Wednesday, October 7, 2009

H1N1 vaccine flu mist package insert - SHOULD READ before taking vaccine

Please read the following excerpts from the package insert for the H1N1 vaccine (delivery - flu-mist) and then, read the insert itself. I have referenced the sections the excerpts were taken from for your convenience. The insert is a PDF file on the FDA website.

Package insert for H1N1 vaccine:


Do NOT give to Children less than 24 months old

5.1 Risks in Children <24 Months of Age

DO NOT give to people with asthma - has not been studied in individuals with severe asthma!

5.2 Asthma/Recurrent Wheezing
Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal or FluMist should not be administered to any individuals with asthma or children < 5 years of age with recurrent wheezing because of the potential for increased risk of wheezing post vaccination unless the potential benefit outweighs the potential risk.
Do not administer Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal or FluMist to individuals with severe asthma or active wheezing because these individuals have not been studied in clinical trials.

DO NOT GIVE TO Immune challenged (was studied in 57 people who were HIV positive but they say not enough data to justify administering in this group)

5.4 Altered Immunocompetence
Administration of Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal, or FluMist live virus vaccine, to immunocompromised persons should be based on careful consideration of potential benefits and risks. Although FluMist was studied in 57 asymptomatic or mildly symptomatic adults with HIV infection [see Clinical Studies (14.3)], data supporting the safety and effectiveness of FluMist administration in immunocompromised individuals are limited.

"May not protect all individuals receiving the vaccine"

5.7 Limitations of Vaccine Effectiveness
Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal may not protect all individuals receiving the vaccine.

Later, they admitted the vaccine had not been evaluated for effectiveness (way down in the document!) Different story from what we have read on the news, right?

Clinical trials - adverse reactions:

6.1 Adverse Reactions in Clinical Trials

Increased hospitalizations in children receiving "flu mist"

Most hospitalizations observed were gastrointestinal and respiratory tract infections and occurred more than 6 weeks post vaccination. In post hoc analysis, rates of hospitalization in children 6-11 months of age (n = 1376) were 6.1% in FluMist recipients and 2.6% in active control recipients.

Adverse reactions in adults: (same section as above)

In adults 18-49 years of age in Study AV009, summary of solicited adverse events occurring in at least 1% of FluMist recipients and at a higher rate compared to placebo include runny nose (44% FluMist vs. 27% placebo), headache (40% FluMist vs. 38% placebo), sore throat (28% FluMist vs. 17% placebo), tiredness/weakness (26% FluMist vs. 22% placebo), muscle aches (17% FluMist vs. 15% placebo), cough (14% FluMist vs. 11% placebo), and chills (9% FluMist vs. 6% placebo).
In addition to the solicited events, other adverse reactions from Study AV009 occurring in at least 1% of FluMist recipients and at a higher rate compared to placebo were: nasal congestion (9% FluMist vs. 2% placebo) and sinusitis (4% FluMist vs. 2% placebo).

Post marketing experience: adverse reactions i.e. these are side effects of the vaccine noticed after they started marketing the vaccine!

6.2 Postmarketing Experience

Congenital, familial and genetic disorder: Exacerbation of symptoms of mitochondrial encephalomyopathy (Leigh syndrome).
Gastrointestinal disorders: Nausea, vomiting, diarrhea
Immune system disorders: Hypersensitivity reactions (including anaphylactic reaction, facial edema and urticaria)
Nervous system disorders: Guillain-BarrĂ© syndrome, Bell’s Palsy
Respiratory, thoracic and mediastinal disorders: Epistaxis
Skin and subcutaneous tissue disorders: Rash

This vaccine is NOT approved for people, over 50 years old:

8.5 Geriatric Use
Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal is not approved for use in individuals .65 years of age. Subjects with underlying high-risk medical conditions (n=200) were studied for safety. Compared to controls, FluMist recipients had a higher rate of sore throat.

8.6 Use in Individuals 50-64 Years of Age
Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal is not approved for use in individuals 50-64 years of age. In Study AV009, effectiveness of FluMist was not demonstrated in individuals 50-64 years of age (n=641). Solicited adverse events were similar in type and frequency to those reported in younger adults.

They don't really understand HOW it works: (and how well it works)

12.1 Mechanism of Action
Immune mechanisms conferring protection against influenza following receipt of FluMist vaccine are not fully understood. Likewise, naturally acquired immunity to wild-type influenza has not been completely elucidated. Serum antibodies, mucosal antibodies and influenza-specific T cells may play a role in prevention and recovery from infection.

They don't know if this vaccine will cause infertility or cancer:

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Neither Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal nor FluMist have been evaluated for carcinogenic or mutagenic potential or potential to impair fertility.

This vaccine has not been found effective in people over 50 years old. In a subgroup of adults, 18-49, the vaccine reduced illness with fever from 10 percent to 23 percent. This was a study in non high risk adults i.e. adults with no other medical conditions.

14.2 Study in Adults

Effectiveness for any of the three endpoints was not demonstrated in a subgroup of adults 50-64 years of age. Primary and secondary effectiveness endpoints from the age group 18-49 years of age are presented in Table 5.

While in a double blind study (57 in experimental group) of adults with HIV, the vaccine did not cause any worsening of their condition, they did not know whether or not it was effective in proventing the swine flu:

14.3 Study in Adults with Human Immunodeficiency Virus (HIV) Infection
Safety and shedding of vaccine virus following FluMist administration were evaluated in 57 HIV-infected [median CD4 cell count of 541 cells/mm3] and 54 HIV-negative adults 18-58 years of age in a randomized, double-blind, placebo controlled trial using the frozen formulation. No serious adverse events were reported during the one-month follow-up period. Vaccine strain (type B) virus was detected in 1 of 28 HIV-infected subjects on Day 5 only and none of the HIV-negative FluMist recipients. No adverse effects on HIV viral load or CD4 counts were identified following FluMist. The effectiveness of FluMist in preventing influenza illness in HIV-infected individuals has not been evaluated.

Medical providers were told that they can receive the shot and immediately go back to their patients without worrying about transmitting the viruses to their patients. But that's NOT what the package insert says... on the contrary, they DO NOT KNOW whether or not these viruses can be transmitted:

14.5 Transmission Study
FluMist contains live attenuated influenza viruses that must infect and replicate in cells lining the nasopharynx of the recipient to induce immunity. Vaccine viruses capable of infection and replication can be cultured from nasal secretions obtained from vaccine recipients. The relationship of viral replication in a vaccine recipient and transmission of vaccine viruses to other individuals has not been established.

Although the PDF distributed to medical providers (containing a bunch of myths about the safety and efficacy of this vaccine) never mentioned this, look what *I* found on the LAST PAGE of the package insert information... basically MEDICAL PROVIDERS SHOULD GIVE INFORMED CONSENT about this vaccine:

That is, the package insert says on the last page that your provider of the vaccine should let you know ALL OF THE ABOVE BEFORE you consent to take the vaccine!

Vaccine recipients or their parents/guardians should be informed by the health care provider of the potential benefits and risks of Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal, and should be advised that there are two influenza vaccine formulations for this influenza season, the monovalent vaccine against disease caused by pandemic (H1N1) 2009 virus and seasonal trivalent influenza vaccine.

Convenient URL to share to read this package insert which is on the FDA website: (copy into email or blog)

Tuesday, October 6, 2009

testing a new vaccine - H1N1 but not telling you about it

ABC has a video on their site showing several doctors who have the same concerns many people have about the swine flu vaccine - fast tracked, untested, too new - and are telling their patients to wait on this one. ABC news "medical expert" stated pretty much the same inaccuracies that our state health dept stated in the PDF below... "oh no, it's totally pure, been throughly tested" (in three months of testing?) And "it's the same as the regular flu vaccine" which is totally inaccurate - it's a totally NEW vaccine in concept, formulation and delivery.

Following are the inaccuracies the CDC in conjunction with the media and health depts are telling people all over the USA - this seems one step further than just not giving us informed consent that they are actually testing a new vaccine on US!

This is taken from a document released from our state health dept, a PDF to medical providers and contains pretty much the same inaccuracies I've heard from several places - here is the "informed consent information" people SHOULD be given about this new vaccine:

1. "You cannot get the flu from attenuated virus vaccines"

Inaccurate: you CAN get the illness from ANY LIVE virus vaccine.... do health care workers really not know this fact?

2. "Fact 6: The H1N1 vaccine has been properly and rigorously tested for safety and efficacy."

Inaccurate: This vaccine was "fast tracked" meaning it's not been well tested for EITHER safety OR efficacy. That's impossible with a fast tracked medication. Furthermore, its delivery as "flu mist" inhaled is controversial because concerns have been raised about the viruses attenuated or other (there are ALWAYS SOME WHICH DO NOT GET WEAKENED in live virus vaccine) crossing the blood / brain barrier and causing problems. Which is why "flu mist" has never been a real popular delivery... despite it being more "attractive" than an injection.

A friend of mine saw a CDC person interviewed on TV - he admitted that they were basically testing this on the public who will receive the vaccine. That's a no brainer with a very different vaccine which has been "fast tracked" to FDA approval.

3. "Fact 7: Multi-dose vials of H1N1 vaccine contain safe amounts of thimerosal, a vaccine preservative, which prevents contamination with bacteria and fungi."

Partially accurate. Thimerosal which is a type of mercury, is used as a preservative but there has been NO SAFE amount established and some studies have linked the receiving of a yearly flu shot with higher risk of neurological disease and Alzheimers. Mercury is highly toxic even in minute amounts.

4. "Fact 8: No causal connection has been found linking the use of thimerosal as a vaccine preservative and the incidence of autism, speech or language delay, or attention deficit hyperactivity disorder"

Not accurate - some studies have found a link between the MMR and autism which has SUDDENLY greatly increased in incidence, including a well done clinical study of several years duration in the UK which has been ignored by the American media. (You know like the 38 worldwide studies suggesting a link between abortion and breast cancer have been ignored by the AMC and the AMA?)

5. "Fact 9: Healthcare workers can safely receive the live attenuated (“weakened”) Influenza virus vaccine (Flumist) and go back to work immediately without risk of spreading the weakened virus to their patients UNLESS they work directly with bone marrow transplant patients."

May be inaccurate as flu can take 7-10 days to incubate and in that period, a person is said to be the most contagious.

6. "Fact 10: There is a much higher risk of getting Guillain-Barré Syndrome (GBS) from having influenza illness than from getting vaccinated for influenza."

The CDC has admitted in other places, that there IS a risk of Guillain Barre with the H1N1 vaccine, specifically, and that it is unknown what that risk is. In 1976, they had 4000 cases of GBS FROM the vaccine and, by the way, the "great pandemic" predicted, never hit.

Australia ordered a version of the H1N1 vaccine without Thimerosal, without squalene and with DEAD viruses.... (i.e. their National Health Service).

The H1N1 vaccine also contains an adjuvant called "squalene" which is supposed to enhance the immune system however this has been poorly tested if at all and some studies have suggested it as a factor in the "Gulf war syndrome" (the vaccines given the soldiers had this in it and vaccines have not contained it since).

OK, Here's my take on this. The vaccine for H1N1 is TOTALLY new in every way for a flu vaccine, even the delivery. They are beta testing it on the public and if they pull it off i.e. do not have disastrous side effects, then think of what they will have... a vaccine which (1) enhances the immune system, (2) delivers a better immunity than a dead virus vaccine (though so far NONE of them deliver more than a couple of years immunity) and (3) has an attractive delivery system.... no shot!

Doing the math... a BIG SELLER! If they do have disastrous side effects, then they will say "oh well" because you know what.. the American public has a very short memory and so not much damage will be done... No one will remember it a couple of years down the line. So not really much of a risk for the pharmaceutical but a big risk for the American public who is NOT getting "informed consent" not even the medical providers... and if they JUST can test it on medical providers that will be enough of a test base for them. thousands. (a large segment of the public is NOT getting the H1N1 vaccine).

There was an article in Scientific American detailing this process - the fact that the pharmaceuticals (and surgeons) have to do this sort of thing with beta testing new procedures and drugs on the public largely because experimentation on human beings is against the law. They took the example of giving O2 to premies on the theory that it would help them... this blinded thousands of kids. They stated that if they had done a double blind study - 600 receive O2 and 600 do not, they would have found out within a year that o2 can cause blindness and you would have had no more than 600 blind babies instead of the thousands blinded over the 10 years they were testing this. But then, even if human experimentation WERE legal, who would volunteer?

They have done this sort of "beta test" several times... it's not a new concept and if Americans READ more instead of getting most of their info from TV, they would know this process... "who does not study history, is doomed to repeat it"