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)


Holly said...

thanks for posting this. so many people will get the shot/mist and not ever read the package insert. Just say NO to the vaccine!

Lara said...

I appreciate you posting this. I want to vaccine, but after having the H1N1 Flu Mist, and reading how ineffective it can be, I now have to go and have the shot once it comes available (and have to pay for it). What a waste of time. At least my husband and 2 year old daughter were given the injection.