On Wednesday; AstraZeneca-Canada, was proud to announce that it’s (MedImmune), ‘LIVE‘ – 2009 SWINE FLU VIRUS loaded (Influenza A (H1N1) 2009 Monovalent Vaccine live) FluMist Intranasal vaccine, received approval from the GOVERNMENT OF CANADA; Also Traded as HEALTH CANADA.
AstraZeneca, which bought MedImmune, but let the company keep its name. AstraZeneca is now trying to put some big pharma marketing muscle, behind FluMist. It’s kinda strange to see a big ad for a flu vaccine in the middle of summer. During last flu season, FluMist had $55 million in sales…a drop in the bucket for AstraZeneca.
MedImmune, Inc., today (September 19, 2007) announced that the U.S. Food and Drug Administration (FDA) approved the expanded use of FluMist® (Influenza Virus Vaccine Live, Intranasal) in children two to five years of age. FluMist is now approved for immunization against influenza A and B viruses in individuals two to 49 years of age.
According the U.S. Centers for Disease Control and Prevention (CDC)–Each year, up to 60 million Americans get the flu, resulting in complications cause more than 200,000 hospitalizations and approximately 36,000 deaths in the U.S. annually.
Hey, what a great plug by the Manitoba Chambers of Commerce—FluMist® is the first vaccine in CANADA, that is administered as a gentle mist, sprayed into the nose–With the introduction of FluMist, it’s encouraging to see another vaccine option to help reduce the overall burden of seasonal flu.
Even the CBC has joined forces, it seems, and running a little marketing campaign of their own…they decided to you a rather bias poll…damned if you do style–Will having a spray option make you more likely to get vaccinated? Let us know.
Here’s a snap shot, of what’s really behind this big green curtain:
Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal Manufactured by MedImmune, LLC Intranasal Spray Initial U.S. Approval: 2003
WARNINGS AND PRECAUTIONS.
5.1 Risks in Children <24 Months of Age
5.2 Asthma/Recurrent Wheezing
5.3 Guillain-Barré Syndrome
5.4 Altered Immunocompetence
5.5 Medical Conditions Predisposing to Influenza Complications
5.6 Management of Acute Allergic Reactions
5.7 Limitations of Vaccine Effectiveness–Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal may not protect all individuals receiving the vaccine.
6.2 Postmarketing Experience– The following adverse reactions have been identified during postapproval use of FluMist. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure.
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-Barré syndrome, Bell’s Palsy – Respiratory, thoracic and mediastinal disorders: Epistaxis-Skin and subcutaneous tissue disorders: Rash
7.1 Aspirin Therapy
7.2 Antiviral Agents Against Influenza A and/or B–The concurrent use of Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal or FluMist with antiviral agents that are active against influenza A and/or B viruses has not been evaluated.
7.3 Concomitant Inactivated Vaccines–There are no data on the concomitant administration of Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal and seasonal trivalent Influenza Virus Vaccines.
7.4 Concomitant Live Vaccines–There are no data on the concomitant administration of Influenza A (H1N1) 2009 Monovalent Vaccine <b>Live</b>, Intranasal and FluMist.
7.5 Intranasal Products–There are no data regarding co-administration of Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal or FluMist with other intranasal preparations.
Pregnancy Category C–Animal reproduction studies have not been conducted with Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal or FluMist. It is not known whether Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal or FluMist can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
8.3 Nursing Mothers.
It is not known whether Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal or FluMist is excreted in human milk. Therefore, as some viruses are excreted in human milk and additionally, because of the possibility of shedding of vaccine virus and the close proximity of a nursing infant and mother, caution should be exercised if Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal or FluMist is administered to nursing mothers.
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action–Immune mechanisms conferring protection against influenza following receipt of FluMist vaccine are not fully understood.
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.
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.
17.2 Vaccination with a Live Virus Vaccine.
Vaccine recipients or their parents/guardians should be informed by the health care provider that Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal is an attenuated live virus vaccine and has the potential for transmission to immunocompromised household contacts.
ASK YOUR DOCTOR: Is this medication right for me…would you (doctor), take this FluMist® yourself, and or, happily give it to your children?