Adverse reactions
3-5 years
6-9 years
Half dose
N=101
Fluarix
N=35
Full dose
N=97
Fluarix
N=34
Half dose
N=100
Fluarix
N=36
Full dose
N=98
Fluarix
N=36
Induration
9.9%
2.9 %
18.6%
0 %
12.0%
22.2%
12.2%
2.8%
Pain
48.5%
28.6%
62.9%
23.5 %
68.0%
58.3%
73.5%
61.1%
Redness
10.9%
5.7 %
19.6%
8.8 %
13.0%
16.7%
6.1%
2.8 %
Swelling
11.9%
2.9 %
24.7%
5.9 %
14.0%
19.4%
20.4%
8.3 %
Fever (>38°C)
2.0%
0%
6.2%
0%
2.0%
2.8%
10.2%
0%
Fever (>39°C)
- per-dose frequency
- per-subject frequency
2.0%
3.9%
0%
0%
5.2%
10.2%
0%
0%
0%
0%
2.8%
5.6%
7.1%
14.3%
0%
0%
Drowsiness
7.9%
2.9 %
13.4%
2.9 %
NA
NA
NA
NA
Irritability
7.9%
2.9 %
18.6%
0 %
NA
NA
NA
NA
Loss of appetite
6.9%
2.9 %
16.5%
2.9 %
NA
NA
NA
NA
Shivering
1.0%
AREP
CAPA01/PIL 1.0
0 %
12.4%
2.9 %
4.0%
5.6 %
14.3%
11.1 %
NA=not available
AREPANRIX™ H1N1 GlaxoSmithKline
SAEs in children
In analyzed clinical databases covering a period of 180 days of follow-up, there were no serious adverse events in children 3 to 9 years of age who received A/Vietnam/1194/04/AS03 vaccine at half dose. Among children who received full dose vaccine, one 5 year old male was hospitalized for gastroenteritis 19 days after the second dose, and a 4 year female sustained a traumatic brain injury 54 days after the second vaccine dose. Neither was considered by the investigator to be vaccine-related, and both recovered. One 3 year old female subject in a trial of an H5N1/AS03 containing a different ratio of antigen to adjuvant than that in Arepanrix™ H1N1 received the diagnosis of auto-immune hepatitis approximately one year after receiving a single vaccine dose. This child was subsequently found to have had significant abnormalities of serum transaminases prior to any vaccine exposure. One 5 year old female received the diagnosis of anterior uveitis eight days after receipt of the second full dose of Pandemrix™ H5N1. The event was assessed as possibly related to the vaccine, but also occurred in the setting of an apparent infectious syndrome of tonsillitis and gingivostomatitis.
Post-marketing surveillance
From Post-marketing surveillance with seasonal trivalent vaccines (without AS03), the following additional adverse events have been reported:
Blood and lymphatic system disorders
Transient thrombocytopenia.
Immune system disorders
Allergic reactions, in rare cases leading to shock.
Nervous system disorders
Neuralgia, convulsions.
Neurological disorders, such as encephalomyelitis, neuritis and Guillain Barré syndrome.
Vascular disorders
Vasculitis with transient renal involvement.
Skin and subcutaneous tissue disorders
Generalised skin reactions including urticaria
Overdose
Insufficient data are available
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4.0 PHARMACOLOGICAL PROPERTIES
Pharmacodynamics
Pharmacotherapeutic group: Influenza vaccines, ATC Code J07BB02.
H1N1 Studies: Health Canada will regularly review any new information which may become available and this Product Information Leaflet will be updated as necessary. The following data is currently available with the H1N1 pandemic strain.
Immune response to an investigational formulation of another AS03-adjuvanted vaccine containing 5.25 μg HA derived from A/California/7/2009 (H1N1) (Pandemrix™) in adults aged 18-60 years
In a clinical study that evaluated the immunogenicity of another AS03-adjuvanted vaccine containing 5.25 μg HA derived from A/California/7/2009 (H1N1)v-like in healthy subjects aged 18-60 years the anti-HA antibody responses post-dose 1 were as follows:
anti-HA antibody
Immune response to A/California/7/2009 (H1N1)v-like
21 days after 1st dose
Non-Adjuvanted H1N1 Vaccine
(21 μg HA)
N=66
AS03-Adjuvanted H1N1 Vaccine
(5.25μg HA)
N=62
Seroprotection rate1
97.0
98.4%
Seroconversion rate2
95.5
98.4%
Seroconversion factor3
41.4
41.4
1 seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40; 2seroconversion rate: proportion of subjects who were either seronegative at pre-vaccination and have a protective post-vaccination titre of ≥1:40, or who were seropositive at pre-vaccination and have a 4-fold increase in titre;
3seroconversion factor: ratio of the post-vaccination geometric mean titre (GMT) and the pre-vaccination GMT.
Immune response to an investigational formulation of another AS03-adjuvanted vaccine containing 3.75 μg HA derived from A/California/7/2009 (H1N1) (Pandemrix™) in adults aged 18-60 years
In a clinical study that evaluated the immunogenicity of another AS03-adjuvanted vaccine containing 3.75 μg HA derived from A/California/7/2009 (H1N1)v-like in healthy subjects aged 18-60 years the anti-HA antibody responses post-dose 1 were as follows:
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anti-HA antibody
Immune response to A/California/7/2009 (H1N1)v-like
21 days after 1st dose
Non-Adjuvanted H1N1 Vaccine
(15μg HA)
N=66
AS03-Adjuvanted H1N1 Vaccine
(3.75 μg HA)
N=61
Seroprotection rate1
93.9%
100%
Seroconversion rate2
84.8%
96.7%
Seroconversion factor3
31.0
43.3
1 seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40; 2seroconversion rate: proportion of subjects who were either seronegative at pre-vaccination and have a protective post-vaccination titre of ≥1:40, or who were seropositive at pre-vaccination and have a 4-fold increase in titre;
3seroconversion factor: ratio of the post-vaccination geometric mean titre (GMT) and the pre-vaccination GMT.
H5N1 Studies: Preliminary data obtained from H1N1 pandemic vaccines suggest that the immunogenicity of the H1N1 vaccines is very different from that of H5N1 vaccines. This section describes the clinical experience with the mock-up vaccines, where clinical studies have been generated with H5N1, another strain with pandemic potential.
Immune response against A/Indonesia/5/2005 (H5N1) in adults (18 years of age, and above):
Clinical studies have evaluated the immunogenicity of AS03-adjuvanted vaccine containing 3.75 μg HA derived from A/Indonesia/5/2005 in subjects from the age of 18 years onwards following a 0, 21 days schedule.
In a consistency study, the anti-haemagglutinin (anti-HA) antibody responses twenty-one days and six months after the second dose were as follows:
anti-HA antibody
Immune response to A/Indonesia/5/2005
18-60 years
>60 years
Day 42
N=1,488
Day 180
N=353
Day 42
N=479
Day 180
N=104
Seroprotection rate1
91%
62%
76.8%
63.5%
Seroconversion rate2
91%
62%
76.4%
62.5%
Seroconversion factor3
51.4
7.4
17.2
7.8
1seroprotection rate (i.e. proportion of subjects with HI titre ≥1:40);
2seroconversion rate (i.e. proportion of subjects who were either seronegative at pre-vaccination and have a protective post-vaccination titre of ≥1:40, or who were seropositive at pre-vaccination and have a 4-fold increase in titre);
3seroconversion factor (i.e. ratio of the post-vaccination GMT and the pre-vaccination GMT)
Twenty-one days after the second dose, a 4-fold increase in serum neutralising antibody against A/Indonesia/5/2005 was achieved in 94.4% of subjects aged 18-60 years and in 80.4% of subjects over 60 years of age.
Immune response against A/Vietnam/1194/2004 (H5N1) strain in children (3 to 9 years of age) CAPA01/PIL 1.0 – 16 -
AREPANRIX™ H1N1 GlaxoSmithKline
A clinical study evaluated the immunogenicity and safety in children aged 3 to 9 years old. In this study, 49 children aged 3 to 5 and 49 children aged 6 to 9 years old received two doses of another 3.75 μg HA/AS03 vaccine containing the A/Vietnam/1194/2004 (H5N1) vaccine strain at 0 and 21 days.
The seroprotection rate, the seroconversion rate and seroconversion factor for anti-haemagglutinin (anti-HA) antibody in these subjects were as follows:
anti-HA antibody
A/Vietnam/1194/2004
Children 3 to 5 years
Children 6 to 9 years
21 days after 1st dose
N=43
21 days after 2nd dose
N=44
21 days after 1st dose
N=30
21 days after 2nd dose
N=43
Seroprotection rate*1
46.5%
100%
56.7%
100%
Seroconversion rate2
46.5%
100%
56.7%
100%
Seroconversion factor3
5.0
191.3
5.5
176.7
*anti-HA ≥1:40
1seroprotection rate (i.e. proportion of subjects with HI titre ≥1:40);
2seroconversion rate (i.e. proportion of subjects who were either seronegative at pre-vaccination and have a protective post-vaccination titre of ≥1:40, or who were seropositive at pre-vaccination and have a 4-fold increase in titre);
3seroconversion factor (i.e; ratio of the post-vaccination GMT and the pre-vaccination GMT)
A 4-fold increase in serum neutralising antibody titres was observed in 97.4% of subjects aged 3 to 5 years and in 100% of subjects aged 6 to 9 years 21 days after the second dose.
The persistence of immunogenicity up to 6 months after the second dose was also evaluated in these children. The seroprotection rate, the seroconversion rate and seroconversion factor for anti-haemagglutinin (anti-HA) antibody at day 180 were respectively 82.8%, 82.8% and 16 in the children aged 3 to 5 years and 78%, 78% and 12.3 in the children aged 6 to 9 years.
Information from non-clinical studies
The ability to induce protection against homologous vaccine strains was assessed non-clinically with A/Indonesia/05/05 (H5N1) using a ferret challenge model.
- Challenge with a homologous pandemic H5N1 strain (A/Indonesia/5/05)
In this protection experiment, the ferrets (six ferrets/group) were immunized intramuscularly with vaccine candidate containing three different doses of H5N1 antigen (7.5, 3.8 and 1.9 μg of HA antigen) adjuvanted with the standard dose or half dose of AS03. Control groups included ferrets immunized with adjuvant alone and non-adjuvanted vaccine (7.5 μg HA). Ferrets immunized with the non adjuvanted H5N1 influenza vaccine were not protected from death and showed similar reduced lung viral loads and degree of viral shedding in the upper respiratory tract as those exhibited by ferrets immunized with the adjuvant alone. Conversely the combination of a range of doses of H5N1 antigen with AS03 adjuvant was able to protect against mortality and to reduce lung virus loads and viral shedding after intra-tracheal challenge with a homologous wild type H5N1 virus. Serological testing indicated a direct correlation
CAPA01/PIL 1.0 – 17 -
AREPANRIX™ H1N1 GlaxoSmithKline
between vaccines induced HI and neutralising antibody titres in protected animals compared to antigen and adjuvant controls.
Vaccines Used in Pharmacological Studies
The Pandemrix™ vaccine is an AS03-adjuvanted H1N1 vaccine containing 5.25 μg or 3.75 μg HA derived from A/California/7/2009 (H1N1) manufactured in Dresden, Germany using a different production process than Arepanrix™ H1N1 (A/California/7/2009).
Another AS03-adjuvanted H5N1 vaccine containing 3.75 μg HA derived from A/Vietnam/1194/2004 (H5N1; previously described as Pandemrix™ H5N1) is also manufactured in Dresden, Germany using a similar production process as the Pandemrix™ vaccine (with H1N1 strain).
The Arepanrix™ H5N1 vaccine is an AS03-adjuvanted H5N1 vaccine containing 3.75 μg HA derived from A/Indonesia/5/2005 (H5N1) manufactured in Quebec, Canada using the same production process as the Arepanrix™ H1N1 (A/California) pandemic vaccine.
Pharmacokinetics
Evaluation of pharmacokinetic properties is not required for vaccines.
Pre-clinical Safety Data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, acute and repeated dose toxicity, local tolerance, female fertility, embryo-fetal and postnatal toxicity up to the end of the lactation period.
Two reproductive studies were conducted with AS03-adjuvanted H5N1 antigen and evaluated the effect on embryo-fetal and peri-and post-natal development in rats, following intramuscular administration. Although no definite conclusion could be reached, regarding a possible relation to treatment with the H5N1 vaccine and/or the adjuvant AS03, and other findings were considered normal, the following observations deserve to be mentioned: In the first study, there was an increased incidence of fetal malformations with markedly medially thickened/kinked ribs and bent scapula as well as an increased incidence of dilated ureter and delayed neurobehavioral maturation. In the second study, there was an increased incidence of post-implantation
loss, and the fetal variation of dilated ureter. Not all findings were observed in both studies, and hence the toxicological significance is uncertain.
CAPA01/PIL 1.0 – 18 -
AREPANRIX™ H1N1 GlaxoSmithKline
5.0 PHARMACEUTICAL PARTICULARS
List of Excipients
Antigen suspension vial: Thimerosal, sodium chloride, disodium hydrogen phosphate, potassium dihydrogen phosphate, potassium chloride, water for injections. The drug substance contains trace residual amounts of egg proteins, formaldehyde, sodium deoxycholate and sucrose.
Adjuvant emulsion vial: sodium chloride, disodium hydrogen phosphate, potassium dihydrogen phosphate, potassium chloride, water for injections.
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf Life
The antigen suspension is stable for 18 months.
The adjuvant emulsion is stable for 3 years.
After mixing, the vaccine should be used within 24 hours. Although it is recommended to maintain the mixed product between 2°C and 8°C, it may be kept at room temperature during this period if required. However, if the product is refrigerated, it must be brought to room temperature before withdrawal. The chemical and physical in-use stability has been demonstrated for 24 hours at 30°C.
Special Precautions for Storage
Store at 2°C to 8°C (in a refrigerator).
Do not freeze.
Store in the original packaging in order to protect from light.
Nature and Contents of Container
One pack contains:
- one pack of 50 vials (type I glass) of 2.5mL suspension (10 x 0.25mL doses) with a stopper (butyl rubber without latex)
- two packs of 25 vials (type I glass) of 2.5mL emulsion (10 x 0.25mL doses) with a stopper (butyl rubber without latex).
CAPA01/PIL 1.0 – 19 -
AREPANRIX™ H1N1 GlaxoSmithKline
The volume after mixing 1 vial of suspension with 1 vial of emulsion allows the withdrawal of 10 doses of 0.5mL vaccine (5mL).
Instructions for Use/Handling
Arepanrix™ H1N1 consists of two containers: one multidose vial containing the antigen (suspension) and a second multidose vial containing the adjuvant (emulsion). The antigen suspension is a translucent to whitish opalescent suspension that may sediment slightly. The emulsion is a whitish homogeneous liquid.
Prior to administration, the two components should be mixed. The entire contents of the adjuvant emulsion must be withdrawn and added to the antigen suspension and mixed.
Instructions for mixing and administration of the vaccine (as depicted in the pictogram below):
1. Before mixing the two components the vials should be brought to room temperature, and the emulsion and suspension should be shaken and inspected visually for any abnormal physical appearance.
2. The vaccine is mixed by withdrawing the entire contents of the vial containing the emulsion by means of a syringe and by adding it to the vial containing the antigen suspension.
3. After the addition of the emulsion to the suspension, the mixture should be well shaken. The mixed vaccine is a whitish emulsion. In the event of other variation being observed, discard the vaccine.
4. The volume of Arepanrix™ H1N1 (5mL) after mixing corresponds to 10 doses of vaccine.
5. The vial should be shaken prior to each administration.
6. Each vaccine dose of 0.5mL is withdrawn into a syringe for injection. The vaccine should be allowed to reach room temperature before use.
7. The needle used for withdrawal must be replaced by a needle suitable for intramuscular injection.
Any unused product or waste material should be disposed of in accordance with local requirements.
CAPA01/PIL 1.0 – 20 -
AREPANRIX™ H1N1 GlaxoSmithKline
CAPA01/PIL 1.0 – 21 -
IMPORTANT: PLEASE READ
CONSUMER INFORMATION
AREPANRIX™ H1N1
AS03-Adjuvanted H1N1Pandemic Influenza Vaccine
This leaflet is part of a “Package Insert” and is designed specifically for Consumers. This leaflet is a summary and will not tell you everything about AREPANRIX™ H1N1. Contact your doctor or pharmacist if you have any questions about the vaccine.
Health Canada has authorized the sale of the Arepanrix™ H1N1 based on limited clinical testing in humans under the provision of an Interim Order (IO) issued on October 13, 2009. The authorization is based on the Health Canada review of the available data on quality, safety and immunogenicity, and given the current pandemic threat and its risk to human health, Health Canada considers that the benefit/risk profile of the Arepanrix™ H1N1 vaccine is favourable for active immunization against the H1N1 2009 influenza strain in an officially declared pandemic situation.
As part of the authorization for sale for Arepanrix™ H1N1, Health Canada has requested the sponsor agree to post-market commitments. Adherence to these commitments, as well as updates to information on quality, non-clinical, and clinical data will be continuously monitored by Health Canada and the Public Health Agency of Canada.
ABOUT THIS VACCINE
What the vaccine is used for:
AREPANRIX™ H1N1is a vaccine to prevent influenza (flu) caused by the H1N1 virus.
What it does:
When a person is given the vaccine, the immune system (the body’s natural defense system) will make antibodies against the H1N1 virus. These antibodies are expected to protect against disease caused by flu. None of the ingredients in the vaccine can cause influenza. There is no live virus in this vaccine.
As with all vaccines, AREPANRIX™ H1N1 may not fully protect all people who are vaccinated.
When it should not be used:
Do not use this vaccine if you have previously experienced a life-threatening allergic reaction to:
• egg proteins (egg or egg products) or chicken proteins
• other influenza vaccination
• any ingredient of the vaccine
Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
What the medicinal ingredient is:
H1N1 influenza antigen from A/California/7/2009, NYMC X-179A (H1N1)v strain and AS03 adjuvant
What the important nonmedicinal ingredients are:
Thimerosal,a mercury derivative is added as preservative. Each dose contains 2.5 micrograms of mercury. Other ingredients include: squalene, vitamin E, polysorbate 80 and trace amounts of egg proteins, formaldehyde, sodium deoxycholate and sucrose.
For a full listing of nonmedicinal ingredients see the first part of the package insert (Section 5.0).
What dosage forms it comes in:
AREPANRIX™ H1N1 is a two component vaccine consisting of a translucent to whitish opalescent suspension that may sediment slightly containing antigen and a whitish emulsion containing the AS03 adjuvant. AREPANRIX™ H1N1 is an emulsion for injection.
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
Advise your doctor or nurse immediately if you experience these reactions shortly after receiving your injection:
• body rash
• tightness in the throat
• shortness of breath
BEFORE you use AREPANRIX™ H1N1 talk to your doctor or nurse if:
• you have a severe infection with a high temperature
• you have a weakened immune system due to medication or disease such as HIV
INTERACTIONS WITH THIS VACCINE
There is currently no information on the administration of AREPANRIX™ H1N1 with other vaccines.
CAPA01/PIL 1.0 – 22 -
IMPORTANT: PLEASE READ
PROPER USE OF THIS VACCINE
Usual dose:
One injection. A second dose of vaccine may be given. The second dose should be given at least 3 weeks after the first dose.
Children (>9 years) and adults: 0.5 mL/dose
Children 3-9 years: 0.25 mL/dose
Children 6-35 months: 0.25mL/dose (No clinical data are available for influenza vaccines with AS03 in this age group)
Information on this product will be updated regularly. Consult with Health Canada website for the most up-to date information on this product:
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/legislation/interimorders-arretesurgence/index-eng.php
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/legislation/interimorders-arretesurgence/index-fra.php
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
As with all medicines, AREPANRIX™ H1N1can cause side effects. The very common and common side effects are usually mild and should only last a day or two.
Very common (may occur with more than 1 in 10 doses):
• Pain at the injection site
• Headache
• Fatigue
• Redness or swelling at the injection site
• Shivering
• Sweating
• Aching muscles, joint pain
Common (may occur with up to 1 in 10 doses):
• Reactions at the injection site such as bruising, itching and warmth
• Fever
• Swollen lympth nodes
• Feeling sick, diarrhea
Uncommon (may occur with up to 1 in 100 doses):
• Dizziness
• Generally feeling unwell
• Unusual weakness
• Vomiting, stomach pain, uncomfortable feeling in the stomach or belching after eating
• Inability to sleep
• Tingling or numbness of the hands or feet
• Shortness of breath
• Pain in the chest
• Itching, rash
• Pain in the back or neck, stiffness in the muscles, muscle spasms, pain in extremity such as leg or hand
Rare (may occur with up to 1 in 1000 doses):
• Allergic reactions leading to a dangerous decrease of blood pressure, which, if untreated, may lead to shock. Doctors are aware of this possibility and have emergency treatment available for use in such cases
• Fits
• Severe stabbing or throbbing pain along one or more nerves
• Low blood platelet count which can result in bleeding or bruising
Very Rare (may occur with up to 1 in 10,000 doses):
• Vasculitis (inflammation of the blood vessels which can cause skin rashes, joint pain and kidney problems)
• Neurological disorders such as encephalomyelitis (inflammation of the central nervous system), neuritis (inflammation of nerves) and a type of paralysis known a Guillain-Barré Syndrome
If any of these side effects occur, please tell your doctor or nurse immediately. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor.
HOW TO STORE IT
Store in a refrigerator (2°C to 8°C) in the original package to protect from light. Do not freeze.
Keep out of reach of children.
CAPA01/PIL 1.0 – 23 -
IMPORTANT: PLEASE READ
REPORTING SUSPECTED SIDE EFFECTS
To monitor vaccine safety, the Public Health Agency of Canada collects information on serious and unexpected adverse events following vaccination. If you suspect you have had a serious or unexpected event following receipt of a vaccine you may notify the Public Health Agency of Canada:
By toll-free telephone: 1-866-844-0018
By toll-free fax: 1-866-844-5931
By email: caefi@phac-aspc.gc.ca
By regular mail:
Vaccine Safety
Centre for Immunization & Respiratory Infectious Diseases,
Public Health Agency of Canada
130 Colonnade Road
Address Locator: 6502A
Ottawa, Ontario K1A 0K9
NOTE: Should you require information related to the management of the side effect, please contact your health care provider before notifying the Public Health Agency of Canada. The Public Health Agency of Canada does not provide medical advice.
MORE INFORMATION
This document plus the full package insert, prepared for health professionals can be found at: http://www.gsk.ca or by contacting the sponsor:
GlaxoSmithKline Inc.
7333Mississauga Road
Mississauga, Ontario L5N 6L4
1-800-387-7374
This leaflet was prepared by GlaxoSmithKline Inc.
© 2009 GlaxoSmithKline Inc. All Rights Reserved
™AREPANRIX H1N1
Last Revised: 21 October 2009
CAPA01/PIL 1.0 – 24 -

Who raised false alarms about vaccines and why?

Andrew Wakefield was made half a million pounds and stood to make millions more on a patent for a single measles vaccine.

The mercury scare confuses methyl mercury (poisonous) with ethyl mercury (non-toxic).

Shocking H1N1 Swine Flu Vaccine Miscarriage Stories From Pregnant Women – Tell Your Doctors That Vaccines And Pregnancy Do Not Mix!

U.S. health authorities have made pregnant women one of the highest priority groups for getting the H1N1 swine flu vaccine, but is it actually safe for pregnant women and their babies? Well, the truth is that miscarriage reports from pregnant women who have taken the H1N1 swine flu vaccine are starting to pour in from all over the nation. Vaccines and pregnancy simply do not mix safely. In fact, the package inserts for the swine flu vaccines actually say that the safety of these vaccines for pregnant women has not been established.

I don’t have an answer for you, but a friend of a friend just had a miscarriage 2-3 days after getting the shot. She was 7weeks. She had no previous history of m/c… No one can answer if they’re related…it hasn’t been out long enough and there haven’t been any studies done on pregnant women. I will tell you, that it has made up my mind on getting it…I won’t and I’m not going to get it for my DD either. My daughter and I both had H1N1 last week, and although it truly sucks…I think I’ll take my chances. One doctor will tell you to get it and the next will tell you not too…you have to do what’s in your heart. Read More Personal Accounts

* * *

H1N1 Package Insert Says Vaccine Is Unsafe

On my other blog, I’ve done an overview of the H1N1 virus and vaccine.

Summary:

The “pandemic” H1N1 (aka “swine flu”) is a very serious strain of flu. It is separate from the standard seasonal flu and to be protected for both you have to vaccinate from both. The actual effects are similar to the normal flu, which kills about 36000 people a year. The expected combined deaths of seasonal flu (3 strains) and H1N1 is about 65000 deaths. The H1N1 vaccine has been shown to be as safe and effective as the normal seasonal vaccine that people take yearly.

What does the science say: H1N1

Introduction

I have no intention of promoting the quack H1N1 claims that are floating around the Internet, so I won’t be linking to them. What you will find here is the official information that is available about the disease and the vaccine. As usual, if you are convinced that the government is lying to us about the flu, then you may as well stop reading now, as I am really just summarizing CDC and FDA  data.

As always, I welcome comments on my blog (http://whatdoesthesciencesay.wordpress.com) or to my email address (josh at 40two org). If anything in here seems factually inaccurate to you, please let me know, but cite your sources. I’m truly not interested in what “Mr. Fit” or any number of random Internet flu scare sites have to say unless they have any genuine science to back them up.

Summary

Disclaimer

The H1N1 virus

So what is H1N1 any way?

This virus was originally referred to as “swine flu” because laboratory testing showed that many of the genes in this new virus were very similar to influenza viruses that normally occur in pigs (swine) in North America. But further study has shown that this new virus is very different from what normally circulates in North American pigs. It has two genes from flu viruses that normally circulate in pigs in Europe and Asia and bird (avian) genes and human genes. Scientists call this a “quadruple reassortant” virus.

The symptoms of 2009 H1N1 flu virus in people include fever, cough, sore throat, runny or stuffy nose, body aches, headache, chills and fatigue. Some people may have vomiting and diarrhea. People may be infected with the flu, including 2009 H1N1 and have respiratory symptoms without a fever. Severe illnesses and deaths have occurred as a result of illness associated with this virus.

In seasonal flu, certain people are at “high risk” of serious complications. This includes people 65 years and older, children younger than five years old, pregnant women, and people of any age with certain chronic medical conditions. About 70 percent of people who have been hospitalized with this 2009 H1N1 virus have had one or more medical conditions previously recognized as placing people at “high risk” of serious seasonal flu-related complications. This includes pregnancy, diabetes, heart disease, asthma and kidney disease.

With seasonal flu, we know that seasons vary in terms of timing, duration and severity. Seasonal influenza can cause mild to severe illness, and at times can lead to death. Each year, in the United States, on average 36,000 people die from flu-related complications and more than 200,000 people are hospitalized from flu-related causes. Of those hospitalized, 20,000 are children younger than 5 years old. Over 90% of deaths and about 60 percent of hospitalization occur in people older than 65.

Is anybody really dying from H1N1?

• First, states are not required to report individual seasonal flu cases or deaths of people older than 18 years of age to CDC.
• Second, seasonal influenza is infrequently listed on death certificates of people who die from flu-related complications.
• Third, many seasonal flu-related deaths occur one or two weeks after a person’s initial infection, either because the person may develop a secondary bacterial co-infection (such as a staph infection) or because seasonal influenza can aggravate an existing chronic illness (such as congestive heart failure or chronic obstructive pulmonary disease).
• Also, most people who die from seasonal flu-related complications are not tested for flu, or they seek medical care later in their illness when seasonal influenza can no longer be detected from respiratory samples. Influenza tests are most likely to detect influenza if performed soon after onset of illness.
• For these reasons, many flu-related deaths may not be recorded on death certificates.

The Vaccine

Was the vaccine rushed?

The viruses in the vaccine change each year based on international surveillance and scientists’ estimations about which types and strains of viruses will circulate in a given year. About 2 weeks after vaccination, antibodies that provide protection against influenza virus infection develop in the body.

Is it safe for pregnant women?

The Recommendation

As usual, let’s go straight to the CDC’s statements about pregnant women and the flu vaccine[¹² ]

The studies

No study to date has demonstrated an increased risk of either maternal complications or adverse fetal outcomes associated with inactivated influenza vaccination. Moreover, no scientific evidence exists that thimerosal-containing vaccines are a cause of adverse events among children born to women who received influenza vaccine during pregnancy. In this article, we review the evidentiary basis for the recommendation of vaccination of all women who will be pregnant during the influenza season and safety data of influenza vaccination during pregnancy.

Miscarriages

Further Resources

CDC’s “key facts” about the flu vaccines: http://www.cdc.gov/flu/protect/keyfacts.htm

I noticed the person who made this video forgot to mention all those, you know, medical researchers who actually work on finding effective autism treatments every single day, opting for these intellectual deficients instead.

If these are the “autism heroes,” I have to say that the person who made this video has extraordinarily low standards for hero worship.

National  11/18/09  physorg.com:  Purdue University is leading a team of researchers in a federally funded effort aimed ultimately at developing better vaccines and antiviral drugs against two types of disease-causing viruses. One group, called flaviviruses, includes West Nile and dengue. The other group, called alphaviruses, includes eastern equine encephalitis and chikungunya. (For more information on chikungunya, see the Natural Unseen Hazards Blog post for September 23, 2009.)

The work is led by Richard Kuhn, top left, a professor and head of the Department of Biological Sciences, Michael Rossmann, right standing, the Hanley Distinguished Professor of Biological Sciences, and Wen Jiang, an assistant professor in the Department of Biological Sciences. (Purdue University photo/Andrew Hancock)

Richard Kuhn, a professor and head of the Department of Biological Sciences at Purdue, said “Viruses within these two groups pose significant risks to large segments of the population, and methods for controlling infection and disease are few. These are really important human diseases.”

Dengue infects more than 50 million people annually, killing about 24,000 each year, primarily in tropical regions,” Kuhn said. Both types of viruses are transmitted by mosquitoes and sometimes ticks.

“Although these viruses are now mostly restricted to the tropics, as population density increases in cities and there is a greater global movement of people, there is the fear that these viruses are going to gain a greater geographical range,” Kuhn said. “There also is the possibility of terrorists using weapons made from these viruses, so a better understanding of their life cycles could lead to ways to defend against attacks.”

The work is funded with a two-year $4 million American Recovery and Reinvestment Act grant through the National Institutes of Health’s National Institute of Allergy and Infectious Diseases.

Here’s Nathan Wolfe explaining how viruses work, quickly and at a high enough level to be entertaining, and explaining why we need to worry about H1N1.

Wolfe also explained a lot at the TED Blog:

Take us back a step or two: How did swine flu enter into the human population?

Swine flu has been known since at least the early part of the 20th century, since the 1930s. It was originally a virus of bird origin — all influenza viruses were originally bird viruses — and it probably spread to humans before it was in pigs.

Now, we still haven’t received definitive information on the underlying genetics of this particular virus. But initial reports suggest that it may be what’s known as a “mosaic virus,” which includes components of swine influenzas, bird influenzas and human influenzas. A cosmopolitan virus like that wouldn’t be unprecedented. (Editor’s Note: see Joe DeRisi’s 2006 TEDTalk for more on state-of-the-art virus detection.)

But in any case, this is a virus that appears to come from pigs, and pigs in close proximity spread the flu in much the same way that humans do — coughing, sneezing, and so on. The virus probably initially entered into human populations through people who work with livestock.

Is swine flu here to stay?

Whether this particular virus will sustain itself and become a permanent part of the human landscape is unclear, but that’s certainly what we’re watching for. As it is, the virus may just disappear because of the weather; summers aren’t good for flu viruses.

So this heat wave is working in our favor?

It might be. The virus has had a good start, from the flu perspective, considering that this is really the end of the season. But the unseasonably hot weather may bode poorly for this virus’ potential to establish itself definitively and cause a pandemic. Had this happened in September or October, it would be much more concerning.

Having said that, it’s not impossible that a virus like this might “go into hiding” — in the southern hemisphere or the tropics — and might come to light again next year. So there will be a lot of discussion about expanding the fall flu vaccine to try to control it next cycle.

Is it really possible for us to prevent future outbreaks like this?

Yes, I believe it is. We spend tons of money trying to predict complex phenomena like tsunamis, hurricanes, earthquakes. There’s no reason to believe that a pandemic is harder to predict than a tsunami. And we’d be foolish not to include forecasting and prevention as part of our overall portfolio to fight these pandemics.

More resources:

• Wolfe on the origins of malaria
• GVFI – the Global Virus Forecasting Initiative
• The Edge, Wolf on “Waiting for the Final Plague”

Help this post go viral:

Each year a million cows in Africa die from East Coast fever. The disease is spread by tick bites. Young cows are most at risk; they can die within days. Farmers and herders can lose up to half or more of their calves to East Coast fever.

The disease is widespread in eleven countries. And experts say it now threatens ten million more animals in new areas including southern Sudan.

Researchers first developed an experimental vaccine against East Coast fever thirty years ago. Now, the nonprofit Global Alliance for Livestock Veterinary Medicines is trying to expand production and lower the cost.

Read more … (VOA Special English Agriculture Report)

[Posted Jun 20, 2005 12:00 AM]