Wednesday, January 25, 2012

Flumist Study (Old Note)

This is worth a read...it is not very long but definitely very interesting!


So you know that the H1N1 live-attenuated viral spray is based on the Flumist seasonal flu spray, right? Here is the manufacturer insert:

http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM182406.pdf

The nasal spray is available to children 2 and older who do not have contraindications and 5 years and older if they have asthma or 'a prior history of wheezing.' They found people who had asthma or wheezing were hospitalized more frequently after the nasal spray.

Anyways, how many people have tracked back to the Flumist and read about it, since the H1N1 vaccine is based on it?

Here is the Flumist package insert. It gets interesting at around 14.5.

http://www.medimmune.com/pdf/products/flumist_pi.pdf

Quote:
- - - - - INDICATIONS AND USAGE - - - - -
//FluMist is a vaccine indicated for the active immunization of individuals 2-49 years of age against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.\\
That is the first thing stated on the insert. (So if you're under 2, you're not supposed to receive flumist)

I read 14.5 ("transmission study") and apparently they thought it was more important to study mostly those under age 2, for whatever reason. (8-36 months)

Quote:
//Using the frozen formulation, a prospective, randomized, double-blind, placebo-controlled trial was performed in a daycare setting in children < 3 years of age to assess the transmission of vaccine viruses from a vaccinated individual to a non-vaccinated individual. A total of 197 children 8-36 months of age were randomized to receive one dose of FluMist (n=98) or placebo (n=99). Virus shedding was evaluated for 21 days by culture of nasal swab specimens. \\

So in real life, people age 2 through 49 are receiving flumist, yet, the "transmission study" studied only babies 8 months through 36 months old.

Nobody is complaining about this? Nobody finds this fraudulent? Nobody cares about this?

To me, it would appear they know exactly what they are doing and the reason they chose that age group to study (and print the results of) is because they didn't like the results of the study in the older age group and didn't want to publish those results. What other reason in the world would they even waste time and money studying a group for which in real life isn't even going to be receiving this vaccine?!?

BTW, if you don't want to read the actual manufacturer insert, here is a brief notation from it:

//Do not administer Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal or FluMist to children

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.

5.3 Guillain-Barré Syndrome
If Guillain-Barré syndrome has occurred within 6 weeks of any prior influenza vaccination, the decision to give Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal or FluMist should be based on careful consideration of the potential benefits and potential risks [see also Adverse Reactions (6.2)].\\

Oh, and here are some quotes from the Flumist insert:

//Pharmacokinetics
Biodistribution
A biodistribution study of intranasally administered radiolabeled placebo was conducted in 7 healthy adult
volunteers. The mean percentage of the delivered doses detected were as follows: nasal cavity 89.7%,
stomach 2.6%, brain 2.4%, and lung 0.4%. The clinical significance of these findings is unknown.

13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
FluMist has not been evaluated for its carcinogenic or mutagenic potential or its potential to impair
fertility.

In the primary efficacy analysis, FluMist demonstrated a 44.5% (95% CI: 22.4, 60.6) reduction
in influenza rate compared to active control as measured by culture-confirmed modified CDC-ILI
caused by wild-type strains antigenically similar to those contained in the vaccine. See Table 3 for a
description of the results by strain and antigenic similarity.\\


Look, mommy! A unicorn! Pooping!

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