[TheForge] Fw: [SCA-Chirurgeon] Fw: Risks of FluMist Vaccine-OT- more info

[Phlip]

From: "Friar Galen of Ockham" <brandt@dca.net>
To: <SCA-Chirurgeon@yahoogroups.com>
Sent: Thursday, December 18, 2003 7:00 PM
Subject: Re: [SCA-Chirurgeon] Fw: Risks of FluMist Vaccine-OT


> Here's a good review of the problems with FluMist that came through the
> USAF medical channels:
>
>
>
> Barb's DTC (Direct To Clinician) Academic Detailing for FluMist
>
> By: LtCol Barbara Roach, USAF, MC
>
> The print ads will begin to appear today (Tuesday, 23 Sept 2003), and the
> DTC (Direct To Consumer) television adds will start in the prime time
hours
> next Monday, 29 Sept 2003. Some of the following may be helpful to your
> providers if there is an onslaught of poorly informed patients. The
answers
> come from the FluMist package insert. The summary below is from the August
> 2003 DoD P&T Committee Minutes regarding FluMist.
>
> Influenza intranasal vaccine (FluMist; Medimmune/Wyeth)
>     * FDA approved on 17 Jun 03:
>     * First nasally administered live influenza virus vaccine.
>     * Approved for active immunization for the prevention of disease
caused
> by influenza A and B viruses in healthy children ages 5-17 and healthy
> adults ages 18-49.
>     * FluMist is not to be administered to asthmatics, immunocompromised
> patients, or patients taking drugs which compromise the immune system
> (chemo agents, high dose steroids, etc).
>     * Not added to the TMOP Formulary since the product is not intended
for
> self-administration and must remain frozen prior to use.
>     * Not added to the BCF - no vaccines are currently on the BCF.
>     * The product is not intended for self-administration and must remain
> frozen prior to use.
>     * The FSS price for FluMist is substantially higher than the
injectable
> trivalent influenza vaccine available through FSS pricing:
>         * FluMist (MedImmune) (0.5ml) dose: $34.43
>         * Monarch influenza trivalent subviron syringe (0.5ml) dose: $2.72
>         * Monarch influenza trivalent subviron vial (0.5ml dose): $1.73
>
> The bullets above should answer most patients' and parents' questions such
as:
>
> Q.        Will this drug replace the flu shot?
> A.        NO - not even remotely. This medication is not approved for the
> people most at risk of dying from flu.
>
> Q.        My child is asthmatic (or diabetic or has cancer, the list can
go
> on and on) and always has to get a flu shot. This seems like a great
> alternative.
> A.        It's only a great alternative if you don't mind them being at
> increased risk of an adverse event due to the medication. FluMist is
> specifically NOT for asthmatics or anyone who is immunocompromised.
> �        "In a large safety study in children 1-17 years of age, children
> <5 years of age who received FluMist were found to have an increased rate
> of asthma within 42 days of vaccination when compared to placebo
> recipients." (From package insert)
> �        "The safety of FluMist in individuals with underlying medical
> conditions that may predispose them to severe disease following wild-type
> influenza infection has not been established. FluMist is not indicated for
> these individuals. According to the Advisory Committee on Immunization
> Practices (ACIP), such individuals include, but are not limited to, adults
> and children with chronic disorders of the cardiovascular and pulmonary
> systems, including asthma; pregnant women who will be in their second or
> third trimesters during influenza season; adults and children who required
> regular medical follow-up or hospitalization during the preceding year
> because of chronic metabolic diseases (including diabetes), renal
> dysfunction, or hemoglobinopathies; and adults and children with
congenital
> or acquired immunosuppression caused by underlying disease or
> immunosuppressive therapy. Intramuscularly administered inactivated
> influenza vaccines are available to immunize high-risk individuals [1]."
>
> 1. Centers for Disease Control and Prevention. Prevention and control of
> Influenza: recommendations of the Advisory Committee on Immunization
> Practices (ACIP). MMWR 2003; 52 (No.RR-8):1-34.
>
> Q.        Well even though my a) child, b) spouse and/or c) someone I live
> with, is immunocompromised, I'm not immunocompromised. I don't want to get
> a shot. I fall within the age range and I'm healthy. Is there a problem
now?
> A.        Then FluMist is a viable alternative for you - unfortunately,
> you'll have to avoid any close contact (household contact) with anyone who
> is immunocompromised for 21 days after you receive the nasal vaccination.
> You'll need to move out for a few weeks.
>
> Q.        But I have (or my child has) an egg allergy so can't get the flu
> shot for that reason. I want to get this alternative.
> A.        Egg allergy is a contraindication for FluMist also.
>
> Q.        But it will save me a trip to doctor's office. I can pick up the
> prescription and give it at home and not have to wait around.
> A.        It is not intended for self-administration, and it must remain
> frozen in a special freezer up to the time of its administration. Your
> freezer at home won't cut it.
>
> Q.        I'm pregnant and I don't want to get a shot. I'd rather take
this
> nasal drug.
> A.        FluMist is contraindicated in pregnancy. The injection isn't.
>
> Q.        My elderly parent has paper-thin skin and I'd like to avoid the
> bleeding and bruising a shot may cause.
> A.        There were few patients over the age of 50 in the Flu Mist
> trials. Therefore the FDA did not approve Flu Mist for patients over 49
> years of age.
>
> Q.        But there's no needle involved. My child hates needles.
> A.        And the child will let someone else squirt something up his/her
> nose?
> Needlephobic children between the ages of 5-17 years old could potentially
> be candidates for vaccine. The Flu Mist package insert recommends two
doses
> - 60 days apart the first year they receive FluMist.
> See the dosing administration pictures below.
>
> clip_image002.jpg
>
> �              According to the American Lung Association, influenza is
> estimated to cost in excess of $14 billion each year in the United States
> alone. Approximately 10% to 20% of the U.S. population becomes infected
> with the influenza virus annually.
>
> �              The flu shot is one of the most important preventive
> medicine interventions with solid data to back its use. There is not much
> reason to mess around with success when FluMist offers no advantage to the
> flu shot except in needlephobic individuals.
>
> �              The CDC website has a lot of excellent information
regarding
> influenza. Go to
>
<http://www.cdc.gov/ncidod/diseases/flu/fluvirus.htm>http://www.cdc.gov/ncid
od/diseases/flu/fluvirus.htm
>
>
>
>
> Disclaimer:  This Direct to Clinician Academic Detailing paper is meant to
> supply some information about this new product. It is not meant to be an
> authoritative source of information, clinicians are invited to consult the
> official package labeling for definitive clinical information. This paper
> reflects the views of the author, and does not necessarily reflect the
> views of any agencies within the Department of Defense.
>
>