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Posts Tagged ‘FluMist recall’

RECALLED

MedImmune announced it is recalling it’s Nasal Spray vaccine, Flu Mist designed to maybe, prevent Swine Flu.  

“Nearly five million doses of an H1N1 swine flu vaccine were recalled today because the strength of the nasal sprays may have decreased over time and they may not be as potent as they are supposed to be, the Food and Drug Administration said. Only about 3,000 of the recalled vaccine doses produced by the MedImmune unit of drug maker AstraZeneca are believed to still be in circulation or storage. The vast majority were administered to patients in October and November, at the peak of the H1N1 vaccination process, according to a Reuters news report.” via http://www.attorneyatlaw.com/2009/12/millions-of-h1n1-vaccine-doses-recalled-due-to-potency-problem/ 

MedImmune has released a pdf with the lot numbers and additional information at http://www.attorneyatlaw.com/2009/12/millions-of-h1n1-vaccine-doses-recalled-due-to-potency-problem/

That’s millions of people who inhaled the live swine flu virus and it probably doesn’t offer any protection at all.  Want to know what else they inhaled and then breathed out on an unsuspecting population? http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM182406.pdf

Each pre-filled refrigerated Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal sprayer contains a single 0.2 mL dose. Each 0.2 mL dose contains 106.5-7.5 FFU of the live attenuated influenza virus reassortant of the pandemic (H1N1) 2009 virus: A/California/7/2009 (H1N1)v. Each 0.2 mL dose also contains 0.188 mg/dose monosodium glutamate, 2.00 mg/dose hydrolyzed porcine gelatin, 2.42 mg/dose arginine, 13.68 mg/dose sucrose, 2.26 mg/dose dibasic potassium phosphate, 0.96 mg/dose monobasic potassium phosphate, and <0.015 mcg/mL gentamicin sulfate. The vaccine contains no preservatives. 

Also on the patient insert- 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

Our most visited page on the Ahrcanum site is all about the Swine Flu Rash!  https://ahrcanum.wordpress.com/2009/10/19/swine-flu-rash-hives-symptoms/

Last week CDC announced that nearly one million does of H1N1 Swine Flu Vaccines intended for children were being recalled that were manufactured by Sanofi Pasteur, Inc..  http://www.cdc.gov/h1n1flu/vaccination/syringes_qa.htm    

“Despite the recall, the vaccine is safe and effective; parents need not worry about unusual side effects or having their children re-vaccinated,” says Anne Schuchat, director of the Centers for Disease Control and Prevention’s Center for Immunization and Respiratory Diseases. “There’s no need for parents to call pediatricians. We think the doses given are protective and safe,” she says. http://www.usatoday.com/news/health/2009-12-15-swine-flu-vaccine_N.htm       

“We think?,” she said, We think she hasn’t a clue and neither does anyone else about these fast tracked Swine Flu vaccines.  Our take on that recall is at https://ahrcanum.wordpress.com/2009/12/16/h1n1-swine-flu-vaccine-for-children-recalled/  In November, we wrote about the Canadian Vaccine Recall from GlaxoSmith Kline at https://ahrcanum.wordpress.com/2009/11/25/h1n1-swine-flu-vaccine-pandemrix-recall/  

Will the third time be the charm that changes people’s mind about getting the Swine Flu Shot or Nasal Spray now that is it generally available to the public? 

Anyone taking bets that this is not the last of the Swine Flu Vaccine recalls?

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